Cholecystectomy, LaparoscopicSOLOGBNCT02978989
Solo and Non-solo Approach for Laparoscopic Cholecystectomy
A study testing nonsolo LC and solo LC in people with Cholecystectomy, Laparoscopic, run by Daejeon St. Mary's hospital.
Trial summary
To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s). Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- What is being tested?
- nonsolo LC and solo LC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Sep 2017
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients planed to undergo elective laparoscopic cholecystectomy
- Benign gallbladder diseases requiring surgery
- The patients who are indicated for single-port laparoscopic cholecystectomy.
Who cannot join
- the patients with complicated cholecystitis
- the patients with the gallbladder with a thickness more than 4mm.
- the patients who are expected to have severe peritoneal adhesion.
- the patients with malignant gallbladder diseases.
- the patients whose operation appears to need human assistant(s)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial Comparing a Solo and Non-solo Approach for Laparoscopic Cholecystectomy
To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).
Read the detailed description
Laporoscopic cholecystectomy usually requires three surgeons, including an operator, a camera assistant, and other instrument assistant. Recent advancement of technology made it possible to develop the conveniently adjustable holders for camera and other laparoscopic instruments. The application of these instruments enables "solo-surgery" wherein an operation is driven by single surgeon. During surgery, human assistant(s) are helpful because of their instant assistance according to the operation's need. Therefore, the utilization of instruments instead of human assistants would be cumbersome. However, the utilization of instruments would be helpful by enabling operation-driven repositioning of the camera and instrument(s). Currently, no attempt has been made to objectively compare the merits and demerits of these two procedures. Therefore, this study was conducted to determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- nonsolo LC, solo LC
- Keywords
- Laparoscopic cholecystectomy, Solo surgery, Camera holder, Cholecystitis
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonsolo LCProcedure or surgery
Also called Nonsolo laparoscopic cholecystectomy
This patient is scheduled to undergo nonsolo laparoscpic cholecystectomy.
solo LCProcedure or surgery
Also called Solo laparoscopic cholecystectomy
This patient is scheduled to undergo solo laparoscpic cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| LC & nonsolo approach | Placebo comparator | The surgical intervention is nonsolo LC. Receives: Procedure: nonsolo LC |
| LC & solo approach | Active comparator | The surgical intervention is solo LC. Receives: Procedure: solo LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
Operation time correlates with surgical difficulity.
Measured: day 1
Secondary outcomes (1)
Pain score
Daily pain scores are assessed.
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daejeon St. Mary's hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Say-June Kim, Daejeon St. Mary's hospital
- Investigators
- Say-June Kim, M.D., Ph.D., Principal investigator, Daejeon St. Mary's hospital, the Catholic University of Korea, 222, Banpo-dong, Seocho-gu, Seoul, 06591, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978989
- Sponsor's protocol ID
- SSGB-1
- Acronym
- SOLOGB
- Status last verified
- Feb 2017
- First submitted
- 29 Nov 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing a Solo and Non-solo Approach for Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02978989
- Acronym / sponsor ID
- SOLOGB / SSGB-1
- Conditions
- Cholecystectomy, Laparoscopic
- Keywords
- Laparoscopic cholecystectomy, Solo surgery, Camera holder, Cholecystitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Daejeon St. Mary's hospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 1 Dec 2016 (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.
To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).
Detailed description
Laporoscopic cholecystectomy usually requires three surgeons, including an operator, a camera assistant, and other instrument assistant. Recent advancement of technology made it possible to develop the conveniently adjustable holders for camera and other laparoscopic instruments. The application of these instruments enables "solo-surgery" wherein an operation is driven by single surgeon. During surgery, human assistant(s) are helpful because of their instant assistance according to the operation's need. Therefore, the utilization of instruments instead of human assistants would be cumbersome. However, the utilization of instruments would be helpful by enabling operation-driven repositioning of the camera and instrument(s). Currently, no attempt has been made to objectively compare the merits and demerits of these two procedures. Therefore, this study was conducted to determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LC & nonsolo approach | Placebo comparator | Procedure: nonsolo LCThe surgical intervention is nonsolo LC. |
| LC & solo approach | Active comparator | Procedure: solo LCThe surgical intervention is solo LC. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The patients planed to undergo elective laparoscopic cholecystectomy
- Benign gallbladder diseases requiring surgery
- The patients who are indicated for single-port laparoscopic cholecystectomy.
Key exclusion criteria (5 listed)
- the patients with complicated cholecystitis
- the patients with the gallbladder with a thickness more than 4mm.
- the patients who are expected to have severe peritoneal adhesion.
- the patients with malignant gallbladder diseases.
- the patients whose operation appears to need human assistant(s)
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 |
|---|---|---|
| nonsolo LCAlso: Nonsolo laparoscopic cholecystectomyThis patient is scheduled to undergo nonsolo laparoscpic cholecystectomy. | Procedure or surgery | LC & nonsolo approach |
| solo LCAlso: Solo laparoscopic cholecystectomyThis patient is scheduled to undergo solo laparoscpic cholecystectomy. | Procedure or surgery | LC & solo approach |
Primary outcome
Operation time
Time frame: day 1
Operation time correlates with surgical difficulity.
1 secondary outcome
Pain score
Time frame: day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Say-June Kim, M.D., Ph.D. principal investigator
Daejeon St. Mary's hospital, the Catholic University of Korea, 222, Banpo-dong, Seocho-gu, Seoul, 06591, South Korea
Questions about this trial
What is this clinical trial studying?
A study testing nonsolo LC and solo LC in people with Cholecystectomy, Laparoscopic, run by Daejeon St. Mary's hospital.
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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Say-June Kim, M.D.,Ph.D. (+821087737616, sayjunekim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: day 1). 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 23 Feb 2017.