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

Sponsor
Chengyi Sun (Other)
Overall Status
Unknown status
CT.gov ID
NCT01822262
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
119
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: minimally invasive cholecystolithotomy with gallbladder reservation
  • Procedure: laparoscopic cholecystectomy
 Phase 4

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
All the Phases Study Will be Operated by the Department of Hepatobiliary Surgery, The Affiliated Hospital of Guiyang Medical College
Study Start Date :
Jan 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: gallbladder reservation

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

Procedure: minimally invasive cholecystolithotomy with gallbladder reservation
Experimental: laparoscopiccholecystectomy

Patients in control group all received LC.

Procedure: laparoscopic cholecystectomy
Other Names:
  • LC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Other Outcome Measures

    1. The improvement of cholelith symptoms [Participants will be followed for overall 1 year after surgery]

    2. The recurrence rate of gallstone [Participants will be followed for overall 1 year after surgery]

      Measure the participants' recurrence rate of gallstone by abdominal ultrasonography after surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Affiliated Hospital of Guiyang Medical College Guiyang Guizhou China 550004

    Sponsors and Collaborators

    • Chengyi Sun

    Investigators

    • Study Chair: Chengyi Sun, M.D, The Affiliated Hospital of Guiyang Medical College

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chengyi Sun, Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT01822262
    Other Study ID Numbers:
    • GYGDWK-01
    First Posted:
    Apr 2, 2013
    Last Update Posted:
    Feb 13, 2018
    Last Verified:
    Mar 1, 2016
    Keywords provided by Chengyi Sun, Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangzhou Medical University
    Cholecystolithotomy with gallbladder reservation
    cholecystolithiasis
    Additional relevant MeSH terms:
    Gallstones

    Study Results

    No Results Posted as of Feb 13, 2018