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

Hvidovre University Hospital

Status and phase: Unknown; Phase 3

Conditions: Colorectal Surgery

Treatments: Procedure: Transrectal vacuum assisted drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT00773981

H-B-2007-061

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Active Comparator group

Description:

Endoluminal vacuum therapy.

Treatment:

Procedure: Transrectal vacuum assisted drainage

2

No Intervention group

Description:

Patients not receiving vacuum therapy should be treated with a catheter with daily rinsing for a minimum of 7 days.