Review of the quality of total mesorectal excision does not improve the prediction of outcome.

AIM: A fair to moderate concordance in grading of the total mesorectal excision (TME) surgical specimen by local pathologists and a central review panel has been observed in the PROCARE (Project on Cancer of the Rectum) project. The aim of the present study was to evaluate the difference, if any, in the accuracy of predicting the oncological outcome through TME grading by local pathologists or by the review panel. METHOD: The quality of the TME specimen was reviewed for 482 surgical specimens registered on a prospective database between 2006 and 2011. Patients with a Stage IV tumour, with unknown incidence date or without follow-up information were excluded, resulting in a study population of 383 patients. Quality assessment of the specimen was based on three grades including mesorectal resection (MRR), intramesorectal resection (IMR) and muscularis propria resection (MPR). Using univariable Cox regression models, local and review panel histopathological gradings of the quality of TME were assessed as predictors of local recurrence, distant metastasis and disease-free and overall survival. Differences in the predictions between local and review grading were determined. RESULTS: Resection planes were concordant in 215 (56.1%) specimens. Downgrading from MRR to MPR was noted in 23 (6.0%). There were no significant differences in the prediction error between the two models; local and central review TME grading predicted the outcome equally well. CONCLUSION: Any difference in grading of the TME specimen between local histopathologists and the review panel had no significant impact on the prediction of oncological outcome for this patient cohort. Grading of the quality of TME as reported by local histopathologists can therefore be used for outcome analysis. Quality control of TME grading is not warranted provided the histopathologist is adequately trained.

Reduced perioperative death following laparoscopic colorectal resection: results of an international observational study.

BACKGROUND: Laparoscopic approaches to colorectal surgery are known to accelerate recovery but the effect on postoperative mortality is uncertain. The purpose of this study was to determine whether differences exist in postoperative mortality between patients undergoing laparoscopic and open colorectal surgery in a group of international healthcare institutions. METHODS: Administrative data from 30 worldwide institutions were searched for patients who underwent elective colorectal surgical resection between January 2007 and December 2011. The primary outcome measure was 30-day-in-hospital mortality rate. Secondary outcome measures were 30-day readmission rate, length of stay, and 30-day reoperation rate. RESULTS: There were 30,369 (20,641 colonic and 9728 rectal) resections recorded over the 5 years. Eight thousand eighty-six were laparoscopic (26.6%) and 22,283 (73.4%) were open. Following propensity-score matching of the laparoscopic and open cohorts, mortality was 0.5% following laparoscopic colectomy and 1.2% after conventional surgery (P < 0.001). After adjusting for differences in preoperative risk factors including gender, age, comorbidity, type of surgery and diagnosis, by matching on propensity score, laparoscopic surgery was a strong determinant of reduced 30-day mortality (odds ratio 0.44; 95% confidence interval 0.31-0.62; P < 0.001), reduced hospital stay (odds ratio 0.42, 95% confidence interval 0.39-0.45; P < 0.001), reduced readmission (odds ratio 0.78, 95% confidence interval 0.71-0.86; P < 0.001) and reduced re-operation (odds ratio 0.75, 95% confidence interval 0.65-0.76; P < 0.001). CONCLUSIONS: Minimally invasive colorectal surgery is associated with reduced in-hospital mortality when compared with conventional techniques. This finding is consistent across international healthcare institutions and supports efforts to disseminate laparoscopic skills.

Scoring the quality of total mesorectal excision for the prediction of cancer-specific outcome.

