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

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"

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Surgery
• Intervention / Treatment: Procedure: Transrectal vacuum assisted drainage

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Hvidovre University Hospital
    • Principal Investigator: Kathrine Holte, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Healing time of the anastomotic leakage	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Braun Aesculap
• Investigators: Principal Investigator: Carl F Nagell, MD, Hamlet Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: October 15, 2008
• First Submitted That Met QC Criteria: October 15, 2008
• First Posted (Estimate): October 16, 2008

Study Record Updates

• Last Update Posted (Estimate): November 4, 2008
• Last Update Submitted That Met QC Criteria: November 3, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: anastomotic leakage
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: H-B-2007-061