Implementing ERAS protocol in oral cancer patients undergoing free flap reconstruction: an experimental prospecting study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Length of hospital stay (LOS)
研究概览
简要总结
This prospective observational cohort study aims to evaluate the impact of the Enhanced Recovery After Surgery (ERAS) protocol on postoperative outcomes in patients undergoing oral cancer reconstruction using free flap surgery at Tata Memorial Hospital, Varanasi.
The ERAS protocol is a multidisciplinary, evidence-based approach designed to optimize perioperative care and promote faster recovery. Although it has shown benefits in various surgical specialties, its application in oral cancer reconstruction remains limited.
The study will include 196 patients (98 in the ERAS group and 98 in the traditional care group) and will assess outcomes such as length of hospital stay (primary outcome), postoperative complications, pain control, opioid consumption, nutritional and functional recovery, and patient satisfaction. Cancer staging (TNM classification) will also be analyzed to determine its influence on recovery outcomes.
By systematically implementing and evaluating the ERAS protocol, this study aims to enhance recovery, reduce complications, and improve overall patient satisfaction following major head and neck reconstructive surgery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients diagnosed with oral cavity cancer requiring free flap reconstruction as part of surgical management.
- •Patients undergoing primary surgical resection and immediate reconstruction using microvascular free flap (e.g., radial forearm, fibula, or anterolateral thigh flap).
- •Patients who are clinically fit for major surgery under general anesthesia.
- •Patients willing to participate and provide written informed consent for inclusion in the study.
排除标准
- •o Patients with a history of previous major reconstructive surgery of the oral cavity.
- •o Patients with severe comorbidities (e.g., advanced heart failure, chronic renal failure, uncontrolled diabetes) that would significantly impact surgical or recovery outcomes.
- •o Pregnancy or lactating women.
结局指标
主要结局
Length of hospital stay (LOS)
时间窗: o 1 week: Clinical check for flap viability, wound healing, and complications. | o 1 month: Assessment of functional recovery (e.g., speech, swallowing, nutrition). | o 3 months: Evaluation of long-term recovery, recurrence, and psychosocial impact.
次要结局
- • Postoperative complications (e.g., flap failure, wound infection, sepsis, pneumonia).(• Pain scores postoperatively, with a focus on the reduction in opioid use ().)
研究者
Dr Aseem Mishra
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi