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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Hvidovre University Hospital
Hvidovre, Hvidovre, Denmark
RECRUITINGHealing time of the anastomotic leakage
Time frame: 1 year
Salvage surgery (abdominal reoperation with debridement of anastomosis)
Time frame: 1 month
Duration of fever and antibiotic treatment
Time frame: 2 months
Duration of hospital stay
Time frame: 2 monts
Number of visits in the outpatient clinic / number of sponge changes
Time frame: 8 weeks
Functional result, defined as +/- closure of temporary ileostomy
Time frame: 2 years
Functional result evaluated by examination of the anal physiology in a smaller patient population (supplementary trial protocol)
Time frame: 2 years
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