Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

Completed

• Conditions: Cholecystectomy
• Interventions: Procedure: Cholecystectomy

• Registration Number: NCT03402542
• Lead Sponsor: Pierre Wauthy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-21
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-18
• Primary Completion: 2018-02-27
• Study Completion: 2018-02-27
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cholecystectomy	Cholecystectomy	Patients with a symptomatic vesicular lithiasis, having undergone cholecystectomy during a scheduled hospitalization in the CHU Brugmann Hospital between May 2016 and November 2017.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Body mass index	5 min	Body mass index of the patient before surgery
Type of surgery	Up to 4 hours	Surgery performed under nuclear magnetic resonance (RMN) or RMN + endoscopic retrograde cholangiography (CWR)
Data extraction from medical files: medical history	5 min	Important surgical or medical antecedents of the patient before surgery (data extraction from medical file).
Physical status score	5 min	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)
Hospitalisation type	Up to 10 days after surgery	Same day (ambulatory) or not

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium