Histologically verified and operable rectal cancer Cancer
Conditions
Interventions
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
Sponsors
Brothers of Mercy Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria
Outcome results
None listed