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

Phase 3

• Conditions: Colorectal Surgery
• Interventions: Procedure: Transrectal vacuum assisted drainage

• Registration Number: NCT00773981
• Lead Sponsor: Hvidovre University Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-10
• Study Start: 2008-10
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Last Update Submitted: 2008-11-03
• Last Update Posted: 2008-11-04
• Primary Completion: 2011-10
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Transrectal vacuum assisted drainage	Endoluminal vacuum therapy.

Primary Outcome Measures

Name	Time	Method
Healing time of the anastomotic leakage	1 year

Secondary Outcome Measures

Name	Time	Method
Salvage surgery (abdominal reoperation with debridement of anastomosis)	1 month
Duration of fever and antibiotic treatment	2 months
Duration of hospital stay	2 monts
Number of visits in the outpatient clinic / number of sponge changes	8 weeks
Functional result, defined as +/- closure of temporary ileostomy	2 years
Functional result evaluated by examination of the anal physiology in a smaller patient population (supplementary trial protocol)	2 years

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark