Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis

Zhejiang University

Status: Enrolling

Conditions: Cholecystectomy, Laparoscopic

Treatments: Procedure: Open cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06074679

2023-0690

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

Single-incision laparoscopic cholecystectomy

Experimental group

Description:

SILC was defined as laparoscopic surgery done through a single trans-umbilical incision

Treatment:

Procedure: Open cholecystectomy

Conventional laparoscopic cholecystectomy

Active Comparator group

Description:

CLC was defined as three or four port surgery carried out with either French or American position.

Treatment:

Procedure: Open cholecystectomy