Feasibility of Microdialysis by Laparoscopy

NCT ID: NCT01786694

Last Updated: 2017-02-01

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-11-30

Brief Summary

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The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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cma microdialysis catheter placement

At the end of the surgery the cma microdialysis catheter is placed near the anastomosis

Group Type EXPERIMENTAL

cma microdialysis catheter placement

Intervention Type DEVICE

the microdialysis catheters are sold by CMA

Interventions

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cma microdialysis catheter placement

the microdialysis catheters are sold by CMA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* rectal disease requiring proctectomy with anastomosis and stomy
* proctectomy by laparoscopy
* written consent

Exclusion Criteria

* history of colorectal surgery
* rectal surgery without anastomosis
* breastfeeding or pregnancy
* ASA score IV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jean marc regimbeau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU amiens

Locations

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Amiens University Hospital

Amiens, , France

Site Status

Countries

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France

References

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Hogberg N, Carlsson PO, Hillered L, Meurling S, Stenback A. Intestinal ischemia measured by intraluminal microdialysis. Scand J Clin Lab Invest. 2012 Feb;72(1):59-66. doi: 10.3109/00365513.2011.629307. Epub 2011 Nov 21.

Reference Type BACKGROUND
PMID: 22103734 (View on PubMed)

Deeba S, Corcoles EP, Hanna GB, Pareskevas P, Aziz O, Boutelle MG, Darzi A. Use of rapid sampling microdialysis for intraoperative monitoring of bowel ischemia. Dis Colon Rectum. 2008 Sep;51(9):1408-13. doi: 10.1007/s10350-008-9375-4. Epub 2008 May 24.

Reference Type BACKGROUND
PMID: 18500500 (View on PubMed)

Verdant CL, Chierego M, De Moor V, Chamlou R, Creteur J, de Dieu Mutijima J, Loi P, Gelin M, Gullo A, Vincent JL, De Backer D. Prediction of postoperative complications after urgent laparotomy by intraperitoneal microdialysis: A pilot study. Ann Surg. 2006 Dec;244(6):994-1002. doi: 10.1097/01.sla.0000225092.45734.e6.

Reference Type BACKGROUND
PMID: 17122625 (View on PubMed)

Other Identifiers

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2012-A01218-35

Identifier Type: OTHER

Identifier Source: secondary_id

PI2012_843_0022

Identifier Type: -

Identifier Source: org_study_id

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