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Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03402542
Enrollment
300
Registered
2018-01-18
Start date
2017-12-21
Completion date
2018-02-27
Last updated
2018-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystectomy

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.

Interventions

PROCEDURECholecystectomy

Cholecystectomy

Sponsors

Pierre Wauthy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Medical complications after surgeryUp to 1 year after surgeryMedical complications after surgery
Surgery durationUp to 4hDuration of the surgical intervention
Post surgical painUp to 1 day after surgeryPain killer medication administered post surgery, expressed in mg
NauseaUp to 1 day after surgeryOccurence of nausea or vomiting post surgery
Post surgery hospitalization durationUp to 10 days after surgeryPost surgery hospitalization duration

Secondary

MeasureTime frameDescription
Data extraction from medical files: medical history5 minImportant surgical or medical antecedents of the patient before surgery (data extraction from medical file).
Physical status score5 minPhysical 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)
Body mass index5 minBody mass index of the patient before surgery
Hospitalisation typeUp to 10 days after surgerySame day (ambulatory) or not
Type of surgeryUp to 4 hoursSurgery performed under nuclear magnetic resonance (RMN) or RMN + endoscopic retrograde cholangiography (CWR)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026