Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

NCT03402542 | Completed

• 1 other identifier: CHUB-cholecystectomy
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystectomy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Data extraction from medical files: medical history

  5 min

• Physical status score

  5 min

• Body mass index

  5 min

• Hospitalisation type

  Up to 10 days after surgery

• Type of surgery

  Up to 4 hours

Study Arms (1)

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

Cholecystectomy PROCEDURE

Cholecystectomy

Cholecystectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pierre Wauthy: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Interventions

Cholecystectomy

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Levon HAKOBYAN

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: December 21, 2017
• Primary Completion: February 27, 2018
• Study Completion: February 27, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)