Laparascopic Assisted Colonoscopic Polypectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colon Polyps

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Standard Therapy

Patients are treated as per current standard of care

Laparoscopic Assisted Polypectomy

Intervention Type PROCEDURE

Laparoscopic Assisted Polypectomy

Patients treated with Laparoscopic Assisted Colonoscopic Polypectomy

Laparoscopic Assisted Polypectomy

Intervention Type PROCEDURE

Interventions

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Laparoscopic Assisted Polypectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No