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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Acute cholecystitis(GradeⅠ,II)

Locations
Other Locations
China
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
RECRUITING
Hangzhou
Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Huangshan City
Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Huzhou
Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Lishui
Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Meicheng
Contact Information
Primary
Liu Daren, MD, PhD
darenliu@zju.edu.cn
+86-15968179036
Backup
Zha Liufan, MD, PhD
liufanZha@outlook.com
+86-18969952245
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 600
Treatments
Experimental: Single-incision laparoscopic cholecystectomy
SILC was defined as laparoscopic surgery done through a single trans-umbilical incision
Active_comparator: Conventional laparoscopic cholecystectomy
CLC was defined as three or four port surgery carried out with either French or American position.
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University, 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

This content was sourced from clinicaltrials.gov