Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Fast-Track protocol:
Preoperative
During surgery
Postoperative
Usual care protocol :
Preoperative
During surgery
Postoperative
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "FAST TRACK" protocol | Active Comparator | "FAST TRACK" protocol Preoperative evaluation and information Patient general health state optimization proposal prior to hospitalization: Preoperative strategy:
Perioperative strategy:
Postoperative strategy:
|
|
| "Conventional setting" protocol | No Intervention | "Conventional setting" protocol Preoperative strategy:
Perioperative strategy: - Balanced anaesthesia via halogens gases Postoperative strategy:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "FAST TRACK" protocol | Procedure | Preoperative evaluation and information Patient general health state optimization proposal prior to hospitalization: Preoperative strategy:
Perioperative strategy:
Postoperative strategy:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay | Hospital stay was retrieved from the computerized patient record | Up to 1 month postoperative |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
women undergoing total laparoscopic hysterectomy for a benign indication
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shahzia Lambat | HUG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUG | Geneva | Switzerland | ||||
| University Hospitals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 34859043 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2015 | Apr 6, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
"FAST TRACK" protocol Preoperative evaluation and information
Patient general health state optimization proposal prior to hospitalization:
Preoperative strategy:
Perioperative strategy:
Postoperative strategy:
Preoperative strategy:
Perioperative strategy:
- Balanced anaesthesia via halogens gases
Postoperative strategy:
Not provided
Not provided
Not provided
Not provided
|
| Up to 1 month postoperative |
| 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 |
| Geneva |
| Switzerland |