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

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.

Study Overview

• Status: Completed
• Conditions: Cholecystectomy, Laparoscopic
• Intervention / Treatment: Procedure: Laparoscopic cholecystectomy

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, No.88 Jiefang Road
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-incision laparoscopic cholecystectomy; SILC was defined as laparoscopic surgery done through a single trans-umbilical incision	Procedure: Laparoscopic cholecystectomy; Laparoscopic cholecystectomy is defined as total or subtotal desection of the gallbladder laparoscopically.
Active Comparator: Conventional laparoscopic cholecystectomy; CLC was defined as three or four port surgery carried out with either French or American position.	Procedure: Laparoscopic cholecystectomy; Laparoscopic cholecystectomy is defined as total or subtotal desection of the gallbladder laparoscopically.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade II or above incidence of complications		2 years
Cosmetic result	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.	2 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Daren Liu, MD, PhD, Chief Physician

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): January 2, 2025
• Study Completion (Actual): January 2, 2025

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Single-incision laparoscopic cholecystectomy; Conventional laparoscopic cholecystectomy
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 2022-0533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No