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Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Odense University Hospital.
Recruitment status was:  Recruiting
Vejle Hospital
Information provided by (Responsible Party):
Mark Ellebaek Pedersen, Odense University Hospital Identifier:
First received: January 28, 2010
Last updated: February 4, 2014
Last verified: February 2014
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.

Condition Intervention
Procedure: Peritoneal Microdialysis, CT-scan, leakage scoring

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage Ore Other Complications

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Significant elevated peritoneal microdialysis parameter like lactate and L/P-ratio [ Time Frame: Clinically complications with in 30th days after surgery ]

Estimated Enrollment: 150
Study Start Date: March 2010
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microdialysis Procedure: Peritoneal Microdialysis, CT-scan, leakage scoring
Peritoneal microdialysis CT-scan before discharge Leakage scoring daily

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. ------


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Exclusion Criteria:

  • Disseminated cancer
  Contacts and Locations
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Please refer to this study by its identifier: NCT01062334

Contact: Mark Ellebæk Pedersen, MD 40880511

Odense University hospital Recruiting
Odense C., Fyn, Denmark, 5000
Contact: Mark Ellebæk Pedersen, MD    40880511   
Vejle hospital Recruiting
Vejle, Denmark, 7100
Contact: Mark Ellebæk Pedersen, MD    40880511   
Sponsors and Collaborators
Odense University Hospital
Vejle Hospital
  More Information

Responsible Party: Mark Ellebaek Pedersen, Doctor, Odense University Hospital Identifier: NCT01062334     History of Changes
Other Study ID Numbers: S-20090147
Study First Received: January 28, 2010
Last Updated: February 4, 2014

Keywords provided by Odense University Hospital:
Anastomotic leakage after LAR

Additional relevant MeSH terms:
Anastomotic Leak
Postoperative Complications
Pathologic Processes processed this record on April 27, 2017