Colorectal Surgery Clinical Trial
Official title:
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"
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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