Fast-track in Minimally Invasive Gynaecology

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Gynecologic Disease

Intervention / Treatment
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* Procedure: FAST TRACK protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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 2) 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FAST TRACK protocol<br>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<br>* 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<br>|
| No Intervention: Conventional setting protocol<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fast-track, laparoscopic hysterectomy, hospital costs