Expired Study
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Stony Brook, New York 11794


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT01986699


Primary Contact:

Principal Investigator
Roberto C Bergamaschi, MD, PhD
Stonybrook University


Backup Contact:

N/A


Location Contact:

Stony Brook, New York 11794
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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