Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer

NCT ID: NCT01062334

Last Updated: 2014-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Brief Summary

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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

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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. ------

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Microdialysis

Group Type EXPERIMENTAL

Peritoneal Microdialysis, CT-scan, leakage scoring

Intervention Type PROCEDURE

Peritoneal microdialysis CT-scan before discharge Leakage scoring daily

Interventions

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Peritoneal Microdialysis, CT-scan, leakage scoring

Peritoneal microdialysis CT-scan before discharge Leakage scoring daily

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vejle Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mark Ellebaek Pedersen

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Odense University hospital

Odense C, Fyn, Denmark

Site Status RECRUITING

Vejle hospital

Vejle, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mark Ellebæk Pedersen, MD

Role: CONTACT

Facility Contacts

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Mark Ellebæk Pedersen, MD

Role: primary

Mark Ellebæk Pedersen, MD

Role: primary

Other Identifiers

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S-20090147

Identifier Type: -

Identifier Source: org_study_id

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