Study of Intraoperative Colonic Irrigation Versus Stent Placement in Obstructive Left-Sided Colonic Cancer

Sponsor

Corporacion Parc Tauli (Other)

Overall Status

Terminated

CT.gov ID

NCT01196494

Collaborator

(none)

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Neoplasm Colorectal Surgery Intestinal Obstruction	Procedure: intraoperative colon lavage with primary anastomosis	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intraoperative colon lavage	Procedure: intraoperative colon lavage with primary anastomosis Patients with obstructive left-sided colonic cancer in wich treatment in one stage procedure is intraoperative colon lavage with primary anastomosis to avoid Hartamnn´s Procedure
Active Comparator: stent and deferred surgery	Procedure: intraoperative colon lavage with primary anastomosis Patients with obstructive left-sided colonic cancer in wich treatment in one stage procedure is intraoperative colon lavage with primary anastomosis to avoid Hartamnn´s Procedure

Arm

Intervention/Treatment

Experimental: intraoperative colon lavage

Procedure: intraoperative colon lavage with primary anastomosis

Patients with obstructive left-sided colonic cancer in wich treatment in one stage procedure is intraoperative colon lavage with primary anastomosis to avoid Hartamnn´s Procedure

Active Comparator: stent and deferred surgery

Procedure: intraoperative colon lavage with primary anastomosis

Patients with obstructive left-sided colonic cancer in wich treatment in one stage procedure is intraoperative colon lavage with primary anastomosis to avoid Hartamnn´s Procedure

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.