Fast-track in Minimally Invasive Gynaecology
- Conditions
- Gynecologic Disease
- Registration Number
- NCT04839263
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
Objective: Evaluate the effects of a fast-track (FT) protocol on costs and postoperative recovery.
Design: randomized trial
Setting: University Hospitals
Population: 170 women undergoing total laparoscopic hysterectomy for a benign indication
Methods: A FT protocol included the combination of minimally invasive surgery, analgesia optimization, early oral refeeding and rapid mobilization of patients was compared to a usual care protocol.
Main outcomes measure: Primary outcome was costs. Secondary outcomes were length of stay, postoperative morbidity and patient satisfaction.
- Detailed Description
1. Fast-Track protocol:
Preoperative
* Anesthetic consultation
* Proposal of optimization of patient's general health state + family meeting if necessary
* Hospitalization on day of surgery
* Solids stopped 6 hours prior to surgery, drinking encouraged up to 2 hours prior to surgery
During surgery
* Anti-infectious prophylaxis
* Anesthesia via IV propofol/remifentanil
* Anti-nausea prophylaxis
* Pain control based on limited systemic opioid use
Postoperative
* Balanced analgesia for pain control
* Antithrombotic prophylaxis
* Early oral refeeding
* Rapid mobilization
* Gum chewing
* Foley catheter removal at the end of surgery
* Peripheral IV catheter removal 6 hours postoperatively
2. Usual care protocol :
Preoperative
* Anesthetic consultation
* Hospitalization on day of surgery
* Fasting beginning at midnight prior to surgery
During surgery
* Anti-infectious prophylaxis
* Balanced anesthesia via halogen gas
* Anti-nausea medication if needed
Postoperative
* Balanced analgesia for pain control
* Antithrombotic prophylaxis
* Same-day refeeding according to patient's wish
* Same-day mobilization according to patient's wish
* Foley and peripheral IV catheter removal on day 1 postoperatively
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 170
- women undergoing total laparoscopic hysterectomy for a benign indication
- the requirement for an additional surgical procedure, such as prolapse repair or urinary incontinence, because a prolonged operative time could compromise early patient discharge and
- the inability to speak French because the patients were required to complete their data collection logbook in French.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hospital costs and ambulatory costs Up to 1 month postoperative The economic evaluation covered hospital inpatient surgical care costs and ambulatory costs. Resource inputs were divided into two main categories: (1) hospital inpatient surgical costs and (2) ambulatory costs further divided into (2a) hospital-related costs (A\&E Department consultations and hospital readmission) and (2b) community costs (community health + social costs and caregiver's loss of production costs). Hospital costs were collected using a computerized hospital information system developed by the University Hospitals of Geneva. The patients recorded community costs in a logbook containing the community health and social invoices and caregivers' number of absent working days. Caregivers' loss of production was extrapolated via Switzerland's median wage per working day.
- Secondary Outcome Measures
Name Time Method Postoperative morbidity rate during the first postoperative month Up to 1 month postoperative Morbidity during the first postoperative month was monitored via patient consultations at the Accident and Emergency (A\&E) Department
Hospital length of stay Up to 1 month postoperative Hospital stay was retrieved from the computerized patient record
Satisfaction assessed by a three-point likert scale Up to 1 month postoperative Patient satisfaction was evaluated on their day of discharge and at their 1-month postoperative follow-up visit based on a three-point likert scale regarding their satisfaction with the care they received. The likert scale ranged from 0 (unsatisfied) to 2 (satisfied).
Trial Locations
- Locations (2)
HUG
🇨🇭Geneva, Switzerland
University Hospitals
🇨🇭Geneva, Switzerland
HUG🇨🇭Geneva, Switzerland