Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Odense University Hospital
Sponsor:
Collaborator:
Vejle Hospital
Information provided by (Responsible Party):
Mark Ellebaek Pedersen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01062334
First received: January 28, 2010
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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
Cancer
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 ] [ Designated as safety issue: No ]

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. ------

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062334

Contacts
Contact: Mark Ellebæk Pedersen, MD 40880511 markep01@gmail.com

Locations
Denmark
Odense University hospital Recruiting
Odense C., Fyn, Denmark, 5000
Contact: Mark Ellebæk Pedersen, MD    40880511    markep01@gmail.com   
Vejle hospital Recruiting
Vejle, Denmark, 7100
Contact: Mark Ellebæk Pedersen, MD    40880511    markep01@gmail.com   
Sponsors and Collaborators
Odense University Hospital
Vejle Hospital
  More Information

No publications provided

Responsible Party: Mark Ellebaek Pedersen, Doctor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01062334     History of Changes
Other Study ID Numbers: S-20090147
Study First Received: January 28, 2010
Last Updated: February 4, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Anastomotic leakage after LAR

Additional relevant MeSH terms:
Anastomotic Leak
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014