Fast-track in Minimally Invasive Gynaecology

NCT04839263 | Completed

• 1 other identifier: CCER 15-103
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 2

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.

Conditions

Gynecologic Disease

Keywords

fast-track; laparoscopic hysterectomy; hospital costs

Outcome Measures

Primary Outcomes (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.

  Up to 1 month postoperative

Secondary Outcomes (3)

• Hospital length of stay

  Up to 1 month postoperative

• Postoperative morbidity rate during the first postoperative month

  Up to 1 month postoperative

• Satisfaction assessed by a three-point likert scale

  Up to 1 month postoperative

Study Arms (2)

"FAST TRACK" protocol

ACTIVE 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

Procedure: "FAST TRACK" protocol

"Conventional setting" protocol

NO 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

Interventions

"FAST TRACK" protocol 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

"FAST TRACK" protocol

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: women undergoing total laparoscopic hysterectomy for a benign indication
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women undergoing total laparoscopic hysterectomy for a benign indication

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (2)

HUG

Geneva, Switzerland

Location

University Hospitals

Geneva, Switzerland

Location

Related Publications (2)

• 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.

  RESULT

• 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.

  PMID: 34859043 DERIVED

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Shahzia Lambat

  HUG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief resident

Model Details: "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

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 9, 2021
• Study Start: September 1, 2015
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)