Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01062334
• Other study ID #: S-20090147
• Status: Recruiting
• Phase: N/A
• First received: January 28, 2010
• Last updated: February 4, 2014
• Start date: March 2010

Study information

• Verified date: February 2014
• Source: Odense University Hospital
• Contact: Mark Ellebæk Pedersen, MD
• Phone: 40880511
• Email: markep01[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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. ------

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anastomotic Leak
• Cancer

Intervention

Procedure:
• Peritoneal Microdialysis, CT-scan, leakage scoring
Peritoneal microdialysis CT-scan before discharge Leakage scoring daily

Locations

Country	Name	City	State
Denmark	Odense University hospital	Odense C.	Fyn
Denmark	Vejle hospital	Vejle

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant elevated peritoneal microdialysis parameter like lactate and L/P-ratio		Clinically complications with in 30th days after surgery	No