Clinical trial NCT04839263: Fast-track in Minimally Invasive Gynaecology
Official title: Fast-track in Minimally Invasive Gynaecology: a Randomized Trial Comparing Costs and Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Disease
Keywords: fast-track
laparoscopic hysterectomy
hospital costs
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief 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 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital costs and ambulatory costs
timeFrame: Up to 1 month postoperative
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Up to 1 month postoperative
measure: Postoperative morbidity rate during the first postoperative month
timeFrame: Up to 1 month postoperative
measure: Satisfaction assessed by a three-point likert scale
timeFrame: Up to 1 month postoperative
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: HUG
city: Geneva
country: Switzerland
facility: University Hospitals
Study officials:
affiliation: HUG
name: Shahzia Lambat
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.