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

NCT ID: NCT06074679

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cholecystectomy, Laparoscopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Single-incision laparoscopic cholecystectomy

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

Group Type EXPERIMENTAL

Open cholecystectomy

Intervention Type PROCEDURE

The experimental group and the control group were changed to open cholecystectomy when the operation was difficult to complete.

Conventional laparoscopic cholecystectomy

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

Group Type ACTIVE_COMPARATOR

Open cholecystectomy

Intervention Type PROCEDURE

The experimental group and the control group were changed to open cholecystectomy when the operation was difficult to complete.

Interventions

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Open cholecystectomy

The experimental group and the control group were changed to open cholecystectomy when the operation was difficult to complete.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

UNKNOWN

Sponsor Role collaborator

Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

UNKNOWN

Sponsor Role collaborator

Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

UNKNOWN

Sponsor Role collaborator

Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liu Daren, MD, PhD

Role: STUDY_DIRECTOR

Chief Physician

Locations

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Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

Huangshan City, Anhui, China

Site Status RECRUITING

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

Hangzhou, Zhejiang, China

Site Status RECRUITING

Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

Huzhou, Zhejiang, China

Site Status RECRUITING

Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

Lishui, Zhejiang, China

Site Status RECRUITING

Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

Meicheng, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liu Daren, MD, PhD

Role: CONTACT

+86-15968179036

Zha Liufan, MD, PhD

Role: CONTACT

+86-18969952245

Facility Contacts

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Liu Xiaojun

Role: primary

+86-18955913095

Liu Daren, MD, PhD

Role: primary

+86-15968179036

Hu Yongfeng

Role: primary

+86-18006821136

Lan Weifeng

Role: primary

+86-15157876857

Peng Junwen

Role: primary

+86-13868117032

Other Identifiers

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2023-0690

Identifier Type: -

Identifier Source: org_study_id

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