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

Colorectal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01196494
• Other study ID #: STENTCSPT01
• Status: Terminated
• Phase: N/A
• First received: September 7, 2010
• Last updated: September 7, 2010

Study information

• Verified date: January 2005
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: CEIC Corporacio Sanitaria Parc Tauli
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colon Neoplasm
• Colonic Neoplasms
• Colorectal Surgery
• Intestinal Obstruction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli