Biliary DyskinesiaNCT01195285
Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy
A study testing Single-Incision Laparoscopic Surgery cholecystectomy and Traditional Laparoscopic Cholecystectomy (TLC) in people with Biliary Dyskinesia and Gallstones, run by Saint Luke's Health System at 1 site in United States.
Trial summary
This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Dyskinesia, Gallstones, Cholecystitis
- What is being tested?
- Single-Incision Laparoscopic Surgery cholecystectomy and Traditional Laparoscopic Cholecystectomy (TLC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jan 2012
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient recommended to undergo cholecystectomy
- Patient age 18-80
- Patient competent to give his/her own informed consent
- Patient speaks English without the need for an interpreter
Who cannot join
- Additional procedures planned during same surgery
- Patient deemed inappropriate for TLC or SILS cholecystectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
About this study
Official title: Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial
This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.
Read the detailed description
Single-Incision Laparoscopic Surgery (SILS) is accepted as a form of surgical treatment. Traditional laparoscopic cholecystectomy (TLC) is well tolerated, with a low complication risk and high patient satisfaction; thus a SILS procedure needs to be at least equivalent to be a justifiable replacement, and should not result in higher costs.
- Conditions
- Biliary Dyskinesia, Gallstones, Cholecystitis, Cholelithiasis
- Being tested
- Single-Incision Laparoscopic Surgery cholecystectomy, Traditional Laparoscopic Cholecystectomy (TLC)
- Keywords
- Laparoscopic cholecystectomy, Quality of life, Biliary Cholic, Chronic Cholecystitis, Symptomatic Cholelithiasis
- Medical subject headings
- Biliary Dyskinesia, Gallstones, Cholecystitis, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Incision Laparoscopic Surgery cholecystectomyProcedure or surgery
Laparoscopic Cholecystectomy
Traditional Laparoscopic Cholecystectomy (TLC)Procedure or surgery
Laparoscopic Cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Single-Incision Laparoscopic Cholecsytectomy (SILS) | Active comparator | Not described Receives: Procedure: Single-Incision Laparoscopic Surgery cholecystectomy |
| Traditional Laparoscopic Cholecystectomy (TLC) | Active comparator | Not described Receives: Procedure: Traditional Laparoscopic Cholecystectomy (TLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost associated with performance of the procedure and post-operative care until discharge
Measured: 4 weeks
Secondary outcomes (4)
Pain scale reported by patient at discharge, 24 and 48 hours
Measured: 24 hours and 48 hours
Amount of pain medicine required during 48 hours after surgery
Measured: 48 hours
Major and minor gastrointestinal surgical complications, including conversion
Measured: 4 weeks
Quality of Life
Measured: 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Investigator decisions based on slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Biliary DyskinesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Tyco Healthcare Group LP (d/b/a Covidien)
- Investigators
- Kimberly M Brown, BS, MD, Principal investigator, St. Luke's Hospital, Kansas City, Missouri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195285
- Sponsor's protocol ID
- 09-423
- Status last verified
- Aug 2011
- First submitted
- 2 Sep 2010
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Single-incision Laparoscopic Surgery Launched at St. Louis University Hospital. www.news-medical.net. April, 2009
Chamberlain RS, Sakpal SV. A comprehensive review of single-incision laparoscopic surgery (SILS) and natural orifice transluminal endoscopic surgery (NOTES) techniques for cholecystectomy. J Gastrointest Surg. 2009 Sep;13(9):1733-40. doi: 10.1007/s11605-009-0902-y. Epub 2009 May 2.
PubMed 19412642Hodgett SE, Hernandez JM, Morton CA, Ross SB, Albrink M, Rosemurgy AS. Laparoendoscopic single site (LESS) cholecystectomy. J Gastrointest Surg. 2009 Feb;13(2):188-92. doi: 10.1007/s11605-008-0735-0. Epub 2008 Nov 22.
