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

NCT06074679 | Recruiting

• 1 other identifier: 2023-0690
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 5

Brief 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. 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

Keywords

Single-incision laparoscopic cholecystectomy; Conventional laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cosmetic result

  3 years

Other Outcomes (1)

• Grade II or above incidence of complications

  3 years

Study Arms (2)

Single-incision laparoscopic cholecystectomy

EXPERIMENTAL

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

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.

Procedure: Open cholecystectomy

Interventions

Open cholecystectomy PROCEDURE

The experimental group and the control group were changed to open cholecystectomy when the operation was difficult to complete.

Conventional laparoscopic cholecystectomy; Single-incision laparoscopic cholecystectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute cholecystitis（GradeⅠ，II）

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (5)

Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

Huangshan City, Anhui, China

RECRUITING

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, No.88 Jiefang Road, China

RECRUITING

Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

Huzhou, Zhejiang, China

RECRUITING

Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

Lishui, Zhejiang, China

RECRUITING

Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

Meicheng, Zhejiang, China

RECRUITING

Study Officials

• Liu Daren, MD, PhD

  Chief Physician

  STUDY DIRECTOR

Central Study Contacts

Liu Daren, MD, PhD

CONTACT

+86-15968179036; darenliu@zju.edu.cn

Zha Liufan, MD, PhD

CONTACT

+86-18969952245; liufanZha@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: October 10, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)