Clinical trial NCT00773981: Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Surgery
Keywords: anastomotic leakage
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Braun Aesculap
First posted: 2008-10-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Healing time of the anastomotic leakage
timeFrame: 1 year
Secondary outcomes:
measure: Salvage surgery (abdominal reoperation with debridement of anastomosis)
timeFrame: 1 month
measure: Duration of fever and antibiotic treatment
timeFrame: 2 months
measure: Duration of hospital stay
timeFrame: 2 monts
measure: Number of visits in the outpatient clinic / number of sponge changes
timeFrame: 8 weeks
measure: Functional result, defined as +/- closure of temporary ileostomy
timeFrame: 2 years
measure: Functional result evaluated by examination of the anal physiology in a smaller patient population (supplementary trial protocol)
timeFrame: 2 years
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hamlet Hospital
name: Carl F Nagell, MD
role: PRINCIPAL_INVESTIGATOR
References: