Role of Multimodal Prehabilitation Program in Improving Surgical Outcomes for Women Undergoing Gynecologic Oncology Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- changing the postoperative morbidity
研究概览
简要总结
The goal of this clinical trial is to evaluate the role of multimodal Prehabilitation program on improve surgical outcomes after gynecological oncology surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed woman with gynecologic cancer by imaging &histopathology
- •Accept participation in the study.
排除标准
- •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
研究组 & 干预措施
Conventional group
Conventional group (woman received hospital care at previous year as a retrospective sample to prevent risk of bias) equal 70 woman
Prehabilitation group
Prehabilitation group (woman who will receive prehabilitation care combine with ERAS post-operative care as a prospective sample) equal 70 woman
干预措施: group (B) Prehabilitation care combine with ERAS post-operative care (Procedure)
结局指标
主要结局
changing the postoperative morbidity
时间窗: "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.)
changing the postoperative mortality
时间窗: "up to 30 days postoperative"
compare the 30 days postoperative mortality of the prehabilitation group and conventional group.
Pain intensity measured by the Visual Analog Scale (VAS) for pain.
时间窗: "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.
次要结局
- improve the Cardiopulmonary fitness of gynecological oncology patient after surgery(up-to 15 days preoperatively & up to 30 days post operatively])
- assess and changing the Nutritional Status of the prehabilitation group(up-to 30 days postoperative)
- change the length of the hospital stay(up to 5 days post-operative)
- Enhance the physical state of gynecological oncology patient using the Eastern Cooperative Oncology Group (ECOG)(through the postoperative period within two hours up-to 30 days after surgery)
- Enhance the psychological wellbeing of gynecological oncology patient(up-to 15 days preoperatively & up to 30 days post operatively])
研究者
Aya M. Abdelhafez
lecturer of maternity, gynecological and obstetric nursing
Assiut University