Laparascopic Assisted Colonoscopic Polypectomy

Colon Polyps Clinical Trial

Official title:

Randomized Controlled Trial-Laparoscopic Assisted Colonoscopic Polypectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986699
• Other study ID #: 144467
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: May 8, 2015
• Start date: March 2010
• Est. completion date: October 2013

Study information

• Verified date: May 2015
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Polyps

Intervention

Procedure:
• Laparoscopic Assisted Polypectomy

Locations

Country	Name	City	State
United States	Stony Brook Medicine	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes