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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00271986
First Posted: January 4, 2006
Last Update Posted: July 22, 2011
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.
Information provided by:
Odense University Hospital
  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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): 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

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
First Submitted: January 3, 2006
First Posted: January 4, 2006
Last Update Posted: July 22, 2011
Last Verified: May 2008

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

Additional relevant MeSH terms:
Anastomotic Leak
Rectal Neoplasms
Postoperative Complications
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases


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