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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"


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Surgery

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Trial Information

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"


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Healing time of the anastomotic leakage

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Carl F Nagell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hamlet Hospital

Authority:

Denmark: Ethics Committee

Study ID:

H-B-2007-061

NCT ID:

NCT00773981

Start Date:

October 2008

Completion Date:

October 2011

Related Keywords:

  • Colorectal Surgery
  • anastomotic leakage
  • Anastomotic Leak

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