NCT01062334

Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer

Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage Ore Other Complications

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients undergoing LAR for rectum cancer is subjected to peritoneal microdialyses during the postoperative period until the 7. postoperative day. 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. Before removing the microdialysis catheter a CT whit rectal enema is preformed. Every day the patient will be evaluated whit a standardised clinical scoring system with attention at anastomotic leakage. A total of 150 patients will be included in this study. The results of the peritoneal microdialyses will be compared with the clinical scorings system 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. ------

Conditions

• Cancer

Interventions

Type	Name	Description
PROCEDURE	Peritoneal Microdialysis, CT-scan, leakage scoring	Peritoneal microdialysis CT-scan before discharge Leakage scoring daily

Timeline

• Start date: 2010-03-01
• Primary completion: 2015-03-01
• First posted: 2010-02-04
• Last updated: 2014-02-05

Locations

2 sites across 1 country: Denmark