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Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia

NCT02195115 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-03-05

No results posted yet for this study

Summary

The goal of this study is to challenge the existing clinical practice of employing laparoscopic cholecystectomy as the treatment for gallbladder dyskinesia by comparing it to a regimen of active non-surgical therapy.

Conditions

  • Gallbladder Dyskinesia

Interventions

PROCEDURE

Laparoscopic Cholecystectomy

DRUG

amitriptyline

OTHER

low-fat and low cholesterol diet

Sponsors & Collaborators

  • University of Kentucky

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • CAMC Health System

    lead OTHER

Principal Investigators

  • Bryan K Richmond, MD · West Virginia University, Charleston Division ; Professor of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02195115 on ClinicalTrials.gov