NCT01822262

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 13, 2018

Status Verified

March 1, 2016

Enrollment Period

9.9 years

First QC Date

March 14, 2013

Last Update Submit

February 11, 2018

Conditions

Gallstones

Keywords

Cholecystolithotomy with gallbladder reservationcholecystolithiasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The thickness of gallbladder wall

    Participants will be followed for overall 1 year after surgery

Other Outcomes (2)

  • The improvement of cholelith symptoms

    Participants will be followed for overall 1 year after surgery

  • The recurrence rate of gallstone

    Participants will be followed for overall 1 year after surgery

Study Arms (2)

gallbladder reservation

EXPERIMENTAL

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

Procedure: minimally invasive cholecystolithotomy with gallbladder reservation

laparoscopiccholecystectomy

EXPERIMENTAL

Patients in control group all received LC.

Procedure: laparoscopic cholecystectomy

Interventions

minimally invasive cholecystolithotomy with gallbladder reservationPROCEDURE
gallbladder reservation
laparoscopic cholecystectomyPROCEDURE
Also known as: LC
laparoscopiccholecystectomy

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of calculous cholecystitis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Guiyang Medical College

Guiyang, Guizhou, 550004, China

RECRUITING

MeSH Terms

Conditions

GallstonesCholecystolithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Chengyi Sun, M.D

    The Affiliated Hospital of Guiyang Medical College

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Hepatobiliary Surgery

Study Record Dates

First Submitted

March 14, 2013

First Posted

April 2, 2013

Study Start

January 1, 2011

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 13, 2018

Record last verified: 2016-03

Locations

CN(1)