Monitoring by Microdialysis of Postoperative Complications After Proctectomy (MTM-COLON-II)

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

NCT01999634

2013-A00261-44 (Other Identifier)

PI2012_843_0024

Details and patient eligibility

About

The aim of this study is to monitor by microdialysis the postoperative outcomes in order to identify anastomotic leaks after rectal surgery.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 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