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Clinical Trials/NCT01196494
NCT01196494TerminatedNot Applicable

Prospective, Controlled, Randomized Study of Intraoperative Colonic Irrigation vs. Stent Placement in Obstructive Left-Sided Colonic Cancer

Corporacion Parc Tauli0 sitesStarted: September 8, 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor

Study Overview

Brief Summary

INTRODUCTION: There are several alternatives for one-stage emergency treatment of obstructive left-sided colonic cancer (OLCC): subtotal colectomy, intraoperative colon lavage (IOCL) with primary anastomosis, and the placement of a stent as a temporary measure prior to scheduled surgery. At present, it is not clear whether emergency perioperative lavage or the placement of a stent is the better technique. The hypothesis is that IOCL and primary anastomosis is equal safe or even safer than placement of a stent as a temporary measure prior to scheduled surgery, less length of stay and less cost.

OBJECTIVE: To establish which of these two techniques is more efficient in OLCC from the point of view of morbimortality, economic cost, and long-term survival.

MATERIAL AND METHODS:

Prospective, controlled, randomized study of patients diagnosed with OLCC. Patients were divided into two groups: group 1: stent and deferred surgery; group 2: emergency IOCL. A simple randomization system was used. The estimated sample size required per group was 21 patients. Demographic variables, risk prediction models, postoperative morbimortality, staging, complications due to the placement of stent, surgical time, clinical follow-up, health costs and follow-up of survival were recorded.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients over the age of 18 diagnosed with complete intestinal obstruction due to tumor in the left colon using abdominal CT scan

Exclusion Criteria

  • Unresectable lesion (intraoperative), severe ischemia or cecal perforation, fecal or advanced purulent peritonitis, hemodynamic instability during surgery, immunodepressed state (corticoids, chemotherapy, HIV, major surgery in the last two months) and septic shock.

Investigators

Sponsor
Corporacion Parc Tauli
Sponsor Class
Other

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