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Completed

NCT Number: NCT06732635

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Lengh of stay

    Time frame: 30 days after surgery

    Days of hospitalitation

  2. Day of discharge

    Time frame: 30 days after surgery

  3. Readmisión

    Time frame: During 1st month after surgery

    yes/no

Other outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Enhanced Recovery After Surgery (ERAS) for Laparoscopic Hysterectomy at Low Risk Endometrial Cancer: A Randomized Controlled Trial

Acronym: FAST-TRACK

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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