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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Surgery

Intervention / Treatment
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* Procedure: Transrectal vacuum assisted drainage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Endoluminal vacuum therapy. | Procedure: Transrectal vacuum assisted drainage<br>* 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.<br>|
| No Intervention: 2<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anastomotic leakage