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Laparascopic Assisted Colonoscopic Polypectomy

Randomized Controlled Trial-Laparoscopic Assisted Colonoscopic Polypectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01986699
Enrollment
34
Registered
2013-11-18
Start date
2010-03-31
Completion date
2013-10-31
Last updated
2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Polyps

Keywords

polypectomy, laparoscopic

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.

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.

Interventions

PROCEDURELaparoscopic Assisted Polypectomy

Sponsors

Stony Brook University
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
hospital cost1-3 daysTo compare the hospital costs between the standard surgical procedure and the LACP technique for patients with advanced polyps in the colon.

Secondary

MeasureTime frameDescription
complication rates1-3 daysto 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026