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Gynecologic DiseaseNCT04839263

Fast-track in Minimally Invasive Gynaecology

A study testing "FAST TRACK" protocol in people with Gynecologic Disease, run by University Hospital, Geneva at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Gynecologic Disease
What is being tested?
"FAST TRACK" protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
2 sitesSwitzerland
Study dates
1 Sep 2015to 1 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • women undergoing total laparoscopic hysterectomy for a benign indication

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • HUG

    Geneva

  • University Hospitals

    Geneva

Other trials in Switzerland

About this study

Official title: 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.

Read the 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
  1. 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
Being tested
"FAST TRACK" protocol
Keywords
fast-track, laparoscopic hysterectomy, hospital costs
Medical subject headings
Genital Diseases, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "FAST TRACK" protocolProcedure or surgery

    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
Study groups in NCT04839263
Study groupRoleWhat they receive
"FAST TRACK" protocolActive comparator"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
Receives: Procedure: "FAST TRACK" protocol
"Conventional setting" protocolNo intervention"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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 1 month postoperative

Secondary outcomes (3)

  1. Hospital length of stay

    Hospital stay was retrieved from the computerized patient record

    Measured: Up to 1 month postoperative

  2. 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

    Measured: Up to 1 month postoperative

  3. 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).

    Measured: Up to 1 month postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2021
  2. Study start1 Sep 2015
  3. Primary completion1 Mar 2021
  4. Study completion1 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04839263
Sponsor's protocol ID
CCER 15-103
Status last verified
Apr 2021
First submitted
31 Mar 2021
Last updated
14 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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, Dallenbach 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.

    PubMed 34859043

Questions about this trial

What is this clinical trial studying?

A study testing "FAST TRACK" protocol in people with Gynecologic Disease, run by University Hospital, Geneva at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital costs and ambulatory costs (time frame: Up to 1 month postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04839263, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.

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