Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer
Primary Purpose
Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Peritoneal Microdialysis, CT-scan, leakage scoring
Sponsored by
About this trial
This is an interventional diagnostic trial for Cancer focused on measuring Anastomotic leakage after LAR
Eligibility 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
Sites / Locations
- Odense University hospitalRecruiting
- Vejle hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Microdialysis
Arm Description
Outcomes
Primary Outcome Measures
Significant elevated peritoneal microdialysis parameter like lactate and L/P-ratio
Secondary Outcome Measures
Full Information
NCT ID
NCT01062334
First Posted
January 28, 2010
Last Updated
February 4, 2014
Sponsor
Odense University Hospital
Collaborators
Vejle Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01062334
Brief Title
Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Vejle Hospital
4. Oversight
5. Study Description
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.
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. ------
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Anastomotic leakage after LAR
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microdialysis
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Peritoneal Microdialysis, CT-scan, leakage scoring
Intervention Description
Peritoneal microdialysis CT-scan before discharge Leakage scoring daily
Primary Outcome Measure Information:
Title
Significant elevated peritoneal microdialysis parameter like lactate and L/P-ratio
Time Frame
Clinically complications with in 30th days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Ellebæk Pedersen, MD
Phone
40880511
Email
markep01@gmail.com
Facility Information:
Facility Name
Odense University hospital
City
Odense C.
State/Province
Fyn
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Ellebæk Pedersen, MD
Phone
40880511
Email
markep01@gmail.com
Facility Name
Vejle hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Ellebæk Pedersen, MD
Phone
40880511
Email
markep01@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer
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