Single incision laparoscopic surgery for treating acute gallbladder inflammation
Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis
This study is testing a new type of surgery that uses just one small cut to treat people with acute gallbladder inflammation to see if it helps them recover faster and feel less pain compared to traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 5 sites (Huangshan City, Anhui and 4 other locations) |
| Trial ID | NCT06074679 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the effectiveness of single incision laparoscopic cholecystectomy in patients suffering from acute cholecystitis, a serious complication of gallstones. The study aims to compare this minimally invasive approach to traditional methods, focusing on postoperative recovery, pain management, and cosmetic outcomes. By utilizing a single incision, the goal is to reduce complications and improve the quality of life for patients. The study will include patients with Grade I and II acute cholecystitis while excluding those with significant comorbidities or prior abdominal surgeries.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with Grade I or II acute cholecystitis.
Not a fit: Patients with liver cirrhosis, significant prior abdominal surgeries, or those who do not consent to the treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and reduced postoperative complications for patients with acute cholecystitis.
How similar studies have performed: Other studies have shown promising results with minimally invasive techniques for gallbladder surgery, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute cholecystitis（GradeⅠ，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
Where this trial is running
Huangshan City, Anhui and 4 other locations
- Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University — Huangshan City, Anhui, China (Recruiting)
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, Zhejiang, China (Recruiting)
- Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University — Huzhou, Zhejiang, China (Recruiting)
- Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University — Lishui, Zhejiang, China (Recruiting)
- Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University — Meicheng, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Liu Daren, MD, PhD
- Email: darenliu@zju.edu.cn
- Phone: +86-15968179036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.