Single Incision Laparoscopic Cholecystectomy Compared with Conventional Laparoscopic Cholecystectomy, a Randomized Controlled Clinical Study

Not Applicable

Completed

• Conditions: Cholecystectomy, Laparoscopic
• Interventions: Procedure: Laparoscopic cholecystectomy

• Registration Number: NCT05728463
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Laparoscopic cholecystectomy has been accepted and is nowadays considered as the gold standard treatment of gallstones disease. Conventional laparoscopic cholecystectomy (CLC) was defined as three or four port surgery carried out with either French or American position. It reduced post-operative pain and shorten post-operative length of stay compared with open cholecystectomy in a great extent. Single-incision laparoscopic cholecystectomy (SILC) as a revolutionized surgery, the main reason for its widespread use being the following: less post-operative pain, faster recovery, better cosmetics and quicker return to full activities, all resulting in the improvement of post-operative quality of life. SILC uses the umbilicus as a natural orifice allowing easy access to peritoneal cavity, easy conversion to standard laparoscopy and its easy closure, has been widely introduced into the clinical practice for benign gallbladder diseases. SILC can easily hide the surgical scar inside the umbilicus, thus has better cosmetic effect. But the real clinical benefits for patients still remain a matter of debate. In the last 5 years, many studies on SILC have been published, trying to answer the question whether such a new approach is worthwhile or not and whether is safe and cost-effective.Based on the above controversy, we conduct a RCT comparing clinical and peri-operative outcomes, such as quality of life (QOL), of SILC and CLC with the intent to assess the actual indications of the single-incision approach.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-05
• Study Start: 2023-02-06
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-15
• Status Verified: 2024-02
• Primary Completion: 2025-01-02
• Study Completion: 2025-01-02
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Benign gallbladder disease

Exclusion Criteria

• Combined with liver cirrhosis (Child grade B and above)
• Upper abdominal surgical history;
• Gallbladder gangrene perforation;
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-incision laparoscopic cholecystectomy	Laparoscopic cholecystectomy	SILC was defined as laparoscopic surgery done through a single trans-umbilical incision
Conventional laparoscopic cholecystectomy	Laparoscopic cholecystectomy	CLC was defined as three or four port surgery carried out with either French or American position.

Primary Outcome Measures

Name	Time	Method
Quality of life (time to return to normal life)	2 years	The quality of life of patients after operation was investigated by a unified SF-36 questionnaire.

Secondary Outcome Measures

Name	Time	Method
Cosmetic result	2 years	Evaluation of postoperative incisional scarring using the Vancouver Scar Scale.The scar was observed after pressing with a special glass sheet for 2 seconds. The highest score was 15 points, and the lowest score was 0 points. The higher the score, the more serious the scar situation.
Grade II or above incidence of complications	2 years

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China