Laparascopic Assisted Colonoscopic Polypectomy

Stony Brook University

Status: Completed

Conditions: Colon Polyps

Treatments: Procedure: Laparoscopic Assisted Polypectomy

Study type: Observational

Funder types: Other

Identifiers

NCT01986699

144467

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

34 participants in 2 patient groups

Standard Therapy

Description:

Patients are treated as per current standard of care

Treatment:

Procedure: Laparoscopic Assisted Polypectomy

Laparoscopic Assisted Polypectomy

Description:

Patients treated with Laparoscopic Assisted Colonoscopic Polypectomy

Treatment:

Procedure: Laparoscopic Assisted Polypectomy