Laparascopic Assisted Colonoscopic Polypectomy

Completed

• Conditions: Colon Polyps
• Interventions: Procedure: Laparoscopic Assisted Polypectomy

• Registration Number: NCT01986699
• Lead Sponsor: Stony Brook University

Brief Summary

Study Objective: To compare the hospital costs between the standard surgical procedure and the Laparascopic Assisted Colonoscopic Polypectomy (LACP) technique for patients with advanced polyps in the colon.

Detailed Description

All patients being referred for possible LACP to the Division of Colorectal Surgery at Stony Brook University Medical Center will be randomized in a 1:1 fashion using a computer generated system to undergo either partial colectomy (performed by means of laparoscopy when possible), or LACP for the treatment of advanced polyp(s). Our research assistant will be present in the operating room to record the data.Patients will then undergo standard clinical management while hospitalized at Stony Brook according to the procedure performed.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-18
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-08
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Polyp spanning 2 or more colonic folds
• Polyp > 20mm
• Polyp spanning greater than 50% of the colonic circumference
• Positive "lift sign" following submucosal injection of saline beneath the polyp
• Difficult location or position of the polyp, thus preventing assurance of complete endoscopic resection.

Exclusion Criteria

• Polyps with histological evidence of adenocarcinoma
• Polyps in the rectum (<15cm from anal verge)
• Patients with known inflammatory bowel disease (IBD).
• Patients with known familiar adenomatous polyposis (FAP) syndrome
• Polyps without known histology (i.e. not previously biopsied)
• Polyps with large ulcerations, or those that demonstrate a "non-lift sign" during submucosal injection at the time of colonoscopy; as these are indicators of adenocarcinoma .
• Severe cardio-pulmonary disease, or irreversible coagulopathy, preventing abdominal surgery at an acceptable risk.
• POSSUM predicted mortality score greater than 2%
• Inability to obtain informed consent
• Patients under the age of 18
• Pregnant patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard Therapy	Laparoscopic Assisted Polypectomy	Patients are treated as per current standard of care
Laparoscopic Assisted Polypectomy	Laparoscopic Assisted Polypectomy	Patients treated with Laparoscopic Assisted Colonoscopic Polypectomy

Primary Outcome Measures

Name	Time	Method
hospital cost	1-3 days	To compare the hospital costs between the standard surgical procedure and the LACP technique for patients with advanced polyps in the colon.

Secondary Outcome Measures

Name	Time	Method
complication rates	1-3 days	to compare complication rates between both techniques including intra-operative polypectomy related perforaton, polypectomy-related bleeding unable to be stopped endoscopically, post operative wound infection, ileus and anastomic leak.

Trial Locations

Locations (1)

Stony Brook Medicine; 🇺🇸 Stony Brook, New York, United States