Fast-track in Minimally Invasive Gynaecology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2021-03-01

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.

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Detailed Description

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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

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Gynecologic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

"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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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"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

Group Type ACTIVE_COMPARATOR

"FAST TRACK" protocol

Intervention Type 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

"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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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"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

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes