A Meta-Analysis of Short-Term Outcomes After Laparoscopic Lavage Versus Colonic Resection in the Treatment of Perforated Diverticulitis.

The management of perforated non-faeculent diverticulitis has traditionally involved performing a colonic resection (CR). Laparoscopic lavage (LL) has emerged as a less invasive alternative in recent years. The aim of this meta-analysis was to assess the role of LL in the surgical treatment of perforated non-faeculent diverticulitis. To that end, we conducted a search on Embase, Medline, and Cochrane databases for comparative studies in the English language published till June 2021 [PROSPERO (CRD42021269410)]. The risk of bias was assessed using the revised Cochrane risk-of-bias tool for randomised trials (RoB 2) and the methodological index for non-randomised studies (MINORS). Data were analysed using Cochrane RevMan. Pooled odds ratio (POR) and cumulative weighted ratios (CWR) were calculated. A total of 13 studies involving 1061 patients were found eligible, including seven studies based on three randomised control trials (RCTs). LL was associated with a reduced risk of wound infection, stoma formation, and need for further surgery by 77% [POR: 0.23, 95% confidence interval (CI): 0.07-0.74], 83% (POR: 0.17, 95% CI: 0.05-0.56), and 53% (POR: 0.47, 95% CI: 0.23-0.97) respectively. Duration of surgery and hospitalisation was reduced by 54% and 43% respectively. However, LL was associated with higher rates of unplanned reoperations (POR: 2.05, 95% CI: 1.22-3.42), recurrence (POR: 9.47, 95% CI: 3.24-27.67), and peritonitis (POR: 8.92, 95% CI: 2.71-29.33). No differences in mortality or readmission rates were observed. LL in Hinchey III diverticulitis lowers the incidence of stoma formation and overall reoperations without an increase in mortality but at the cost of higher recurrence rates and peritonitis. A limitation of this study was the inclusion of non-RCTs. An elective resection should be considered after LL. Guidelines for surgical techniques in LL need to be standardised.

Is "pelvic radiation disease" always the cause of bowel symptoms following prostate cancer intensity-modulated radiotherapy?

BACKGROUND: Pelvic radiation disease (PRD) also widely known as "radiation proctopathy" is a well recognised late side-effect following conventional prostate radiotherapy. However, endoscopic evaluation and/or specialist referral for new or persistent post-prostate radiotherapy bowel symptoms is not routine and serious diagnoses may potentially be missed. Here we report a policy of endoscopic evaluation of bowel symptoms persisting >90 days post radiotherapy for prostate cancer. METHODS AND MATERIALS: A consecutive series of 102 patients who had radical prostate intensity-modulated radiotherapy (IMRT)/image-guided radiotherapy (IGRT) and who had new or ongoing bowel symptoms or positive faecal occult blood tests (FOBT) on follow up visits more than three months after treatment, were referred for endoscopic examination. All but one (99%) had full colonoscopic investigation. RESULTS: Endoscopic findings included gastric/colonic/rectal polyps (56%), diverticular disease (49%), haemorrhoids (38%), radiation proctopathy (29%), gastritis/oesophagitis (8%) and rarer diagnoses, including bowel cancer which was found in 3%. Only four patients (4%) had radiation proctopathy without associated pathology and 65 patients (63%) had more than one diagnosis. If flexible sigmoidoscopy alone were used, 36.6% of patients and 46.6% patients with polyp(s) would have had their diagnoses missed. CONCLUSIONS: Our study has shown that bowel symptoms following prostate IMRT/IGRT are due to numerous diagnoses other than PRD, including malignancy. Routine referral pathways should be developed for endoscopic evaluation/specialist review for patients with new or persistent bowel symptoms (or positive FOBT) following prostate radiotherapy. This recommendation should be considered for incorporation into national guidelines.

Multicenter randomized trial of centralized nurse-led telephone-based care coordination to improve outcomes after surgical resection for colorectal cancer: the CONNECT intervention.

