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临床试验/NCT07047729
NCT07047729招募中不适用

COMPARATIVE OUTCOME OF EARLY AND STANDARD ORAL FEEDING AFTER EMERGENCY BOWEL SURGERY

Dr Hamail Khanum2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Hospital stay

研究概览

简要总结

Informed consent will be obtained from patients or their legal representatives in cases where the patient is unconscious. Patient information, including names, ages, gender, smoking history, comorbidities, and the indication for emergency surgical procedures, will be documented. All surgical procedures will follow standard protocols and will be conducted by a single surgical team led by at least two consultants, each with more than five years of experience. All 60 patients will be randomly allocated into two groups using a random number table: Group A (early oral feeding), consisting of 30 patients, and Group B (standard oral feeding), consisting of 30 patients. In Group A, a liquid diet will be initiated within 24 hours after surgery and, if well-tolerated without vomiting, will transition to a regular diet over the subsequent 24 hours. On the other hand, in Group B, a standard diet (late feeding), including liquid filtrates, will only be introduced after the resolution of the ileus, during which these patients will remain NPO (nothing by mouth).

详细描述

Informed consent will be obtained from patients or their legal representatives in cases where the patient is unconscious. Patient information, including names, ages, gender, smoking history, comorbidities, and the indication for emergency surgical procedures, will be documented. All surgical procedures will follow standard protocols and will be conducted by a single surgical team led by at least two consultants, each with more than five years of experience. All 60 patients will be randomly allocated into two groups using a random number table: Group A (early oral feeding), consisting of 30 patients, and Group B (standard oral feeding), consisting of 30 patients. In Group A, a liquid diet will be initiated within 24 hours after surgery and, if well-tolerated without vomiting, will transition to a regular diet over the subsequent 24 hours. On the other hand, in Group B, a standard diet (late feeding), including liquid filtrates, will only be introduced after the resolution of the ileus, during which these patients will remain NPO (nothing by mouth). Tolerance to oral feeding will be evaluated by monitoring for vomiting within the first 24 hours after initiating a regular diet, and this evaluation will be conducted by the researcher herself. Patients will be discharged from the hospital once they have tolerated a regular diet for at least 24 hours and the duration of hospital stay will be noted as well. All data will be documented on a predefined proforma. Other variables like febrile episode and need for additional NPO will also be recorded.

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
Single (Participant)

入排标准

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

入选标准

  • •Either Gender
  • •Requiring emergency surgery due to conditions such as obstructive bowel disease, GI perforation, colorectal surgery, blunt abdominal trauma (resulting from falls or roadside accidents), and penetrating abdominal trauma (involving firearm injuries and stab wounds).

排除标准

  • •Patients with terminal cancer need palliative surgery (as their focus is on comfort care rather than surgical intervention).
  • •Patients who had undergone surgery within the past 30 days (to avoid potential complications associated with recent surgical procedures).
  • •Patients receive regular renal replacement therapy (to prevent additional stress on their medical condition).
  • •Pregnant women (as surgical interventions may pose risks to both the mother and the unborn child).

研究组 & 干预措施

Group A with early oral feeding (ERAS)

Experimental

Group A (early oral feeding), consisting of 30 patients. In Group A, a liquid diet will be initiated within 24 hours after surgery and, if well-tolerated without vomiting, will transition to a regular diet over the subsequent 24 hours. Tolerance to oral feeding will be evaluated by monitoring for vomiting within the first 24 hours after initiating a regular diet. Patients will be discharged from the hospital once they have tolerated a regular diet for at least 24 hours and the duration of hospital stay will be noted as well.

干预措施: Early oral feeding (Other)

Group B with standard oral feeding

Experimental

Group B (standard oral feeding), consisting of 30 patients. A standard diet (late feeding), including liquid filtrates, will only be introduced after the resolution of the ileus, during which these patients will remain NPO (nothing by mouth). Tolerance to oral feeding will be evaluated by monitoring for vomiting within the first 24 hours after initiating a regular diet. Patients will be discharged from the hospital once they have tolerated a regular diet for at least 24 hours and the duration of hospital stay will be noted as well.

干预措施: Standard oral feeding (Other)

结局指标

主要结局

Hospital stay

时间窗: 10 Days

Duration from day of surgery till discharge following discharge criteria

Feed tolerance

时间窗: 24 hours

Tolerance to oral feeding will be evaluated by monitoring for vomiting within the first 24 hours after initiating a regular diet

Hospital stay

时间窗: 10 Days

Duration from day of surgery till discharge following discharge criteria

Feed tolerance

时间窗: 24 hours

Tolerance to oral feeding will be evaluated by monitoring for vomiting within the first 24 hours after initiating a regular diet

次要结局

未报告次要终点

研究者

发起方
Dr Hamail Khanum
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr Hamail Khanum

Consultant

Gulab Devi Hospital

研究点 (2)

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