Actively Recruiting
Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-11-21
600
Participants Needed
5
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
C
Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute cholecystitis (Grade I or II)
- Age between 18 and 70 years
You will not qualify if you...
- Liver cirrhosis with Child grade B or higher
- History of upper abdominal surgery
- Changes in surgical plan such as conversion to laparotomy, cholangiography, bile duct exploration, bile duct injury repair, abscess clearance, or multivisceral resection
- Patients or families who do not agree with treatment or are lost to follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
Huangshan City, Anhui, China
Actively Recruiting
2
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China, No.88 Jiefang Road
Actively Recruiting
3
Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
Huzhou, Zhejiang, China
Actively Recruiting
4
Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
Lishui, Zhejiang, China
Actively Recruiting
5
Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
Meicheng, Zhejiang, China
Actively Recruiting
Research Team
L
Liu Daren, MD, PhD
CONTACT
Z
Zha Liufan, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here