Laparascopic Assisted Colonoscopic Polypectomy

Study Overview
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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.

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.

Official Title
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Randomized Controlled Trial-Laparoscopic Assisted Colonoscopic Polypectomy

Conditions
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Colon Polyps

Intervention / Treatment
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* Procedure: Laparoscopic Assisted Polypectomy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard Therapy<br>Patients are treated as per current standard of care | Procedure: Laparoscopic Assisted Polypectomy<br> <br> |
| Laparoscopic Assisted Polypectomy<br>Patients treated with Laparoscopic Assisted Colonoscopic Polypectomy | Procedure: Laparoscopic Assisted Polypectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital cost | To compare the hospital costs between the standard surgical procedure and the LACP technique for patients with advanced polyps in the colon. | 1-3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rates | 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. | 1-3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polypectomy, laparoscopic