Monitoring by Microdialysis of Postoperative Complications After Proctectomy

NCT ID: NCT01999634

Last Updated: 2025-09-22

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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-05

Study Completion Date

2017-03-23

Brief Summary

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The aim of this study is to monitor by microdialysis the postoperative outcomes 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

DIAGNOSTIC

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 or laparotomy
* 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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Solligard E, Juel IS, Spigset O, Romundstad P, Gronbech JE, Aadahl P. Gut luminal lactate measured by microdialysis mirrors permeability of the intestinal mucosa after ischemia. Shock. 2008 Feb;29(2):245-51. doi: 10.1097/SHK.0b013e3180cab3ce.

Reference Type BACKGROUND
PMID: 17693938 (View on PubMed)

Cibicek N, Zivna H, Zadak Z, Kulir J, Cermakova E, Palicka V. Colon submucosal microdialysis: a novel in vivo approach in barrier function assessment - a pilot study in rats. Physiol Res. 2007;56(5):611-617. doi: 10.33549/physiolres.931004. Epub 2006 Dec 19.

Reference Type BACKGROUND
PMID: 17184153 (View on PubMed)

Krejci V, Hiltebrand L, Buchi C, Ali SZ, Contaldo C, Takala J, Sigurdsson GH, Jakob SM. Decreasing gut wall glucose as an early marker of impaired intestinal perfusion. Crit Care Med. 2006 Sep;34(9):2406-14. doi: 10.1097/01.CCM.0000233855.34344.29.

Reference Type BACKGROUND
PMID: 16878039 (View on PubMed)

Beauchemin M, Gonzalez-Frankenberger B, Tremblay J, Vannasing P, Martinez-Montes E, Belin P, Beland R, Francoeur D, Carceller AM, Wallois F, Lassonde M. Mother and stranger: an electrophysiological study of voice processing in newborns. Cereb Cortex. 2011 Aug;21(8):1705-11. doi: 10.1093/cercor/bhq242. Epub 2010 Dec 13.

Reference Type RESULT
PMID: 21149849 (View on PubMed)

Other Identifiers

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2013-A00261-44

Identifier Type: OTHER

Identifier Source: secondary_id

PI2012_843_0024

Identifier Type: -

Identifier Source: org_study_id

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