Long term outcomes of simple clinical risk stratification in management of differentiated thyroid cancer.

OBJECTIVE: To establish the long term outcomes of risk stratified management of differentiated thyroid cancer (DTC). BACKGROUND: Guidelines for management of DTC lack a strong evidence base and expose patients to overtreatment. This prospective study of patients diagnosed with DTC between 1977 and 2012 describes the long term outcomes of a conservative risk stratified (AMES) management policy. METHODS: Outcomes were analysed around patient and tumour characteristics, primary intervention (surgery ± radioiodine (RAI)), in terms of mortality, recurrence and reintervention. RESULTS: Median follow-up in 348 patients was 14 years: mean age 48 (range 10-91) years, 257 (73.9%) female, 222 (68.3%) papillary cancer, tumour size 3.4 ± 2.0 cm (mean ± SD). 89 (25.6%) AMES high risk, 116 (33.3%) TNM stage III/IV and 16 (4.6%) had distant metastases. Primary surgery comprised lobectomy in 189 (54.3%): 11 (5.8%) patients had subsequent completion total thyroidectomy with cancer present in five. Primary nodal surgery was performed in 142 (40.8%) patients. 35 (13.5%) low and 43 (48.3%) high risk patients received RAI following initial surgery. Overall disease specific survival (DSS) was 92.1% at 10 years and 90.7% at 20 years. DSS at 20 years was 99.2% in low risk cases. AMES risk scoring predicted both survival and recurrence. Patients receiving RAI and AMES high risk were significantly associated with increased risk of death and recurrence. CONCLUSIONS: Routine total thyroidectomy and RAI are not justifiable for low risk DTC. Treatment should be tailored to risk and AMES risk stratification remains a simple reliable clinical tool.

A cross-specialty survey to assess the application of risk stratified surgery for differentiated thyroid cancer in the UK.

INTRODUCTION: This study describes variability of treatment for differentiated thyroid cancer among thyroid surgeons, in the context of changing patterns of thyroid surgery in the UK. METHODS: Hospital Episodes Statistics on thyroid operations between 1997 and 2012 were obtained for England. A survey comprising six scenarios of varying 'risk' was developed. Patient/tumour information was provided, with five risk stratified or non-risk stratified treatment options. The survey was distributed to UK surgical associations. Respondent demographics were categorised and responses analysed by assigned risk stratified preference. RESULTS: From 1997 to 2012, the Hospital Episode Statistics data indicated there was a 55% increase in the annual number of thyroidectomies with a fivefold increase in otolaryngology procedures and a tripling of cancer operations. Of the surgical association members surveyed, 264 respondents reported a thyroid surgery practice. Management varied across and within the six scenarios, and was not related consistently to the level of risk. Associations were demonstrated between overall risk stratified preference and higher volume practice (>25 thyroidectomies per year) (p=0.011), fewer years of consultant practice (p=0.017) and multidisciplinary team participation (p=0.037). Logistic regression revealed fewer years of consultant practice (odds ratio [OR]: 0.96/year in practice, 95% confidence interval [CI]: 0.922-0.997, p=0.036) and caseload of >25/year (OR 1.92, 95% CI: 1.044-3.522, p=0.036) as independent predictors of risk stratified preference. CONCLUSIONS: There is a substantial contribution to thyroid surgery in the UK by otolaryngology surgeons. Adjusting management according to established case-based risk stratification is not widely applied. Higher caseload was associated with a preference for management tailored to individual risk.

Sentinel node biopsy in papillary thyroid cancer--what is the potential?

PURPOSE: Sentinel node biopsy (SNB) may identify lymph node metastases in patients with papillary thyroid cancer (PTC), enabling selective application of central node dissection (CND). The aim of this study was to assess the feasibility of implementing SNB in patients undergoing thyroidectomy for a cytologically indeterminate/suspicious/malignant thyroid nodule and to determine the potential improvement in clinical outcomes and the costs associated with the SNB technique. METHODS: The treatment strategies and clinical and pathological outcomes of two retrospective cohorts of patients who underwent preoperative thyroid FNA over a 5-year period in two different centres were studied. The potential for implementing the SNB technique and the benefits and costs associated with implementation were estimated. RESULTS: In centre 1, in 819 adult patients who had thyroid fine-needle aspiration cytology, the final cytology was indeterminate, suspicious and diagnostic of malignancy in 113, 29 and 28 patients, respectively. One hundred eight patients were 'suitable' for SNB. Twenty-three of these patients had PTC, six of whom underwent CND. Of these six patients, node metastasis was absent in five--the cohort in whom prophylactic CND may have been avoided consequent to a negative 'sentinel node' biopsy. Morbidity attributable to CND may have been avoided in up to four patients over a 5-year period. Costs associated with implementation of SNB outweighed any potential savings. Analysis of 491 patients in centre 2 confirmed that the benefit of SNB in PTC was similarly limited; morbidity attributable to CND may have been avoided in up to seven patients over a 5-year period. CONCLUSIONS: Even under ideal conditions (assuming 100 % node identification rate and 0 % false negative rate), the potential short- to medium-term benefit of sentinel node biopsy in patients with thyroid cancer in centres implementing a policy of selective or routine prophylactic CND is low.

Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial).

BACKGROUND: Despite promising evidence that laparoscopic fundoplication provides better short-term relief of gastro-oesophageal reflux disease (GORD) than continued medical management, uncertainty remains about whether benefits are sustained and outweigh risks. OBJECTIVE: To evaluate the long-term clinical effectiveness, cost-effectiveness and safety of laparoscopic surgery among people with GORD requiring long-term medication and suitable for both surgical and medical management. DESIGN: Five-year follow-up of a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. Cost-effectiveness was assessed alongside the trial using a NHS perspective for costs and expressing health outcomes in terms of quality-adjusted life-years (QALYs). SETTING: Follow-up was by annual postal questionnaire and selective hospital case notes review; initial recruitment in 21 UK hospitals. PARTICIPANTS: Questionnaire responders among the 810 original participants. At entry, all had documented evidence of GORD and symptoms for > 12 months. Questionnaire response rates (years 1-5) were from 89.5% to 68.9%. INTERVENTIONS: Three hundred and fifty-seven participants were recruited to the randomised comparison (178 randomised to surgical management and 179 randomised to continued medical management) and 453 to the preference groups (261 surgical management and 192 medical management). The surgeon chose the type of fundoplication. MAIN OUTCOME MEASURES: Primary: disease-specific outcome measure (the REFLUX questionnaire); secondary: Short Form questionnaire-36 items (SF-36), European Quality of Life-5 Dimensions (EQ-5D), NHS resource use, reflux medication, complications. RESULTS: The randomised groups were well balanced. By 5 years, 63% in the randomised surgical group and 13% in the randomised medical management group had received a total or partial wrap fundoplication (85% and 3% in the preference groups), with few perioperative complications and no associated deaths. At 1 year (and 5 years) after surgery, 36% (41%) in the randomised surgical group - 15% (26%) of those who had surgery - were taking proton pump inhibitor medication compared with 87% (82%) in the randomised medical group. At each year, differences in the REFLUX score significantly favoured the randomised surgical group (a third of a SD; p< 0.01 at 5 years). SF-36 and EQ-5D scores also favoured surgery, but differences attenuated over time and were generally not statistically significant at 5 years. The worse the symptoms at trial entry, the larger the benefit observed after surgery. Those randomised to medical management who subsequently had surgery had low baseline scores that markedly improved after surgery. Following fundoplication, 3% had surgical treatment for a complication and 4% had subsequent reflux-related operations - most often revision of the wrap. Dysphagia, flatulence and inability to vomit were similar in the two randomised groups. The economic analysis indicated that surgery was the more cost-effective option for this patient group. The incremental cost-effectiveness ratio for surgery in the base case was £7028 per additional QALY; these findings were robust to changes in approaches and assumptions. The probability of surgery being cost-effective at a threshold of £20,000 per additional QALY was > 0.80 for all analyses. CONCLUSIONS: After 5 years, laparoscopic fundoplication continues to provide better relief of GORD symptoms with associated improved health-related quality of life. Complications of surgery were uncommon. Despite being initially more costly, a surgical policy is highly likely to be cost-effective. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15517081. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 22. See the HTA programme website for further project information.

Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX).

OBJECTIVES: To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD). DESIGN: Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups). SETTING: Initial recruitment in 21 UK hospitals. PARTICIPANTS: Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months. INTERVENTION: The surgeon chose the type of fundoplication. Medical therapy was reviewed and optimised by a specialist. Subsequent management was at the discretion of the clinician responsible for care, usually in primary care. MAIN OUTCOME MEASURES: Primary outcome measure was self reported quality of life score on disease-specific REFLUX questionnaire. Other measures were health status (with SF-36 and EuroQol EQ-5D questionnaires), use of antireflux medication, and complications. RESULTS: By five years, 63% (112/178) of patients randomised to surgery and 13% (24/179) of those randomised to medical management had received a fundoplication (plus 85% (222/261) and 3% (6/192) of those who expressed a preference for surgery and for medical management). Among responders at 5 years, 44% (56/127) of those randomised to surgery were taking antireflux medication versus 82% (98/119) of those randomised to medical management. Differences in the REFLUX score significantly favoured the randomised surgery group (mean difference 8.5 (95% CI 3.9 to 13.1), P<0.001, at five years). SF-36 and EQ-5D scores also favoured surgery, but were not statistically significant at five years. After fundoplication, 3% (12/364) had surgical treatment for a complication and 4% (16) had subsequent reflux-related operations-most often revision of the wrap. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the two randomised groups. CONCLUSIONS: After five years, laparoscopic fundoplication continued to provide better relief of GORD symptoms than medical management. Adverse effects of surgery were uncommon and generally observed soon after surgery. A small proportion had re-operations. There was no evidence of long term adverse symptoms caused by surgery. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15517081.

