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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79721331
Enrollment
84
Registered
2009-03-27
Start date
2006-04-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer/colorectal surgery Cancer Malignant neoplasm of rectum

Interventions

Resections were performed according to the standard technique of optimal mesorectal excision (either partial or total according to the level of the rectal tumour) either by laparotomy or laparoscopy.

Sponsors

Brothier Laboratories S.A. (France)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Volume of fluid collected by the pelvic suction drain.

Secondary

MeasureTime frame
1. Duration of drainage 2. Post-operative mortality and morbidity rates 3 months after surgery

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026