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

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)

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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