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

NCT06732635 | Completed Phase 3

• 1 other identifier: ERAS
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (3)

• Lengh of stay

  Days of hospitalitation

  30 days after surgery

• Day of discharge

  30 days after surgery

• Readmisión

  yes/no

  During 1st month after surgery

Other Outcomes (3)

• Complications

  30 days after surgery

• Quality of life (QoL)

  Preoperative, 3, 10 and 30 days after surgery

• Level of Pain

  Preoperative, 3, 10 and 30 days after surgery

Study Arms (2)

Conventional

NO INTERVENTION

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.

Procedure: Enhanced recovery after surgery (ERAS)

Interventions

Enhanced recovery after surgery (ERAS) PROCEDURE

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

ERAS

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing laparoscopic hysterectomy for stage 1A and 1B endometrial cancer

You may not qualify if:

• Age under 18 years
• ASA IV
• Liver cirrhosis
• Psychiatric illness
• Urgent surgery
• The patient's desire not to participate.

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 13, 2024
• Study Start: June 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

ES (1)