AIM: A three-grade system for macroscopic evaluation of the resection plane is used to describe the quality of total mesorectal excision (TME). In several studies, two of the three grades have been combined when analysing the outcome. The aim of our study was to compare the predictive value of the three-graded with that of a two-graded TME score. METHOD: The quality of TME in 1382 patients who underwent elective resection for mid or low rectal adenocarcinoma was registered by 65 hospitals in PROCARE, a Belgian multidisciplinary improvement project. Prediction of outcome based on the classic three-grade score was compared with a two-grade scoring system in which intramesorectal resection (IMR) was combined with mesorectal (MRR) or with muscularis propria resection (MPR). End-points included the local recurrence rate, distant metastasis rate (DMR), disease-free survival (DFS) and overall survival (OS). RESULTS: Among the 1382 resections, 63% were MRR, 27% IMR and 9% MPR. No significant differences were found in local recurrence between the different grades of TME. A two-grade score distinguishing MRR from the others was found to predict DMR, DFS and OS as well as the three-grade score. CONCLUSION: The discriminatory and predictive value of a two-grade score, differentiating MRR from the combined IMR and MPR, was as good as the classic three-grade score.

Completeness and registration bias in PROCARE, a Belgian multidisciplinary project on cancer of the rectum with participation on a voluntary basis.

BACKGROUND: PROCARE, a Belgian multidisciplinary project on rectal cancer, started in 2006 with participation on a voluntary basis. Completeness and bias of registration in PROCARE were assessed. METHODS: Data from 6353 patients with rectal cancer were extracted from the population based Belgian Cancer Registry for the period 2006-2008. Registration bias was studied by comparing patient, tumour and treatment characteristics of cases registered and non-registered in PROCARE. Relative survival (RS) of patient subgroups was analysed. RESULTS: PROCARE included 37% of all Belgian rectal cancer patients. Registration was highly variable between participating centres which recorded on average 56% of their patients. Significant differences in patient, tumour and treatment related characteristics were observed between registered and non-registered patients. The 5-year RS was 77% (95% confidence interval (CI): 74-80%) for registered patients and 56% (95% CI: 53-59%) for non-registered patients. After adjustment for patient, tumour characteristics and volume of centre, the relative excess risk of dying (RER) between registered and non-registered patients was 2.15 (95% CI: 1.85-2.50, p<0.001). The 5-year RS of patients treated in centres that never participated in the project was 59% (95% CI: 55-63%) and, after adjustment, the RER was 1.16 (95% CI: 1.00-1.35, p<0.050) compared to patients of the participating centres. CONCLUSION: Registration of PROCARE patient data was incomplete, biased and variable between centres. Participation on a voluntary basis should be avoided for further projects. Quality assurance on a centre level requires compulsory and complete registration with a minimal but relevant data set for all patients treated in all centres.

Differences in pre-operative treatment for rectal cancer between Norway, Sweden, Denmark, Belgium and the Netherlands.

Several studies have shown remarkable differences in colorectal cancer survival across Europe. Most of these studies lacked information about stage and treatment. In this study we compared short-term survival as well as differences in tumour stage and treatment strategies between five European countries: Norway, Sweden, Denmark, Belgium, and the Netherlands. For this retrospective cohort study all patients aged 18 years or older and operated on adenocarcinoma of the rectum without distant metastases and diagnosed in 2008 and 2009 were selected in national audit registries from Norway, Sweden, Denmark, Belgium, and the Netherlands. Differences in pre-operative treatment between the countries were compared using univariable and multivariable logistic regression. One year relative survival and one year relative excess risk of death (RER) were compared between the five countries. Large variation in the use of preoperative radiotherapy and chemoradiation was found between the countries. Even though, there was little variation in relative survival between the countries, except Sweden, which had a significant better one year RER of death among the elderly patients after adjustment. The differences in survival are expected to be caused by differences in peri-operative care, selection of patients, and especially management of elderly patients. The effects of preoperative treatment are expected to be seen on long term follow-up.

Effect of hospital volume on quality of care and outcome after rectal cancer surgery.

BACKGROUND: Research on the relationship between hospital volume and quality of care in the treatment of rectal cancer is limited. METHODS: Process and outcome indicators were assessed in patients with rectal adenocarcinoma who underwent total mesorectal excision, registered on a voluntary basis in the PROCARE clinical database. Volume was derived from an administrative database and analysed as a continuous variable. Sphincter preservation, 30-day mortality and survival rates were cross-checked against population-based data. RESULTS: A total of 1469 patients registered in PROCARE between 2006 and 2011 were included in this study. A volume effect was observed regarding neoadjuvant therapy for stage II-III disease, reporting of the circumferential resection margin, R0 resection rate, sphincter preservation rate, and number of nodes examined after chemoradiotherapy. The global estimate of quality of care was highly variable, but surgery was the single domain in which quality correlated with volume. No volume effect was observed for recurrence and overall survival rates. In the population-based data set (5869 patients), volume was associated with 30-day mortality adjusted for age (odds ratio 0·99, 95 per cent confidence interval (c.i.) 0·98 to 1·00; P = 0·014) and adjusted overall survival (HR 0·99 (95 per cent c.i. 0·99 to 1·00) per additional procedure; P = 0·001), but not with the sphincter preservation rate. Because of incomplete and biased registration on a voluntary basis, results from a clinical database could not be extrapolated to the population. CONCLUSION: Some volume effects were observed, but their effect size was limited.

Reconciliation of international administrative coding systems for comparison of colorectal surgery outcome.

AIM: Significant variation in colorectal surgery outcomes exists between different countries. Better understanding of the sources of variable outcomes using administrative data requires alignment of differing clinical coding systems. We aimed to map similar diagnoses and procedures across administrative coding systems used in different countries. METHOD: Administrative data were collected in a central database as part of the Global Comparators (GC) Project. In order to unify these data, a systematic translation of diagnostic and procedural codes was undertaken. Codes for colorectal diagnoses, resections, operative complications and reoperative interventions were mapped across the respective national healthcare administrative coding systems. Discharge data from January 2006 to June 2011 for patients who had undergone colorectal surgical resections were analysed to generate risk-adjusted models for mortality, length of stay, readmissions and reoperations. RESULTS: In all, 52 544 case records were collated from 31 institutions in five countries. Mapping of all the coding systems was achieved so that diagnosis and procedures from the participant countries could be compared. Using the aligned coding systems to develop risk-adjusted models, the 30-day mortality rate for colorectal surgery was 3.95% (95% CI 0.86-7.54), the 30-day readmission rate was 11.05% (5.67-17.61), the 28-day reoperation rate was 6.13% (3.68-9.66) and the mean length of stay was 14 (7.65-46.76) days. CONCLUSION: The linkage of international hospital administrative data that we developed enabled comparison of documented surgical outcomes between countries. This methodology may facilitate international benchmarking.

Sperm motility after laparoscopic inguinal hernia repair with lightweight meshes: 3-year follow-up of a randomised clinical trial.

PURPOSE: To analyse the effects of lightweight meshes in laparoscopic inguinal hernia repair on male fertility aspects, chronic pain development and recurrence at 3-year follow-up. METHODS: Fifty-nine male patients with a primary, unilateral or bilateral inguinal hernia were randomised to laparoscopic inguinal hernia repair using a standard polypropylene (Marlex(®)) or lightweight mesh (VyproII(®), TiMesh(®)). Patients attended clinical follow-up 3 years postoperatively, at which male fertility aspects, by semen analysis and scrotal ultrasound, chronic pain status (McGill Pain Questionnaire), quality of life (SF-36) and recurrence were assessed, or completed quality of life, pain and hernia-specific questionnaires at home. RESULTS: In total, 49 patients (83.1 %) completed follow-up (median follow-up = 39.1 months), by questionnaire and/or clinical follow-up. As other semen parameters and scrotal ultrasound results, sperm motility was unchanged compared to 1 year postoperatively, but not significantly different between VyproII(®) and TiMesh(®) versus Marlex(®) patients (-8.5 % and -8 % vs. -2.8 %; P = 0.23). Pain perception and quality of life were comparable between the heavyweight and lightweight groups, and no change was noted in comparison with 1 year postoperatively. Chronic pain incidence was 6.1 % (3 patients), without occurrence of disabling pain. Three patients were clinically diagnosed with a recurrent hernia (5.9 %). CONCLUSIONS: The decrease in sperm motility in patients operated on with a lightweight mesh compared to patients operated on with a heavyweight mesh 1 year after laparoscopic inguinal hernia repair could not be confirmed at 3 years follow-up. Furthermore, heavyweight and lightweight groups were comparable regarding quality of life, chronic pain and recurrence rate.

Endoscopic versus radiology-based location of rectal cancer.

BACKGROUND: Rigid proctosigmoidoscopy is recommended for measuring the height of rectal neoplasms but appears to be performed in only a minority of patients. Our aim was to compare endoscopic and radiological measurement of rectal tumour location with a focus on differentiation between mid and high rectal cancer. METHODS: Medical records of 66 rectal cancer patients were reviewed. Tumour location defined at colonoscopy (66 patients), rigid proctosigmoidoscopy (20 patients) and endorectal ultrasound (35 patients) was recorded. Rectilinear and curvilinear methods were used to estimate the distance between the lower tumour level and the anal verge on sagittal CT or MR images (66 patients). Agreement, intra- and inter-observer variation of radiology-based measurements were -assessed using intra-class correlation (ICC) and within-subject coefficient of variation (WSCV). RESULTS: Tumour location was performed at rigid proctosigmoidoscopy in 30% of patients. Intra- and inter-observer agreement for radiology-based measurements were high. Tumour location using the rectilinear method or proctosigmoidoscopy was similar on average, for a difference of only 0.34 cm (SD 2.0 cm, p = 0.330), although agreement was -moderate (ICC = 0.54, WSCV = 16.7%). Measurements based on colonoscopy and the curvilinear radiological method were -characterized by a systematic overestimation of the location, increasing with tumour height. CONCLUSIONS: Radiology-based measurement of the lower tumour level is a reproducible alternative for tumour location at rigid or flexible endoscopy. Its validity should be further assessed.

Outcome following laparoscopic and open total mesorectal excision for rectal cancer.

BACKGROUND: There are few reports on the oncological quality of resection and outcome after laparoscopic versus open total mesorectal excision (TME) for rectal cancer in everyday surgical practice. METHODS: Between January 2006 and October 2011, data for patients with mid or low rectal adenocarcinoma who underwent elective TME were recorded in the PROCARE database. A multivariable model and the propensity score as a co-variable in Cox or logistic regression models were used for adjustment of differences in patient mix and non-random assignment of surgical approach. RESULTS: Data for 2660 patients from 82 hospitals were recorded. Implementation of laparoscopic TME was highly variable. The oncological quality of resection was similar in the laparoscopic and the open group: incomplete mesorectal excision in 13·2 and 11·4 per cent respectively, circumferential resection margin positivity in 18·1 per cent, and a median of 11 lymph nodes examined per specimen in both groups. The hazard ratio for survival after laparoscopic versus open TME was 1·05 (95 per cent confidence interval 0·88 to 1·24) after correction for differences in patient mix, and 1·06 (0·89 to 1·25) after correction for the propensity score. The definitive colostomy rate was similar in the two groups: 31·0 per cent after open and 31·4 per cent after laparoscopic TME. Postoperative morbidity was lower and length of stay was shorter after laparoscopic TME compared with open TME. Survival was not negatively affected by converted laparoscopic resection, whereas postoperative morbidity, mortality and length of stay after converted laparoscopy were comparable with those after open TME. CONCLUSION: Oncological outcome is comparable after laparoscopic and open TME in everyday surgical practice.

Lessons learned after more than 400 laparoscopic ventral rectopexies.

