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OpenTrials
Completed

NCT Number: NCT03402542

Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

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.

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Key information

Conditions

Cholecystectomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecystectomy

Procedure

Cholecystectomy

Primary outcomes

  1. Surgery duration

    Time frame: Up to 4h

    Duration of the surgical intervention

  2. Post surgical pain

    Time frame: Up to 1 day after surgery

    Pain killer medication administered post surgery, expressed in mg

  3. Nausea

    Time frame: Up to 1 day after surgery

    Occurence of nausea or vomiting post surgery

  4. Post surgery hospitalization duration

    Time frame: Up to 10 days after surgery

    Post surgery hospitalization duration

  5. Medical complications after surgery

    Time frame: Up to 1 year after surgery

    Medical complications after surgery

Secondary outcomes

  1. Data extraction from medical files: medical history

    Time frame: 5 min

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

  2. Physical status score

    Time frame: 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)

  3. Body mass index

    Time frame: 5 min

    Body mass index of the patient before surgery

  4. Hospitalisation type

    Time frame: Up to 10 days after surgery

    Same day (ambulatory) or not

  5. Type of surgery

    Time frame: Up to 4 hours

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

Sponsors and collaborators

Lead sponsor

Pierre Wauthy

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2018
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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