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OpenTrials
Completed

NCT Number: NCT01986699

Laparascopic 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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stony Brook Medicine

Stony Brook, New York, 11794, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic Assisted Polypectomy

Procedure

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

Randomized Controlled Trial-Laparoscopic Assisted Colonoscopic Polypectomy

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 18, 2013
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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