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Completed

NCT Number: NCT07188662

Multimodal Prehabilitation Program for Women Undergoing Gynecologic Oncology Surgery

The goal of this clinical trial is to evaluate the role of multimodal Prehabilitation program on improve surgical outcomes after gynecological oncology surgery.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Woman's Health Hospital

Asyut, Egypt

About this study

Multimodal prehabilitation program focused on improving woman physical and psychological wellbeing before gynecological oncology surgery. Multimodal prehabilitation refers to a combination of preoperative interventions targeting physical, nutritional, psychological, and medical optimization. This program included various element such preoperative physical exercise, nutritional support, psychological counselling, social support and education about surgical processes. Multimodal Prehabilitation programs play an important role in improving surgical outcomes after gynecological oncology surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly diagnosed woman with gynecologic cancer by imaging &histopathology
  • Accept participation in the study.

Exclusion criteria

  • Patient with advanced and metastatic stage
  • Patient who received neoadjuvant chemotherapy
  • Patient who have psychological disorder such as suicidal attempt
  • Patient who have cerebral stroke, hemiplegia or paralyses

Treatment and study plan

group (B) Prehabilitation care combine with ERAS post-operative care

Procedure

intervention will includes receiving prehabilitation care combine with ERAS post-operative care.

Primary outcomes

  1. changing the postoperative morbidity

    Time frame: "up to 30 days postoperative"

    compare the 30 days postoperative morbidity of the prehabilitation and conventional group, it included (Assess the post-operative complications by using Clavien-Dindo classification; from Grade I-IV; higher grades indicate more severe complications.)

  2. changing the postoperative mortality

    Time frame: "up to 30 days postoperative"

    compare the 30 days postoperative mortality of the prehabilitation group and conventional group.

  3. Pain intensity measured by the Visual Analog Scale (VAS) for pain.

    Time frame: "up to 30 days postoperative"

    compare the 30 days postoperative Pain intensity; Unit of Measure: Units on a scale (0-10 cm).

    Scale: 0 = no pain, 10 = worst pain imaginable; higher scores indicate worse pain of the prehabilitation group and conventional group.

Secondary outcomes

  1. change the length of the hospital stay

    Time frame: up to 5 days post-operative

    compare the days of the hospital stay between the prehabilitation group and conventional group to measure the effect of the intervention program in changing the length of hospital stays (Number of days from surgery until hospital discharge).

  2. Enhance the physical state of gynecological oncology patient using the Eastern Cooperative Oncology Group (ECOG)

    Time frame: through the postoperative period within two hours up-to 30 days after surgery

    • Eastern Cooperative Oncology Group (ECOG) is a performance method used to assess a cancer patient's level of functioning and ability to care for themselves, work, and carry out daily activities. ECOG Performance Status Scale included 5 grades from 0- 5
    • Grade 0: Fully active, able to carry all activities without restriction.
    • Grade 1: Restricted in physically and able to do light work
    • Grade 2: Ambulatory and capable of self-care, but unable to carry out any work activities; up >50% of waking hours.
    • Grade 3: Capable of only limited self-care; confined to bed or chair >50% of waking hours.
    • Grade 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
    • Grade 5: Dead.
  3. Enhance the psychological wellbeing of gynecological oncology patient

    Time frame: up-to 15 days preoperatively & up to 30 days post operatively]

    • measure the Psychological aspect by using DASS21(Depression, Anxiety, and Stress Scale - 21 items):

    . 1- Depression

    • Unit of Measure: Units on a scale (0-42).
    • Scale: Higher scores indicate worse depression. 2- Anxiety
    • Unit of Measure: Units on a scale (0-42).
    • Scale: Higher scores indicate worse anxiety. 3- Stress
    • Unit of Measure: Units on a scale (0-42).
    • Scale: Higher scores indicate worse stress
  4. assess and changing the Nutritional Status of the prehabilitation group

    Time frame: up-to 30 days postoperative

    Nutritional Status measured through the following:

    • Nutritional Status - Height/m Description: Patient height measured in meters.
    • Nutritional Status - Weight/kg Description: Patient body weight measured in kilograms.
    • weight and height combined to report BMI in kg/m^2
  5. assess and changing the Nutritional Status of the prehabilitation group

    Time frame: up-to 30 days postoperative

    Nutritional Status measured through:

    • Clinical Signs using Patient-Generated Subjective Global Assessment (PG-SGA): The PG-SGA is a subjective nutritional assessment tool used in oncology; include questions about:
    • Weight change (past 1 month and 6 months (increased 0 or decreased 1
    • Eating patterns changed over last weeks or months (normal, less than normal, only liquids, very little, etc.)
    • Gastrointestinal Symptoms affecting intake (e.g., nausea, vomiting ,pain, diarrhea, etc.)
    • Functional capacity& activity (normal activity, reduced, bed/chair bound, etc.) Scoring system of PG-SGA: A)Well-nourished (0-3) B)Moderately malnourished 4-8 C)Severely malnourished more then >9
  6. improve the Cardiopulmonary fitness of gynecological oncology patient after surgery

    Time frame: up-to 15 days preoperatively & up to 30 days post operatively]

    Cardiopulmonary Fitness measured by use of:

    1- 6-Minute Walk Test (6MWT) Distance

    • Description: Distance walked in meters.
    • Time Frame: Up to 30 days post operatively .
  7. improve the Cardiopulmonary fitness of gynecological oncology patient after surgery

    Time frame: up-to 15 days preoperatively & up to 30 days post operatively]

    Cardiopulmonary Fitness measured by use of:

    • VO2max (calculated): Estimated VO2max in mL/kg/min using the predictive equation from 6MWT distance and BMI.
    • Time Frame: up to 30 postoperatively
    • Unit of Measure: mL/kg/min.
  8. improve the Cardiopulmonary fitness of gynecological oncology patient after surgery

    Time frame: up-to 15 days preoperatively & up to 30 days post operatively]

    Cardiopulmonary Fitness measured by use of:

    • Fatigue - Visual Analog Scale (VAS) for Fatigue
    • Time Frame: Up to 15 days preoperatively -operative.
    • Unit of Measure: Units on a scale (0-10 cm).
    • Scale: 0 = no fatigue, 10 = worst fatigue imaginable; higher scores indicate worse fatigue.
  9. improve the Cardiopulmonary fitness of gynecological oncology patient after surgery

    Time frame: up-to 15 days preoperatively & up to 30 days post operatively]

    Cardiopulmonary Fitness measured by use of:

    • Dyspnea - Visual Analog Scale (VAS) for Dyspnea
    • Description: Breathlessness severity measured by VAS.
    • Time Frame: Up to 15 days post-operative.
    • Unit of Measure: Units on a scale (0-10 cm).
    • Scale: 0 = no breathlessness, 10 = worst breathlessness imaginable; higher scores indicate worse dyspnea.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Role of Multimodal Prehabilitation Program in Improving Surgical Outcomes for Women Undergoing Gynecologic Oncology Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

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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