search
Back to results

Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis

Primary Purpose

Cholecystectomy, Laparoscopic

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Open 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: Acute cholecystitis(GradeⅠ,II) Exclusion Criteria: Combined with liver cirrhosis (Child grade B and above) Upper abdominal surgical history; 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

  • Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting
  • Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
  • Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
  • Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

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. The higher the final score, the better the quality of life.

Secondary Outcome Measures

Cosmetic result
Evaluation of postoperative incisional scarring using the Vancouver Scar Scale. The lower the score, the higher the scar satisfaction.

Full Information

First Posted
September 23, 2023
Last Updated
October 5, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University, Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University, Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
search

1. Study Identification

Unique Protocol Identification Number
NCT06074679
Brief Title
Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis
Official Title
Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2023 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University, Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University, Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shexian Branch, 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
Gallstone is a common disease in China.At present, the prevalence of gallstones in China is 15 %, and about 210 million people are sick. Acute cholecystitis is acute gallbladder inflammation, is one of the main complications of cholelithiasis or gallstones. The removal of gallbladder and gallstones in patients with acute cholecystitis in the presence of biliary pain will prevent the recurrence of gallbladder and reduce the risk of cholecystitis progression. If gallbladder perforation is not treated in time, the mortality rate is 30 %. Acute acalculous cholecystitis without treatment will be life-threatening, with a mortality rate of up to 50 %. At present, the vast majority of patients with acute cholecystitis are treated with 4-hole traditional laparoscopic cholecystectomy and open cholecystectomy. Their postoperative quality of life, pain and scar-related complications, remain major factors for patients.In recent years, with the renewal of the concept of minimally invasive surgery and the continuous advancement of instruments and technology, single-incision laparoscopic cholecystectomy has also maximized the quality of life after surgery and reduced postoperative pain and scar-related complications. At present, there are few reports on randomized controlled clinical trials of SILC in patients with acute cholecystitis, and there is a lack of large sample size studies.Due to the difficulty of SILC operation, the longer learning curve, the different equipment conditions and technical characteristics of each center, and the lack of standardized training, there is no effective consensus on the application indications and operation procedures of SILC in acute cholecystitis surgery. Based on the current status, the purpose of this study was to investigate the effect of SILC on postoperative quality of life, postoperative pain, scar assessment and postoperative complications in patients with acute cholecystitis, so as to propose a standardized single incision laparoscopic operation procedure in the treatment of acute cholecystitis.

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
600 (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)
Open cholecystectomy
Intervention Description
The experimental group and the control group were changed to open cholecystectomy when the operation was difficult to complete.
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. The higher the final score, the better the quality of life.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Cosmetic result
Description
Evaluation of postoperative incisional scarring using the Vancouver Scar Scale. The lower the score, the higher the scar satisfaction.
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Grade II or above incidence of complications
Description
Postoperative complications were defined by the clavien-dindo classification system.
Time Frame
3 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: Acute cholecystitis(GradeⅠ,II) Exclusion Criteria: Combined with liver cirrhosis (Child grade B and above) Upper abdominal surgical history; 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
Liu Daren, MD, PhD
Phone
+86-15968179036
Email
darenliu@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zha Liufan, MD, PhD
Phone
+86-18969952245
Email
liufanZha@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Daren, MD, PhD
Organizational Affiliation
Chief Physician
Official's Role
Study Director
Facility Information:
Facility Name
Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Huangshan
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Xiaojun
Phone
+86-18955913095
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
Liu Daren, MD, PhD
Phone
+86-15968179036
Email
darenliu@zju.edu.cn
Facility Name
Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Huzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu Yongfeng
Phone
+86-18006821136
Facility Name
Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Jiande
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Junwen
Phone
+86-13868117032
Facility Name
Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Lishui
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Weifeng
Phone
+86-15157876857

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis

We'll reach out to this number within 24 hrs