Gynecologic Disease
Conditions
Keywords
fast-track, laparoscopic hysterectomy, hospital costs
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
Interventions
PROCEDUREFAST TRACK protocol
Preoperative evaluation and information Patient general health state optimization proposal prior to hospitalization: Preoperative strategy: * Hospitalization on surgery day * No prolonged fasting Perioperative strategy: * Pain control based on limited systemic opioid therapy use * Anti-nausea prophylaxis * Anaesthesia via IV propofol / remifentanyl * Bladder catheter removal postoperative Postoperative strategy: * Pain control using balanced analgesia * Gum chewing * Early oral refeeding and rapid mobilization * Venflon removal 6 hours post-op
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
FAST TRACK protocol Preoperative evaluation and information Patient general health state optimization proposal prior to hospitalization: Preoperative strategy: * Hospitalization on surgery day * No prolonged fasting Perioperative strategy: * Pain control based on limited systemic opioid therapy use * Anti-nausea prophylaxis * Anaesthesia via IV propofol / remifentanyl * Bladder catheter removal postoperative Postoperative strategy: * Pain control using balanced analgesia * Gum chewing * Early oral refeeding and rapid mobilization * Venflon removal 6 hours post-op 2) Conventional setting protocol Preoperative strategy: * Hospitalization on surgery day * Fasting as of midnight prior to the day of surgery Perioperative strategy: \- Balanced anaesthesia via halogens gases Postoperative strategy: * Same day refeeding and mobilization minimum 6 hours post operation * Bladder catheter and Venflon removal on day 1
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* women undergoing total laparoscopic hysterectomy for a benign indication
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Switzerland
Outcome results
None listed