Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

Study Overview
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Brief Summary
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Cold laparoscopic cholecystectomy is the gold standard for the management of symptomatic vesicular stones. There is considerable controversy as to whether it should be practiced in outpatient surgery or as part of inpatient surgery, regarding to patient safety. Minor surgical procedures, such as anal surgery or simple inguinal hernia interventions, were initially considered eligible for an outpatient procedure. Advances in surgical techniques, anesthesia and early rehabilitation have also made it possible to consider more heavy interventions, such as cholecystectomy. The aim of this study is to identify eligible patients for laparoscopic cholecystectomy in outpatient surgery, taking surgical criteria into account.

Official Title
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Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

Conditions
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Cholecystectomy

Intervention / Treatment
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* Procedure: Cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have had a laparoscopic cholecystectomy with a single cholecystectomy procedure without other associated interventions (bariatric surgery or other) Exclusion Criteria: Pregnant women Diabetic patients under insulin treatment History of major abdominal surgery Acute cholecystitis as per anatomo-pathological examination

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cholecystectomy<br>Patients with a symptomatic vesicular lithiasis, having undergone cholecystectomy during a scheduled hospitalization in the CHU Brugmann Hospital between May 2016 and November 2017. | Procedure: Cholecystectomy<br>* Cholecystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery duration | Duration of the surgical intervention | Up to 4h | 
| Post surgical pain | Pain killer medication administered post surgery, expressed in mg | Up to 1 day after surgery | 
| Nausea | Occurence of nausea or vomiting post surgery | Up to 1 day after surgery | 
| Post surgery hospitalization duration | Post surgery hospitalization duration | Up to 10 days after surgery | 
| Medical complications after surgery | Medical complications after surgery | Up to 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data extraction from medical files: medical history | Important surgical or medical antecedents of the patient before surgery (data extraction from medical file). | 5 min | 
| Physical status score | Physical status score (also called ASA score for American Society of Anesthesiologists score) of the patient before surgery. The ASA score ranges from I (normal healthy patient) to VI (declared brain-dead patient whose organs are being removed for donor purposes) | 5 min | 
| Body mass index | Body mass index of the patient before surgery | 5 min | 
| Hospitalisation type | Same day (ambulatory) or not | Up to 10 days after surgery | 
| Type of surgery | Surgery performed under nuclear magnetic resonance (RMN) or RMN + endoscopic retrograde cholangiography (CWR) | Up to 4 hours |