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

Gallstones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01822262
• Other study ID #: GYGDWK-01
• Status: Recruiting
• Phase: Phase 4
• First received: March 14, 2013
• Last updated: February 11, 2018
• Start date: January 2011
• Est. completion date: December 2020

Study information

• Verified date: March 2016
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gallstones

Intervention

Procedure:
• minimally invasive cholecystolithotomy with gallbladder reservation

• laparoscopic cholecystectomy

Locations

Country	Name	City	State
China	The Affiliated Hospital of Guiyang Medical College	Guiyang	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Chengyi Sun

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The improvement of cholelith symptoms		Participants will be followed for overall 1 year after surgery
Other	The recurrence rate of gallstone	Measure the participants' recurrence rate of gallstone by abdominal ultrasonography after surgery	Participants will be followed for overall 1 year after surgery
Primary	The contraction function of the gallbladder	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	The thickness of gallbladder wall	Measure the participants' thickness of gallbladder wall by abdominal ultrasonography after surgery	Participants will be followed for overall 1 year after surgery