Back to resultsContrastive Study for Minimally Invasive Cholecystolithotomy With Gallbladder Reservation and Laparoscopic Cholecystectomy
Primary Purpose
Gallstones
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
minimally invasive cholecystolithotomy with gallbladder reservation
laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional prevention trial for Gallstones focused on measuring Cholecystolithotomy with gallbladder reservation, cholecystolithiasis
Eligibility Criteria
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.
Sites / Locations
- The Affiliated Hospital of Guiyang Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
gallbladder reservation
laparoscopiccholecystectomy
Arm Description
Patients in trial group all took minimally invasive cholecystolithotomy with gallbladder reservation
Patients in control group all received LC.
Outcomes
Primary Outcome Measures
The contraction function of the gallbladder
Measure the participants' contraction function of gallbladder by the trial for contraction function of gallbladder
Secondary Outcome Measures
The thickness of gallbladder wall
Measure the participants' thickness of gallbladder wall by abdominal ultrasonography after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01822262
Brief Title
Contrastive Study for Minimally Invasive Cholecystolithotomy With Gallbladder Reservation and Laparoscopic Cholecystectomy
Official Title
All the Phases Study Will be Operated by the Department of Hepatobiliary Surgery, The Affiliated Hospital of Guiyang Medical College
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chengyi Sun
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstones
Keywords
Cholecystolithotomy with gallbladder reservation, cholecystolithiasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gallbladder reservation
Arm Type
Experimental
Arm Description
Patients in trial group all took minimally invasive cholecystolithotomy with gallbladder reservation
Arm Title
laparoscopiccholecystectomy
Arm Type
Experimental
Arm Description
Patients in control group all received LC.
Intervention Type
Procedure
Intervention Name(s)
minimally invasive cholecystolithotomy with gallbladder reservation
Intervention Type
Procedure
Intervention Name(s)
laparoscopic cholecystectomy
Other Intervention Name(s)
LC
Primary Outcome Measure Information:
Title
The contraction function of the gallbladder
Description
Measure the participants' contraction function of gallbladder by the trial for contraction function of gallbladder
Time Frame
Participants will be followed for overall 1 year after surgery
Secondary Outcome Measure Information:
Title
The thickness of gallbladder wall
Description
Measure the participants' thickness of gallbladder wall by abdominal ultrasonography after surgery
Time Frame
Participants will be followed for overall 1 year after surgery
Other Pre-specified Outcome Measures:
Title
The improvement of cholelith symptoms
Time Frame
Participants will be followed for overall 1 year after surgery
Title
The recurrence rate of gallstone
Description
Measure the participants' recurrence rate of gallstone by abdominal ultrasonography after surgery
Time Frame
Participants will be followed for overall 1 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chengyi Sun, M.D
Organizational Affiliation
The Affiliated Hospital of Guiyang Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
The Affiliated Hospital of Guiyang Medical College
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengyi Sun, M.D
Phone
+86-0851-6771326
Email
chengyisun@medmail.com.cn
12. IPD Sharing Statement
Learn more about this trial
Contrastive Study for Minimally Invasive Cholecystolithotomy With Gallbladder Reservation and Laparoscopic Cholecystectomy
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