NCT05728463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2025

Completed
Last Updated

January 7, 2025

Status Verified

February 1, 2024

Enrollment Period

1.9 years

First QC Date

February 5, 2023

Last Update Submit

January 5, 2025

Conditions

Cholecystectomy, Laparoscopic

Keywords

Single-incision laparoscopic cholecystectomyConventional laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Cosmetic result

    2 years

  • Grade II or above incidence of complications

    2 years

Study Arms (2)

Single-incision laparoscopic cholecystectomy

EXPERIMENTAL

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

Procedure: Laparoscopic cholecystectomy

Conventional laparoscopic cholecystectomy

ACTIVE COMPARATOR

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

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE

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

Conventional laparoscopic cholecystectomySingle-incision laparoscopic cholecystectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Benign gallbladder disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, No.88 Jiefang Road, China

Location

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Daren Liu, MD, PhD

    Chief Physician

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2023

First Posted

February 15, 2023

Study Start

February 6, 2023

Primary Completion

January 2, 2025

Study Completion

January 2, 2025

Last Updated

January 7, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)