Diverting ileostomy after low anterior resection

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN15655996
• Date of registration: 12/06/2015
• Prospective Registration: No
• Primary sponsor: Brothers of Mercy Hospital
• Public title: Diverting ileostomy after low anterior resection
• Scientific title: Diverting ileostomy versus no diversion after low anterior resection for rectal cancer: a prospective randomised multicenter trial
• Date of first enrolment: 01/01/2004
• Target sample size: 210
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN15655996
• Study type: Interventional
• Study design: Two-arm randomised open-label multicentre study (Treatment)

Countries of recruitment

Austria

Contacts

• Name: Jörg Tschmelitsch

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Histologically verified and operable rectal cancer
Cancer

Intervention(s)

Patients were stratified by gender, anastomotic height and preoperative radio-chemotherapy to be operated either by rectal resection and colo-anal/rectal anastomosis with a diverting ileostomy (group A) or rectal resection and colo-anal/rectal anastomosis without protective ileostomy (group B). Patients in both groups with low anastomoses (< 8 cm) were planned to receive a colonic J-pouch reconstruction.

Primary Outcome(s)

The primary efficacy endpoint of the present study was the overall anastomotic leakage rate as defined by one of the following:
1. Radiologic leak: radiologic evidence of a leak in a Gastrografin enema and/or CT scan without clinical signs of anastomotic leakage
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(s)

1. Surgical complications related to primary surgery, to the stoma before closure and to secondary surgery for stoma closure
2. Postoperative mortality defined as death on account of any cause during the hospital stay due to the primary operation or stoma closure
3. The length of hospital stay in days for the primary operation and stoma closure

Secondary ID(s)

N/A

Source(s) of Monetary Support

Brothers of Mercy Hospital (Austria)