Fast-track in Minimally Invasive Gynaecology

Gynecologic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04839263
• Other study ID #: CCER 15-103
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gynecologic Disease

Intervention

Procedure:
• "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

Locations

Country	Name	City	State
Switzerland	HUG	Geneva
Switzerland	University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospital length of stay	Hospital stay was retrieved from the computerized patient record	Up to 1 month postoperative
Secondary	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
Secondary	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