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

January 3, 2006
July 20, 2011
January 2006
November 2007   (final data collection date for primary outcome measure)
anastomotic leakage [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00271986 on ClinicalTrials.gov Archive Site
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Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection (LAR) for Recto-sigmoid Cancer
Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage

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.

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. ------

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients undergoing Loa Anterior Resection (LAR) or rectal cancer

Cancer of Rectum
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2008
November 2007   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00271986
VF20050008
No
Niels Qvist, professor, Niels Qvist, Professor, Surgical Department A, Odense Universityt Hospital
Odense University Hospital
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Study Chair: Niels Qvist, Professor Odense University Hospital
Odense University Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP