Enhanced Recovery After Surgery (ERAS) for Laparoscopic Hysterectomy at Low Risk Endometrial Cancer (FAST-TRACK)
December 12, 2024 updated by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Enhanced Recovery After Surgery (ERAS) for Laparoscopic Hysterectomy at Low Risk Endometrial Cancer: A Randomized Controlled Trial
Enhanced recovery after surgery (ERAS) programs are designed to achieve early recovery after surgery and a shorter length of stay (LOS) at hospital.
So far there are only three prospective, randomised studies that exclusively analyze patients affected by oncogynecological pathology providing a high level of scientific evidence. To our knowledge, no studies have been conducted specifically on ERAS pathways in endometrial cancer treated by laparoscopy. This study aims to evaluate whether ERAS pathways are beneficial for patients with endometrial cancer, particularly among low-risk early endometrial cancer operated by laparoscopy. Length of stay (LOS), perioperative morbidity and mortality, and perioperative quality of life were analyzed comparing both ERAS and Conventional protocols groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Murcia, Spain, 30120
- Hospital Clinico Universitario Virgen de La Arrixaca
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients undergoing laparoscopic hysterectomy for stage 1A and 1B endometrial cancer
Exclusion Criteria:
- Age under 18 years
- ASA IV
- Liver cirrhosis
- Psychiatric illness
- Urgent surgery
- The patient's desire not to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Conventional
|
|
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Experimental: ERAS
Enhanced recovery after surgery (ERAS) programs are designed to achieve early recovery after surgery and a shorter length of stay (LOS) at hospital.
|
Enhanced recovery after surgery (ERAS) programs are designed to achieve early recovery after surgery and a shorter length of stay (LOS) at hospital.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lengh of stay
Time Frame: 30 days after surgery
|
Days of hospitalitation
|
30 days after surgery
|
|
Day of discharge
Time Frame: 30 days after surgery
|
30 days after surgery
|
|
|
Readmisión
Time Frame: During 1st month after surgery
|
yes/no
|
During 1st month after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complications
Time Frame: 30 days after surgery
|
Clavien-Dindo Classification.
Scale rated from grade 1 to grade 5 The Clavien-Dindo (CD) classification is widely used in the reporting of surgical complications in scientific literature.
It groups complications based on the level of intervention required to resolve them, and benefits from simplicity and ease of use, both of which contribute its to high inter-rater reliability
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30 days after surgery
|
|
Quality of life (QoL)
Time Frame: Preoperative, 3, 10 and 30 days after surgery
|
Core Quality of Life questionnaire (EORTC QLG Core Questionnaire) (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients.
You should select the option that best represents you from the options 1Not at All, 2A little, 3Quite a bit, 4Very much
|
Preoperative, 3, 10 and 30 days after surgery
|
|
Level of Pain
Time Frame: Preoperative, 3, 10 and 30 days after surgery
|
Visual Analogue Scale (VAS) measures pain intensity.
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Ask the patient to rate their current level of pain by placing a mark on the line.
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Preoperative, 3, 10 and 30 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2019
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
March 1, 2022
Study Registration Dates
First Submitted
December 5, 2024
First Submitted That Met QC Criteria
December 12, 2024
First Posted (Estimated)
December 13, 2024
Study Record Updates
Last Update Posted (Estimated)
December 13, 2024
Last Update Submitted That Met QC Criteria
December 12, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERAS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.