Cholecystectomy, LaparoscopicNCT05728463
Single Incision Laparoscopic Cholecystectomy Compared with Conventional Laparoscopic Cholecystectomy, a Randomized Controlled Clinical Study
A study testing Laparoscopic cholecystectomy in people with Cholecystectomy, Laparoscopic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Laparoscopic cholecystectomy has been accepted and is nowadays considered as the gold standard treatment of gallstones disease. Conventional laparoscopic cholecystectomy (CLC) was defined as three or four port surgery carried out with either French or American position. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2023to 2 Jan 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign gallbladder disease
Who cannot join
- Combined with liver cirrhosis (Child grade B and above)
- Upper abdominal surgical history;
- Gallbladder gangrene perforation;
- Changes in surgical plan (conversion to laparotomy,cholangiography, bile duct exploration, bile duct injury repair, abscess clearance, multivisceral resection.)
- patients and their families do not agree with the treatment lost follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, No.88 Jiefang Road
About this study
Laparoscopic cholecystectomy has been accepted and is nowadays considered as the gold standard treatment of gallstones disease. Conventional laparoscopic cholecystectomy (CLC) was defined as three or four port surgery carried out with either French or American position. It reduced post-operative pain and shorten post-operative length of stay compared with open cholecystectomy in a great extent. Single-incision laparoscopic cholecystectomy (SILC) as a revolutionized surgery, the main reason for its widespread use being the following: less post-operative pain, faster recovery, better cosmetics and quicker return to full activities, all resulting in the improvement of post-operative quality of life. SILC uses the umbilicus as a natural orifice allowing easy access to peritoneal cavity, easy conversion to standard laparoscopy and its easy closure, has been widely introduced into the clinical practice for benign gallbladder diseases. SILC can easily hide the surgical scar inside the umbilicus, thus has better cosmetic effect. But the real clinical benefits for patients still remain a matter of debate. In the last 5 years, many studies on SILC have been published, trying to answer the question whether such a new approach is worthwhile or not and whether is safe and cost-effective.Based on the above controversy, we conduct a RCT comparing clinical and peri-operative outcomes, such as quality of life (QOL), of SILC and CLC with the intent to assess the actual indications of the single-incision approach.
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- Laparoscopic cholecystectomy
- Keywords
- Single-incision laparoscopic cholecystectomy, Conventional laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy is defined as total or subtotal desection of the gallbladder laparoscopically.
| Study group | Role | What they receive |
|---|---|---|
| Single-incision laparoscopic cholecystectomy | Experimental | SILC was defined as laparoscopic surgery done through a single trans-umbilical incision Receives: Procedure: Laparoscopic cholecystectomy |
| Conventional laparoscopic cholecystectomy | Active comparator | CLC was defined as three or four port surgery carried out with either French or American position. Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (time to return to normal life)
The quality of life of patients after operation was investigated by a unified SF-36 questionnaire.
Measured: 2 years
Secondary outcomes (2)
Cosmetic result
Evaluation of postoperative incisional scarring using the Vancouver Scar Scale.The scar was observed after pressing with a special glass sheet for 2 seconds. The highest score was 15 points, and the lowest score was 0 points. The higher the score, the more serious the scar situation.
Measured: 2 years
Grade II or above incidence of complications
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start6 Feb 2023
- Primary completion2 Jan 2025
- Study completion2 Jan 2025
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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daren Liu, MD, PhD, Study director, Chief Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728463
- Sponsor's protocol ID
- 2022-0533
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2023
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Laparoscopic Cholecystectomy Compared with Conventional Laparoscopic Cholecystectomy, a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05728463
- Acronym / sponsor ID
- 2022-0533
- Conditions
- Cholecystectomy, Laparoscopic
- Keywords
- Single-incision laparoscopic cholecystectomy, Conventional laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 15 Feb 2023 (actual)
- 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.
Laparoscopic cholecystectomy has been accepted and is nowadays considered as the gold standard treatment of gallstones disease. Conventional laparoscopic cholecystectomy (CLC) was defined as three or four port surgery carried out with either French or American position. It reduced post-operative pain and shorten post-operative length of stay compared with open cholecystectomy in a great extent. Single-incision laparoscopic cholecystectomy (SILC) as a revolutionized surgery, the main reason for its widespread use being the following: less post-operative pain, faster recovery, better cosmetics and quicker return to full activities, all resulting in the improvement of post-operative quality of life. SILC uses the umbilicus as a natural orifice allowing easy access to peritoneal cavity, easy conversion to standard laparoscopy and its easy closure, has been widely introduced into the clinical practice for benign gallbladder diseases. SILC can easily hide the surgical scar inside the umbilicus, thus has better cosmetic effect. But the real clinical benefits for patients still remain a matter of debate. In the last 5 years, many studies on SILC have been published, trying to answer the question whether such a new approach is worthwhile or not and whether is safe and cost-effective.Based on the above controversy, we conduct a RCT comparing clinical and peri-operative outcomes, such as quality of life (QOL), of SILC and CLC with the intent to assess the actual indications of the single-incision approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-incision laparoscopic cholecystectomy | Experimental | Procedure: Laparoscopic cholecystectomySILC was defined as laparoscopic surgery done through a single trans-umbilical incision |
| Conventional laparoscopic cholecystectomy | Active comparator | Procedure: Laparoscopic cholecystectomyCLC was defined as three or four port surgery carried out with either French or American position. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Benign gallbladder disease
Key exclusion criteria (5 listed)
- Combined with liver cirrhosis (Child grade B and above)
- Upper abdominal surgical history;
- Gallbladder gangrene perforation;
- Changes in surgical plan (conversion to laparotomy,cholangiography, bile duct exploration, bile duct injury repair, abscess clearance, multivisceral resection.)
- patients and their families do not agree with the treatment lost follow-up
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 |
|---|---|---|
| Laparoscopic cholecystectomyLaparoscopic cholecystectomy is defined as total or subtotal desection of the gallbladder laparoscopically. | Procedure or surgery | Conventional laparoscopic cholecystectomy, Single-incision laparoscopic cholecystectomy |
Primary outcome
Quality of life (time to return to normal life)
Time frame: 2 years
The quality of life of patients after operation was investigated by a unified SF-36 questionnaire.
2 secondary outcomes
Cosmetic result
Time frame: 2 years
Grade II or above incidence of complications
Time frame: 2 years
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 7 Jan 2025.
- 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.
Daren Liu, MD, PhD study director
Chief Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cholecystectomy in people with Cholecystectomy, Laparoscopic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 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 7 Jan 2025. 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 China. 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?
Quality of life (time to return to normal life) (time frame: 2 years). 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 7 Jan 2025.