Diverting ileostomy after low anterior resection
| ISRCTN | ISRCTN15655996 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15655996 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/06/2015
- Registration date
- 12/06/2015
- Last edited
- 04/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
At the moment it's unclear if patients suffering from rectal cancer who undergo surgical treatment (rectal resection) have a potential benefit of a temporary protective stoma (ileostomy)in terms of lower postoperative complications, especially at the colorectal anastomosis. Postoperative complications may lead to significant morbidity and mortality. The aim of our study is to investigate if a protective stoma may prevent severe postoperative complications.
Who can participate?
Adult patients of both sexes (age 19-85 years) suffering from rectal cancer.
What does the study involve?
All patients undergo surgical treatment (rectal resection). Before surgery a randomization of all patients is performed and two groups are created: in one group patients receive a temporary protective stoma (ileostomy) additionally to rectal surgery, in the other group patients are treated without this protective stoma. After the operation and hospital dismissal, all patients are invited to a planned study visit 10 weeks after the operation. Patients who are treated with temporary stoma gets their stoma revised 6 to 8 weeks after the primary operation. In all patients the postoperative course is documented and gets compared in a statistical analysis.
What are the possible benefits and risks of participating?
At the moment it's unclear whether patients who undergo rectal resection without protective stoma have a higher risk of postoperative complication compared to patients treated with temporary stoma. A possible benefit for lower postoperative complications may be the performance of a protective stoma.
Where is he study run from?
Brothers of Mercy Hospital St. Veit/Glan (Austria)
When is the study starting and how long is it expected to run for?
January 2004 to September 2014
Who is funding the study?
Brothers of Mercy Hospital St. Veit/Glan (Austria)
Who is the main contact?
Prof. Jörg Tschmelitsch
Contact information
Scientific
Department of Surgery
Brothers of Mercy Hospital St. Veit
Spitalgasse 26
9300 St. Veit/Glan
St. Veit/Glan
9300
Austria
| Phone | +43 (0)421 249 9475 |
|---|---|
| joerg.tschmelitsch@bbstveit.at |
Study information
| Study design | Two-arm randomised open-label multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Diverting ileostomy versus no diversion after low anterior resection for rectal cancer: a prospective randomised multicenter trial |
| Study hypothesis | To determine whether a protective diverting ileostomy improves short-term outcome in patients with rectal resection and colonic J-pouch reconstruction for low anastomoses. |
| Ethics approval(s) | Ethik-kommission des landes kärnten,14/11/2003, ref: A34/03 |
| Condition | Histologically verified and operable rectal cancer |
| Intervention | 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/01/2004 |
| Overall study end date | 01/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 210 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/01/2004 |
| Recruitment end date | 01/09/2014 |
Locations
Countries of recruitment
- Austria
Study participating centres
-
Austria
-
Austria
-
Austria
Sponsor information
Hospital/treatment centre
Spitalgasse 26
St. Veit/Glan
9300
Austria
| Phone | +43 (0)4212499475 |
|---|---|
| joerg.tschmelitsch@bbstveit.at | |
"ROR" |
https://ror.org/01fxzb657 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2016 | Yes | No |
Editorial Notes
04/08/2016: Publication reference added.
