Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01062334
Recruitment Status : Unknown
Verified February 2014 by Mark Ellebaek Pedersen, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : February 4, 2010
Last Update Posted : February 5, 2014
Vejle Hospital
Information provided by (Responsible Party):
Mark Ellebaek Pedersen, 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.

Condition or disease Intervention/treatment
Cancer Procedure: Peritoneal Microdialysis, CT-scan, leakage scoring

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2010
Estimated Primary Completion Date : March 2015

Arm Intervention/treatment
Experimental: Microdialysis Procedure: Peritoneal Microdialysis, CT-scan, leakage scoring
Peritoneal microdialysis CT-scan before discharge Leakage scoring daily

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Mark Ellebaek Pedersen, Doctor, Odense University Hospital Identifier: NCT01062334     History of Changes
Other Study ID Numbers: S-20090147
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014

Keywords provided by Mark Ellebaek Pedersen, Odense University Hospital:
Anastomotic leakage after LAR

Additional relevant MeSH terms:
Anastomotic Leak
Postoperative Complications
Pathologic Processes