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

Primary Purpose

Cholecystectomy, Laparoscopic

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystectomy, Laparoscopic focused on measuring Single-incision laparoscopic cholecystectomy, Conventional laparoscopic cholecystectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single-incision laparoscopic cholecystectomy

Conventional laparoscopic cholecystectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cosmetic result
Evaluation of postoperative incisional scarring using the Vancouver Scar Scale
Grade II or above incidence of complications

Full Information

First Posted
February 5, 2023
Last Updated
February 14, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05728463
Brief Title
Single Incision Laparoscopic Cholecystectomy Compared With Conventional Laparoscopic Cholecystectomy, a Randomized Controlled Clinical Study
Official Title
Single Incision Laparoscopic Cholecystectomy Compared With Conventional Laparoscopic Cholecystectomy, a Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
February 6, 2025 (Anticipated)
Study Completion Date
February 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystectomy, Laparoscopic
Keywords
Single-incision laparoscopic cholecystectomy, Conventional laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-incision laparoscopic cholecystectomy
Arm Type
Experimental
Arm Description
SILC was defined as laparoscopic surgery done through a single trans-umbilical incision
Arm Title
Conventional laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
CLC was defined as three or four port surgery carried out with either French or American position.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Laparoscopic cholecystectomy is defined as total or subtotal desection of the gallbladder laparoscopically.
Primary Outcome Measure Information:
Title
Quality of life (time to return to normal life)
Description
The quality of life of patients after operation was investigated by a unified SF-36 questionnaire.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Cosmetic result
Description
Evaluation of postoperative incisional scarring using the Vancouver Scar Scale
Time Frame
2 years
Title
Grade II or above incidence of complications
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daren Liu, MD, PhD
Phone
+86-15968179036
Email
darenliu@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daren Liu, MD, PhD
Organizational Affiliation
Chief Physician
Official's Role
Study Director
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
No.88 Jiefang Road
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daren Liu, MD, PhD
Phone
+86-15968179036
Email
darenliu@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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