Psychological risk factors for chronic post-surgical pain after inguinal hernia repair surgery: a prospective cohort study.

A significant proportion of patients experience chronic post-surgical pain (CPSP) following inguinal hernia surgery. Psychological models are useful in predicting acute pain after surgery, and in predicting the transition from acute to chronic pain in non-surgical contexts. This is a prospective cohort study to investigate psychological (cognitive and emotional) risk factors for CPSP after inguinal hernia surgery. Participants were asked to complete questionnaires before surgery and 1 week and 4 months after surgery. Data collected before surgery and 1 week after surgery were used to predict pain at 4 months. Psychological risk factors assessed included anxiety, depression, fear-avoidance, activity avoidance, catastrophizing, worry about the operation, activity expectations, perceived pain control and optimism. The study included 135 participants; follow-up questionnaires were returned by 119 (88.1%) and 115 (85.2%) participants at 1 week and 4 months after surgery respectively. The incidence of CPSP (pain at 4 months) was 39.5%. After controlling for age, body mass index and surgical variables (e.g. anaesthetic, type of surgery and mesh type used), lower pre-operative optimism was an independent risk factor for CPSP at 4 months; lower pre-operative optimism and lower perceived control over pain at 1 week after surgery predicted higher pain intensity at 4 months. No emotional variables were independently predictive of CPSP. Further research should target these cognitive variables in pre-operative psychological preparation for surgery.

Identification of risk factors by systematic review and development of risk-adjusted models for surgical site infection.

BACKGROUND: Surgical site infections (SSIs) are complications of surgery that cause significant postoperative morbidity. SSI has been proposed as a potential indicator of the quality of care in the context of clinical governance and monitoring of the performance of NHS organisations against targets. OBJECTIVES: We aimed to address a number of objectives. Firstly, identify risk factors for SSI, criteria for stratifying surgical procedures and evidence about the importance of postdischarge surveillance (PDS). Secondly, test the importance of risk factors for SSI in surveillance databases and investigate interactions between risk factors. Thirdly, investigate and validate different definitions of SSI. Lastly, develop models for making risk-adjusted comparisons between hospitals. DATA SOURCES: A single hospital surveillance database was used to address objectives 2 and 3 and the UK Surgical Site Infection Surveillance Service database to address objective 4. STUDY DESIGN: There were four elements to the research: (1) systematic reviews of risk factors for SSI (two reviewers assessed titles and abstracts of studies identified by the search strategy and the quality of studies was assessed using the Newcastle Ottawa Scale); (2) assessment of agreement between four SSI definitions; (3) validation of definitions of SSI, quantifying their ability to predict clinical outcomes; and (4) development of operation-specific risk models for SSI, with hospitals fitted as random effects. RESULTS: Reviews of SSI risk factors other than established SSI risk indices identified other risk; some were operation specific, but others applied to multiple operations. The factor most commonly identified was duration of preoperative hospital stay. The review of PDS for SSI confirmed the need for PDS if SSIs are to be compared meaningfully over time within an institution. There was wide variation in SSI rate (SSI%) using different definitions. Over twice as many wounds were classified as infected by one definition only as were classified as infected by both. Different SSI definitions also classified different wounds as being infected. The two most established SSI definitions had broadly similar ability to predict the chosen clinical outcomes. This finding is paradoxical given the poor agreement between definitions. Elements of each definition not common to both may be important in predicting clinical outcomes or outcomes may depend on only a subset of elements which are common to both. Risk factors fitted in multivariable models and their effects, including age and gender, varied by surgical procedure. Operative duration was an important risk factor for all operations, except for hip replacement. Wound class was included least often because some wound classes were not applicable to all operations or were combined because of small numbers. The American Association of Anesthesiologists class was a consistent risk factor for most operations. CONCLUSIONS: The research literature does not allow surgery-specific or generic risk factors to be defined. SSI definitions varied between surveillance programmes and potentially between hospitals. Different definitions do not have good agreement, but the definitions have similar ability to predict outcomes influenced by SSI. Associations between components of the National Nosocomial Infections Surveillance risk index and odds of SSI varied for different surgical procedures. There was no evidence for effect modification by hospital. Estimates of SSI% should be disseminated within institutions to inform infection control. Estimates of SSI% across institutions or countries should be interpreted cautiously and should not be assumed to reflect quality of medical care. Future research should focus on developing an SSI definition that has satisfactory psychometric properties, that can be applied in everyday clinical settings, includes PDS and is formulated to detect SSIs that are important to patients or health services. FUNDING: The National Institute for Health Research Technology Assessment programme.

The effectiveness and cost-effectiveness of minimal access surgery amongst people with gastro-oesophageal reflux disease - a UK collaborative study. The REFLUX trial.

