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临床试验/NCT04584060
NCT04584060Unknown不适用

Conventional VS Enhanced Recovery After Surgery Protocols in Emergency GIT Surgery

Assiut University0 个研究点目标入组 60 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Length of hospital stay

研究概览

简要总结

Although the ERAS program is widely used in elective procedures in many surgical subspecialties, the place of this program in emergency surgery remains uncertain probably because of the significant challenges in applying all ERAS pathways in the emergency setting. Nevertheless, the ERAS program is often modified in elective procedures on an individual and/ or institutional basis and thus may also have a role in the emergency setting albeit in a modified form.

详细描述

The cases will be randomized simply into two groups, Group (A) for conventional care and Group (B) for ERAS. Random assignment of intervention will be done after subjects have been assessed for eligibility and recruited. The sealed envelope method will be used for randomization.

Both groups will have pre-operative ryle inserted, urinary catheter applied, Tracheal intubation and with General anesthesia, exploration laparotomy Group (A) Fatsing for at least 6 hours pre-operative, No restriction of IV fluids and traditional analgesia including opiates. Post-operative Ambulation-as per patients' own request, Removal of urinary catheter when patient ambulates, patient will keep fasting for 3 days postoperative, oral fluids for 3 days, semi-solid for another 3 days and then can take full diet, removal of nasogastric tube just before starting oral fluids, drain removal just before discharge.

Group (B) Preoperative information, education and counselling, If possible, Clear fluids are allowed up to 2 h and solids up to 6 h prior to induction of anaesthesia, Short acting anesthetic agents,avoid opioid agents, Post operative nausea and vomiting prophylaxis, Patient will wear well-fitting compression stockings and receive pharmacological prophylaxis with LMWH. Encourage to mobilize out of bed after effect of general anesthesia has weaned off, Chewing gum, oral magnesium and alvimopan can be started early postoperatively, Initiation of feeding-Oral sips on day 1, step up day 2 onward, Removal of nasogastric tube-immediately after surgery after aspirating the gastric content through nasogastric tube, Removal of urinary catheter-after weaning from the effect of general anesthesia and drain removal -anytime within 24 hours;drain will not be removed if fluid is bilious or pus.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pateint presented with acute abdomen necessitating urgent GIT surgery

排除标准

  • Known Chronic kidney disease/ Chronic liver disease patients Patients with history of chronic steroid abuse. Patient requiring Positive Pressure Ventilator support post operatively for more than 12 hours.
  • Patient presented with Acute Appendicitis or Acute Cholecystitis. Patient refusing for consent

结局指标

主要结局

Length of hospital stay

时间窗: Up to one month

In days

次要结局

  • Time to ambulation(Up to one month)
  • Time to first fluid diet(Up to one month)
  • Time to first flatus(Up to one month)
  • Time to removal of drains(Up to one month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ramy Raouf Rida Naguib

Resident doctor

Assiut University

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