CholecystolithiasisSPoCOTNCT00974194
Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies
A study testing Single Trocar CCK and Standard CCK in people with Cholecystolithiasis, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
Many feasibility studies have been published on Single Port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. The purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholecystolithiasis
- What is being tested?
- Single Trocar CCK and Standard CCK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2009to 1 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cholecystolithiasis
- Age 18 to 75 y.o.
- BMI < 35
Who cannot join
- Immunodeficiency
- Choledocholithiasis
- Previous upperGI open surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial
Many feasibility studies have been published on Single Port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. The purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and three trocars.
Read the detailed description
Design:
- Prospective Randomized Controlled trial
- Population analysis based on Intention To Treat
- Patient and data analyzer blinded (double-blind trial)
Outcomes observed:
- Primary: pain
- Secondaries: overall operative time, complication rate, cost-effectiveness analysis, cosmetic evaluation, quality of life, CO2 consumption
Nbr of patients included: 260
Port used: Triport, Olympus
- Conditions
- Cholecystolithiasis
- Being tested
- Single Trocar CCK, Standard CCK
- Keywords
- Cholecystolithiasis, Cholecystectomy, Laparoscopic surgery, Single port
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Trocar CCKProcedure or surgery
CCK using Triport
Standard CCKProcedure or surgery
CCK using three or four ports
| Study group | Role | What they receive |
|---|---|---|
| SinglePort CCK | Experimental | CCK using Triport Receives: Procedure: Single Trocar CCK |
| LS CCK | Active comparator | CCK using three or four trocars Receives: Procedure: Standard CCK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (value on a Visual Analog Scale)
VAS
Measured: 1 day
Pain (value on a Visual Analog Scale)
VAS
Measured: 2 days
Pain (value on a Visual Analog Scale)
VAS
Measured: 1 month
Pain (value on a Visual Analog Scale)
VAS
Measured: 3 month
Pain (value on a Visual Analog Scale)
VAS
Measured: 1 year
Secondary outcomes (8)
Complications
In euro
Measured: 1 month
Operative time
In euro
Measured: Operative day
Cost analysis
In euro
Measured: 1 year
Cosmetic results
According to POSAS score
Measured: 1 month
Cosmetic results
According to POSAS score
Measured: 3 month
Cosmetic results
According to POSAS score
Measured: 1 year
Complications
According to Clavien classification and CCI
Measured: 3 month
Complications
According to Clavien classification and CCI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startSep 2009
- Primary completion1 Sep 2017
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystolithiasisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
- Investigators
- Pierre Allemann, MD, Principal investigator, CHV/CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974194
- Sponsor's protocol ID
- SPoCOT_2009
- Acronym
- SPoCOT
- Status last verified
- Oct 2018
- First submitted
- 8 Sep 2009
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00974194
- Acronym / sponsor ID
- SPoCOT / SPoCOT_2009
- Conditions
- Cholecystolithiasis
- Keywords
- Cholecystolithiasis, Cholecystectomy, Laparoscopic surgery, Single port
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 10 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.
Many feasibility studies have been published on Single Port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. The purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and three trocars.
Detailed description
Design:
- Prospective Randomized Controlled trial
- Population analysis based on Intention To Treat
- Patient and data analyzer blinded (double-blind trial)
Outcomes observed:
- Primary: pain
- Secondaries: overall operative time, complication rate, cost-effectiveness analysis, cosmetic evaluation, quality of life, CO2 consumption
Nbr of patients included: 260
Port used: Triport, Olympus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SinglePort CCK | Experimental | Procedure: Single Trocar CCKCCK using Triport |
| LS CCK | Active comparator | Procedure: Standard CCKCCK using three or four trocars |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cholecystolithiasis
- Age 18 to 75 y.o.
- BMI < 35
Key exclusion criteria (3 listed)
- Immunodeficiency
- Choledocholithiasis
- Previous upperGI open surgery
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 CCKCCK using Triport | Procedure or surgery | SinglePort CCK |
| Standard CCKCCK using three or four ports | Procedure or surgery | LS CCK |
Primary outcome
Pain (value on a Visual Analog Scale)
Time frame: 1 day
VAS
Pain (value on a Visual Analog Scale)
Time frame: 2 days
VAS
Pain (value on a Visual Analog Scale)
Time frame: 1 month
VAS
Pain (value on a Visual Analog Scale)
Time frame: 3 month
VAS
Pain (value on a Visual Analog Scale)
Time frame: 1 year
VAS
8 secondary outcomes
Complications
Time frame: 1 month
Operative time
Time frame: Operative day
Cost analysis
Time frame: 1 year
Cosmetic results
Time frame: 1 month
Cosmetic results
Time frame: 3 month
Cosmetic results
Time frame: 1 year
Complications
Time frame: 3 month
Complications
Time frame: 1 year
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 17 Oct 2018.
- Internet page of our departementLink provided by the sponsor.
Related trials for Cholecystolithiasis
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Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
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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.
Pierre Allemann, MD principal investigator
CHV/CHUV
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 CCK and Standard CCK in people with Cholecystolithiasis, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 3 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 17 Oct 2018. 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 Switzerland. 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?
Pain (value on a Visual Analog Scale) (time frame: 1 day). The study lists 5 primary outcomes in all. 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 17 Oct 2018.