PURPOSE: To investigate the effectiveness of a centralized, nurse-delivered telephone-based service to improve care coordination and patient-reported outcomes after surgery for colorectal cancer. PATIENTS AND METHODS: Patients with a newly diagnosed colorectal cancer were randomly assigned to the CONNECT intervention or usual care. Intervention-group patients received standardized calls from the centrally based nurse 3 and 10 days and 1, 3, and 6 months after discharge from hospital. Unmet supportive care needs, experience of care coordination, unplanned readmissions, emergency department presentations, distress, and quality of life (QOL) were assessed by questionnaire at 1, 3, and 6 months. RESULTS: Of 775 patients treated at 23 public and private hospitals in Australia, 387 were randomly assigned to the intervention group and 369 to the control group. There were no significant differences between groups in unmet supportive care needs, but these were consistently low in both groups at both follow-up time points. There were no differences between the groups in emergency department presentations (10.8% v 13.8%; P = .2) or unplanned hospital readmissions (8.6% v 10.5%; P = .4) at 1 month. By 6 months, 25.6% of intervention-group patients had reported an unplanned readmission compared with 27.9% of controls (P = .5). There were no significant differences in experience of care coordination, distress, or QOL between groups at any follow-up time point. CONCLUSION: This trial failed to demonstrate substantial benefit of a centralized system to provide standardized, telephone follow-up for postoperative patients with colorectal cancer. Future interventions could investigate a more tailored approach.

Enhanced recovery after surgery programs hasten recovery after colorectal resections.

Colorectal resection was traditionally associated with significant morbidity and prolonged stay in hospital. Laparoscopic colorectal resection was first described in 1991 as a minimally invasive form of colorectal surgery. It was later on assessed by multiple randomized controlled trials and meta-analysis and was found to be associated with a faster recovery, lower complication rates and a shorter stay in hospital compared with open resection. To assess the effect of enhanced recovery after surgery (ERAS) program on postoperative length of stay after elective colorectal resections, a literature review was conducted, supplemented by the results of 111 ERAS colorectal resections at regional NWS Hospital using a protocol based on the Fast Track approach described by Kehlet in 1999. ERAS has been shown to improve postoperative recovery, reduce length of stay and enhance early return to normal function when compared with traditional colorectal surgical protocols. The role of laparoscopic surgery in colorectal resections within a fast-track (ERAS) program is controversial. The current evidence suggests that within such a program, there is no difference between laparoscopic and open colorectal surgery in terms of postoperative recovery rates or length of hospital stay.

Meta-analysis of well-designed nonrandomized comparative studies of surgical procedures is as good as randomized controlled trials.

OBJECTIVE: To compare the results of meta-analysis of nonrandomized comparative studies (NRCSs) of a surgical procedure with that of randomized controlled trials (RCTs), and to assess the effect of design and conduct issues in NRCSs on measured outcomes. STUDY DESIGN AND SETTING: Two meta-analyses of RCTs and NRCSs (2,512 and 6,438 procedures, respectively) of laparoscopic resection for colorectal cancer were performed according to accepted protocols, and 13 outcomes common between them were compared. Odds ratios (ORs) and 95% confidence intervals (CI) for dichotomous outcomes were assessed for the degree of overlap. Continuous outcomes were compared using cumulative weighted ratios (CWRs) and percentages for which a mean and standard deviation (SD) were calculated. The effects of design and conduct issues in the meta-analysis of NRCSs on measured morbidity rates were assessed using subgroup analysis. RESULTS: The ORs of the three dichotomous outcomes overlapped widely. For the 10 continuous variables, the mean difference (SD) in the results of the two meta-analyses was only 5.6% (4.9%). Fulfillment of certain quality and conduct issues in the NRCSs determined the statistical homogeneity of the results of meta-analysis and their comparability with the "gold standard." CONCLUSION: Meta-analysis of well-designed NRCSs of surgical procedures is probably as accurate as that of RCTs.

Meta-analysis of non-randomized comparative studies of the short-term outcomes of laparoscopic resection for colorectal cancer.

Laparoscopic resection remains to be established as the procedure of first choice for operable colorectal cancer. The aim of the study was to conduct a systematic review of non-randomized comparative studies of laparoscopic resection for colorectal cancer. Published work in English was searched for relevant articles published by the end of 2003. The MOOSE statement was used to conduct the meta-analysis. Study quality was assessed by two investigators using the MINORS tool and the analysis was conducted using Comprehensive Meta-analysis software (Biostat, Englewood, NJ, USA) and Microsoft Excel (Microsoft, Redmond, WA, USA). One thousand two hundred and twenty abstracts were reviewed and 398 articles examined in detail. Out of 108 articles reporting the results of relevant studies, 75 were reports of 64 non-randomized comparative studies. Fifteen studies were excluded. Analysis of the outcomes of 6438 resections showed that the conversion rate was 13.3% with a statistically significant difference between studies with more than 50 versus those with 50 or less attempted resections (11.7 vs 16.5%; P<0.001). Laparoscopic resection took 27.6% (41 min) longer to carry out than open resection. There was no significant difference between the two groups in early mortality rates (1.2 vs 1.1%; P=0.787) or likelihood of re-operation (2.3 vs 1.5%; P=0.319). Laparoscopic resection was associated with a lower morbidity rate (24.05 vs 30.80%, odds ratio (95% confidence interval)=0.77 (0.63-0.95); P=0.014, n=4111, random-effects model). Time until passage of first flatus, passage of a bowel motion, tolerating oral fluids and a solid diet was 1.2-1.6 days (26 to 37%) shorter, measurements of pain and narcotic analgesic requirements were 16-35% lower and hospital stay was 3.5 days (18.8%) shorter following laparoscopic resection compared with open resection. The two approaches were 99% similar in terms of adequacy of oncological clearance. Meta-analysis of non-randomized comparative studies favours laparoscopic over open resection for colorectal cancer. The results were remarkably similar to those of a contemporaneous meta-analysis of randomized controlled trials published by the end of 2002.

Non-entry of eligible patients into the Australasian Laparoscopic Colon Cancer Study.

BACKGROUND: There is currently a need to assess the reasons for non-entry of eligible patients into surgical randomized controlled trials to determine measures to improve the low recruitment rates in such trials. METHODS: Reasons for non-entry of all eligible patients not recruited into the Australasian Laparoscopic Colon Cancer Study were prospectively recorded using a survey completed by the participating surgeons for a period of 6 months. RESULTS: In the 6-month period of the study, 51 (45%) out of 113 eligible patients examined by the 18 actively participating surgeons were recruited into the trial. Eighty-nine reasons were recorded for the non-entry of the 62 eligible patients. The most commonly recorded reason was preference for one form of surgery (42%) or the surgeon (31%) by the patient (45 patients (73%) in total). This was followed by lack of time (10 patients (16%)), hospital accreditation (7 patients (11%)) or staffing/equipment (6 patients (10%)). Concern about the doctor-patient relationship or causing the patient anxiety was recorded for three (5%) and two (3%) patients, respectively. Recruitment was positively associated with the availability of a data manager (chi2 = 19.91; P < 0.001, odds ratio (95% confidence interval) = 9.50 (3.53-25.53)) and negatively associated with an increased caseload (more than five eligible patients seen by the surgeon in the study period) (continuity adjusted chi2 = 16.052; P < 0.001, odds ratio (95% confidence interval) = 0.11(0.04-0.30)). CONCLUSION: Having a preference for one form of surgery by the patient or the surgeon was the most common reason for non-entry of eligible patients in the Australasian Laparoscopic Colon Cancer Study. Concern about the doctor-patient relationship played a minimal role in determining the outcome of recruitment. Patient and surgeon preferences, caseload and the distribution of supportive staff such as data managers according to patient population density should be considered in the planning of future trials.

Will the dilemma of evidence-based surgery ever be resolved?

Exponents of evidence-based medicine do not undermine the importance of clinical expertise and skills, but they emphasize that decision-making in medicine should be based on the best available evidence derived from the systematic analysis of observations made in an objective, unbiased and a reproducible fashion. The randomized controlled trial (RCT) is the most scientifically rigorous means of hypothesis testing in epidemiology. Discrepancies between established surgical and other interventions and best available evidence are common. These can be in the form of significant delay in adopting a new intervention despite strong supportive evidence, adopting an intervention before supportive evidence becomes available for reasons of novelty or pear pressure and the lack of supportive evidence for many established common practices. This is compounded further by the paucity of good quality evidence for most surgical procedures. This is arguably because of the inherent difficulties in conducting surgical RCT. The practical, ethical and financial ramifications are complex and the nature of surgical disease often compromise the chances of success or completion of RCT. Carrying out surgical RCT may have more implications on the clinician's authority, autonomy and income and their results are more likely to be influenced by his/her expertise and competence than medical RCT. Furthermore, the success of surgical RCT is often jeopardized by very low recruitment rates. The aim of this study is to discuss the dilemma of producing evidence in surgery.

