Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT03247257
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 18 and 65 years of age
* ASA I or II
* Patient has a diagnosis of biliary colic with documented cholecystitis, symptomatic gallstones, polyps by imaging or biliary dyskinesia with documented EF \< 30%
* No cardiopulmonary disease
* Normal coagulation profile
Exclusion Criteria:
* Any female patient, who is pregnant, suspected pregnant, or nursing
* Contraindication for pneumoperitoneum
* Contraindication for epidural anesthesia
* Allergy to local anesthetic agents
* Any patient with acute calculus or acalculous cholecystitis
* Any patient who has had an upper midline or right sub costal incision
* Any patient with preoperative indication for a cholangiogram
* Any patient with ASA ≥ 3
* Any patient who is undergoing Peritoneal Dialysis (PD)
* History of long term analgesic use requiring pain management (\>1 week)
* Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair
* Any patient with obstructive sleep apnea (OSA), history of OSA or at high risk of OSA as determined by the STOP Questionnaire
* BMI \> 35 kg/m2
* Any patient with a history of severe, uncontrolled GERD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03247257
Study Brief:
Protocol Section:
NCT03247257