BACKGROUND: Laparoscopic ventral recto(colpo)pexy (LVR) is a minimally invasive, autonomic nerve-sparing technique to treat rectal prolapse syndromes. The position of the mesh on the anterior aspect of the rectum in the rectovaginal septum allows correction of concomitant rectocele and enterocele. METHODS: Demographic, perioperative, and follow-up data of consecutive patients were analyzed in order to audit our 10-years' experience with the technique. RESULTS: From January 1999 to December 2008, 405 patients (93% female) underwent LVR for internal rectal prolapse (45.9%, n = 186), total rectal prolapse (43%, n = 174) and rectocele or enterocele (11.1%, n = 45). Mean age was 54.6 years (SD 15). The median hospital stay was 4 days (range 2-21). Conversion rate was 2%. There was no postoperative mortality. At a mean follow-up of 25.3 months, recurrence was observed in 4.6% (19 patients). Most often detachment of the mesh at the sacral promontory was found. Late complications occurred in 18% of patients. In five patients, LVR combined with perineotomy was complicated by mesh erosion into the vagina. Mesh erosion was not observed after LVR without perineotomy. Symptomatic improvement was observed in 85% of patients with total rectal prolapse and in 70% of patients with internal rectal prolapse (p < 0.050). The difference was mainly due to a lesser effect on obstructed defecation symptoms. CONCLUSIONS: LVR, with or without perineotomy, appears to be safe and feasible, with relatively low morbidity. Functional outcome data support its efficacy. The indication for LVR in patients with internal rectal prolapse could be optimised.

Persisting anorectal dysfunction after rectal cancer surgery.

AIM: Sphincter-saving rectal cancer management affects anorectal function. This study evaluated persisting anorectal dysfunction and its impact on patients' well-being. METHOD: Seventy-nine patients with a follow-up of 12-37 (median 22) months and 79 age- and sex-matched control subjects completed questionnaires. RESULTS: The median number of diurnal bowel movements was three in patients and one in controls (P < 0.0001). Nocturnal defaecation occurred in 53% of patients. The median Vaizey score was 8 in patients and 4 in controls (P < 0.0001). Urgency without incontinence was reported by 47% of patients and 49% of controls (P = 0.873), soiling by 28% of patients and 3% of controls (P < 0.0001), incontinence for flatus by 73% of patients and 49% of controls (P = 0.0019), and incontinence for solid stools by 16% of patients and 4% of controls (P = 0.0153). Incontinence of liquid stools occurred in 17 of 20 patients and in one of five controls who had liquid stools (P = 0.0123). Incontinence for gas, liquid or solid stool occurred once or more weekly in 47%, 19% and 6% of patients respectively. Evacuation difficulties were reported by 98% of patients, but also by 77% of controls. Neoadjuvant radio(chemo)therapy adversely affected defaecation frequency and continence. Incontinence was associated with severe discomfort in 50% of patients, severe anxiety in 40% and severe embarrassment in 48%. CONCLUSION: Anorectal dysfunction is a frequent problem after management of rectal cancer with an impact on the well-being of patients.

Treatment options to improve anorectal function following rectal resection: a systematic review.

AIM: Common problems after rectal resection are loose stools, faecal incontinence, increased frequency and evacuation difficulties, for which there are various therapeutic options. A systematic review was conducted to assess the outcome of treatment options aimed to improve anorectal function after rectal surgery. METHOD: Publications including a therapeutic approach to improve anorectal function after rectal surgery were searched using the following databases: MEDLINE, PubMed, EMBASE, Pedro, CINAHL, Web of Science, PsychInfo and the Cochrane Library. The focus was on outcome parameters of symptomatic improvement of faecal incontinence, evaluation of defaecation and quality of life. RESULTS: The degree of agreement on eligibility and methodological quality between reviewers calculated with kappa was 0.85. Fifteen studies were included. Treatment options included pelvic floor re-education (n=7), colonic irrigation (n=2) and sacral nerve stimulation (SNS) (n=6). Nine studies reported reduced incontinence scores and a decreased number of incontinent episodes. In 10 studies an improvement in resting and squeeze pressure was observed after treatment with pelvic floor re-education or SNS. Three studies reported improved quality of life after pelvic floor re-education. Significant improvement of the Fecal Incontinence Quality of Life Scale was found in three studies after SNS. CONCLUSION: Conservative therapies such as pelvic floor re-education and colonic irrigation can improve anorectal function. SNS might be an effective solution in selected patients. However, methodologically qualitative studies are limited and randomized controlled trials are needed to draw evidence-based conclusions.

