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临床试验/NCT07087366
NCT07087366招募中不适用

Enhanced Recovery After Surgery(ERAS) Pathway Following Gynecological Oncology Surgery in a Tertiary Level Hospital:A Prospective Randomized Controlled Trial

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
130
试验地点
2
主要终点
hospital stay

研究概览

简要总结

Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery.

The principle of ERAS is to optimize the patient's health before surgery, minimize stress to the body, and restore function to normal rapidly by taking steps before, during, and after surgery, to decrease the length of stay in the hospital, reduce recovery time, prevent complications, readmissions, same day discharge (SDD) and patient's satisfaction.

The aim of this study is to introduce the ERAS recommendations into the management of gynaecological surgical procedures in compared to conventional procedures.

After taking permission from Institutional Review Board (IRB) of BSMMU, the proposed study will be started. After taking informed written consent and matching eligibility criteria, a total 160 patients will be selected in this prospective randomized control study. This study will be conducted in the Department of gynecological oncology, BSMMU for two years from April 2024 to March 2026. There will be two group in this study, patients of Group A will be selected for ERAS protocol from preoperative to postoperative event up to follow up. Patients of Group B will be selected for conventional method. Outcome of both procedure in terms of hospital stay, costs, requirement of analgesia and complications will be compared. Statistical analyses of the results will be obtained by using window-based computer software devised with Statistical Packages for Social Sciences (SPSS-25).

详细描述

Over 234 million major surgical procedures are performed globally each year and despite advances in surgical and anaesthetic care, morbidity after abdominal surgery is still high. Fasttrack or enhanced recovery after surgery (ERAS) clinical pathways have been proposed to improve the quality of perioperative care with the aim of attenuating the loss of functional capacity and accelerating the recovery process.

The ERAS pathways reduce the delay until full recovery after major abdominal surgery by attenuating surgical stress and maintaining postoperative physiological functions. The implementation of the ERAS pathways has been shown to impact positively in reducing postoperative morbidity, and as a consequence, length of stay in hospital.

The concept of ERAS was first published by Engelman and colleagues in cardiac surgery in 1994. Subsequently, ERAS Society was formed in the early 2000s by a group of European surgeons (ERAS Society guidelines was formed). Early studies were primarily focused on colorectal surgery, and in 2003 (Marx and colleagues) this concept was demonstrated in gynecologic oncology. The first ERAS guidelines in gynecologic oncology were published in 2016. Updated guidelines for ERAS in gynecologic oncology were published in 2019.

Components of ERAS are preoperative, intraoperative and post operative. Pre-operative component includes: Patient education regarding the surgery and the expected post-operative course, ensuring the patient is as healthy as possible prior to surgery through exercise & weight loss, optimal pre-operative fasting guidelines that will allow solid food until 6 hours pre-operatively and intake of clear fluids until 2 hours prior to surgery. A Cochrane review reported that preoperative carbohydrate treatment was associated with reduced post-operative insulin resistance, enhanced return of bowel function, and shorter hospital stay with no effect on post-operative complication rates, length of hospital stay (LOSH) and its related costs. In recent years, several studies have highlighted the impact of the anaesthetic management on postoperative morbidity and mortality.

In view of the evidence that many elements of the ERAS programme published by the ERAS Society in 2009 are of related to anaesthetic care, it is imperative that guidelines on perioperative care include recommendations approved by an interdisciplinary team comprising anaesthesiologists and surgeons.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Patients between the age of 18-70 years,
  • diagnosed case with cervical, uterine or ovarian cancer,
  • Admitted for surgical management .

排除标准

  • Patients with severe comorbidity, including DM,CRD,CLD
  • patients with American Society of Anesthesiologists risk ≥ 4,
  • severe organ dysfunction or failure.

结局指标

主要结局

hospital stay

时间窗: 3 to 4 days

duration of hospital stay in ERAS group

hospital stay

时间窗: 3 to 4 days

duration of hospital stay in ERAS group

次要结局

  • Day of first flatus(upto 24 hours)
  • postoperative nausea and vomiting(upto 24 hours)
  • complications related to the intervention(upto 2 weeks)
  • readmission rate(upto 21days)
  • mortality rate after the procedure(5 to 7 days)
  • Day of first flatus(upto 24 hours)
  • postoperative nausea and vomiting(upto 24 hours)
  • pain score by the visual analogue scale with score minimum 0 and maximum 10(upto 48 hours)
  • readmission rate(upto 21days)
  • Total hospital cost(3to 4 days)
  • complications related to the intervention(upto 2 weeks)
  • mortality rate after the procedure(5 to 7 days)

研究者

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

JANNAT FERDOUS

Professor of Department of gynaecological-oncology

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (2)

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