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NCT01999634 Clinical Trial

Monitoring by Microdialysis of Postoperative Complications After Proctectomy

Rectal Cancer Clinical Trial

— MTM-COLON-II  

Official title:
Evaluation of Microdialysis to Monitor Postoperative Outcomes After Proctectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01999634
Other study ID # PI2012_843_0024
Secondary ID 2013-A00261-44
Status Completed
Phase Phase 3
First received
Last updated
Start date February 5, 2014
Est. completion date March 23, 2017

Study information
Verified date July 2020
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date March 23, 2017
Est. primary completion date March 23, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• cma microdialysis catheter placement
the microdialysis catheters are sold by CMA

Locations
Country Name City State
France Amiens university hospital Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

References & Publications (3)

Cibicek N, Zivná H, Zadák Z, Kulír J, Cermáková 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):611-7. Epub 2006 Dec 19. — View Citation

Krejci V, Hiltebrand L, Büchi 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. — View Citation

Solligård E, Juel IS, Spigset O, Romundstad P, Grønbech JE, Aadahl P. Gut luminal lactate measured by microdialysis mirrors permeability of the intestinal mucosa after ischemia. Shock. 2008 Feb;29(2):245-51. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 superficial surgical site infection rate the surgical site infection rate is defined as the number of infection near the incision postoperative day 30
Secondary functional success of microdialysis the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter postoperative day 5
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