Cholecystectomy, LaparoscopicNCT06074679
Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis
A study testing Open cholecystectomy in people with Cholecystectomy, Laparoscopic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in China.
Trial summary
Gallstone is a common disease in China.At present, the prevalence of gallstones in China is 15 %, and about 210 million people are sick. Acute cholecystitis is acute gallbladder inflammation, is one of the main complications of cholelithiasis or gallstones. 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?
- Open cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesChina
- Study dates
- 1 Oct 2023to 30 Sep 2026
- 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
- Acute cholecystitis（GradeⅠ，II）
Who cannot join
- Combined with liver cirrhosis (Child grade B and above)
- Upper abdominal surgical history;
- 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
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, No.88 Jiefang Road
Liu Daren, MD, PhD, +86-15968179036, darenliu@zju.edu.cn
- Recruiting
Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
Huangshan City, Anhui
Liu Xiaojun, +86-18955913095
- Recruiting
Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
Huzhou, Zhejiang
Hu Yongfeng, +86-18006821136
- Recruiting
Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
Lishui, Zhejiang
Lan Weifeng, +86-15157876857
- Recruiting
Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
Meicheng, Zhejiang
Peng Junwen, +86-13868117032
About this study
Gallstone is a common disease in China.At present, the prevalence of gallstones in China is 15 %, and about 210 million people are sick. Acute cholecystitis is acute gallbladder inflammation, is one of the main complications of cholelithiasis or gallstones. The removal of gallbladder and gallstones in patients with acute cholecystitis in the presence of biliary pain will prevent the recurrence of gallbladder and reduce the risk of cholecystitis progression. If gallbladder perforation is not treated in time, the mortality rate is 30 %. Acute acalculous cholecystitis without treatment will be life-threatening, with a mortality rate of up to 50 %. At present, the vast majority of patients with acute cholecystitis are treated with 4-hole traditional laparoscopic cholecystectomy and open cholecystectomy. Their postoperative quality of life, pain and scar-related complications, remain major factors for patients.In recent years, with the renewal of the concept of minimally invasive surgery and the continuous advancement of instruments and technology, single-incision laparoscopic cholecystectomy has also maximized the quality of life after surgery and reduced postoperative pain and scar-related complications. At present, there are few reports on randomized controlled clinical trials of SILC in patients with acute cholecystitis, and there is a lack of large sample size studies.Due to the difficulty of SILC operation, the longer learning curve, the different equipment conditions and technical characteristics of each center, and the lack of standardized training, there is no effective consensus on the application indications and operation procedures of SILC in acute cholecystitis surgery. Based on the current status, the purpose of this study was to investigate the effect of SILC on postoperative quality of life, postoperative pain, scar assessment and postoperative complications in patients with acute cholecystitis, so as to propose a standardized single incision laparoscopic operation procedure in the treatment of acute cholecystitis.
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- Open 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.
Open cholecystectomyProcedure or surgery
The experimental group and the control group were changed to open cholecystectomy when the operation was difficult to complete.
| 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: Open 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: Open 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. The higher the final score, the better the quality of life.
Measured: 3 years
Secondary outcomes (1)
Cosmetic result
Evaluation of postoperative incisional scarring using the Vancouver Scar Scale. The lower the score, the higher the scar satisfaction.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Oct 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (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.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Changxing People's Hospital, Suichang County People's Hospital, Jiande First People's Hospital, Shexian People's Hospital
- Responsible party
- Sponsor
- Investigators
- Liu Daren, MD, PhD, Study director, Chief Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074679
- Sponsor's protocol ID
- 2023-0690
- Status last verified
- Oct 2024
- First submitted
- 23 Sep 2023
- Last updated
- 21 Nov 2024
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT06074679
- Acronym / sponsor ID
- 2023-0690
- Conditions
- Cholecystectomy, Laparoscopic
- Keywords
- Single-incision laparoscopic cholecystectomy, Conventional laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Changxing People's Hospital, Suichang County People's Hospital, Jiande First People's Hospital, Shexian People's Hospital
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Oct 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.
Gallstone is a common disease in China.At present, the prevalence of gallstones in China is 15 %, and about 210 million people are sick. Acute cholecystitis is acute gallbladder inflammation, is one of the main complications of cholelithiasis or gallstones. The removal of gallbladder and gallstones in patients with acute cholecystitis in the presence of biliary pain will prevent the recurrence of gallbladder and reduce the risk of cholecystitis progression. If gallbladder perforation is not treated in time, the mortality rate is 30 %. Acute acalculous cholecystitis without treatment will be life-threatening, with a mortality rate of up to 50 %. At present, the vast majority of patients with acute cholecystitis are treated with 4-hole traditional laparoscopic cholecystectomy and open cholecystectomy. Their postoperative quality of life, pain and scar-related complications, remain major factors for patients.In recent years, with the renewal of the concept of minimally invasive surgery and the continuous advancement of instruments and technology, single-incision laparoscopic cholecystectomy has also maximized the quality of life after surgery and reduced postoperative pain and scar-related complications. At present, there are few reports on randomized controlled clinical trials of SILC in patients with acute cholecystitis, and there is a lack of large sample size studies.Due to the difficulty of SILC operation, the longer learning curve, the different equipment conditions and technical characteristics of each center, and the lack of standardized training, there is no effective consensus on the application indications and operation procedures of SILC in acute cholecystitis surgery. Based on the current status, the purpose of this study was to investigate the effect of SILC on postoperative quality of life, postoperative pain, scar assessment and postoperative complications in patients with acute cholecystitis, so as to propose a standardized single incision laparoscopic operation procedure in the treatment of acute cholecystitis.
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: Open cholecystectomySILC was defined as laparoscopic surgery done through a single trans-umbilical incision |
| Conventional laparoscopic cholecystectomy | Active comparator | Procedure: Open 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)
- Acute cholecystitis（GradeⅠ，II）
Key exclusion criteria (4 listed)
- Combined with liver cirrhosis (Child grade B and above)
- Upper abdominal surgical history;
- 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 |
|---|---|---|
| Open cholecystectomyThe experimental group and the control group were changed to open cholecystectomy when the operation was difficult to complete. | Procedure or surgery | Conventional laparoscopic cholecystectomy, Single-incision laparoscopic cholecystectomy |
Primary outcome
Quality of life (time to return to normal life)
Time frame: 3 years
The quality of life of patients after operation was investigated by a unified SF-36 questionnaire. The higher the final score, the better the quality of life.
1 secondary outcome
Cosmetic result
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- 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.
Liu Daren, MD, PhD study director
Chief Physician
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open cholecystectomy in people with Cholecystectomy, Laparoscopic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites 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 4 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Daren, MD, PhD (+86-15968179036, darenliu@zju.edu.cn), or a site near the patient. 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: 3 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 21 Nov 2024.