Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00773981
NCT00773981
Unknown
Phase 3

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"

Hvidovre University Hospital1 site in 1 country60 target enrollmentStarted: October 2008Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsColorectal Surgery

Overview

Phase
Phase 3
Enrollment
60
Locations
1
Primary Endpoint
Healing time of the anastomotic leakage
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Healing time of the anastomotic leakage

Time Frame: 1 year

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Not Applicable
The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic LeakageRectal CancerRectal NeoplasmsAnastomotic Leak
NCT03325361University of Rome Tor Vergata100
Unknown
Not Applicable
Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer SurgeryRectal Cancer
NCT02279771Donato F Altomare140
Not yet recruiting
Phase 2
Prospective Phase II Study on Continuous Circumferential Reinforcement of Laparoscopic Rectal Anastomosis to Prevent ComplicationsAnastomotic LeakageColorectal CancerOperation
NCT06495853ZHI-ZHONG PAN208
Not yet recruiting
Not Applicable
Quantification of Anastomostic Blood Flow With Fluorescence Imaging in Low Anterior Resection for Rectal CancerAnastomotic Leak
NCT05627934Odense University Hospital168
Unknown
Phase 4
Prevention of Anastomotic Leak in Gastrointestinal (GI) Anastomosis With the Application of Tisseal in the Anastomotic LineAnastomotic Leak
NCT01306851Hospital General Universitario Gregorio Marañon200