OBJECTIVES: To evaluate the clinical effectiveness, cost-effectiveness and safety of a policy of relatively early laparoscopic surgery compared with continued medical management amongst people with gastro-oesophageal reflux disease (GORD) judged suitable for both policies. DESIGN: Relative clinical effectiveness was assessed by a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. The economic evaluation compared the cost-effectiveness of the two management policies in order to identify the most efficient provision of future care and describe the resource impact that various policies for fundoplication would have on the NHS. SETTING: A total of 21 hospitals throughout the UK with a local partnership between surgeon(s) and gastroenterologist(s) who shared the secondary care of patients with GORD. PARTICIPANTS: The 810 participants, who were identified retrospectively or prospectively via their participating clinicians, had both documented evidence of GORD (endoscopy and/or manometry/24-hour pH monitoring) and symptoms for longer than 12 months. In addition, the recruiting clinician(s) was clinically uncertain about which management policy was best. INTERVENTION: Of the 810 eligible patients who consented to participate, 357 were recruited to the randomised arm of the trial (178 allocated to surgical management, 179 allocated to continued, but optimised, medical management) and 453 recruited to the parallel non-randomised preference arm (261 chose surgical management, 192 chose to continue with best medical management). The type of fundoplication was left to the discretion of the surgeon. MAIN OUTCOME MEASURES: Participants completed a baseline REFLUX questionnaire, developed specifically for this study, containing a disease-specific outcome measure, the Short Form with 36 Items (SF-36), the EuroQol-5 Dimensions (EQ-5D) and the Beliefs about Medicines and Surgery questionnaires (BMQ/BSQ). Postal questionnaires were completed at participant-specific time intervals after joining the trial (equivalent to approximately 3 and 12 months after surgery). Intraoperative data were recorded by the surgeons and all other in-hospital data were collected by the research nurse. At the end of the study period, participants completed a discrete choice experiment questionnaire. RESULTS: The randomised groups were well balanced at entry. Participants had been taking GORD medication for a median of 32 months; the mean age of participants was 46 years and 66% were men. Of 178 randomised to surgery, 111 (62%) actually had fundoplication. There was a mixture of clinical and personal reasons why some patients did not have surgery, sometimes related to long waiting times. A total or partial wrap procedure was performed depending on surgeon preference. Complications were uncommon and there were no deaths associated with surgery. By the equivalent of 12 months after surgery, 38% in the randomised surgical group (14% amongst those who had surgery) were taking reflux medication compared with 90% in the randomised medical group. There were substantial differences (one-third to one-half standard deviation) favouring the randomised surgical group across the health status measures, the size depending on assumptions about the proportion that actually had fundoplication. These differences were the same or somewhat smaller than differences observed at 3 months. The lower the REFLUX score, the worse the symptoms at trial entry and the larger the benefit observed after surgery. The preference surgical group had the lowest REFLUX scores at baseline. These scores improved substantially after surgery, and by 12 months they were better than those in the preference medical group. The BMQ/BSQ and discrete choice experiment did distinguish the preference groups from each other and from the randomised groups. The latter indicated that the risk of serious complications was the most important single attribute of a treatment option. A within-trial cost-effectiveness analysis suggested that the surgery policy was more costly (mean 2049 pounds) but also more effective [+0.088 quality-adjusted life-years (QALYs)]. The estimated incremental cost per QALY was 19,000-23,000 pounds, with a probability between 46% (when 62% received surgery) and 19% (when all received surgery) of cost-effectiveness at a threshold of 20,000 pounds per QALY. Modelling plausible longer-term scenarios (such as lifetime benefit after surgery) indicated a greater likelihood (74%) of cost-effectiveness at a threshold of 20,000 pounds, but applying a range of alternative scenarios indicated wide uncertainty. The expected value of perfect information was greatest for longer-term quality of life and proportions of surgical patients requiring medication. CONCLUSIONS: Amongst patients requiring long-term medication to control symptoms of GORD, surgical management significantly increases general and reflux-specific health-related quality of life measures, at least up to 12 months after surgery. Complications of surgery were rare. A surgical policy is, however, more costly than continued medical management. At a threshold of 20,000 pounds per QALY it may well be cost-effective, especially when putative longer-term benefits are taken into account, but this is uncertain. The more troublesome the symptoms, the greater the potential benefit from surgery. Uncertainty about cost-effectiveness would be greatly reduced by more reliable information about relative longer-term costs and benefits of surgical and medical policies. This could be through extended follow-up of the REFLUX trial cohorts or of other cohorts of fundoplication patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15517081.

The accuracy of clinical data: a comparison between central and local data collection.

BACKGROUND: The recent liberalisation of public access to information, including surgical performance, emphasises the necessity for accurate data collection. The Information and Statistics Division of the Scottish Executive (ISD) collect such data for each patient episode, but there is concern about the reliability of this information compared with that collected in local surgical departmental audit. AIM: To determine if diagnostic and operative details were consistent between local audited and national non-audited data sets. METHODS: Three surgical units comprising eight consultants were studied. Epidemiological, diagnostic and operative data for each consultant were accessed from the eScrips Internet resource (ISD Data) and from the departmental database. A unique patient number and date of birth matched individual patient episodes and the correlation between datasets graded for accuracy and consistency. RESULTS: 8375 individual data entries were recorded (ISD 4642, local databases 3733). 3402 pairs, 6408 (76.5%) of the total, matched accurately. 742 (16%) of the ISD entries were duplicates, and in 21% of unpaired entries the wrong consultant was recorded. Overall a clinically acceptable match occurred in 86.9% of paired entries for diagnosis and 84.0% for operation. The highest match with ISD data for diagnosis (88.8%) and operation (91.8%) occurred in the unit which holds a weekly audit meeting to validate information. DISCUSSION: There are significant discrepancies in surgical data between the local audit databases and central data. There is significant duplication of entries and inaccurate consultant allocation in ISD data. The promulgation of inaccurate information could threaten reputation or career and clinicians should play a more active role in ensuring clinical data are correct.

Outcome of a conservative policy for managing acute sigmoid diverticulitis.

BACKGROUND: A conservative policy for patients presenting with acute sigmoid diverticulitis is associated with a low operation rate, and low overall and operative mortality rates. The long-term consequences of such a policy were investigated. METHODS: Data were collected prospectively for 232 patients with acute sigmoid diverticulitis between 1990 and 2004. Details of all subsequent readmissions were obtained and survival to August 2005 was analysed. RESULTS: Of the 232 patients admitted, 60 (25.9 per cent) were known to have diverticulosis; in 172 patients it was a new diagnosis. Thirty-eight patients (16.4 per cent) underwent sigmoid resection, with one death. Three elderly patients in whom a decision was made not to operate had perforated diverticulitis at autopsy. Of 191 patients discharged without resection, 35 (18.3 per cent) subsequently underwent sigmoid resection: 26 (13.6 per cent) elective and nine (4.7 per cent) emergency, with one death. CONCLUSION: A conservative policy is safe in both the short term and the long term.

Clinical effectiveness and cost-effectiveness of laparoscopic surgery for colorectal cancer: systematic reviews and economic evaluation.

OBJECTIVE: The aim of this study was to determine the clinical effectiveness and cost-effectiveness of laparoscopic, laparoscopically assisted (hereafter together described as laparoscopic surgery) and hand-assisted laparoscopic surgery (HALS) in comparison with open surgery for the treatment of colorectal cancer. DATA SOURCES: Electronic databases were searched from 2000 to May 2005. A review of economic evaluations was undertaken by the National Institute for Health and Clinical Excellence in 2001. This review was updated from 2000 until July 2005. REVIEW METHODS: Data from selected studies were extracted and assessed. Dichotomous outcome data from individual trials were combined using the relative risk method and continuous outcomes were combined using the Mantel-Haenszel weighted mean difference method. Summaries of the results from individual patient data (IPD) meta-analyses were also presented. An economic evaluation was also carried out using a Markov model incorporating the data from the systematic review. The results were first presented as a balance sheet for comparison of the surgical techniques. It was then used to estimate cost-effectiveness measured in terms of incremental cost per life-year gained and incremental cost per quality-adjusted life-year (QALY) for a time horizon up to 25 years. RESULTS: Forty-six reports on 20 studies [19 randomised controlled trials (RCTs) and one IPD meta-analysis] were included in the review of clinical effectiveness. The RCTs were of generally moderate quality with the number of participants varying between 16 and 1082, with 10 having less than 100 participants. The total numbers of trial participants who underwent laparoscopic or open surgery were 2429 and 2139, respectively. A systematic review of four papers suggested that laparoscopic surgery is more costly than open surgery. However, the data they provided on effectiveness was poorer than the evidence from the review of effectiveness. The estimates from the systematic review of clinical effectiveness were incorporated into a Markov model used to estimate cost-effectiveness for a time horizon of up to 25 years. In terms of incremental cost per life-year, laparoscopic surgery was found to be more costly and no more effective than open surgery. With respect to incremental cost per QALY, few data were available to differentiate between laparoscopic and open surgery. The results of the base-case analysis indicate that there is an approximately 40% chance that laparoscopic surgery is the more cost-effective intervention at a threshold willingness to pay for a QALY of pound 30,000. A second analysis assuming equal mortality and disease-free survival found that there was an approximately 50% likelihood at a similar threshold value. Broadly similar results were found in the sensitivity analyses. A threshold analysis was performed to investigate the magnitude of QALY gain associated with quicker recovery following laparoscopic surgery required to provide an incremental cost per QALY of pound 30,000. The implied number of additional QALYs required would be 0.009-0.010 compared with open surgery. CONCLUSIONS: Laparoscopic resection is associated with a quicker recovery (shorter time to return to usual activities and length of hospitalisation) and no evidence of a difference in mortality or disease-free survival up to 3 years following surgery. However, operation times are longer and a significant number of procedures initiated laparoscopically may need to be converted to open surgery. The rate of conversion may be dependent on experience in terms of both patient selection and performing the technique. Laparoscopic resection appears more costly to the health service than open resection, with an estimated extra total cost of between pound 250 and pound 300 per patient. In terms of relative cost-effectiveness, laparoscopic resection is associated with a modest additional cost, short-term benefits associated with more rapid recovery and similar long-term outcomes in terms of survival and cure rates up to 3 years. Assuming equivalence of long-term outcomes, a judgement is required as to whether the benefits associated with earlier recovery are worth this extra cost. The long-term follow-up of the RCT cohorts would be very useful further research and ideally these data should be incorporated into a wider IPD meta-analysis. Data on the long-term complications of surgery such as incisional hernias and differences in outcomes such as persisting pain would also be valuable. Once available, further data on both costs and utilities should be included in an updated model. At this point, further consideration should then be given as to whether additional data should be collected within ongoing trials. Few data were available to assess the relative merits of HALS. Ideally, there should be more data from methodologically sound RCTs. Further research is needed on whether the balance of advantages and disadvantages of laparoscopic surgery varies within subgroups based on the different stages and locations of disease. Research relating to the effect of experience on performance is also required.

