CholelithiasisNCT00732550
Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy
A study testing Single trocar cholecystectomy and Standard laparoscopic cholecystectomy in people with Cholelithiasis, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Single trocar cholecystectomy and Standard laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to Sep 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60
- symptomatic cholelithiasis
- ASA 1-2
Who cannot join
- pregnancy
- morbid obesity with BMI>35
- other gallbladder pathology like polyps or tumor
- history of upper abdomen laparotomy
- suspected choledocholithiasis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.
- Conditions
- Cholelithiasis
- Being tested
- Single trocar cholecystectomy, Standard laparoscopic cholecystectomy
- Keywords
- cholelithiasis, cholecystitis
- Medical subject headings
- Cholelithiasis, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single trocar cholecystectomyProcedure or surgery
Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach
Standard laparoscopic cholecystectomyProcedure or surgery
Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Single trocar | Experimental | Patients will undergo cholecystectomy by the single trocar approach Receives: Procedure: Single trocar cholecystectomy |
| Standard lap cholecystectomy | Active comparator | Standard lap choly Receives: Procedure: Standard laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques.
Measured: Continuous
Secondary outcomes (2)
To assess pain associated with the single trocar approach
Measured: Continuous
To assess scar formation associated with single trocar approach
Measured: Continuous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoav Mintz, MD, Principal investigator, Hadassah Medical OrganizationAvraham Rivkind, MD, Study chair, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732550
- Sponsor's protocol ID
- Single trocar HMO-CTIL
- Status last verified
- Apr 2016
- First submitted
- 3 Aug 2008
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT00732550
- Acronym / sponsor ID
- Single trocar HMO-CTIL
- Conditions
- Cholelithiasis
- Keywords
- cholelithiasis, cholecystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 12 Aug 2008 (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.
The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single trocar | Experimental | Procedure: Single trocar cholecystectomyPatients will undergo cholecystectomy by the single trocar approach |
| Standard lap cholecystectomy | Active comparator | Procedure: Standard laparoscopic cholecystectomyStandard lap choly |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60
- symptomatic cholelithiasis
- ASA 1-2
Key exclusion criteria (5 listed)
- pregnancy
- morbid obesity with BMI>35
- other gallbladder pathology like polyps or tumor
- history of upper abdomen laparotomy
- suspected choledocholithiasis
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 trocar cholecystectomyPatients with symptomatic cholelithiasis will be operated using the single trocar surgery approach | Procedure or surgery | Single trocar |
| Standard laparoscopic cholecystectomyPatients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy | Procedure or surgery | Standard lap cholecystectomy |
Primary outcome
To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques.
Time frame: Continuous
2 secondary outcomes
To assess pain associated with the single trocar approach
Time frame: Continuous
To assess scar formation associated with single trocar approach
Time frame: Continuous
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 30 Jul 2020.
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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.
Yoav Mintz, MD principal investigator
Hadassah Medical Organization
Avraham Rivkind, MD study chair
Hadassah Medical Organization
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 trocar cholecystectomy and Standard laparoscopic cholecystectomy in people with Cholelithiasis, run by Hadassah Medical Organization at 1 site in Israel.
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 3 inclusion and 5 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 30 Jul 2020. 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 Israel. 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?
To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques. (time frame: Continuous). 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 30 Jul 2020.