Feasibility of Microdialysis by Laparoscopy (MTM-COLON-I)

C

Centre Hospitalier Universitaire, Amiens

Status and phase

Completed
Phase 3

Conditions

Rectal Cancer

Treatments

Device: cma microdialysis catheter placement

Study type

Interventional

Funder types

Other

Identifiers

NCT01786694
2012-A01218-35 (Other Identifier)
PI2012_843_0022

Details and patient eligibility

About

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

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

cma microdialysis catheter placement
Experimental group
Description:
At the end of the surgery the cma microdialysis catheter is placed near the anastomosis
Treatment:
Device: cma microdialysis catheter placement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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