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

NCT ID: NCT05728463

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2025-01-02

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.

Conditions

Cholecystectomy, Laparoscopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Single-incision laparoscopic cholecystectomy

SILC was defined as laparoscopic surgery done through a single trans-umbilical incision

Group Type: EXPERIMENTAL

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Laparoscopic cholecystectomy is defined as total or subtotal desection of the gallbladder laparoscopically.

Conventional laparoscopic cholecystectomy

CLC was defined as three or four port surgery carried out with either French or American position.

Group Type: ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Laparoscopic cholecystectomy is defined as total or subtotal desection of the gallbladder laparoscopically.

Interventions

Laparoscopic cholecystectomy

Laparoscopic cholecystectomy is defined as total or subtotal desection of the gallbladder laparoscopically.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daren Liu, MD, PhD

Role: STUDY_DIRECTOR

Chief Physician

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2022-0533

Identifier Type: -

Identifier Source: org_study_id