ClinicalTrials.gg
CompletedNCT03402542Updated May 31, 2018

Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

An observational study in Cholecystectomy, sponsored by Pierre Wauthy. Completed at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-31.

Sponsored by Pierre Wauthy · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cholecystectomy
03

In context

Lead sponsor

Pierre Wauthy is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients who have had a laparoscopic cholecystectomy with a single cholecystectomy procedure without other associated interventions (bariatric surgery or other). Hospitalisation within the CHU Brugmann Hospital between May 2016 and November 2017.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who have had a laparoscopic cholecystectomy with a single cholecystectomy procedure without other associated interventions (bariatric surgery or other)

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Diabetic patients under insulin treatment
  • History of major abdominal surgery
  • Acute cholecystitis as per anatomo-pathological examination
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Procedure: Cholecystectomy

Interventions

  • ProcedureCholecystectomy

    Cholecystectomy

06

What researchers measure

Primary outcomes

  1. Surgery duration

    Duration of the surgical intervention

    Time frame: Up to 4h

  2. Post surgical pain

    Pain killer medication administered post surgery, expressed in mg

    Time frame: Up to 1 day after surgery

  3. Nausea

    Occurence of nausea or vomiting post surgery

    Time frame: Up to 1 day after surgery

  4. Post surgery hospitalization duration

    Post surgery hospitalization duration

    Time frame: Up to 10 days after surgery

  5. Medical complications after surgery

    Medical complications after surgery

    Time frame: Up to 1 year after surgery

Secondary outcomes

  1. Data extraction from medical files: medical history

    Important surgical or medical antecedents of the patient before surgery (data extraction from medical file).

    Time frame: 5 min

  2. 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)

    Time frame: 5 min

  3. Body mass index

    Body mass index of the patient before surgery

    Time frame: 5 min

  4. Hospitalisation type

    Same day (ambulatory) or not

    Time frame: Up to 10 days after surgery

  5. Type of surgery

    Surgery performed under nuclear magnetic resonance (RMN) or RMN + endoscopic retrograde cholangiography (CWR)

    Time frame: Up to 4 hours

07

Study locations

1 site
  • CHU Brugmann
    Brussels, 1020, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Feb 2018, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2018
First posted
Jan 18, 2018
StartActual
Dec 21, 2017
Primary completionActual
Feb 27, 2018
CompletionActual
Feb 27, 2018
Last update
May 31, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03402542
Lead sponsor
Pierre Wauthy
Responsible party
Pierre Wauthy (Head of clinic, Brugmann University Hospital) — Sponsor-investigator
First posted
Jan 18, 2018
Start date
Dec 21, 2017
Primary completion
Feb 27, 2018
Completion
Feb 27, 2018
Last update
May 31, 2018

Study contacts

Levon HAKOBYAN
principal investigator · CHU Brugmann

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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