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

NCT ID: NCT00773981

Last Updated: 2008-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-10-31

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.

Conditions

Colorectal Surgery

Keywords

anastomotic leakage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Endoluminal vacuum therapy.

Group Type: ACTIVE_COMPARATOR

Transrectal vacuum assisted drainage

Intervention Type: PROCEDURE

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.

2

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braun Aesculap

UNKNOWN

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hamlet Hospital

Principal Investigators

Carl F Nagell, MD

Role: PRINCIPAL_INVESTIGATOR

Hamlet Hospital

Locations

Hvidovre University Hospital

Hvidovre, Hvidovre, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Carl F Nagell, MD

Role: CONTACT

Phone: + 45 44443343

Email: rikke.frederik@dadlnet.dk

Kathrine Holte, MD

Role: CONTACT

Phone: + 45 51903229

Email: kathrine.holte@dadlnet.dk

Other Identifiers

H-B-2007-061

Identifier Type: -

Identifier Source: org_study_id