A randomised study of colostomies in low colorectal anastomoses. Diverting stoma after low anterior resection: more arguments in favor. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Protective colostomy in low anterior resection of the rectum using the EEA stapling instrument. A randomized study. Comparison of J-pouch and coloplasty pouch for low rectal cancers: a randomized, controlled trial investigating functional results and comparative anastomotic leak rates.
To assess the value of covering colostomy for patients undergoing low anterior resection for rectal neoplasms.
                Prospective randomised study.
                Two university hospitals, Finland.
                38 patients with air-tight stapled end-to-end anastomoses and complete anastomotic tissue rings were randomly allocated to have a covering colostomy (n = 19) or not.
                Postoperative mortality, anastomotic leaks, reoperations for leaks.
                The clinical leak rate was 24% (9/38) and six patients (16%) had radiological leaks. The total number of leaks (clinical and radiological together) was similar in the two groups, 7/19 compared with 8/19, respectively. There were fewer clinical leaks in the colostomy group (3/19; 16% compared with 6/19; 32%), but the difference was not significant. Reoperations for leaks were necessary more often in patients who did not have a covering colostomy (6/19; 32% compared with 1/19; 5%, p = 0.09). Two patients who did not have a stoma died from the infective complications of their leaks and one died of heart failure in the colostomy group. One patient who had not been given a stoma initially was left with a permanent colostomy after a leak.
                Our results suggest that a covering colostomy does not reduce the leak rate after low anterior resection, but prevents most of the severe infective consequences of the leaks. The necessity of a protective stoma in patients undergoing low anterior resection with total mesorectal excision for primary rectal cancer is discussed controversially. We conducted a randomized, controlled, pilot-study to evaluate the need for diverting ileostomy in patients undergoing low anterior resection [NCT00457327].
                Forty patients after elective sphincter-saving low anterior resection were eligible for intraoperative randomization. The primary objective of this trial was to demonstrate similar risks after the resection with both techniques. A priori stopping rules were defined for early termination of the trial.
                Between July 4, 2006 and March 12, 2007, a total of 41 patients were screened and 34 patients were randomized. Eighteen patients were randomized to the stoma group and 16 patients to the nonstoma group The symptomatic anastomotic leakage rate was significantly higher in the nonstoma group (37.5 percent) than in the stoma group (5.5 percent, P = 0.02). In all six cases in the nonstoma group, reoperations were necessary. The study was stopped after 34 patients were included. A meta-analysis of the available data confirmed the value of a protective ostomy for patients undergoing low anterior resection.
                The data demonstrate a high risk for patients undergoing low anterior resection without diverting ileostomy. 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.
                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.
                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 < or =7 cm above the anal verge, negative air leakage test, intact anastomotic rings, and absence of major intraoperative adverse events.
                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.
                Defunctioning loop stoma decreased the rate of symptomatic anastomotic leakage and is therefore recommended in low anterior resection for rectal cancer. The need for protective transverse colostomy in low anterior resection using the EEA stapler was tested in a randomized series of 50 patients, half of whom received peroperative protective colostomy. Gastrografin enema on the tenth postoperative day showed a leakage frequency of 30 per cent in both groups. Clinical leakage was noted in 4 per cent (one patient) in the colostomy group and 12 per cent (three patients) in the noncolostomy group. Protective colostomy was followed by stenosis in nine instances, compared with only two in the noncolostomy group (2 alpha = 0.05). Routine protective colostomy should not be used in low anterior resection when the EEA stapling instrument is used. The occasional clinical leakage, which may appear in the postoperative period, can be revealed by close observation and successfully treated by an emergency colostomy. The majority of patients with anterior resection of the rectum, therefore, can be spared the inconvenience and cost of temporary colostomy. To assess the efficacy of a novel coloplasty colonic pouch design in optimizing bowel function after ultralow anterior resection.
                A colonic J-pouch may reduce excessive stool frequency and incontinence after anterior resection, but at the risk of evacuation problems. Experimental surgery on pigs has suggested that a coloplasty pouch (CP) may be a useful alternative. Although CP has recently been shown to be feasible in patients, there is no randomized controlled trial comparing bowel function with the J-pouch.
                After anterior resection for cancer, patients were allocated to either J-pouch or CP-anal anastomoses. Continence scoring, anorectal manometry, and endoanal ultrasound assessments were made before surgery. All complications were recorded, and these preoperative assessments were repeated at 4 months. The assessments were repeated again at 1 year, and a quality of life questionnaire was added.
                Eighty-eight patients were recruited from October 1998 to April 2000. Both groups were well matched for age, gender, staging, adjuvant therapy, and mean follow-up. There were no differences in the intraoperative time and hospital stay. CP resulted in more anastomotic leaks. At 4 months, J-pouch patients had 10.3% less stool fragmentation but poorer stool deferment and more nocturnal leakage. However, there were no differences in the bowel function, continence score, and quality of life at 1 year. There were no differences in the anorectal manometry and endoanal ultrasound findings.
                Coloplasty pouches resulted in more anastomotic leaks and minimal differences in bowel function. At present, the J-pouch remains the benchmark for routine clinical practice, and due care (including defunctioning stoma) should be exercised in situations requiring CP.
Covering stoma seems to be useful to prevent anastomotic leakage and urgent re-operations in patients receiving low anterior resection for rectal cancer. However, covering stoma does not seems to offer advantage in term of 30 days or long term mortality.