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

Cholecystectomy, Laparoscopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074679
• Other study ID #: 2023-0690
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cholecystectomy, Laparoscopic
• Cholecystitis
• Cholecystitis, Acute

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