How does an historic control study of a surgical procedure compare with the "gold standard"?

PURPOSE: It has been suggested that nonrandomized studies of interventions can neither discriminate between the effect of an intervention and that of bias nor accurately estimate the magnitude of measured effects. This study was designed to compare the results of an historic control study of a surgical procedure with those of a subsequent randomized control trial conducted under similar circumstances. METHODS: The results of an historic control study and a randomized, controlled trial of the safety and efficacy of laparoscopic rectopexy for rectal prolapse that were conducted 17 months apart by the same group of surgeons at the same institution were compared in terms of direction and magnitude of measured effects. RESULTS: The historic control study was reliable in determining the direction of measured effects in six of six (100 percent) outcomes common between the two studies, and there was agreement on the statistical significance (or lack of it) in five (83 percent); however, the magnitude of measured effects for all but one outcome assessed was 33 to 107 percent larger than in the randomized, controlled trial. There was no agreement in the medical literature on the effect of the historic control design on the direction and magnitude of measured effects. CONCLUSIONS: The results of a surgical historic control trial compared favorably with those of a randomized, controlled trial conducted under similar circumstances in determining the direction of measured effects but tended to yield larger estimates of effect magnitudes. The medical literature is divided on the effect of the historic control study design on study outcomes and more research is required to further define its role in evidence-based surgery.

A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials.

BACKGROUND: The low recruitment rates into surgical randomized controlled trials (RCTs) threaten the validity of their findings. We reviewed the reasons for nonentry of eligible patients into surgical RCTs that would form the basis for future prospective research. METHODS: A systematic review of the English language literature for studies reporting reasons for nonentry of eligible patients into surgical RCTs and of recommendations made to improve the low recruitment rates. RESULTS: We reviewed 401 articles, including 94 articles presenting the results of 62 studies: 23 reports of recruitment into real surgical RCTs, 11 surveys of patients regarding hypothetical surgical RCTs, 10 surveys of clinicians and 18 literature reviews. The most frequently reported patient-related reasons for nonentry into surgical RCTs were preference for one form of treatment, dislike of the idea of randomization, and the potential for increased demands. Distrust of clinicians caused by a struggle to understand, explicit refusal of a no-treatment (placebo) arm, and the mere inability to make a decision were frequently reported in studies of real RCTs and patient surveys, but were not emphasized in surveys of clinicians and review articles. Difficulties with informed consent, the complexity of study protocols, and the clinicians' loss of motivation attributable to lack of recognition were the most commonly reported clinician-related reasons. CONCLUSIONS: There seems to be a discrepancy between real reasons for nonentry of eligible patients into surgical RCTS and those perceived by the clinicians, which require further prospective research. A summary and discussion of main recommendations sighted in the literature is presented.

A prospective study of subclinical myocardial damage in endovascular versus open repair of infrarenal abdominal aortic aneurysms.

