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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
January 3, 2006
January 4, 2006
July 22, 2011
January 2006
November 2007   (Final data collection date for primary outcome measure)
anastomotic leakage [ Time Frame: within 30 days ]
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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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00271986
VF20050008
No
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Niels Qvist, professor, Niels Qvist, Professor, Surgical Department A, Odense Universityt Hospital
Odense University Hospital
Not Provided
Study Chair: Niels Qvist, Professor Odense University Hospital
Odense University Hospital
May 2008