Laparascopic Assisted Colonoscopic Polypectomy
Randomized Controlled Trial-Laparoscopic Assisted Colonoscopic Polypectomy
1 other identifier
observational
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 29, 2013
CompletedFirst Posted
Study publicly available on registry
November 18, 2013
CompletedMay 12, 2015
May 1, 2015
3.6 years
October 29, 2013
May 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
complication rates
1-3 days
Study Arms (2)
Standard Therapy
Patients are treated as per current standard of care
Laparoscopic Assisted Polypectomy
Patients treated with Laparoscopic Assisted Colonoscopic Polypectomy
Interventions
Eligibility Criteria
GI clinic
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stony Brook Medicine
Stony Brook, New York, 11794, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto C Bergamaschi, MD, PhD
Stonybrook University
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2013
First Posted
November 18, 2013
Study Start
March 1, 2010
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
May 12, 2015
Record last verified: 2015-05