Effect of Enhanced Recovery After Surgery on Length of hospital stay among patients undergoing surgery for Oral cancers- A Randomized Controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- To assess the effect of ERAS on LOS among the patients with Oral cancers undergoing surgery
研究概览
简要总结
Introduction: ERAS pathways include evidence-based measures designed to reduce perioperative stress, maintain postoperative physiological function and accelerate recovery after surgical intervention. Using this multimodal stress minimizing approach it has been proven repeatedly to reduce the morbidity by 40%, length of hospital stay (LOS) and improve recovery after colorectal surgery.Oral cancers is one of the most common cancers in the Indian subcontinent and surgery is an integral part of treatment and that enormous prevalence along with the morbidity of surgery amounts to a huge burden on our healthcare system. Though there are many studies evaluating the effect of ERAS in reducing LOS after surgery in Oral cancers, they are limited in terms of the cases studied, having retrospective analysis and inclusion of only a particular subgroup of patients. In this study, we expect to find the effect of ERAS in reducing LOS among patients with Oral cancers undergoing surgery by the specified perioperative and postoperative interventions as per ERAS as an adjunct to the standard of care that may reduce the LOS and reduce the postsurgical complications.
**Aim and Objectives:**Primary -To assess the effect of ERAS on LOS among the patients with Oral cancers undergoing surgery
Secondary - To compare the mean ICU stay, morbidity and mortality and 30-day readmission rate
Methods: In this RCT we will include patients who are all meeting the inclusion and exclusion criteria with oral cancers and after randomization they be divided into intervention and control arm. The intervention arm will receive ERAS care (With prespecified preoperative, intraoperative, postoperative measures) in addition to the standard perioperative care, and the control arm will receive standard perioperative care. After that study population will be followed prospectively and will be assessed for the primary and secondary objectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult Population aged 18 years and above 2)Diagnosed case of Oral cancers undergoing surgery 3)ECOG Performance Status of 0 to 2.
排除标准
- •Free Osteocutaneous flaps taken from lower limbs.
- •Use of multiple (2 and above) regional/distant flaps and central Mandibulectomy
- •Post radiation therapy
- •Salvage surgery for residual/recurrent disease
- •Patients with Renal and Liver decompensation
- •Not consenting for the study.
结局指标
主要结局
To assess the effect of ERAS on LOS among the patients with Oral cancers undergoing surgery
时间窗: Duration of total hospital stay will assessed at 30 days after surgery.
次要结局
- To compare the mean ICU stay, morbidity & mortality & 30-day readmission rate(Outcomes will be assessed till postoperative day 30)