Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

Cholecystectomy Clinical Trial

Official title:

Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402542
• Other study ID #: CHUB-cholecystectomy
• Status: Completed
• Start date: December 21, 2017
• Est. completion date: February 27, 2018

Study information

• Verified date: May 2018
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 27, 2018
• Est. primary completion date: February 27, 2018
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystectomy

Intervention

Procedure:
• Cholecystectomy
Cholecystectomy

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Wauthy

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery duration	Duration of the surgical intervention	Up to 4h
Primary	Post surgical pain	Pain killer medication administered post surgery, expressed in mg	Up to 1 day after surgery
Primary	Nausea	Occurence of nausea or vomiting post surgery	Up to 1 day after surgery
Primary	Post surgery hospitalization duration	Post surgery hospitalization duration	Up to 10 days after surgery
Primary	Medical complications after surgery	Medical complications after surgery	Up to 1 year after surgery
Secondary	Data extraction from medical files: medical history	Important surgical or medical antecedents of the patient before surgery (data extraction from medical file).	5 min
Secondary	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
Secondary	Body mass index	Body mass index of the patient before surgery	5 min
Secondary	Hospitalisation type	Same day (ambulatory) or not	Up to 10 days after surgery
Secondary	Type of surgery	Surgery performed under nuclear magnetic resonance (RMN) or RMN + endoscopic retrograde cholangiography (CWR)	Up to 4 hours