Contrastive Study for Minimally Invasive Cholecystolithotomy With Gallbladder Reservation and Laparoscopic Cholecystectomy

February 11, 2018 updated by: Chengyi Sun

All the Phases Study Will be Operated by the Department of Hepatobiliary Surgery, The Affiliated Hospital of Guiyang Medical College

To explore the therapeutic effects for treatment of cholecystolithiasis by minimally invasive cholecystolithotomy with gallbladder reservation and laparoscopic cholecystectomy. Method： patients with cholecystolithiasis who received minimally invasive Cholecystolithotomy with gallbladder reservation and patients with cholecystolithiasis who received laparoscopic cholecystectomy(LC) in The Affiliated Hospital of Guiyang Medical College from May 2011 to December 2013. Patients who received minimally invasive cholecystolithotomy with gallbladder reservation as trial group, patients who received LC as control group.the overall follow-up period is 1 year. Then the investigators statistically analyze improvement of cholecystolithiasis symptoms in every group, thickness of gall bladder wall, the gallbladder function and the rate of the recurrence of cholesterol gallstone in trial group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators Prospect： Minimally invasive cholecystolithotomy with gallbladder reservation is meaningful for recovering the function of gallbladder.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Recruiting
        • The affiliated Hospital of Guiyang Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of calculous cholecystitis.

Exclusion Criteria:

  • Gallbladder's wall >3mm, atrophied gallbladder,gallstone obstruct the Hartmann's pouch.
  • Abdominal ultrasound display the contractibility of gallbladder is poor.
  • The aged patients with bad heart and lung function.
  • Patients who has acute cholecystitis,pancreatitis,pancreaticobiliary diseases, especially choledocholithiasis.
  • Pregnant or lactational women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gallbladder reservation
Patients in trial group all took minimally invasive cholecystolithotomy with gallbladder reservation
Procedure: minimally invasive cholecystolithotomy with gallbladder reservation
Experimental: laparoscopiccholecystectomy
Patients in control group all received LC.
Procedure: laparoscopic cholecystectomy
Other Names:
  • LC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The contraction function of the gallbladder
Time Frame: Participants will be followed for overall 1 year after surgery
Measure the participants' contraction function of gallbladder by the trial for contraction function of gallbladder
Participants will be followed for overall 1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The thickness of gallbladder wall
Time Frame: Participants will be followed for overall 1 year after surgery
Measure the participants' thickness of gallbladder wall by abdominal ultrasonography after surgery
Participants will be followed for overall 1 year after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement of cholelith symptoms
Time Frame: Participants will be followed for overall 1 year after surgery
Participants will be followed for overall 1 year after surgery
The recurrence rate of gallstone
Time Frame: Participants will be followed for overall 1 year after surgery
Measure the participants' recurrence rate of gallstone by abdominal ultrasonography after surgery
Participants will be followed for overall 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengyi Sun

Investigators

  • Study Chair: Chengyi Sun, M.D, The affiliated Hospital of Guiyang Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

April 1, 2013

First Posted (Estimate)

April 2, 2013

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 11, 2018

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GYGDWK-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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