Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection (LAR) for Recto-sigmoid Cancer
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.
Cancer of Rectum
|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|
- anastomotic leakage [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||January 2008|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
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. ------
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271986
|Odense, Denmark, 5000|
|Study Chair:||Niels Qvist, Professor||Odense University Hospital|