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

Not Applicable

Recruiting

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

• Registration Number: NCT07210164
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-18
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Study Start: 2025-12-01
• Primary Completion: 2029-12-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative morbidity	Up to the 30th post operative day	Systematic recording of complications based on the Clavien Dindo system, during hospitalization and in the immediate postoperative period (up to the 30th postoperative day).
Duration of hospitalization	Until the patient discharged (assessed up to 4 days)	The discharge day is defined as the postoperative day on which the following criteria are met in their entirety: 1. adequate mobilization, 2. tolerance of solid foods and adequate oral water intake, 3. adequate analgesia only with oral analgesics, 4. mobilization of intestinal function / flatus, 5. Absence of Clavien Dindo \>II complication.
General Quality of Life (QoL)	Up to the time of discharge (assessed up to 4 days)	Use of metric tools: structured and weighted questionnaires in Greek language EORTC QLQ-C30 (version 3.0) (general quality of life).; The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.; Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.; All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Secondary Outcome Measures

Name	Time	Method
Time interval between the onset of adjuvant anti-neoplastic therapy	Up to 120 days after surgery	The number of days between the day of surgery and the start of adjuvant therapy (includes systemic chemotherapy/immunotherapy, external radiation, brachytherapy).
Hospital readmission at 90 days	Up to the 90th postoperative day	Any admission to a nursing facility up to the 90th postoperative day.
Cachexia	Up to the time of discharge (assessed up to 5 days)	Assessments using unique measurements EORTC QLQ-CAX24 (cachexia). The Cancer Cachexia Module is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-CAX24 incorporates five multi-item scales to assess food aversion, eating and weight-loss worry, eating difficulties, loss of control, and physical decline. In addition, four single items assess dry mouth, indigestion/heartburn, forcing self to eat and inadequate information.; All of the scales and single-item measures range in score from 0 to 100. A high score for the symptom scales represents a high level of symptomatology or problems.
Sexual Health	Up to the time of discharge (assessed up to 4 days)	The EORTC Quality of Life Questionnaire Sexual Health (SH-22) is a stand-alone questionnaire, but can also be used as a supplementary questionnaire to be employed in conjunction with the QLQ-C30. The SH-22 incorporates 2 multi-item scales to assess Sexual satisfaction and Sexual pain. In addition, 11 single items assess sexual activity and cover treatment-related and partner-related questions, general questions of sexual health and 4 gender specific questions.; Interpretation: All of the Multi-item scales and Single-item measures range in score from 0 to 100. A high score represents a high level of symptomatology or problems.; Reporting: The two multi-item scales have a different number of items depending on whether the patient had or does not have a partner, and has or does not have sexual activity. It is advised to always report how many items were used to calculate each scale; and which ones. This will allow comparison between different subgroups of patients.
Quality of Life in ovarian cancer	Up to the time of discharge (assessed up to 4 days)	The Ovarian Cancer Module (QLQ-OV28) is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-OV28 incorporates seven multi-item scales to assess body image, sexuality, attitude to disease or treatment, abdominal or gastro-intestinal symptoms, peripheral neuropathy, hormonal or menopausal symptoms and other chemotherapy side-effects.; The scoring approach for the QLQ-OV28 is identical in principle to that for the \[function and/or symptom scales / single items\] of the QLQ-C30.; Interpretation: All of the scales and single-item measures range in score from 0 to 100. A high score for the \[functional scales and/or single items\] represents a high level of functioning, whereas a high score for the \[symptom scales and/or single items\] represents a high level of symptomatology or problems.
Quality of Life in endometrial cancer	Up to the time of discharge (assessed up to 4 days)	The Endometrial Cancer Module (QLQ-EN24) is a supplementary questionnaire module designed for patients with all stages of endometrial cancer and should always be employed in conjunction with the QLQ-C30. The QLQ-EN24 incorporates 5 multi-item scales to assess lymphoedema, urological symptoms, gastrointestinal symptoms, body image and sexual/vaginal problems. In addition, 8 single items assess pain in back and pelvis, tingling/numbness, muscular pain, hair loss, taste change, sexual interest, sexual activity and sexual enjoyment.; The scoring approach for the QLQ-EN24 is identical in principle to that for the symptom scales/single-items of the QLQ-C30.; Interpretation: All of the scales and single-item measures range in score from 0 to 100. A high score for the functional items represents a high level of functioning, whereas a high score for the symptom scales and single-items represents a high level of symptomatology or problems.

Trial Locations

Locations (1)

General Hospital of Papageorgiou; 🇬🇷 Thessaloniki, Greece