Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer

Not Applicable

• Conditions: Cancer
• Interventions: Procedure: Peritoneal Microdialysis, CT-scan, leakage scoring

• Registration Number: NCT01062334
• Lead Sponsor: Odense University Hospital

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.

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. ------

Study Timeline

• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Study Start: 2010-03
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-04
• Last Update Posted: 2014-02-05
• Primary Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Histological verified cancer
• The cancer must be located in rectum maximum of 15 cm.
• Diverting stoma is allowed
• Perioperative radio-chemotherapy is allowed

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Exclusion Criteria

• Disseminated cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microdialysis	Peritoneal Microdialysis, CT-scan, leakage scoring	-

Primary Outcome Measures

Name	Time	Method
Significant elevated peritoneal microdialysis parameter like lactate and L/P-ratio	Clinically complications with in 30th days after surgery

Trial Locations

Locations (2)

Odense University hospital; 🇩🇰 Odense C., Fyn, Denmark

Vejle hospital; 🇩🇰 Vejle, Denmark