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

Phase 4

• Conditions: Gallstones
• Interventions: Procedure: minimally invasive cholecystolithotomy with gallbladder reservation; Procedure: laparoscopic cholecystectomy

• Registration Number: NCT01822262
• Lead Sponsor: Chengyi Sun

Brief Summary

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

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-02
• Status Verified: 2016-03
• Last Update Submitted: 2018-02-11
• Last Update Posted: 2018-02-13
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gallbladder reservation	minimally invasive cholecystolithotomy with gallbladder reservation	Patients in trial group all took minimally invasive cholecystolithotomy with gallbladder reservation
laparoscopiccholecystectomy	laparoscopic cholecystectomy	Patients in control group all received LC.

Primary Outcome Measures

Name	Time	Method
The contraction function of the gallbladder	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

Secondary Outcome Measures

Name	Time	Method
The thickness of gallbladder wall	Participants will be followed for overall 1 year after surgery	Measure the participants' thickness of gallbladder wall by abdominal ultrasonography after surgery

Trial Locations

Locations (1)

The Affiliated Hospital of Guiyang Medical College; 🇨🇳 Guiyang, Guizhou, China