Surgical wound infection as a performance indicator: agreement of common definitions of wound infection in 4773 patients.

OBJECTIVE: To assess the level of agreement between common definitions of wound infection that might be used as performance indicators. DESIGN: Prospective observational study. SETTING: London teaching hospital group receiving emergency cases as well as tertiary referrals. PARTICIPANTS: 4773 surgical patients staying in hospital at least two nights. MAIN OUTCOME MEASURES: Numbers of wound infections based on purulent discharge alone, on the Centers for Disease Control (CDC) definition of wound infection, on the nosocomial infection national surveillance scheme (NINSS) version of the CDC definition, and on the ASEPSIS scoring method. RESULTS: 5804 surgical wounds were assessed during 5028 separate hospital admissions. The mean percentage of wounds classified as infected differed substantially with different definitions: 19.2% with the CDC definition (95% confidence interval 18.1% to 20.4%), 14.6% (13.6% to 15.6%) with the NINSS version, 12.3% (11.4% to 13.2%) with pus alone, and 6.8% (6.1% to 7.5%) with an ASEPSIS score > 20. The agreement between definitions with respect to individual wounds was poor. Wounds with pus were automatically defined as infected with the CDC, NINSS, and pus alone definitions, but only 39% (283/714) of these had ASEPSIS scores > 20. CONCLUSIONS: Small changes made to the CDC definition or even in its interpretation, as with the NINSS version, caused major variation in estimated percentage of wound infection. Substantial numbers of wounds were differently classified across the grades of infection. A single definition used consistently can show changes in percentage wound infection over time at a single centre, but differences in interpretation prevent comparison between different centres.

Comparison of three different procedures for antireflux surgery.

BACKGROUND: No long-term comparisons of the various open and laparoscopic antireflux procedures have been undertaken. The aim of this study was to compare symptomatic outcomes of three procedures for antireflux surgery performed at three specialist units. METHODS: Patients undergoing open Nissen fundoplication, laparoscopic Nissen fundoplication and laparoscopic anterior partial fundoplication between December 1993 and February 2001 were identified. Patient outcome was assessed by means of a postal questionnaire. This was a hypothesis-generating study. RESULTS: Three hundred and fifty-seven patients (80.0 per cent) completed the questionnaire, with no differences in response rate between centres. Overall, a mean of only 7.6 per cent of patients reported a poor outcome. Logistic regression revealed no significant differences amongst the three procedures for any symptoms, after allowing for the effect of time. There was a general increase in the DeMeester score with increasing time from operation. The incidence of revisional reflux surgery was similar in the three groups. CONCLUSION: Medium-term symptomatic outcome following all three procedures was similar. There was some recurrence of symptoms of gastro-oesophageal reflux with time for all procedures, suggesting that the effects of surgery diminish with time. The level of experience of the surgeon in a particular operation was more important than the procedure performed.

Systematic review of the quality of surgical mortality monitoring.

BACKGROUND: Mortality is the most tightly defined and used adverse event for audit and performance monitoring in surgery. However, to identify cause and therefore scope for improvement, accurate and timely data are required. The aim of this study was to perform a systematic review of the quality of measurement, reporting and monitoring of mortality as an outcome after surgery. METHODS: A systematic review of published literature was undertaken for the 7-year interval 1993-1999. Grey and unpublished literature was obtained through the Royal College of Surgeons of England, from UK national audits and routine national hospital data collections. RESULTS: Eligible monitoring systems included six UK national surgical audits, and cardiac and vascular surgery monitoring systems from North America and the UK. The definitions of 'surgical death' varied in several respects and deaths after discharge from hospital were rarely ascertained unless there was routine linkage to national death registers. There were very few published studies on validation of the completeness and accuracy of the data collection. CONCLUSION: A comprehensive data collection system is needed for improving clinical performance, with ownership, but not necessarily data collection, resting with the surgeons concerned. Recording of risk factors and deaths after discharge from hospital is essential, whatever data collection system is used.

Right hemicolectomy: mechanical bowel preparation is not required.

