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Clinical Trials/NCT01999634
NCT01999634
Completed
Phase 3

Evaluation of Microdialysis to Monitor Postoperative Outcomes After Proctectomy

Centre Hospitalier Universitaire, Amiens1 site in 1 country21 target enrollmentFebruary 5, 2014
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ConditionsRectal Cancer

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Rectal Cancer
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
21
Locations
1
Primary Endpoint
anastomotic leaks rate
Status
Completed
Last Updated
7 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 5, 2014
End Date
March 23, 2017
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

anastomotic leaks rate

Time Frame: postoperative day 30

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

Secondary Outcomes

  • functional success of microdialysis(postoperative day 5)
  • superficial surgical site infection rate(postoperative day 30)

Study Sites (1)

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