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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01822262
Other study ID # GYGDWK-01
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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