Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection (LAR) for Recto-sigmoid Cancer

Cancer of Rectum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271986
• Other study ID #: VF20050008
• Status: Completed
• Phase: N/A
• First received: January 3, 2006
• Last updated: July 20, 2011
• Start date: January 2006
• Est. completion date: January 2008

Study information

• Verified date: May 2008
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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 develops.

Description:

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. ------

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anastomotic Leak
• Cancer of Rectum

Locations

Country	Name	City	State
Denmark	Deparment A	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anastomotic leakage		within 30 days	No