Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after resolution of pain for mild gallstone pancreatitis.
The purpose of this study is to perform a single-center randomized trial to compare laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) within 24 hours of presentation versus after clinical resolution during index admission for mild gallstone pancreatitis on clinical and patient-reported outcomes. Additionally, this study aims to determine patients' values and preferences that influence decision-making regarding treatment options for gallstone pancreatitis. Hypothesis: During index admission for mild gallstone pancreatitis, early cholecystectomy within 24 hours of presentation regardless of symptoms or laboratory values versus after clinical resolution results in a shorter 30-day total hospital length of stay.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The intervention will be laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) on admission within 24 hours of presentation regardless of whether pain or tenderness are present or laboratory values are elevated.
The control will be laparoscopic cholecystectomy with IOC once the patient has met the following criteria: (a) a score of less than 2 on the Visual Analogue Pain Scale, (b) no tenderness on physical exam, and (c) decreased lipase to either less than half of the peak value or within normal range (73-393 U/L).
Lyndon B. Johnson General Hospital
Houston, Texas, United States
30-day hospital length of stay
Time frame: 30 days
Time from admission to cholecystectomy
Time frame: up to 10 days
Initial hospital LOS
Time frame: up to 30 days
Number of participants who underwent conversion to open cholecystectomy
Time frame: 30 days
Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI)
Time frame: baseline, 1 week
Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI) and Patients' Experience of Surgery Questionnaire (PESQ)
Time frame: baseline, 6 weeks
Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)
Time frame: baseline, 1 week
Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)
Time frame: baseline, 6 weeks
Change in health-related quality of life as assessed by the standard gamble
Time frame: baseline, 1 week
Change in health-related quality of life as assessed by the standard gamble
Time frame: baseline, 6 weeks
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