Feasibility of Microdialysis by Laparoscopy

Rectal Cancer Clinical Trial

— MTM-COLON-I  

Official title:

Feasibility of Microdialysis by Laparoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786694
• Other study ID #: PI2012_843_0022
• Secondary ID: 2012-A01218-35
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2013
• Last updated: January 31, 2017
• Start date: October 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• 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

• written consent

Exclusion Criteria:

• history of colorectal surgery

• rectal surgery without anastomosis

• breastfeeding or pregnancy

• ASA score IV

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

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)

Deeba S, Corcoles EP, Hanna GB, Pareskevas P, Aziz O, Boutelle MG, Darzi A. Use of rapid sampling microdialysis for intraoperative monitoring of bowel ischemia. Dis Colon Rectum. 2008 Sep;51(9):1408-13. doi: 10.1007/s10350-008-9375-4. Erratum in: Dis Colon Rectum. 2008 Nov;51(11):1741. Hanna, B G [corrected to Hanna, G B]. — View Citation

Högberg N, Carlsson PO, Hillered L, Meurling S, Stenbäck A. Intestinal ischemia measured by intraluminal microdialysis. Scand J Clin Lab Invest. 2012 Feb;72(1):59-66. doi: 10.3109/00365513.2011.629307. — View Citation

Verdant CL, Chierego M, De Moor V, Chamlou R, Creteur J, de Dieu Mutijima J, Loi P, Gelin M, Gullo A, Vincent JL, De Backer D. Prediction of postoperative complications after urgent laparotomy by intraperitoneal microdialysis: A pilot study. Ann Surg. 2006 Dec;244(6):994-1002. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional success of microdialysis	the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter	postoperative day 5
Secondary	anastomotic leaks rate	the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan	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	the mortality rate	the mortality rate is defined as the number of death after the surgery	postoperative day 30
Secondary	the quality of life after the surgery	the quality of life will be evaluated with the QLQ C30 CR 29 prior to the surgery, at the hospital discharge and on postoperative day 30	postoperative day 30