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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06074679
Other study ID # 2023-0690
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2023
Est. completion date September 30, 2026

Study information

Verified date September 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Liu Daren, MD, PhD
Phone +86-15968179036
Email darenliu@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date September 30, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Acute cholecystitis(Grade?,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 Design


Intervention

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

Locations

Country Name City State
China 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang
China Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University Huangshan Anhui
China Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University Huzhou Zhejiang
China Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University Jiande Zhejiang
China Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University Lishui Zhejiang

Sponsors (5)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University Changxing 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, Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Grade II or above incidence of complications Postoperative complications were defined by the clavien-dindo classification system. 3 years
Primary 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 Cosmetic result Evaluation of postoperative incisional scarring using the Vancouver Scar Scale. The lower the score, the higher the scar satisfaction. 3 years
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