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临床试验/CTRI/2025/09/094288
CTRI/2025/09/094288尚未招募不适用

Evaluate the effect of Early vs Standard Enteral Feeding in cases of small and large bowel surgeries

ICMR1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年9月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
ICMR
入组人数
64
试验地点
1
主要终点
Early enteral feeding aims to maintain gut integrity, reduce inflammation, and prevent complications like ileus. Delayed enteral feeding may be considered to mitigate potential risks, balancing the benefits of early nutrition with individual patient factors and surgical considerations. The rationale involves optimising recovery while minimising postoperative complications.

研究概览

简要总结

A prospective interventional case control study will be conducted for 64 patients of small and large bowel surgeries in a tertiary care centre in central India.

The patients will be randomised alternatively in each group.

In control group patients, Standard enteral feeding will not be started until resolution of postoperative ileus i.e. until the appearance of bowel sounds on auscultation and passage of flatus, then followed by clear liquid diet, followed by regular diet.

In cases group patients, Early enteral feeding will be started within 12-24 hours after surgery at the rate of 20-50 ml/hour until the first postoperative morning, starting with sips of water, oral rehydration solution, orange juice, tea and fat free milk, advance to regular diet within the next 24 - 48 hours, and increase as tolerated to the target rate on 2nd and 3rd postoperative day.

Intolerance to feeding (usually abdominal distension and vomiting) to be managed by decreasing and discontinuing feeding as required for few hours until clinical resolution.

All the patients are to be monitored clinically and investigations (lab investigations and radiological studies) are to be sent accordingly for vomiting, abdominal distension, length of ileus, tolerance to regular diet, length of hospitalisation, septic complications like pneumonia (fever, leukocytosis, purulent sputum, new pulmonary infiltrates), intra-abdominal abscess, empyema, line sepsis, necrotising fasciitis and wound infection associated with wound dehiscence are considered, diarrhoea i.e. unformed, watery stool occurring for more than 3-4 times for a period of 24 hours.

The timing of enteral feeding post-bowel surgery is crucial due to potential impacts on healing, complications, and patient outcomes. Early enteral feeding aims to maintain gut integrity, reduce inflammation, and prevent complications like ileus. Delayed enteral feeding may be considered to mitigate potential risks, balancing the benefits of early nutrition with individual patient factors and surgical considerations. The rationale involves optimising recovery while minimising postoperative complications. These parameters are taken into consideration along with certain important things like propped up position feeding and feeding tolerated or not.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Procedures involving the gastrointestinal tract, such as elective bowel resections, colonic or small bowel surgeries, anastomoses (Hand suture/ Stapler) Adults more than 18 years of age undergoing elective small and large bowel surgeries.
  • Patient capable of receiving enteral nutrition.
  • Patients with controlled co-morbidities like DM and HTN.

排除标准

  • Patients with contraindications to enteral feeding for example, pre-existing malabsorption syndrome.
  • Patients with serious comorbidities such as severe cardiac anomalies, liver cirrhosis, ascites, CKD, patient unfit for surgery.
  • Patients requiring immediate postoperative parenteral nutrition and patients on TPN.
  • Severe gastrointestinal contamination for example significant intra operative peritoneal soiling Known case of Cancer metastasis, active TB and history of radiation.

结局指标

主要结局

Early enteral feeding aims to maintain gut integrity, reduce inflammation, and prevent complications like ileus. Delayed enteral feeding may be considered to mitigate potential risks, balancing the benefits of early nutrition with individual patient factors and surgical considerations. The rationale involves optimising recovery while minimising postoperative complications.

时间窗: 15 - 30 days

次要结局

  • Standard enteral feeding is better than early enteral feeding, & has better postoperative outcome.(15-30 days)

研究者

发起方
ICMR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Yashasvi Trivedi

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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