K80.2
Conditions
Interventions
Group 1: Participants undergo elective laparoscopic cholecystectomy in an outpatient setting. After surgery, postoperative monitoring is performed in the recovery room. In the absence of intraoperativ
Sponsors
Spital Thurgau AG
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Elective laparoscopic cholecystectomy for benign gallbladder disease Age = 18 years and = 65 years Written informed consent after adequate information Fulfilment of all organizational requirements for outpatient management
Exclusion criteria
Exclusion criteria: Previous acute cholecystitis or pancreatitis Clinical or radiological suspicion of choledocholithiasis or malignancy Calcified gallbladder Body mass index greater than 35 kg/m² ASA classification greater than III Previous open abdominal or extensive laparoscopic surgery Residence more than 30 km from the hospital or lack of an adult companion for at least 24 hours after discharge Regular intake of opioid analgesics or systemic steroids greater than 5 mg per day for at least 7 days before surgery Pregnancy or breastfeeding Participation in another interventional trial with potential interference Suspected non compliance, alcohol or drug abuse Impaired capacity to give informed consent or relevant language barriers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint consists of three components: 1. Feasibility Proportion of patients successfully treated in an outpatient setting according to the study protocol, defined as discharge on the day of surgery without readmission within 14 days, relative to all screened, included, and randomized patients in the outpatient group. 2. Effectiveness (Costs) Health care system costs within 14 days after laparoscopic cholecystectomy, based on hospital invoiced costs. The endpoint assesses the difference between actual case costs calculated according to REKOLE® and reimbursement under the Swiss DRG system for outpatient versus inpatient treatment. 3. Safety Safety of elective laparoscopic cholecystectomy assessed using the Comprehensive Complication Index (CCI) within 14 days after surgery, aiming to demonstrate non inferiority of the outpatient setting compared to the inpatient setting. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mortality within 14 days, including cause of death and potential association with the trial intervention - Postoperative complications within 14 days, classified according to the Clavien Dindo classification, in particular: -- Postoperative bleeding -- Bile leakage -- Intra abdominal fluid collection -- Choledocholithiasis -- Surgical site infections according to the Centers for Disease Control and Prevention definition - Reintervention rate within 14 days after surgery - Reoperation rate within 14 days after surgery - Postoperative pain assessed using a numeric rating scale - Postoperative nausea and vomiting - Length of hospital stay - Prolonged hospitalization and reason - Readmission rate within 14 days after surgery and reason - Emergency department visits after discharge within 14 days and reason - Time to return to work in days, assessed 14 days after surgery - Hospital costs per case | — |
Countries
Switzerland
Contacts
Public ContactPascal Probst
Spital Thurgau AG
Outcome results
None listed