Endometrial CancerPhase 3FAST-TRACKNCT06732635
Enhanced Recovery After Surgery (ERAS) for Laparoscopic Hysterectomy at Low Risk Endometrial Cancer
A Phase 3 study testing Enhanced recovery after surgery (ERAS) in people with Endometrial Cancer, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Enhanced recovery after surgery (ERAS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 1 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic hysterectomy for stage 1A and 1B endometrial cancer
Who cannot join
- Age under 18 years
- ASA IV
- Liver cirrhosis
- Psychiatric illness
- Urgent surgery
- The patient's desire not to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Endometrial Cancer
- Being tested
- Enhanced recovery after surgery (ERAS)
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery after surgery (ERAS)Procedure or surgery
Enhanced recovery after surgery (ERAS) programs are designed to achieve early recovery after surgery and a shorter length of stay (LOS) at hospital.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | No intervention | Not described |
| ERAS | Experimental | Enhanced recovery after surgery (ERAS) programs are designed to achieve early recovery after surgery and a shorter length of stay (LOS) at hospital. Receives: Procedure: Enhanced recovery after surgery (ERAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lengh of stay
Days of hospitalitation
Measured: 30 days after surgery
Day of discharge
Measured: 30 days after surgery
Readmisión
yes/no
Measured: During 1st month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Jun 2019
- Primary completion1 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A controlled, randomized, parallel-group, open-label, interventional, single-center clinical trial in which the intervention group will be managed according to the multimodal rehabilitation protocol (RICA clinical pathway), and the control group will receive traditional care that has been provided up to now.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732635
- Sponsor's protocol ID
- ERAS
- Acronym
- FAST-TRACK
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery (ERAS) for Laparoscopic Hysterectomy at Low Risk Endometrial Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06732635
- Acronym / sponsor ID
- FAST-TRACK / ERAS
- Conditions
- Endometrial Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A controlled, randomized, parallel-group, open-label, interventional, single-center clinical trial in which the intervention group will be managed according to the multimodal rehabilitation protocol (RICA clinical pathway), and the control group will receive traditional care that has been provided up to now.
| Arm | Type | Receives |
|---|---|---|
| Conventional | No intervention | – |
| ERAS | Experimental | Procedure: Enhanced recovery after surgery (ERAS)Enhanced recovery after surgery (ERAS) programs are designed to achieve early recovery after surgery and a shorter length of stay (LOS) at hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing laparoscopic hysterectomy for stage 1A and 1B endometrial cancer
Key exclusion criteria (6 listed)
- Age under 18 years
- ASA IV
- Liver cirrhosis
- Psychiatric illness
- Urgent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced recovery after surgery (ERAS)Enhanced recovery after surgery (ERAS) programs are designed to achieve early recovery after surgery and a shorter length of stay (LOS) at hospital. | Procedure or surgery | ERAS |
Primary outcome
Lengh of stay
Time frame: 30 days after surgery
Days of hospitalitation
Day of discharge
Time frame: 30 days after surgery
Readmisión
Time frame: During 1st month after surgery
yes/no
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enhanced recovery after surgery (ERAS) in people with Endometrial Cancer, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lengh of stay (time frame: 30 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.