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

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00271986
Collaborator
(none)
60
Enrollment
1
Location
24
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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. ------

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    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
    Study Start Date :
    Jan 1, 2006
    Actual Primary Completion Date :
    Nov 1, 2007
    Actual Study Completion Date :
    Jan 1, 2008

    Outcome Measures

    Primary Outcome Measures

    1. anastomotic leakage [within 30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Deparment A Odense Denmark 5000

    Sponsors and Collaborators

    • Odense University Hospital

    Investigators

    • Study Chair: Niels Qvist, Professor, Odense University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00271986
    Other Study ID Numbers:
    • VF20050008
    First Posted:
    Jan 4, 2006
    Last Update Posted:
    Jul 22, 2011
    Last Verified:
    May 1, 2008
    Keywords provided by , ,
    Peritoneal microdialysis
    Low anterior resection
    Recto-sigmoid cancer
    Anastomotic leakage
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Jul 22, 2011