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

NCT00773981 | Unknown Phase 3

• 1 other identifier: H-B-2007-061
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Healing time of the anastomotic leakage

  1 year

Secondary Outcomes (6)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Endoluminal vacuum therapy.

Procedure: Transrectal vacuum assisted drainage

2

NO INTERVENTION

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

Interventions

Transrectal vacuum assisted drainage 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Braun Aesculap: collaborator

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carl F Nagell, MD

  Hamlet Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl F Nagell, MD

CONTACT

+ 45 44443343; rikke.frederik@dadlnet.dk

Kathrine Holte, MD

CONTACT

+ 45 51903229; kathrine.holte@dadlnet.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 4, 2008

Record last verified: 2008-10

Locations

DK (1)