Enhanced recovery after surgery (ERAS) protocol: prospective study of outcome in colorectal surgery.

BACKGROUND: Fast-track programs (ERAS) have been shown to improve postoperative recovery in colorectal surgery, combining newer anesthetic and minimally invasive surgery with evidence-based adjustments to facilitate revalidation. This prospective study evaluated the outcome of an ERAS protocol implementation in a university colorectal unit. METHODS: Between 2009 and 2010, 94 patients (49 males and 45 females) underwent an elective colorectal resection and were included in this protocol. All data were prospectively gathered in an electronic database. A cohort comparison was performed with 120 patients operated on in 2008 before ERAS implementation. RESULTS: The median age was 58 years [range: 29-76 years] and the median ASA score was 2. All colorectal procedures (85 sigmoid resections, 7 right hemicolectomies and 2 low anterior resections) were performed laparoscopically, with a conversion rate of 9,5%. Complications were noted in 14 patients (14,9%); two patients (2,1%) required a laparoscopic drainage of an infected hematoma during initial hospital stay. A significant (p < 0,001) reduced median postoperative hospital stay of 4 days [range : 2-11 days] in the ERAS group, compared with 6 days [range : 3-37] in the non fast-track group was noted. Early readmission occurred in five patients (5,3%) because of anastomotic leakage (n = 2), ileus (n = 2) and a wound infection (n = 1). CONCLUSION: These results of length of stay, morbidity and readmission-rates have important implications for the organization of health care, waiting lists and costs. Therefore the ERAS principles should be more wide-spread implemented.

HIPEC in T4a colon cancer: a defendable treatment to improve oncologic outcome?

BACKGROUND: Adequate estimation of the potential benefits of 'adjuvant' hyperthermia and intraperitoneal chemotherapy (HIPEC) in T4 patients through assessment of the burden of peritoneal carcinomatosis (PC) in T4 tumors and the risk of PC as the only metastatic site. PATIENTS AND METHODS: Analysis of prospectively collected data on patients who underwent surgery for colon cancer (Jan 2004-Jan 2007). RESULTS: About 379 patients (M/F = 204/175) were included, with a median age of 71.8 years (range 35.4-95.0): 39 stage I, 126 stage II, 89 stage III, 116 stage IV disease (+9 with unknown stage). The median follow-up was 34.8months [range 0.0-79.4]. The 3- and 5-year overall survival rates (OS) were 68.4% (95% confidence interval (CI) 63.9%-72.4%) and 60.3% (95%CI 55.6%-64.7%). Relapse analysis was restricted to stages II-III T3 (N = 154) and T4 tumors (N = 19) with complete relapse data, of which 13.2% developed PC. PC has a detrimental effect on OS [HR 6.3 (95%CI: 3.1-13.0, P < 0.0001)]. 50% of T4a and 20% of T4b developed PC. The 1- and 3-year PC percentage was significantly lower for T3 (4.5% and 9.3%) than T4 tumors (15.6% and 36.7%) (P = 0.008). PC was the only metastatic site in 3/15 T3 [proportion 0.20, 95%CI (0.043-0.481)] and 5/8 T4 tumors with PC [proportion 0.625, 95%CI (0.245-0.915)] (P = 0.071). CONCLUSIONS: T4a colon tumors have a significantly higher risk of developing PC. Twenty-five percent (5/19) of stages II-III T4 tumors develop PC as the only metastatic site. This could define the possible window of opportunity for adjuvant HIPEC to prevent PC.

Exploring limits for data registration in the context of PROCARE, a quality improvement project on rectal cancer.

