NCT00773981

Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection

Transrectal Vacuum Assisted Drainage: A NEW METHOD OF TREATING ANASTOMOTIC LEAKAGE AFTER RECTAL RESECTION. A Prospective Randomized Multicenter Study in Cooperation With "The Danish Colorectal Cancer Group"

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Anastomotic leakage is a major and potentially mortal complication with an incidence of 10-13% after resection of the rectum. For patients showing no clinical signs of peritonitis, the traditional method has been a conservative treatment with transrectal rinsing. This treatment is often associated with a very protracted postoperative course with healing times of up to a year or more for the anastomotic leakage. Treatment with vacuum drainage (VD) is a new method primarily developed for wound therapy. The objective of this study is to investigate the effects of transrectal vacuum treatment on the healing of anastomotic leakage after rectum resection in a prospective, randomized, controlled multicentre trial in 60 patients found to develop clinically significant anastomotic leakages after elective rectal resection.

Conditions

• Colorectal Surgery

Interventions

Type	Name	Description
PROCEDURE	Transrectal vacuum assisted drainage	Treatment with vacuum drainage (VD) is a new method primarily developed for wound therapy. The principle of the method is application of negative pressure on the wound surface with the help of a sponge that is connected to a pump. Sponge dressings should be changed 3 times pr week as long as vacuum therapy is used. If there has been no development of granulation tissue or no shrinking of the cavity in 3 weeks Vacuum therapy can be stopped. Maximum vacuum therapy is 8 weeks.

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2008-10-16
• Last updated: 2008-11-04

Locations

1 site across 1 country: Denmark