Assessing the impact of Enhanced Recovery After Surgery Protocol (ERAS) on outcomes in elective Glioma surgery; A Randomized control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1 Length of stay after operation with in 5 days
研究概览
简要总结
We are inviting eligible patients diagnosed with supratentorial gliomas to participate in a randomized controlled trial evaluating the outcomes of advanced surgical techniques in glioma resection. Participants will be randomly assigned to one of the treatment arms involving either standard microsurgical resection or surgery guided by advanced adjuncts such as intraoperative navigation, neurophysiological monitoring, or fluorescence imaging. All procedures will be performed by experienced neurosurgeons adhering to current best practices. Participation is voluntary, and comprehensive information about the study, including potential risks and benefits, will be provided before obtaining informed consent. The aim of the trial is to improve surgical outcomes, reduce neurological deficits, and optimize overall survival and quality of life in glioma patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 years and above.
- •Patients must be adults capable of giving informed consent.
- •Radiologically suspected supratentorial glioma.
- •Diagnosis should be based on MRI brain with contrast suggestive of glioma (low-grade or high-grade, as per study protocol).
- •Karnofsky Performance Status (KPS)
- •Patients should be functionally independent and fit for surgery.
- •Operable tumor as determined by neurosurgical evaluation.
- •Tumor must be deemed safely accessible for resection based on preoperative imaging.
- •No prior cranial surgery or radiotherapy for the same lesion.
- •To ensure treatment-naive status and reduce confounding variables.
- •Informed written consent obtained.
- •Patients must be willing to participate and comply with the protocol including randomization and follow-up.
- •No evidence of multifocal disease or diffuse leptomeningeal spread.
- •Ability to undergo MRI with or without contrast.
- •Required for surgical planning and postoperative assessment.
排除标准
- •Age below 18 years.
- •Pediatric patients are excluded due to differing tumor biology and management protocols.
- •Karnofsky Performance Status (KPS) less than
- •Patients with poor functional status may not tolerate surgery or postoperative rehabilitation well.
- •Evidence of multifocal glioma or diffuse leptomeningeal spread.
- •These cases are typically not suitable for focal surgical resection.
- •Previous surgery or radiotherapy for the current brain lesion.
- •Prior treatment may alter tumor characteristics and surgical planes, affecting study outcomes.
- •Deep seated tumors involving eloquent cortex or midline structures that preclude safe resection.
- •To avoid undue surgical risk and standardize resectability.
- •Contraindications to MRI MRI is essential for both preoperative planning and postoperative follow-up.
- •Significant comorbidities or systemic illness Which may increase perioperative risk or interfere with followup.
- •Pregnancy or breastfeeding.
- •Due to potential risks from anesthesia imaging and surgical intervention.
- •Known allergy or contraindication to contrast agents or surgical adjuncts used in the study Inability or unwillingness to provide informed consent or comply with follow-up.
- •Including cognitive impairment or language barriers that impede understanding of the study.
结局指标
主要结局
1 Length of stay after operation with in 5 days
时间窗: with in 6 weeks
2. 30 days re admission rate with in 4 weeks
时间窗: with in 6 weeks
次要结局
未报告次要终点
研究者
Dr G Praneeth prem kumar
SVIMS