BACKGROUND: A high burden of registration in the context of quality improvement projects may result in registration fatigue. METHODS: Time required for data collection and registration was measured. Quality of care indicators (QCI) were scored and factors for adjusted benchmarking were identified. The PROCARE data set was compared with 5 other European data sets. RESULTS: Time required for data collection varied per domain while time for registration was more uniform. On average, per item 33 seconds were needed for collection and registration. The number of data to be registered per patient was 48-276, depending on the stage of the disease, resulting in a minimum of 25 minutes and a maximum of 2 hours 4 minutes per patient, follow-up not included. Focusing on 43 clinically relevant QCIs would result in a 50% reduction, using aggregate scores for performance audit in a 71% reduction. The PROCARE data set was larger than comparable European data sets. Linkage of the PROCARE database with administrative databases provided confident data on the patients' survival status, but did not appear to be a practical option for other QCIs. CONCLUSIONS: Limiting the aim to performance audit could significantly reduce the burden of registration. In the context of a quality improvement project, the PROCARE Steering Group concluded that detailed clinical data from all centres are still required, which can be reconsidered in the future. Maintenance of a specific database remains of crucial value. Data collection and registration cannot be based on benevolence but should be compensated for.

Defunctioning stoma and anastomotic leak rate after total mesorectal excision with coloanal anastomosis in the context of PROCARE.

BACKGROUND: Anastomotic leakage (AL) after total mesorectal excision is a major adverse event. Construction of a defunctioning stoma (DS) reduces the morbidity of AL. This study aims to illustrate the AL rate and its related morbidity with and without primary stoma formation in the context of a Belgian project, PROCARE. METHODS: Between January 2006 and March 2011, 1912 patients who underwent elective TME with colo-anal anastomosis for invasive rectal adenocarcinoma up to 15 cm above the anal verge were registered. A primary DS was constructed in 1183 patients (62%). Early clinical AL rate, AL-related re-operation rate, length of stay (LoS), in-hospital mortality were analysed. RESULTS: In patients without leak, mortality was 1.1% and the mean LoS was 14.7 days. AL occurred in 6.5%, varying from 0%-25% between participating centres. In patients with AL, mortality was 4.8% (p < 0.001). In the presence of a primary DS, AL rate was 4.3%, requiring re-operation under narcosis in 78% with no mortality, resulting in a mean LoS of 30.4 days. In the absence of a primary DS, AL rate was 10.2%, requiring re-operation under narcosis in 93% with a mortality of 8.1% and a mean LoS of 33.4 days. Analysis per centre showed a weak relation between percentage of DS construction and AL rate. CONCLUSION: Construction of a primary DS significantly reduced the incidence of early AL, re-operation rate, and mortality. Although technical aspects of colo-anal anastomosis are of paramount importance, construction of a DS at primary surgery has to be considered by those teams with high early AL rate and/or high AL related mortality.

Risk adjusted benchmarking of clinical anastomotic leakage rate after total mesorectal excision in the context of an improvement project.

AIM: Anastomotic leakage (AL) after total mesorectal excision (TME) is a major adverse event. This study evaluates variability in AL between centres participating on a voluntary basis in PROCARE, a Belgian improvement project, and how further improvement of the AL rate might be achieved. METHOD: Between January 2006 and March 2011, detailed data on 1815 patients (mean age 65.5 years, 63% male) who underwent elective TME with colo-anal reconstruction for rectal cancer were registered by 48 centres. Variability in early clinical AL rate was analysed before and after adjustment for gender, age > 60 years, American Society of Anesthesiologists score of 3 or more and body mass index > 25 kg/m(2). RESULTS: The overall AL rate was 6.7% (95% CI 5.6%-7.9%). Early AL required reoperation in 86.8% of patients. It increased length of hospital stay from 14.7 days to 32.4 days and in-hospital mortality from 1.1% to 4.8%. Statistically significant variability in AL rate between centres was not observed, either before or after risk adjustment. Nonetheless, further improvement may be achievable in some centres by targeting the adjusted performance of better performing centres. These centres used neoadjuvant treatment, rectal irrigation, mobilization of the splenic flexure, resection of the sigmoid colon, side-to-end colo-anastomosis with or without pouch and defunctioning stoma at primary surgery in a significantly higher proportion of patients than less well performing centres. CONCLUSION: The overall AL rate was low but needs to be interpreted with caution because of incomplete registration. Further improvement might be achieved by adopting the approach of better performing centres.