Colon PolypsNCT01986699
Laparascopic Assisted Colonoscopic Polypectomy
An observational study of Colon Polyps, run by Stony Brook University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colon Polyps
- What is being tested?
- Laparoscopic Assisted Polypectomy
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: GI clinic
Who may be able to join
- 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.
Who cannot join
- 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 .
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial-Laparoscopic 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.
Read the 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.
- Conditions
- Colon Polyps
- Being tested
- Laparoscopic Assisted Polypectomy
- Keywords
- polypectomy, laparoscopic
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Assisted PolypectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Patients are treated as per current standard of care Receives: Procedure: Laparoscopic Assisted Polypectomy | |
| Laparoscopic Assisted Polypectomy | Patients treated with Laparoscopic Assisted Colonoscopic Polypectomy Receives: Procedure: Laparoscopic Assisted Polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital cost
To compare the hospital costs between the standard surgical procedure and the LACP technique for patients with advanced polyps in the colon.
Measured: 1-3 days
Secondary outcomes (1)
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.
Measured: 1-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startMar 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto C Bergamaschi, MD, PhD, Principal investigator, Stonybrook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986699
- Sponsor's protocol ID
- 144467
- Status last verified
- May 2015
- First submitted
- 29 Oct 2013
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial-Laparoscopic Assisted Colonoscopic Polypectomy
- ClinicalTrials.gov ID
- NCT01986699
- Acronym / sponsor ID
- 144467
- Conditions
- Colon Polyps
- Keywords
- polypectomy, laparoscopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | – | Procedure: Laparoscopic Assisted PolypectomyPatients are treated as per current standard of care |
| Laparoscopic Assisted Polypectomy | – | Procedure: Laparoscopic Assisted PolypectomyPatients treated with Laparoscopic Assisted Colonoscopic Polypectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- GI clinic
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Assisted Polypectomy | Procedure or surgery | Laparoscopic Assisted Polypectomy, Standard Therapy |
Primary outcome
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.
1 secondary outcome
complication rates
Time frame: 1-3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto C Bergamaschi, MD, PhD principal investigator
Stonybrook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Polyps, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital cost (time frame: 1-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.