Laparascopic Assisted Colonoscopic Polypectomy

May 8, 2015 updated by: Stony Brook University

Randomized Controlled Trial-Laparoscopic Assisted Colonoscopic Polypectomy

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

GI clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard Therapy
Patients are treated as per current standard of care
Procedure: Laparoscopic Assisted Polypectomy
Laparoscopic Assisted Polypectomy
Patients treated with Laparoscopic Assisted Colonoscopic Polypectomy
Procedure: Laparoscopic Assisted Polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital cost
Time Frame: 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.
1-3 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 11, 2013

First Posted (ESTIMATE)

November 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 8, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 144467

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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