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Completed

NCT Number: NCT04839263

Fast-track in Minimally Invasive Gynaecology

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.

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Key information

Conditions

Gynecologic Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HUG, Geneva, Switzerland

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About this study

  • 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
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"FAST TRACK" protocol

Procedure

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

Primary outcomes

  1. Hospital costs and ambulatory costs

    Time frame: 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 outcomes

  1. Hospital length of stay

    Time frame: Up to 1 month postoperative

    Hospital stay was retrieved from the computerized patient record

  2. Postoperative morbidity rate during the first postoperative month

    Time frame: Up to 1 month postoperative

    Morbidity during the first postoperative month was monitored via patient consultations at the Accident and Emergency (A&E) Department

  3. Satisfaction assessed by a three-point likert scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2021
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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