The goal of this clinical trial is to evaluate the role of multimodal Prehabilitation program on improve surgical outcomes after gynecological oncology surgery.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
140
intervention will includes receiving prehabilitation care combine with ERAS post-operative care.
Woman's Health Hospital
Asyut, Egypt
changing the postoperative morbidity
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.)
Time frame: "up to 30 days postoperative"
changing the postoperative mortality
compare the 30 days postoperative mortality of the prehabilitation group and conventional group.
Time frame: "up to 30 days postoperative"
Pain intensity measured by the Visual Analog Scale (VAS) for pain.
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.
Time frame: "up to 30 days postoperative"
change the length of the hospital stay
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).
Time frame: up to 5 days post-operative
Enhance the physical state of gynecological oncology patient using the Eastern Cooperative Oncology Group (ECOG)
\- 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.
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Time frame: through the postoperative period within two hours up-to 30 days after surgery
Enhance the psychological wellbeing of gynecological oncology patient
\- 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
Time frame: up-to 15 days preoperatively & up to 30 days post operatively]
assess and changing the Nutritional Status of the prehabilitation group
Nutritional Status measured through the following: 1. Nutritional Status - Height/m Description: Patient height measured in meters. 2. Nutritional Status - Weight/kg Description: Patient body weight measured in kilograms. * weight and height combined to report BMI in kg/m\^2
Time frame: up-to 30 days postoperative
assess and changing the Nutritional Status of the prehabilitation group
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
Time frame: up-to 30 days postoperative
improve the Cardiopulmonary fitness of gynecological oncology patient after surgery
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 .
Time frame: up-to 15 days preoperatively & up to 30 days post operatively]
improve the Cardiopulmonary fitness of gynecological oncology patient after surgery
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.
Time frame: up-to 15 days preoperatively & up to 30 days post operatively]
improve the Cardiopulmonary fitness of gynecological oncology patient after surgery
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.
Time frame: up-to 15 days preoperatively & up to 30 days post operatively]
improve the Cardiopulmonary fitness of gynecological oncology patient after surgery
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.
Time frame: up-to 15 days preoperatively & up to 30 days post operatively]