Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Open cholecystectomy.
- Who it may be relevant to
- Registry conditions: Cholecystectomy, Laparoscopic. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Open cholecystectomy
The experimental group and the control group were changed to open cholecystectomy when the operation was difficult to complete.
Primary outcome measures
- Quality of life (time to return to normal life) [Time frame: 3 years]
Secondary outcome measures (1)
- Cosmetic result [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Acute cholecystitis（GradeⅠ，II）
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 5 centers
- Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University — Huangshan City
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou
- Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University — Huzhou
- Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University — Lishui
- Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University — Meicheng
Identifiers
NCT: NCT06074679 · 2023-0690