Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. A randomised study of colostomies in low colorectal anastomoses. Diverting stoma after low anterior resection: more arguments in favor. Protective colostomy in low anterior resection of the rectum using the EEA stapling instrument. A randomized study. Defunctioning loop ileostomy with low anterior resection for distal rectal cancer: should we make an ileostomy as a routine procedure? A prospective randomized study.
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. 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 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. Anastomotic leakage is a major problem in colorectal surgery particularly in low rectal cancer. The defunctioning loop ileostomy was introduced as a technique to create a manageable stoma that would divert the fecal stream from a more distal anastomosis in order to reduce the consequences of any anastomotic leakage. Therefore, the use of a defunctioning stoma has been suggested, but limited data exist to clearly determine the necessity of routine diversion. This study was designed to evaluate early morbidity, mortality and hospital stay in patients undergoing lower rectal cancer surgery concerned with or without loop ileostomy.
                This is a prospective randomized study that was performed between May 2001 and March 2008. There were 256 patients who underwent elective low anterior resection and stapler anastomosis. They were divided into two groups. Group A consisted of 120 patients who underwent straight anastomosis without ileostomy and group B consisted of 136 patients who underwent straight anastomosis with loop ileostomy. Data regarding patient demographics, underlying pathology, anastomotic problems, and ileostomy-related problems were gathered. The patients were all monitored closely after surgery for an anastomotic leak and all stoma-related complications were recorded. Inclusion criteria consisted of biopsy proven adenocarcinoma of the rectum located at < or = 5 cm above the anal verge, age > or = 22 years, and informed consent. Exclusion criteria included age more than 90 years, associated co morbid conditions Stage IV with disease spread to liver and peritoneum.
                Indications for surgery were lower rectal cancer (n=256). Mean age 55.5 years (range 22-90 years) and a male: female ratio of 1.1:1. All patients were undergoing elective surgery for lower rectal cancer. In our study 12 patients in group A developed anastomotic leak, two of them were re-explored for anastomotic leak and Hartman's colostomy was carried out. There were two deaths in Group A. In group B anastomotic leak was seen in three patients. In all three, anastomotic healing took place at a later period of time on the 18th, 20th, and 25th postoperative day respectively without any additional morbidity and mortality. Ileostomy-related problems were minor and limited to the stoma and complaints requiring stoma nurse evaluation (n=8), dehydration requiring outpatient care (n=3), bleeding at the stoma closure site (n=l). No stoma site hernias have been identified so far.
                The use of defunctioning loop ileostomy in all patients undergoing lower rectal surgery with stapler anastomosis is beneficial and safe. Defunctioning loop ileostomy use has resulted in no anastomotic leak rate and considerable low morbidity. So according to our study, we strongly recommend defunctioning loop ileostomy as a routine procedure in patients undergoing lower rectal cancer surgery.
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.