NCT04839263

Fast-track in Minimally Invasive Gynaecology

Fast-track in Minimally Invasive Gynaecology: a Randomized Trial Comparing Costs and Clinical Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Gynecologic Disease

Interventions

Type	Name	Description
PROCEDURE	"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

Timeline

• Start date: 2015-09-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2021-04-09
• Last updated: 2021-04-14

Locations

2 sites across 1 country: Switzerland