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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional group | No Intervention | Conventional group (woman received hospital care at previous year as a retrospective sample to prevent risk of bias) equal 70 woman | |
| Prehabilitation group | Experimental | Prehabilitation group (woman who will receive prehabilitation care combine with ERAS post-operative care as a prospective sample) equal 70 woman |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| group (B) Prehabilitation care combine with ERAS post-operative care | Procedure | intervention will includes receiving prehabilitation care combine with ERAS post-operative care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | "up to 30 days postoperative" |
| changing the postoperative mortality | compare the 30 days postoperative mortality of the prehabilitation group and conventional group. | "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. | "up to 30 days postoperative" |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 5 days post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aziza M Mohammed, Head nurse | Woman's Health Hospital, Assiut University, Egypt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woman's Health Hospital | Asyut | Egypt |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| 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
|
| 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
| 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:
| 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:
| 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
| 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.
| 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
| 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
| up-to 15 days preoperatively & up to 30 days post operatively] |