Status:
UNKNOWN
Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection
Lead Sponsor:
Hvidovre University Hospital
Collaborating Sponsors:
Braun Aesculap
Conditions:
Colorectal Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 met...
Eligibility Criteria
Inclusion
- Patients with clinically significant\* anastomotic leakage after intended curative rectal resection (LAR) for rectal cancer with primary anastomosis.
- Patients whose operation did not include ileostomy must have surgery to create a stoma within two days after beginning of the vacuum therapy and before randomization. Anastomotic leakage must have been diagnosed within 21 days of the primary operation.
- Patients with and without preoperative radiation therapy may participate.
- Groups will be formed accordingly, because patients who had preoperative radiation therapy heal more slowly.
- Patients with anastomotic leakage (diagnosed by endoscopic or radiology techniques) and clinical signs and symptoms indicating a health impairment (fever, pain, elevated creatinine levels).
- Anastomotic leakage after rectal cancer surgery
Exclusion
- Informed consent
- Age \< 18 years
- Acute surgery
- Leakage diagnosed more than 21 days after the primary operation
- Patient does not consent to temporary ileostomy
- Anastomosis technically inaccessible for vacuum-assisted drainage
- Small intestine visible in abscess cavity
- Residual cancer tissue in the pelvic cavity
- Suspicion of fistulation between the abscess cavity and internal genitalia, urinary tract system, or small intestines.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00773981
Start Date
October 1 2008
End Date
October 1 2011
Last Update
November 4 2008
Active Locations (1)
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1
Hvidovre University Hospital
Hvidovre, Hvidovre, Denmark, 2650