Gallbladder Dyskinesia Clinical Trial
Official title:
Randomized Controlled Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia
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.
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 throughout the 18 month period. In addition to the
monthly calls, Patients will be contacted every three months after their initial treatment
to take the SF-8 questionnaire and obtain an assessment of symptoms using the Rome III
criteria.
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment