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Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Hvidovre University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00773981
First Posted: October 16, 2008
Last Update Posted: November 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Braun Aesculap
Information provided by:
Hvidovre University Hospital
  Purpose

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 Intervention Phase
Colorectal Surgery Procedure: Transrectal vacuum assisted drainage Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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"

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Healing time of the anastomotic leakage [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: October 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Carl F Nagell, MD + 45 44443343 rikke.frederik@dadlnet.dk
Contact: Kathrine Holte, MD + 45 51903229 kathrine.holte@dadlnet.dk

Locations
Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Denmark, 2650
Principal Investigator: Kathrine Holte, MD         
Sponsors and Collaborators
Hvidovre University Hospital
Braun Aesculap
Investigators
Principal Investigator: Carl F Nagell, MD Hamlet Hospital
  More Information

Responsible Party: Dr Carl Frederik Nagell, Hamlet Hospital
ClinicalTrials.gov Identifier: NCT00773981     History of Changes
Other Study ID Numbers: H-B-2007-061
First Submitted: October 15, 2008
First Posted: October 16, 2008
Last Update Posted: November 4, 2008
Last Verified: October 2008

Keywords provided by Hvidovre University Hospital:
anastomotic leakage

Additional relevant MeSH terms:
Anastomotic Leak
Postoperative Complications
Pathologic Processes