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
N/A
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 disease is common in China, affecting about 15% of the population, with 210 million people affected. Acute cholecystitis, a sudden inflammation of the gallbladder often caused by gallstones, can lead to serious complications such as gallbladder perforation and high mortality if untreated. This study investigates the effects of single-incision laparoscopic cholecystectomy (SILC) compared to conventional laparoscopic cholecystectomy (CLC) on patient outcomes after surgery for acute cholecystitis, aiming to improve quality of life and reduce pain and scarring. The trial compares two surgical methods: SILC, which uses a single incision through the navel, and CLC, which involves three or four small incisions. Both groups may switch to open cholecystectomy if the surgery is difficult to complete. The study is randomized and triple-blinded to ensure unbiased results. Researchers want to establish a standardized procedure for SILC in treating acute cholecystitis and evaluate its safety and impact on postoperative recovery. Participants will be followed for three years to assess the time it takes to return to normal life, the cosmetic results of surgery, postoperative pain, scar quality, and any complications. The study includes regular monitoring and evaluation to measure these outcomes and ensure participant safety. This long-term follow-up will provide valuable information on the effectiveness and patient experience with SILC compared to traditional laparoscopic surgery.
CONDITIONS
Brief 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...
- Adults aged 18 to 70 years
- Diagnosed with acute cholecystitis Grade I or II
You will not qualify if you...
- Liver cirrhosis at 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, multivisceral resection
- Patients and 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge
Participants undergo single-incision laparoscopic cholecystectomy or conventional laparoscopic cholecystectomy. If the surgery is difficult to complete, it may be changed to open cholecystectomy.
1 surgical procedure and immediate post-operative care
Duration - Up to 3 years
Participants are followed to assess recovery, quality of life, and cosmetic results after surgery.
Follow-up visits as scheduled for up to 3 years
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
Z
Zha Liufan, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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