Monitoring by Microdialysis of Postoperative Complications After Proctectomy

NCT01999634 | Completed Phase 3 DMC

• 2 other identifiers: PI2012_843_00242013-A00261-44
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rectal Cancer

Keywords

rectum; microdialysis; anastomotic leaks

Outcome Measures

Primary Outcomes (1)

• anastomotic leaks rate

  the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan or at the clinical examination

  postoperative day 30

Secondary Outcomes (2)

• superficial surgical site infection rate

  postoperative day 30

• functional success of microdialysis

  postoperative day 5

Study Arms (1)

cma microdialysis catheter placement

EXPERIMENTAL

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

Device: cma microdialysis catheter placement

Interventions

cma microdialysis catheter placement DEVICE

the microdialysis catheters are sold by CMA

cma microdialysis catheter placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• rectal disease requiring proctectomy with anastomosis and stomy
• proctectomy by laparoscopy or laparotomy
• written consent

You may not qualify if:

• history of colorectal surgery
• rectal surgery without anastomosis
• breastfeeding or pregnancy
• ASA score IV

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Amiens university hospital

Amiens, 80054, France

Location

Related Publications (4)

• 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.

  PMID: 17693938 BACKGROUND

• 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.

  PMID: 17184153 BACKGROUND

• 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.

  PMID: 16878039 BACKGROUND

• 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.

  PMID: 21149849 RESULT

MeSH Terms

Conditions

Rectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• jean marc regimbeau, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: February 5, 2014
• Primary Completion: March 23, 2017
• Study Completion: March 23, 2017
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

FR (1)