Pre-habilitation Within ERAS Protocol for Gynecologic Oncology Surgery: The Pre_ERAS Study

Aristotle University Of Thessaloniki

Status: Enrolling

Conditions: Gynaecologic Cancer; ERAS; Laparotomy Patients; Excercise; Gynaecological Oncology; Quality of Life (QOL); Compliance; Surgical Complication; Gynaecological Malignancies; Immunonutrition; Post Operative Pain

Treatments: Dietary Supplement: Ocoxin; Procedure: Structured self-guided exercise

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07210164

337/2025, 18.09.2025

Details and patient eligibility

About

ERAS (Enhanced Recovery After Surgery) protocols are step-by-step care plans that help patients recover faster after surgery. They focus on keeping the body's normal functions, lowering stress from surgery, and supporting a quicker recovery. In gynecologic cancer surgeries, ERAS has been shown to help patients do better, have fewer problems, and leave the hospital sooner.

A prehabilitation program, in combination with ERAS protocols, aims to optimize patients' physical and psychological condition prior to surgery for gynecological cancers. Interventions may include tailored exercise, nutritional support, respiratory training, and psychological preparation. By enhancing baseline fitness and resilience, prehabilitation improves the body's ability to tolerate surgical stress, reduces complications, and facilitates a faster, smoother recovery within the ERAS framework.

Full description

The purpose of this study is to investigate the impact of multifactorial preoperative empowerment (pre-habilitation protocol) on patients with gynecological cancer who undergo oncological surgery. The objective of this study is to demonstrate whether the implementation of pre-habilitation program empowerment as opposed to its non-implementation leads to an improvement in quality of life, a reduction in days of hospitalization, a reduction in immediate (up to discharge) and long term (up to 40th post-surgery day) postoperative complications (as measured with the Clavien Dindo system), a reduction in hospital readmission rates, and postoperative morbidity and mortality.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type of gynecological malignancy: endometrial cancer, ovarian cancer, cervical cancer, treated with laparotomy after the decision of the gynecological-oncology unit (positive opinion of the Multidisciplinary Tumor Board - MDT)
• Patient age: 18 to 85 years
• General condition of the patient: ASA score I-III
• Consent to implement the accelerated recovery protocol - Enhanced recovery after surgery (ERAS)
• Sufficient understanding of the Greek language
• Provision of signed, after thorough information, consent to participate in the study

Exclusion criteria

• Women with performance status: ECOG >2 and ASA score >III
• Women who have not been informed and have given written consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Prehabilitation group

Experimental group

Description:

This group undergo a structured preoperative self-guided exercise protocol (consisting of mild physical activity with a defined exercise program, respiratory exercise, muscle strengthening), immunonutrition (Ocoxin©) and usual clinical practice (stopping alcohol, regulating anemia and glucose levels). During the period of hospitalatization adhere to the 21-point ERAS protocol .

Treatment:

Procedure: Structured self-guided exercise

Dietary Supplement: Ocoxin

Control group

No Intervention group

Description:

This group follow the usual clinical practice (stopping alcohol, regulating anemia and glucose levels). During the period of hospitalatization adhere to the 21-point ERAS protocol .