Parastomal Hernia Prevention Trial

Not Applicable

• Conditions: Parastomal Hernia; Permanant colostomy; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Surgery - Other surgery

• Registration Number: ACTRN12611001252909
• Lead Sponsor: The Lyell McEwin Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-06
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Subjects requiring elective admission for an open colon or colorectal resection to include the formation of a permanent end colostomy. The procedures will include the following:
a. Abdomino-perineal resection of the rectum;
b. Rectosigmoidectomy (Hartmann’s procedure); or
c. Formation of end colostomy for incontinence.

Exclusion Criteria

1. Subjects who do not consent to participate in the trial or are unable to provide informed consent. This may include patients who are not able to understand or follow the trial protocol because English is not their first language, or because of medical or psychiatric conditions.
2. Subjects who are having emergency operations.
3. Subjects with grossly disseminated disease, who are not expected to live longer than 12 months.
4. Subjects in whom there is significant spillage of faecal contents in the area of the wound or the stoma site during the procedure.
5. Subjects with inflammatory bowel disease, including Crohn's disease or irritable bowel syndrome.
6. Subjects with concurrent infection at the operating site or the stoma site at the time of the surgery.
7. Females who are pregnant or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The formation of clinically-apparent parastomal herniae.<br>Assessment:<br>Clinical assessment of stoma site.[6 weeks and 6, 12, 36 and 120 months postoperatively.];The formation of radiologically-apparent parastomal herniae.<br>Assessment:<br>CT scan of abdomen[12, 36 and 120 months postoperatively.]