Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-31 @ 12:47 AM
Study NCT ID:
NCT01062334
Status:
UNKNOWN
Last Update Posted:
2014-02-05
First Post:
2010-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer
Sponsor:
Odense University Hospital
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2014-02
Last Known Status:
RECRUITING
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.
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. ------
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: