Fast-track in Minimally Invasive Gynaecology

University Hospitals (UH)

Status: Completed

Conditions: Gynecologic Disease

Treatments: Procedure: "FAST TRACK" protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04839263

CCER 15-103

Details and patient eligibility

About

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.

Full 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

Enrollment: 170 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

"FAST TRACK" protocol

Active Comparator group

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

Treatment:

Procedure: "FAST TRACK" protocol

"Conventional setting" protocol

No Intervention group

Description:

"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