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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00271986

Enrollment

Registered

2006-01-04

Start date

2006-01-31

Completion date

2008-01-31

Last updated

2011-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of Rectum

Keywords

Peritoneal microdialysis, Low anterior resection, Recto-sigmoid cancer, Anastomotic leakage

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 develops.

Detailed 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. ------

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
anastomotic leakage	within 30 days

Countries

Denmark

Outcome results