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

NCT ID: NCT01822262

Last Updated: 2018-02-13

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Gallstones

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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gallbladder reservation

Patients in trial group all took minimally invasive cholecystolithotomy with gallbladder reservation

Group Type EXPERIMENTAL

minimally invasive cholecystolithotomy with gallbladder reservation

Intervention Type PROCEDURE

laparoscopiccholecystectomy

Patients in control group all received LC.

Group Type EXPERIMENTAL

laparoscopic cholecystectomy

Intervention Type PROCEDURE

Interventions

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minimally invasive cholecystolithotomy with gallbladder reservation

Intervention Type PROCEDURE

laparoscopic cholecystectomy

Intervention Type PROCEDURE

Other Intervention Names

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LC

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chengyi Sun

OTHER

Sponsor Role lead

Responsible Party

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Chengyi Sun

Department of Hepatobiliary Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chengyi Sun, M.D

Role: STUDY_CHAIR

The Affiliated Hospital of Guiyang Medical College

Locations

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The Affiliated Hospital of Guiyang Medical College

Guiyang, Guizhou, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Chengyi Sun, M.D

Role: primary

+86-0851-6771326

Other Identifiers

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GYGDWK-01

Identifier Type: -

Identifier Source: org_study_id

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