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
• 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
• 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

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)

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