Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection
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|ClinicalTrials.gov Identifier: NCT00773981|
Recruitment Status : Unknown
Verified October 2008 by Hvidovre University Hospital.
Recruitment status was: Recruiting
First Posted : October 16, 2008
Last Update Posted : November 4, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Surgery||Procedure: Transrectal vacuum assisted drainage||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2008|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||October 2011|
Active Comparator: 1
Endoluminal vacuum therapy.
Procedure: Transrectal 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.
No Intervention: 2
Patients not receiving vacuum therapy should be treated with a catheter with daily rinsing for a minimum of 7 days.
- Healing 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773981
|Contact: Carl F Nagell, MD||+ 45 firstname.lastname@example.org|
|Contact: Kathrine Holte, MD||+ 45 email@example.com|
|Hvidovre University Hospital||Recruiting|
|Hvidovre, Denmark, 2650|
|Principal Investigator: Kathrine Holte, MD|
|Principal Investigator:||Carl F Nagell, MD||Hamlet Hospital|