Enhanced Recovery After Surgery (ERAS) for Laparoscopic Hysterectomy at Low Risk Endometrial Cancer

NCT ID: NCT06732635

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2022-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional

Group Type NO_INTERVENTION

No interventions assigned to this group

ERAS

Enhanced recovery after surgery (ERAS) programs are designed to achieve early recovery after surgery and a shorter length of stay (LOS) at hospital.

Group Type EXPERIMENTAL

Enhanced recovery after surgery (ERAS)

Intervention Type PROCEDURE

Enhanced recovery after surgery (ERAS) programs are designed to achieve early recovery after surgery and a shorter length of stay (LOS) at hospital.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital ClĂ­nico Universitario Virgen de la Arrixaca

Murcia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ERAS

Identifier Type: -

Identifier Source: org_study_id