Colorectal Surgery
Conditions
Keywords
anastomotic leakage
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.
Interventions
PROCEDURETransrectal 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.
Sponsors
Braun Aesculap
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing time of the anastomotic leakage | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Duration of fever and antibiotic treatment | 2 months |
| Duration of hospital stay | 2 monts |
| Salvage surgery (abdominal reoperation with debridement of anastomosis) | 1 month |
| 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 |
| Number of visits in the outpatient clinic / number of sponge changes | 8 weeks |
Countries
Denmark
Contacts
Primary ContactCarl F Nagell, MD
Backup ContactKathrine Holte, MD
Outcome results
None listed