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

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 Overview

• Status: Recruiting
• Conditions: Cholecystectomy, Laparoscopic
• Intervention / Treatment: Procedure: Open cholecystectomy

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liu Daren, MD, PhD; Phone Number: +86-15968179036; Email: darenliu@zju.edu.cn
• Study Contact Backup: Name: Zha Liufan, MD, PhD; Phone Number: +86-18969952245; Email: liufanZha@outlook.com

Study Locations

• China
  • Anhui
    • Huangshan, Anhui, China
      • Recruiting
      • Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Liu Xiaojun; Phone Number: +86-18955913095
  • Zhejiang
    • Hangzhou, Zhejiang, China, No.88 Jiefang Road
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Liu Daren, MD, PhD; Phone Number: +86-15968179036; Email: darenliu@zju.edu.cn
    • Huzhou, Zhejiang, China
      • Recruiting
      • Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Hu Yongfeng; Phone Number: +86-18006821136
    • Jiande, Zhejiang, China
      • Recruiting
      • Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Peng Junwen; Phone Number: +86-13868117032
    • Lishui, Zhejiang, China
      • Recruiting
      • Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Lan Weifeng; Phone Number: +86-15157876857

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-incision laparoscopic cholecystectomy; SILC was defined as laparoscopic surgery done through a single trans-umbilical incision	Procedure: Open cholecystectomy; The experimental group and the control group were changed to open cholecystectomy when the operation was difficult to complete.
Active Comparator: Conventional laparoscopic cholecystectomy; CLC was defined as three or four port surgery carried out with either French or American position.	Procedure: Open cholecystectomy; The experimental group and the control group were changed to open cholecystectomy when the operation was difficult to complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic result	Evaluation of postoperative incisional scarring using the Vancouver Scar Scale. The lower the score, the higher the scar satisfaction.	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade II or above incidence of complications	Postoperative complications were defined by the clavien-dindo classification system.	3 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University; Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University; Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University; Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Liu Daren, MD, PhD, Chief Physician

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 23, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Estimated): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Single-incision laparoscopic cholecystectomy; Conventional laparoscopic cholecystectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: 2023-0690

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No