CholelithiasisSILSNCT00981604
Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy
A study testing SILS and Standard Laparoscopic Cholecystectomy in people with Cholelithiasis and Biliary Dyskinesia, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Cholelithiasis, Biliary Dyskinesia
- What is being tested?
- SILS and Standard Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2011
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Need for cholecystectomy
Who cannot join
- Need for cholangiogram
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Single Incision Versus Laparoscopic Cholecystectomy
Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.
Read the detailed description
This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.
This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.
After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.
- Conditions
- Cholelithiasis, Biliary Dyskinesia
- Being tested
- SILS, Standard Laparoscopic Cholecystectomy
- Keywords
- SILS, Laparoscopic Cholecystectomy, Children
- Medical subject headings
- Cholelithiasis, Biliary Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILSProcedure or surgery
Single Incision Laparoscopic Cholecystectomy
Standard Laparoscopic CholecystectomyProcedure or surgery
Also called Laparoscopic Cholecystectomy
4 port technique
| Study group | Role | What they receive |
|---|---|---|
| SILS Cholecystectomy | Active comparator | Single Incision Laparoscopic Cholecystectomy Receives: Procedure: SILS |
| Standard Laparoscopic Cholecystectomy | Active comparator | 4 port laparoscopic cholecystectomy Receives: Procedure: Standard Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Measured: 1 day
Secondary outcomes (6)
Operative complications
Measured: 2 weeks
length of hospitalization
Measured: 1 week
doses of analgesics
Measured: 1 week
hospital/operation charges
Measured: 1 week
surgeon perception of difficulty
Measured: 1 day
cosmetic scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn St. Peter, Children's Mercy Hospital Kansas City
- Investigators
- Daniel J Ostlie, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981604
- Sponsor's protocol ID
- 09 07 132
- Acronym
- SILS
- Status last verified
- Dec 2011
- First submitted
- 21 Sep 2009
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ostlie DJ, Juang OO, Iqbal CW, Sharp SW, Snyder CL, Andrews WS, Sharp RJ, Holcomb GW 3rd, St Peter SD. Single incision versus standard 4-port laparoscopic cholecystectomy: a prospective randomized trial. J Pediatr Surg. 2013 Jan;48(1):209-14. doi: 10.1016/j.jpedsurg.2012.10.039.
PubMed 23331817
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Versus Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT00981604
- Acronym / sponsor ID
- SILS / 09 07 132
- Conditions
- Cholelithiasis, Biliary Dyskinesia
- Keywords
- SILS, Laparoscopic Cholecystectomy, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Sep 2009 (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.
Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.
Detailed description
This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.
This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.
After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SILS Cholecystectomy | Active comparator | Procedure: SILSSingle Incision Laparoscopic Cholecystectomy |
| Standard Laparoscopic Cholecystectomy | Active comparator | Procedure: Standard Laparoscopic Cholecystectomy4 port laparoscopic cholecystectomy |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Need for cholecystectomy
Key exclusion criteria (1 listed)
- Need for cholangiogram
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 |
|---|---|---|
| SILSSingle Incision Laparoscopic Cholecystectomy | Procedure or surgery | SILS Cholecystectomy |
| Standard Laparoscopic CholecystectomyAlso: Laparoscopic Cholecystectomy4 port technique | Procedure or surgery | Standard Laparoscopic Cholecystectomy |
Primary outcome
Operative Time
Time frame: 1 day
6 secondary outcomes
Operative complications
Time frame: 2 weeks
length of hospitalization
Time frame: 1 week
doses of analgesics
Time frame: 1 week
hospital/operation charges
Time frame: 1 week
surgeon perception of difficulty
Time frame: 1 day
cosmetic scores
Time frame: 6 months
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 13 Dec 2011.
- Derived from this study: PubMed 23331817Ostlie DJ, Juang OO, Iqbal CW, Sharp SW, Snyder CL, Andrews WS, Sharp RJ, Holcomb GW 3rd, St Peter SD. Single incision versus standard 4-port laparoscopic cholecystectomy: a prospective randomized trial. J Pediatr Surg. 2013 Jan;48(1):209-14. doi: 10.1016/j.jpedsurg.2012.10.039.
Related trials for Cholelithiasis
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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.
Daniel J Ostlie, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SILS and Standard Laparoscopic Cholecystectomy in people with Cholelithiasis and Biliary Dyskinesia, run by Children's Mercy Hospital Kansas City 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 1 inclusion and 1 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 13 Dec 2011. 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?
Operative Time (time frame: 1 day). 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 NCT00981604, which also lists 1 linked publication.
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 13 Dec 2011.