Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laparascopic Assisted Colonoscopic Polypectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986699
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Colon Polyps Procedure: Laparoscopic Assisted Polypectomy

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 34 participants
Time Perspective: Prospective
Official Title: Randomized Controlled Trial-Laparoscopic Assisted Colonoscopic Polypectomy
Study Start Date : March 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
GI clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986699


Locations
Layout table for location information
United States, New York
Stony Brook Medicine
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Investigators
Layout table for investigator information
Principal Investigator: Roberto C Bergamaschi, MD, PhD Stonybrook University
Layout table for additonal information
Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT01986699    
Other Study ID Numbers: 144467
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by Stony Brook University:
polypectomy
laparoscopic
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical