Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia
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|ClinicalTrials.gov Identifier: NCT02195115|
Recruitment Status : Unknown
Verified July 2014 by CAMC Health System.
Recruitment status was: Recruiting
First Posted : July 21, 2014
Last Update Posted : March 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gallbladder Dyskinesia||Procedure: Laparoscopic Cholecystectomy Drug: amitriptyline Other: low-fat and low cholesterol diet||Phase 2|
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
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2015|
Active Comparator: Laparoscopic cholecystectomy
surgical removal of gallbladder
Procedure: Laparoscopic Cholecystectomy
Active Comparator: Non-operative treatment
Administration of amitriptyline 25mg daily, Low Fat-Low Cholesterol Diet
Other: low-fat and low cholesterol diet
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195115
|Contact: Jerri Walker||304-388-9995||jerri.walker@CAMC.org|
|Contact: Kristi Sutphinemail@example.com|
|United States, West Virginia|
|Charleston Area Medical Center||Recruiting|
|Charleston,, West Virginia, United States, 25304|
|Principal Investigator: Bryan K Richmond, MD|
|Principal Investigator:||Bryan K Richmond, MD||West Virginia University, Charleston Division ; Professor of Surgery|