Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection (LAR) for Recto-sigmoid Cancer

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00271986
First received: January 3, 2006
Last updated: July 20, 2011
Last verified: May 2008
  Purpose

Anastomotic leakage is a serious complication after LAR with high morbidity and mortality rates. Early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of peritoneal microdialysis and whether is able to detect anastomotic leakage prior to clinical symptoms develops.


Condition
Cancer of Rectum

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • anastomotic leakage [ Time Frame: within 30 days ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2006
Study Completion Date: January 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Patients undergoing LAR for recto-sigmoid cancer is subjected to peritoneal microdialyses during the postoperative period until discharge. Subcutaneous microdialysis serve as control. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient.

Patients undergoing abdomino-perineal rectal resection will serve as a control group.

A total of 50 patients will be included in this pilot study. The results of the peritoneal microdialyses will be compared with the clinical course in each patient. The results form the uncomplicated courses will be used to define the normal variations in peritoneal microdialysis. This will be compared to results from patients with various complications.

The study is approved by the local scientific ethical committee No. ------

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing Loa Anterior Resection (LAR) or rectal cancer

Criteria

Inclusion Criteria:

  • Histological verified cancer
  • The cancer must be located in rectum or the sigmoid colon
  • Diverting stoma is allowed
  • Perioperative radio-chemotherapy is allowed

Exclusion Criteria:

  • Disseminated cancer
  • ASA-group 4 ore higher
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00271986

Locations
Denmark
Deparment A
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Study Chair: Niels Qvist, Professor Odense University Hospital
  More Information

No publications provided

Responsible Party: Niels Qvist, professor, Niels Qvist, Professor, Surgical Department A, Odense Universityt Hospital
ClinicalTrials.gov Identifier: NCT00271986     History of Changes
Other Study ID Numbers: VF20050008
Study First Received: January 3, 2006
Last Updated: July 20, 2011
Health Authority: Denmark: Ethics Committee

Keywords provided by Odense University Hospital:
Peritoneal microdialysis
Low anterior resection
Recto-sigmoid cancer
Anastomotic leakage

Additional relevant MeSH terms:
Anastomotic Leak
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on October 22, 2014