PubMed 19031097
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT01195285
- Acronym / sponsor ID
- 09-423
- Conditions
- Biliary Dyskinesia, Gallstones, Cholecystitis, Cholelithiasis
- Keywords
- Laparoscopic cholecystectomy, Quality of life, Biliary Cholic, Chronic Cholecystitis, Symptomatic Cholelithiasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator decisions based on slow enrollment.
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Collaborators
- Tyco Healthcare Group LP (d/b/a Covidien)
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Sep 2010 (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.
This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.
Detailed description
Single-Incision Laparoscopic Surgery (SILS) is accepted as a form of surgical treatment. Traditional laparoscopic cholecystectomy (TLC) is well tolerated, with a low complication risk and high patient satisfaction; thus a SILS procedure needs to be at least equivalent to be a justifiable replacement, and should not result in higher costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Incision Laparoscopic Cholecsytectomy (SILS) | Active comparator | Procedure: Single-Incision Laparoscopic Surgery cholecystectomy |
| Traditional Laparoscopic Cholecystectomy (TLC) | Active comparator | Procedure: Traditional Laparoscopic Cholecystectomy (TLC) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient recommended to undergo cholecystectomy
- Patient age 18-80
- Patient competent to give his/her own informed consent
- Patient speaks English without the need for an interpreter
Key exclusion criteria (2 listed)
- Additional procedures planned during same surgery
- Patient deemed inappropriate for TLC or SILS cholecystectomy
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 |
|---|---|---|
| Single-Incision Laparoscopic Surgery cholecystectomyLaparoscopic Cholecystectomy | Procedure or surgery | Single-Incision Laparoscopic Cholecsytectomy (SILS) |
| Traditional Laparoscopic Cholecystectomy (TLC)Laparoscopic Cholecystectomy | Procedure or surgery | Traditional Laparoscopic Cholecystectomy (TLC) |
Primary outcome
Cost associated with performance of the procedure and post-operative care until discharge
Time frame: 4 weeks
4 secondary outcomes
Pain scale reported by patient at discharge, 24 and 48 hours
Time frame: 24 hours and 48 hours
Amount of pain medicine required during 48 hours after surgery
Time frame: 48 hours
Major and minor gastrointestinal surgical complications, including conversion
Time frame: 4 weeks
Quality of Life
Time frame: 2 weeks and 4 weeks
Results and safety
The study was stopped early (reason given: Investigator decisions based on slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- BackgroundSingle-incision Laparoscopic Surgery Launched at St. Louis University Hospital. www.news-medical.net. April, 2009
- Background: PubMed 19412642Chamberlain RS, Sakpal SV. A comprehensive review of single-incision laparoscopic surgery (SILS) and natural orifice transluminal endoscopic surgery (NOTES) techniques for cholecystectomy. J Gastrointest Surg. 2009 Sep;13(9):1733-40. doi: 10.1007/s11605-009-0902-y. Epub 2009 May 2.
- Background: PubMed 19031097Hodgett SE, Hernandez JM, Morton CA, Ross SB, Albrink M, Rosemurgy AS. Laparoendoscopic single site (LESS) cholecystectomy. J Gastrointest Surg. 2009 Feb;13(2):188-92. doi: 10.1007/s11605-008-0735-0. Epub 2008 Nov 22.
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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.
Kimberly M Brown, BS, MD principal investigator
St. Luke's Hospital, Kansas City, Missouri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Incision Laparoscopic Surgery cholecystectomy and Traditional Laparoscopic Cholecystectomy (TLC) in people with Biliary Dyskinesia and Gallstones, run by Saint Luke's Health System 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 30 Apr 2012. 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 was stopped early (reason given: Investigator decisions based on slow enrollment.). Results are not available in the source record.
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?
Cost associated with performance of the procedure and post-operative care until discharge (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01195285, which also lists 3 linked publications.
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 30 Apr 2012.