BACKGROUND: Endovascular repair of abdominal aortic aneurysms (AAAs) is considered to be less invasive and better tolerated by the cardiovascular system than open repair. Our aim was to assess the true incidence of perioperative myocardial damage associated with endovascular vs open infrarenal AAA repair. METHODS: Between July 1999 and June 2001, preoperative and postoperative serum troponin T (TnT) levels were measured in all patients presenting for elective AAA repair at Royal Prince Alfred Hospital. The incidence of myocardial damage was recorded on the basis of standard clinical, biochemical, and electrocardiographic changes or a subclinical increase of 50% or more in serum TnT. Patients were excluded if the TnT increase was associated with a significant increase of serum creatinine (> or =50%) with no other evidence of myocardial ischemia. The differences between the two groups were analyzed with the chi 2 test and odds ratios. RESULTS: A total of 35 open and 112 endovascular AAA repairs were included in the study. There was no significant difference in age, sex, preoperative serum creatinine, or preoperative serum TnT between the two treatment groups. Seventeen patients had biochemical evidence of myocardial damage, which was clinically obvious in only one patient. Even though the incidence of previous myocardial infarction was significantly higher in patients undergoing endovascular repair (41%) than open repair (22%; P < .05), the overall incidence of myocardial damage (clinical or subclinical) was significantly higher in the open group compared with the endovascular group (8 [25%] of 32 vs 9 [8%] of 109, respectively; odds ratio, 3.7; 95% confidence interval, 1.28-10.49; P < .02). CONCLUSIONS: There is a previously underestimated incidence of subclinical myocardial damage associated with surgery for infrarenal AAA which is lower after endovascular than open repair.

Is smoking an indirect risk factor for the development of ulcerative colitis? An age- and sex-matched case-control study.

BACKGROUND: It has been suggested that smoking protects against the development of ulcerative colitis (UC). Evidence is mainly driven from the way data from a multitude of case-control studies have been interpreted. METHODS: An age- and sex-matched case-control study was conducted to further assess the association between history of smoking, past surgery, childhood, and other potential causative factors with the development of UC using the answers to a detailed questionnaire. The data were analyzed using univariate analysis and logistic regression. The results are presented as odds ratios (OR) and 95% confidence intervals. RESULTS: One hundred and two cases and an equal number of matched controls were included in the study. Using a three-level comparison, at the age of diagnosis, the risks of developing UC were 0.41 (0.19-0.87), 3.45 (1.62-7.35) and 0.78 (0.44-1.37) for smokers, ex-smokers and non-smokers, respectively. When compared to individuals who have never smoked, ex-smokers were at a higher risk of developing the disease (OR = 3.00 (1.38-6.51)). The specific history of quitting smoking prior to the age of onset of symptoms was associated with an increased risk for developing the disease (OR = 3.45 (1.62-7.35)). CONCLUSIONS: Active smoking was associated with a low risk for the development of UC, but the lack of history of smoking was not associated with an increase in the risk. History of quitting smoking prior to the onset of symptoms, in contrast, was associated with a significant increase in the risk of developing the disease. These findings make the theory of a simple protective effect of smoking on the development of UC difficult to justify. It may be plausible to suggest that the withdrawal of the immunosuppressive effect of smoking triggers the disease onset in a genetically susceptible individual or simply unmasks its symptoms.

Appendectomy protects against the development of ulcerative colitis but does not affect its course.

OBJECTIVES: Appendectomy has been shown to protect against the development of ulcerative colitis. The objective of this study was to examine the effect of appendectomy on the clinical features and natural history of colitis. METHODS: A total of 259 consecutive adults patients with ulcerative colitis were studied. Of the patients, 20 had undergone appendectomy (12 before onset of colitis and eight after diagnosis). RESULTS: The frequency of appendectomy was significantly less than in a group of 280 controls, which comprised partners of the patients and a group from the community (OR = 0.25; 95% CI = 0.14-0.44). This was even more significant if only the 12 patients who underwent surgery before the onset of colitis were considered (OR = 0.15; 95% CI = 0.07-0.28). Patients with prior appendectomy developed symptoms of ulcerative colitis for the first time at a significantly later age than those without appendectomy (42.5 +/- 6.5 vs 32.1 +/- 0.8 yr; p < 0.01) or those who had appendectomy after the onset of colitis (24.6 +/- 3.4 yr; p < 0.05). Appendectomy did not influence disease extent, need for immunosuppressive treatment with azathioprine or 6-mercaptopurine (as a marker of resistant disease), or the likelihood of colectomy. Five patients in the appendectomy group had clinical evidence of primary sclerosing cholangitis (25%). This was more common than in those without appendectomy (8%; OR = 4.09; 95% CI = 1.04-13.60). CONCLUSIONS: These results indicate that although appendectomy may delay onset of colitis, it does not influence its course. However, it is associated with the development of primary sclerosing cholangitis. Appendectomy is unlikely to be of benefit in established ulcerative colitis.