Diverting ileostomy after low anterior resectio
Completed
- Conditions
- Histologically verified and operable rectal cancerCancer
- Registration Number
- ISRCTN15655996
- Lead Sponsor
- Brothers of Mercy Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
1. Patients aged 19 to 85 years with biopsy-proven and operable rectal cancer
2. Patients with or without preoperative radio-chemotherapy
3. Patients with a distal border of the tumour within 16 cm from the anal verge as demonstrated by rigid rectoscopy
4. Patients with a WHO performance status = 2
Exclusion Criteria
1. Patients with previous rectal surgery
2. Emergency cases
3. Planned laparoscopic resections
4. Patients suffering from metastatic disease or synchronous colon cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint of the present study was the overall anastomotic leakage rate as defined by one of the following: <br>1. Radiologic leak: radiologic evidence of a leak in a Gastrografin enema and/or CT scan without clinical signs of anastomotic leakage<br>2. Clinical leak: radiologic evidence of a leak in a Gastrografin enema and/or CT scan and/or sigmoidoscopy with one or more of the following clinical signs: elevated temperature (> 380C), leucocytosis, peritonitis, putrid or faecal discharge over the drainage or fistulas (recto-vaginal)
- Secondary Outcome Measures
Name Time Method 1. Surgical complications related to primary surgery, to the stoma before closure and to secondary surgery for stoma closure<br>2. Postoperative mortality defined as death on account of any cause during the hospital stay due to the primary operation or stoma closure<br>3. The length of hospital stay in days for the primary operation and stoma closure