BACKGROUND: Mechanical bowel preparation before colonic surgery is widely advocated but remains controversial. Recent guidelines published by the Clinical Standards Board for Scotland recommend mechanical bowel preparation prior to surgery for all colorectal cancers but this may be inappropriate. This study examines the outcome of a policy of no mechanical preparation before elective right hemicolectomy. METHOD: Data on 102 consecutive patients undergoing elective right or extended right hemicolectomy for colonic adenocarcinoma were extracted from a prospective database. RESULTS: No clinical anastomotic leaks were observed. Two patients developed wound infections and one patient died with no autopsy evidence of anastomotic leak. CONCLUSION: Mechanical bowel preparation can safely be omitted prior to right hemicolectomy in patients with colonic cancer.

Revisional surgery after failed laparoscopic anterior fundoplication.

BACKGROUND: Partial fundoplication may have functional advantages over a circumferential wrap but the reconstruction is more complex. Revisional surgery for recurrent reflux may be more difficult because of the additional suturing involved in the original operation. We report experience with revisional surgery in a large cohort of patients who had undergone laparoscopic anterior fundoplication and hiatal repair. METHODS: Between August 1993 and September 1999, 11 (3.5%) of 309 patients who had laparoscopic anterior fundoplication for uncomplicated gastroesophageal reflux disease required revisional surgery (1 open and 10 laparoscopic revisions). Data were retrieved from a prospective database supplemented by a postal questionnaire following the second operation. RESULTS: The operative findings were posterior hiatal disruption (n = 9), anterior paraesophageal hernia (n = 1), and inadequate initial esophageal mobilization (n = 1). There were no conversions to open surgery in the laparoscopic group. Ten (91%) of the respondents described the outcome of their repeat procedure as either good or excellent. All patients would recommend the repeat procedure to patients with similar symptoms. CONCLUSIONS: Revisional surgery after laparoscopic anterior fundoplication can be performed safely with a good outcome. Modifications to technique both in the primary procedure and for revision may decrease the incidence of early technical failure.

Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery.

BACKGROUND: Anastomotic leak after gastrointestinal surgery is an important postoperative event that leads to significant morbidity and mortality. Postoperative leak rates are frequently used as an indicator of the quality of surgical care provided. Comparison of rates between and within institutions depends on the use of standard definitions and methods of measurement of anastomotic leak. The aim of this study was to review the definition and measurement of anastomotic leak after oesophagogastric, hepatopancreaticobiliary and lower gastrointestinal surgery. METHODS: A systematic review was undertaken of the published literature. Searches were carried out on five bibliographical databases (Medline, Embase, The Cochrane Library, Cumulative Index for Nursing and Allied Health Literature and HealthSTAR) for English language articles published between 1993 and 1999. Articles were critically appraised by two independent reviewers and data on definition and measurement of anastomotic leak were extracted. RESULTS: Ninety-seven studies were reviewed and a total of 56 separate definitions of anastomotic leak were identified at three sites: upper gastrointestinal (13 definitions), hepatopancreaticobiliary (14) and lower gastrointestinal (29). The majority of studies used a combination of clinical features and radiological investigations to define and detect anastomotic leak. CONCLUSION: There is no universally accepted definition of anastomotic leak at any site. The definitions and values used to measure anastomotic failure vary extensively and preclude accurate comparison of rates between studies and institutions.

The measurement and monitoring of surgical adverse events.

