Prevention of post-operative pelvic bleeding and collection after sphincter-saving surgery for rectal cancer using a calcium-alginate haemostatic

Completed

• Conditions: Rectal cancer/colorectal surgery; Cancer; Malignant neoplasm of rectum

• Registration Number: ISRCTN79721331
• Lead Sponsor: Brothier Laboratories S.A. (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Written informed consent from all patients at least the day before surgery
2. Patients aged 18 years or older, either sex
3. Scheduled for elective restorative proctectomy for rectal cancer

Exclusion Criteria

1. Advanced local disease (tumour staged T4 on pre-operative rectal ultrasound, magnetic resonance imaging, or intra-operative findings)
2. No temporary protective ileostomy or colostomy after rectal resection
3. Anticoagulation or antiplatelet treatment which cannot be postponed for surgery
4. Known associated haemostasis disorder
5. Synchronous other surgical resection (excepted appendectomy and liver biopsy)
6. Emergency presentation
7. Systemic infection
8. Pelvic infection
9. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified