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

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00773981

Collaborator

Braun Aesculap (Other)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Surgery	Procedure: Transrectal vacuum assisted drainage	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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"

Study Start Date :

Oct 1, 2008

Anticipated Primary Completion Date :

Oct 1, 2011

Anticipated Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Endoluminal vacuum therapy.	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.
No Intervention: 2 Patients not receiving vacuum therapy should be treated with a catheter with daily rinsing for a minimum of 7 days.

Arm

Intervention/Treatment

Active Comparator: 1

Endoluminal vacuum therapy.

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.

No Intervention: 2

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

Outcome Measures

Primary Outcome Measures

Healing time of the anastomotic leakage [1 year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hvidovre University Hospital	Hvidovre		Denmark	2650

Sponsors and Collaborators

Hvidovre University Hospital
Braun Aesculap

Investigators

Principal Investigator: Carl F Nagell, MD, Hamlet Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00773981

Other Study ID Numbers:

H-B-2007-061

First Posted:

Oct 16, 2008

Last Update Posted:

Nov 4, 2008

Last Verified:

Oct 1, 2008

Keywords provided by , ,

anastomotic leakage

Additional relevant MeSH terms:

Anastomotic Leak

Study Results

No Results Posted as of Nov 4, 2008