Condition category
Cancer
Date applied
04/06/2015
Date assigned
12/06/2015
Last edited
04/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jörg Tschmelitsch

ORCID ID

Contact details

Department of Surgery
Brothers of Mercy Hospital St. Veit
Spitalgasse 26
9300 St. Veit/Glan
St. Veit/Glan
9300
Austria
+43 (0)421 249 9475
joerg.tschmelitsch@bbstveit.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Diverting ileostomy versus no diversion after low anterior resection for rectal cancer: a prospective randomised multicenter trial

Acronym

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

Ethik-kommission des landes kärnten,14/11/2003, ref: A34/03

Study design

Two-arm randomised open-label multicentre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2004

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

210

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

Trial participating centre

Department of Surgery, Hospital of the Brothers of Mercy
Sankt Veit an der Glan
-
Austria

Trial participating centre

Department of Surgery, Hospital of the Brothers of Mercy
Graz
-
Austria

Trial participating centre

Department of Surgery, University of Salzburg
Salzburg
-
Austria

Sponsor information

Organisation

Brothers of Mercy Hospital

Sponsor details

Spitalgasse 26
St. Veit/Glan
9300
Austria
+43 (0)4212499475
joerg.tschmelitsch@bbstveit.at

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Brothers of Mercy Hospital (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26706610

Publication citations

Additional files

Editorial Notes

04/08/2016: Publication reference added.