An interventional study of "FAST TRACK" protocol in Gynecologic Disease, sponsored by University Hospital, Geneva. Completed at 2 sites in Switzerland. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-14.
Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Supportive care
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.
Fast-Track protocol:
Preoperative
During surgery
Postoperative
Preoperative
During surgery
Postoperative
154 studies on the registry are indexed under Genital Diseases, Female; 32 are open to participants now.
This study's enrollment of 170 is above the median of 80 across 111 interventional studies indexed under Genital Diseases, Female.
Browse Genital Diseases, Female studies →University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
"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
Procedure: "FAST TRACK" protocol
"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
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
Hospital costs and ambulatory costs
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.
Time frame: Up to 1 month postoperative
Hospital length of stay
Hospital stay was retrieved from the computerized patient record
Time frame: Up to 1 month postoperative
Postoperative morbidity rate during the first postoperative month
Morbidity during the first postoperative month was monitored via patient consultations at the Accident and Emergency (A\&E) Department
Time frame: Up to 1 month postoperative
Satisfaction assessed by a three-point likert scale
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).
Time frame: Up to 1 month postoperative
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Geneva