BACKGROUND: Surgical adverse events contribute significantly to postoperative morbidity, yet the measurement and monitoring of events is often imprecise and of uncertain validity. Given the trend of decreasing length of hospital stay and the increase in use of innovative surgical techniques--particularly minimally invasive and endoscopic procedures--accurate measurement and monitoring of adverse events is crucial. OBJECTIVES: The aim of this methodological review was to identify a selection of common and potentially avoidable surgical adverse events and to assess whether they could be reliably and validly measured, to review methods for monitoring their occurrence and to identify examples of effective monitoring systems for selected events. This review is a comprehensive attempt to examine the quality of the definition, measurement, reporting and monitoring of selected events that are known to cause significant postoperative morbidity and mortality. METHODS - SELECTION OF SURGICAL ADVERSE EVENTS: Four adverse events were selected on the basis of their frequency of occurrence and likelihood of evidence of measurement and monitoring: (1) surgical wound infection; (2) anastomotic leak; (3) deep vein thrombosis (DVT); (4) surgical mortality. Surgical wound infection and DVT are common events that cause significant postoperative morbidity. Anastomotic leak is a less common event, but risk of fatality is associated with delay in recognition, detection and investigation. Surgical mortality was selected because of the effort known to have been invested in developing systems for monitoring surgical death, both in the UK and internationally. Systems for monitoring surgical wound infection were also included in the review. METHODS - LITERATURE SEARCH: Thirty separate, systematic literature searches of core health and biomedical bibliographic databases (MEDLINE, EMBASE, CINAHL, HealthSTAR and the Cochrane Library) were conducted. The reference lists of retrieved articles were reviewed to locate additional articles. A matrix was developed whereby different literature and study designs were reviewed for each of the surgical adverse events. Each article eligible for inclusion was independently reviewed by two assessors. METHODS - CRITICAL APPRAISAL: Studies were appraised according to predetermined assessment criteria. Definitions and grading scales were assessed for: content, criterion and construct validity; repeatability; reproducibility; and practicality (surgical wound infection and anastomotic leak). Monitoring systems for surgical wound infection and surgical mortality were assessed on the following criteria: (1) coverage of the system; (2) whether or not denominator data were collected; (3) whether standard and agreed definitions were used; (4) inclusion of risk adjustment; (5) issues related to data collection; (6) postdischarge surveillance; (7) output in terms of feedback and wider dissemination. RESULTS - SURGICAL WOUND INFECTION: A total of 41 different definitions and 13 grading scales of surgical wound infection were identified from 82 studies. Definitions of surgical wound infection varied from presence of pus to complex definitions such as those proposed by the Centres for Disease Control in the USA. A small body of literature has been published on the content, criterion and construct validity of different definitions, and comparisons have been made against wound assessment scales and multidimensional indices. There are examples of comprehensive hospital-based monitoring systems of surgical wound infection, mainly under the auspices of nosocomial surveillance. To date, however, there is little evidence of systematic measurement and monitoring of surgical wound infection after hospital discharge. RESULTS - ANASTOMOTIC LEAK: Over 40 definitions of anastomotic leak were extracted from 107 studies of upper gastrointestinal, hepatopancreaticobiliary and lower gastrointestinal surgery. No formal evaluations were found that assessed the validity or reliability of definitions or severity scales of anastomotic leak. One definition was proposed during a national consensus workshop, but no evidence of its use was found in the surgical literature. The lack of a single definition or gold standard hampers comparison of postoperative anastomotic leak rates between studies and institutions. RESULTS - DEEP VEIN THROMBOSIS: Although a critical review of the DVT literature could not be completed within the realms of this review, it was evident that a number of new techniques for the detection and diagnosis of DVT have emerged in the last 20 years. The group recommends a separate review be undertaken of the different diagnostic tests to detect DVT. RESULTS - SURGICAL MORTALITY MONITORING SYSTEMS: The definition of surgical mortality is relatively consistent between monitoring systems, but duration of follow-up of death postdischarge varies considerably. The majority of systems report in-hospital mortality rates; only some have the potential to link deaths to national death registers. Risk assessment is an important factor and there should be a distinction between recording pre-intervention factors and postoperative complications. A variety of risk scoring systems was identified in the review. Factors associated with accurate and complete data collection include the employment of local, dedicated personnel, simple and structured prompts to ensure that clinical input is complete, and accurate and automated data capture and transfer. CONCLUSIONS: The use of standardised, valid and reliable definitions is fundamental to the accurate measurement and monitoring of surgical adverse events. This review found inconsistency in the quality of reporting of postoperative adverse events, limiting accurate comparison of rates over time and between institutions. The duration of follow-up for individual events will vary according to their natural history and epidemiology. Although risk-adjusted aggregated rates can act as screening or warning systems for adverse events, attribution of whether events are avoidable or preventable will invariably require further investigation at the level of the individual, unit or department. CONCLUSIONS - RECOMMENDATIONS FOR RESEARCH: (1) A single, standard definition of surgical wound infection is needed so that comparisons over time and between departments and institutions are valid, accurate and useful. Surgeons and other healthcare professionals should consider adopting the 1992 Centers for Disease Control (CDC) definition for superficial incisional, deep incisional and organ/space surgical site infection for hospital monitoring programmes and surgical audits. There is a need for further methodological research into the performance of the CDC definition in the UK setting. (2) There is a need to formally assess the reliability of self-diagnosis of surgical wound infection by patients. (3) There is a need to assess formally the reliability of case ascertainment by infection control staff. (4) Work is needed to create and agree a standard, valid and reliable definition of anastomotic leak which is acceptable to surgeons. (5) A systematic review is needed of the different diagnostic tests for the diagnosis of DVT. (6) The following variables should be considered in any future DVT review: anatomical region (lower limb, upper limb, pelvis); patient presentation (symptomatic, asymptomatic); outcome of diagnostic test (successfully completed, inconclusive, technically inadequate, negative); length of follow-up; cost of test; whether or not serial screening was conducted; and recording of laboratory cut-off values for fibrinogen equivalent units. (7) A critical review is needed of the surgical risk scoring used in monitoring systems. (8) In the absence of automated linkage there is a need to explore the benefits and costs of monitoring in primary care. (9) The growing potential for automated linkage of data from different sources (including primary care, the private sector and death registers) needs to be explored as a means of improving the ascertainment of surgical complications, including death. This linkage needs to be within the terms of data protection, privacy and human rights legislation. (10) A review is needed of the extent of the use and efficiency of routine hospital data versus special collections or voluntary reporting.