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临床试验/NCT06363318
NCT06363318已完成不适用

Comparison of Open and Laparoscopic Appendectomy in Pediatric Population

King Edward Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Postoperative pain

研究概览

简要总结

Introduction: In the era of minimally invasive surgery, changing trends are towards laparoscopic surgery, first introduced in 1983. Now the preferred operation for children with appendicitis, laparoscopic appendectomy is associated with a reduced risk of wound infection, less postoperative pain and shorter hospital stay as compared to open appendectomy.

Objectives: To compare the outcome of open and laparoscopic appendectomy in children presenting with appendicitis in terms of operative time, postoperative pain, wound infection and hospital stay.

详细描述

A total of 100 children presenting with acute appendicitis were included in this study, In group A, patients were undergone laparoscopic appendectomy.

In group B, patients were undergone open appendectomy. During surgery, operative time was noted. After surgery, patients were shifted to surgical wards and were followed-up there till discharge. Patients were followed regularly by the researcher for mean post-operative pain at 24 hours. At discharge, hospital stay was noted. Then patients followed up in outpatient department for 10 days for any evidence of wound infection.

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
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children of age 7-12 years of either gender diagnosed as acute appendicitis
  • •pediatric appendicitis score >4

排除标准

  • •Children with comorbidities,
  • •Perforated appendix
  • •Appendicular mass (on clinical examination). -

研究组 & 干预措施

Group A laparoscopic appendicectomy

Experimental

In Group A (50 patients) laparoscopic appendicectomy was done

干预措施: Laparoscopic appendicectomy (Procedure)

Group B open appendicectomy

Active Comparator

In Group B(50 patients) open appendicectomy was done

干预措施: Laparoscopic appendicectomy (Procedure)

结局指标

主要结局

Postoperative pain

时间窗: 48 hours

It was measured by using visual analogue scale (VAS), which consists of score minimum zero to maximum ten score

wound infection

时间窗: 10 days

It was labelled if there was redness, swelling or pus present at surgical wound site

Hospital stay

时间窗: 5 days

It was measured in terms of days required to stay in hospital after surgery. The start time will be the day of operation and end time was the day of discharge from hospital.

Operative time

时间窗: during surgery

from time of incision to skin closure

次要结局

未报告次要终点

研究者

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

Muhammad Sharif

PROFESSOR

King Edward Medical University

研究点 (1)

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