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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomized Controlled Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia

Brief 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.

Detailed Summary:

Willing and eligible patients will be enrolled into the trial and randomized to surgical vs non-surgical treatment following informed consent. The following information will be collected over the next 18 months: age,race, sex, baseline and follow-up quality of life quationnaire scores, a complete medical history, including co-morbid illnesses, medications and surgical history, and a complete assessment of symptoms, including disease specific symptoms against the Rome III criteria for functional gallbladder disorder. Patients randomized to surgery will be referred for immediate laparoscopic cholecystectomy. Patients in the non-surgical management group will be counseled on maintenance of a low-fat diet, and provided with a prescription for amitriptyline 25mg once daily.

Patients with persistent, non responsive symptoms that fail to respond to at least one week of administration of amitriptyline will be allowed to voluntarily, cross over into the surgically treated group.

After randomization, certain data collection points will be unique to the two groups. These are as follows and are in addition to the general data which will be collected from both groups:

Surgery group: operative/pathology findings & operative complications

Non-surgical group:

Patients will be asked to maintain a food diary and a symptom diary. Patients will be asked to report any medication related side effects.

Both groups will receive a phone call for assessment of conditions. Non-surgical groups will be asked to report any medication related side effects.

Follow-up for both groups will continue througho
Sponsor: CAMC Health System

Current Primary Outcome: SF-8 [ Time Frame: 18 months ]

Administration of SF-8 (health questionnaire) survey prior to the initiation of treatment and periodically after the initiation of treatment to assess the ability of cholecystectomy to provide durable symptomatic relief.


Original Primary Outcome: Same as current

Current Secondary Outcome: Rome III Criteria [ Time Frame: 18 months ]

Comparison of the results of surgery to those of non-surgical treatment based on degree of relief of symptoms described in the Rome III criteria and follow-up SF-8 scores.


Original Secondary Outcome: Same as current

Information By: CAMC Health System

Dates:
Date Received: July 17, 2014
Date Started: February 2014
Date Completion: July 2015
Last Updated: March 4, 2015
Last Verified: July 2014