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

Primary Purpose

Colorectal Surgery

Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Transrectal vacuum assisted drainage
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Surgery focused on measuring anastomotic leakage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hvidovre University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

Endoluminal vacuum therapy.

Patients not receiving vacuum therapy should be treated with a catheter with daily rinsing for a minimum of 7 days.

Outcomes

Primary Outcome Measures

Healing time of the anastomotic leakage

Secondary Outcome Measures

Salvage surgery (abdominal reoperation with debridement of anastomosis)
Duration of fever and antibiotic treatment
Duration of hospital stay
Number of visits in the outpatient clinic / number of sponge changes
Functional result, defined as +/- closure of temporary ileostomy
Functional result evaluated by examination of the anal physiology in a smaller patient population (supplementary trial protocol)

Full Information

First Posted
October 15, 2008
Last Updated
November 3, 2008
Sponsor
Hvidovre University Hospital
Collaborators
Braun Aesculap
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1. Study Identification

Unique Protocol Identification Number
NCT00773981
Brief Title
Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection
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 Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital
Collaborators
Braun Aesculap

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Surgery
Keywords
anastomotic leakage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Endoluminal vacuum therapy.
Arm Title
2
Arm Type
No Intervention
Arm Description
Patients not receiving vacuum therapy should be treated with a catheter with daily rinsing for a minimum of 7 days.
Intervention Type
Procedure
Intervention Name(s)
Transrectal vacuum assisted drainage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healing time of the anastomotic leakage
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Salvage surgery (abdominal reoperation with debridement of anastomosis)
Time Frame
1 month
Title
Duration of fever and antibiotic treatment
Time Frame
2 months
Title
Duration of hospital stay
Time Frame
2 monts
Title
Number of visits in the outpatient clinic / number of sponge changes
Time Frame
8 weeks
Title
Functional result, defined as +/- closure of temporary ileostomy
Time Frame
2 years
Title
Functional result evaluated by examination of the anal physiology in a smaller patient population (supplementary trial protocol)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carl F Nagell, MD
Phone
+ 45 44443343
Email
rikke.frederik@dadlnet.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Kathrine Holte, MD
Phone
+ 45 51903229
Email
kathrine.holte@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl F Nagell, MD
Organizational Affiliation
Hamlet Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathrine Holte, MD

12. IPD Sharing Statement

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

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