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临床试验/CTRI/2022/05/042834
CTRI/2022/05/042834尚未招募不适用

Impact of an enhanced recovery after surgery (ERAS) protocol on length of stay, perioperative outcomes and complications in paediatric laparoscopic surgeries

Department of Anaesthesiology Pain Medicine and Critical Care AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年8月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To determine the length of hospital stay

研究概览

简要总结

Today in the era of minimally invasive surgery, paediatric laparoscopy has become widely popular. The safety and efficacy of Enhanced recovery after surgery (ERAS) protocols in adult surgeries has been well established. There is particularly a limited data in the Indian scenario regarding the perioperative outcomes of paediatric patients undergoing surgeries with ERAS protocols. Therefore, this prospective study is being planned to determine the safety and feasibility of ERAS protocols in paediatric patients undergoing laparoscopic surgeries.

The study will be conducted in the Department of Anaesthesia, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi. The trial will be registered with the Central Trial Registry of India.Children between 2 to 14 years, ASA grade I/II satisfying the inclusion criteria scheduled for elective laparoscopic surgeries (thoracic and abdomino-perineal) will be recruited for the study**.** It will be aProspective, single arm, feasibility study.

ERAS protocol elements will be applied in the three phases of perioperative period. The elements in the preoperative period will include risk assessment, detailed preoperative counselling, patient optimization, avoidance of prolonged fasting with preoperative carbohydrate loading, avoidance of mechanical bowel preparation and anxiolytic premedication. The intraoperative elements will include adequate analgesia (regional with minimal use of short acting opioids), antiemetic prophylaxis, antibiotic prophylaxis, maintainence of near zero fluid balance, maintenance of normothermia, adequate glycaemic control, thromboprophylaxis and avoidance of surgical drains, tube and catheters Postoperative elements will include early removal of nasogastric tube and urinary catheter (if placed), early diet advancement, near zero fluid balance, early postop mobilization, adequate analgesia (regional and nonnarcotic) observing pain scores and treatment of nausea and vomiting. Start time and duration of surgery will be noted. Laparoscopic surgery which gets converted to open will be excluded.

Discharge criteria will be followed strictly and a post discharge follow-up plan will be explained to the parents. All patients will be audited for compliance especially with the patient driven elements of the protocol. The number of protocol elements followed in each patient will be noted. The number of protocol elements not followed and the reasons thereof will also be documented. The rate of complications and the rate of readmissions will be noted. This study will recruit 30 patients initially and an interim analysis will be done to find the practices most likely to be followed and most likely leading to early discharge. The initial protocol will undergo necessary changes if needed and the next 30 patients will receive the modified ERAS protocol.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
2.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • All paediatric patients, ASA grade I/II, undergoing various elective laparoscopic surgeries at our center who are eligible for the ERAS protocol.

排除标准

  • 未提供

结局指标

主要结局

To determine the length of hospital stay

时间窗: Patients will be assessed daily till discharge . Primary outcome being in days

次要结局

  • 1.To determine the perioperative complications (within 30-days)(2.To determine the incidence and reason for 30-day readmission)

研究者

发起方
Department of Anaesthesiology Pain Medicine and Critical Care AIIMS New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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