Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00271986
Status:
COMPLETED
Last Update Posted:
2011-07-22
First Post:
2006-01-03
Brief Title:
Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection LAR for Recto-sigmoid Cancer
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ------
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 ------
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None