Fast-track in Minimally Invasive Gynaecology

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

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Disease
• Intervention / Treatment: Procedure: "FAST TRACK" protocol

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

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland
    • HUG
  • Geneva, Switzerland
    • University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: "FAST TRACK" protocol; "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; 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
No Intervention: "Conventional setting" 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 1 month postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Hospital stay was retrieved from the computerized patient record	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	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).	Up to 1 month postoperative

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Shahzia Lambat, HUG

Publications and helpful links

General Publications

• 1. Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. 2. Basse L, Hjort Jakobsen D, Billesbølle P, Werner M, Kehlet H. A clinical pathway to accelerate recovery after colonic resection. Ann Surg. 2000 Jul;232(1):51-7. 3. Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. 4. Kehlet H, Büchler MW, Beart RW Jr, Billingham RP, Williamson R. Care after colonic operation--is it evidence-based? Results from a multinational survey in Europe and the United States. J Am Coll Surg. 2006 Jan;202(1):45-54. 5. Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, et al. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77.
• Lambat Emery S, Brossard P, Petignat P, Boulvain M, Pluchino N, Dällenbach P, Wenger JM, Savoldelli GL, Rehberg-Klug B, Dubuisson J. Fast-Track in Minimally Invasive Gynecology: A Randomized Trial Comparing Costs and Clinical Outcomes. Front Surg. 2021 Nov 11;8:773653. doi: 10.3389/fsurg.2021.773653. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: fast-track; hospital costs; laparoscopic hysterectomy
• Other Study ID Numbers: CCER 15-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No