Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer

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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01062334

Enrollment

150

Registered

2010-02-04

Start date

2010-03-31

Completion date

Unknown

Last updated

2014-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Anastomotic leakage after LAR

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. ------

Interventions

PROCEDUREPeritoneal Microdialysis, CT-scan, leakage scoring

Peritoneal microdialysis CT-scan before discharge Leakage scoring daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Significant elevated peritoneal microdialysis parameter like lactate and L/P-ratio	Clinically complications with in 30th days after surgery

Countries

Denmark

Contacts

Primary ContactMark Ellebæk Pedersen, MD

markep01@gmail.com40880511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026