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临床试验/NCT04543214
NCT04543214已完成不适用

Outcome of Enhanced Recovery After Surgery (ERAS) Protocols in Patients Undergoing Small Bowel Surgery

Services Hospital, Lahore1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Length of hospital stay

研究概览

简要总结

It was a descriptive case series conducted it Department of Surgery, Services Hospital, Lahore. Total of 140 patients who underwent small bowel resection anastomosis were subjected to ERAS protocols.The objective of this study was to determine the outcome of applying enhanced recovery after surgery (ERAS) protocols in patients undergoing small bowel surgery.

详细描述

It was a descriptive case series study conducted at Surgical Unit II, Services Hospital, Lahore. Sample size of 140 cases was calculated with 95% confidence level, 4.5% margin of error while taking expected percentage of anastomotic leakage in 8% cases passed through Enhanced Recovery after Surgery protocole.9 Patients were selected by Non-probability Purposive Sampling. Patients of both sex groups with ages between 20-45 years. Having elective surgery of small bowel resection and anastomosis admitted through OPD were included in the study. Patient with co-morbid conditions falling in ASA Class III or greater and patients with metastatic tumours of small bowel were excluded from the study. 140 patients presenting in the surgical outdoor of Services Hospital, Lahore who fulfilled the inclusion criteria were included in the study. A detailed history was taken including demographic data (age, gender and address). Patients were requested to sign an informed consent after explaining them the details of the study. ERAS protocols were implemented. Patients were followed after 4 weeks post-operatively in outdoor and outcome were measured in terms of length of hospital stay, post-operative wound infection, anastomotic leakage and death. All the surgeries and the follow ups were performed by the consultant in charge of the unit to eliminate bias. Confounding variables were controlled by exclusion. All the data was recorded into the attached proforma.(annexed). All the collected data was entered into SPSS version 10. Numerical variables like age and length of hospital stay have been presented by mean ±SD. Categorical variables i-e gender, post-operative wound infection, anastomotic leakage and mortality have been presented by frequency and percentage. Data has been stratified for anastomotic leakage to deal with effect modifier. Chi square test has been applied post stratification with P-value ≤0.05 taken as significant.

研究设计

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

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Elective surgery of small bowel resection
  • Benign and malignant non metastatic disease
  • ASA-I and ASA-II patients

排除标准

  • Uncontrolled diabetes
  • Metastatic disease
  • Malnourished patients
  • Chronic renal Failure
  • Chronic liver disease

结局指标

主要结局

Length of hospital stay

时间窗: 2 weeks

Number of days patients stays in hospital

Anastomotic leakage

时间窗: 4 weeks

Number of patients developing leak from anastomotic site

Postoperative wound infection

时间窗: 2 weeks

Number of patients developing erythema and purulent discharge from wound site

次要结局

未报告次要终点

研究者

发起方
Services Hospital, Lahore
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. SamiUllah

Principal Investigator

Services Hospital, Lahore

研究点 (1)

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