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Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: A randomized multicenter trial
Linköping University, Department of Biomedicine and Surgery, Surgery. Linköping University, Faculty of Health Sciences.
Linköping University, Faculty of Health Sciences. Linköping University, Department of Biomedicine and Surgery, Division of surgery. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Surgery in Östergötland.
Departments of Surgery, Örebro University Hospital, Örebro, Sweden.
Höglandssjukhuset, Eksjö, Sweden.
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2007 (English)In: Annals of Surgery, ISSN 0003-4932, Vol. 246, no 2, 207-214 p.Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: The aim of this randomized multicenter trial was to assess the rate of symptomatic anastomotic leakage in patients operated on with low anterior resection for rectal cancer and who were intraoperatively randomized to a defunctioning stoma or not.

SUMMARY BACKGROUND DATA: The introduction of total mesorectal excision surgery as the surgical technique of choice for carcinoma in the lower and mid rectum has led to decreased local recurrence and improved oncological results. Despite these advances, perioperative morbidity remains a major issue, and the most feared complication is symptomatic anastomotic leakage. The role of the defunctioning stoma in regard to anastomotic leakage is controversial and has not been assessed in any randomized trial of sufficient size.

METHODS: From December 1999 to June 2005, a total of 234 patients were randomized to a defunctioning loop stoma or no loop stoma. Loop ileostomy or loop transverse colostomy was at the choice of the surgeon. Inclusion criteria for randomization were expected survival >6 months, informed consent, anastomosis ≤7 cm above the anal verge, negative air leakage test, intact anastomotic rings, and absence of major intraoperative adverse events.

RESULTS: The overall rate of symptomatic leakage was 19.2% (45 of 234). Patients randomized to a defunctioning stoma (n = 116) had leakage in 10.3% (12 of 116) and those without stoma (n = 118) in 28.0% (33 of 118) (odds ratio = 3.4, 95% confidence interval, 1.6-6.9, P < 0.001). The need for urgent abdominal reoperation was 8.6% (10 of 116) in those randomized to stoma and 25.4% (30 of 118) in those without (P < 0.001). After a follow-up of median 42 months (range, 6-72 months), 13.8% (16 of 116) of the initially defunctioned patients still had a stoma of any kind, compared with 16.9% (20 of 118) those not defunctioned (not significant). The 30-day mortality after anterior resection was 0.4% (1 of 234) and after elective reversal a defunctioning stoma 0.9% (1 of 111). Median age was 68 years (range, 32-86 years), 45.3% (106 of 234) were females, 79.1% (185 of 234) had preoperative radiotherapy, the level of anastomosis was median 5 cm, and intraoperative blood loss 550 mL, without differences between the groups.

CONCLUSION: Defunctioning loop stoma decreased the rate of symptomatic anastomotic leakage and is therefore recommended in low anterior resection for rectal cancer.

Place, publisher, year, edition, pages
2007. Vol. 246, no 2, 207-214 p.
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:liu:diva-39703DOI: 10.1097/SLA.0b013e3180603024Local ID: 50858OAI: oai:DiVA.org:liu-39703DiVA: diva2:260552
Available from: 2009-10-10 Created: 2009-10-10 Last updated: 2009-12-02Bibliographically approved
In thesis
1. Rectal cancer surgery: Defunctioning stoma, anastomotic leakage and postoperative monitoring
Open this publication in new window or tab >>Rectal cancer surgery: Defunctioning stoma, anastomotic leakage and postoperative monitoring
2006 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

The understanding of the mesorectal spread in rectal cancer has lead to wide acceptance of total mesorectal excision (TME) as the surgical technique of choice for carcinoma in the lower and mid rectum. While oncological results and survival have improved with TME-surgery, morbidity and mortality remain important issues. The most feared complication is symptomatic anastomotic leakage. The aim of this thesis was to focus on the role of the defunctioning stoma, risk factors, and postoperative monitoring in regard to anastomotic leakage in sphincter saving resection of the rectum.

Intraoperative adverse events were analysed in a retrospective population based case-control study in which all patients who underwent elective anterior resection in Sweden between 1987 and 1995, and who died within 30 days or during the initial hospital stay (n=140), were compared with patients chosen at random (n=423) who underwent the same operation during the same period, but survived the operation. Intraoperative adverse events were more frequent in those who died, and reconstruction of an anastomosis judged unsatisfactory by the surgeon improved the outcome.

In a population based retrospective case-control study, risk factors for symptomatic anastomotic leakage were investigated in randomly chosen sample of patients who underwent anterior resection in Sweden between 1987 and 1995 (n=432). Twelve per cent of the patients developed symptomatic leakage, and 25% of the patients with leakage ended up with a permanent stoma. In multivariate regression analysis, low anastomosis, preoperative radiotherapy, male gender and intraoperative adverse events were independent riskfactors for anastomotic leakage.

In a randomised multicentre trial patients operated with sphincter saving TME¨surgery for rectal cancer were randomised to a defunctioning stoma (n=116) or not (n=118). The overall rate symptomatic leakage was 19%. Patienst without a defunctioning stoma leaked in 28% and patients with a defunctioing stoma in 10%, a statistically significant difference (p<0.001) not previously demonstrated in any randomised trial of adequate size.

Postoperative monitoring with computed tomography scan (CT-scan) on postoperative day 2 and 7, and C-reactive protein (CRP) daily in 33 patients operated on with anterior resection of the rectum, demonstrated larger pelvic fluid collections in patients with leakage before the leakage was clinically diagnosed. CRP was increased from postoperative day 2 and onwards in patients in whom clinical leakage was diagnosed on median postoperative day 8.

In 23 patients who underwent anterior resection of the rectum, intraperitoneal metabolism was investigated using microdialysis technique measuring the carbohydrate metabolites lactate, pyruvate and glucose. Intraperitoneal cytokines IL-6, IL-10 and TNF-α were collected through a pelvic drain and analysed. In patients who developed leakage, the latate/pyruvate ratio was increased near the anastomosis on postoperative day 5 and 6, as well as IL-6 and IL-10 which were increased postoperatively day 1 and 2, while TNF-α was higher on day 1.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronci Press, 2006. 72 p.
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 940
Keyword
Anterior resection of the rectum, total mesorectal excision, TME, anastomotic leakage, defunctioning stoma, risk factors, intraoperative adverse events, population based study, postoperative monitoring, CT-scan microdialysis, cytokines
National Category
Surgery
Identifiers
urn:nbn:se:liu:diva-7695 (URN)91-85497-80-0 (ISBN)
Public defence
2006-04-20, Wilandersalen, Universitetssjukhuset i Örebro, Örebro, 09:15 (English)
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Supervisors
Available from: 2006-11-06 Created: 2006-11-06 Last updated: 2009-12-03Bibliographically approved

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Matthiessen, PeterHallböök, OlofSjödahl, Rune

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