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临床试验/NCT03791229
NCT03791229Unknown不适用

The Evaluation of Pain and Discomfort After Appendectomy in Children and Their Effects on Quality of Life

Sakarya University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Prevalence of chronic pain

研究概览

简要总结

Appendectomy is the most common surgical procedure. Chronic abdominal pain is an uncommon complication following appendectomy. It is observed that pediatric patients who have undergone abdominal surgical procedure complained of pain and discomfort in the postoperative period and these complaints may affect quality of life. We aimed to investigate the presence of postoperative chronic abdominal pain and discomfort in children aged 8-18 years underwent appendectomy and their social and physical effects. The records of children aged 8-18 years who underwent appendectomy, such as age, gender, American Society of Anesthesiology (ASA) classification score, the type of surgical procedure, and anesthetic technique were obtained. Children had inclusions crietrias, pain was assessed using numerical rating scale and their effects on life were assessed Pediatric Quality of Life Inventory parent and child versions questionnaire at sixth months after surgery.

详细描述

Acute appendicitis is a diagnosis with clinical findings, laboratory tests and radiological imaging. The main pathology of appendicitis is usually the onset of the inflammatory process in the appendix vermiformis in the right lower abdomen. If untreated, the inflammatory process may progress to the perforation of the appendix and develop peritonitis. Appendectomy is an emergency surgical procedure for treatments of patients diagnosed with acute appendicitis and is the most common surgical procedure (1). Complications of appendectomy are wound site infection, postoperative intestinal adhesions and obstruction, peritonitis, bleeding, inguinal hernia, and chronic abdominal pain.

It is observed that pediatric patients who have undergone abdominal surgical procedure complained of pain and discomfort in the postoperative period (2). It should be noted that these complaints may affect quality of life. To the best of our knowledge, since there is no study in the literature, we aimed to investigate the presence of postoperative chronic abdominal pain and discomfort in children aged 8-18 years underwent appendectomy and their social and physical effects.

After Local Ethics Committee approval had been obtained, the records of children aged 8-18 years who underwent appendectomy, such as age, gender, American Society of Anesthesiology (ASA) classification score, the type of surgical procedure, and anesthetic technique were obtained from hospital information management system and anesthetic charts. Inclusion criterias were children between the ages of 8-18 years who underwent appendectomy, had ASA I physical score, and those who agree to participate for this research. Children who aged under 8 and over 18 years, had ASA II and those with higher physical score, had previously undergone surgery from the right lower abdomen, had preoperative pain complaint over 6 month, had psychiatric disorders, and whose parents do not agree to participate were excluded in this study. By calling parents, at the 6th month after the surgical procedure, the presence of chronic pain and discomfort were asked via face to face or talking on the phone. The primary endpoint of this study is to investigate the prevalence of chronic pain and discomfort at the 6th month after appendectomy in pediatric patients. The secondary endpoint is to determine the effects of chronic pain on the children's quality of life.

Pain was defined as the presence of intermittent or continuous hurtfully sensation. Discomfort was defined as an abnormal bad feeling. Children were asked whether they felt pain or discomfort while resting, coughing, and exercise. Pain was assessed using verbal numeric rating scale. Their effects on life were assessed Pediatric Quality of Life Inventory parent and child versions questionnaire at sixth months after surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Children between the ages of 8-18 years who underwent appendectomy,
  • who had ASA I physical score
  • who agree to participate for this research

排除标准

  • Children who aged under 8 and over 18 years,
  • who had ASA II and those with higher physical score,
  • who had previously undergone surgery from the right lower abdomen,
  • who had preoperative pain complaint over 6 month,
  • who had psychiatric disorders,
  • who do not agree to participate

结局指标

主要结局

Prevalence of chronic pain

时间窗: at the 6th month after appendectomy in pediatric patients

The primary endpoint of this study is to investigate the prevalence of chronic pain and discomfort. Chronic pain is going to be assessed using numeric rating scale (NRS). The NRS for pain is a unidimensional measure of pain intensity in adults and children. The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "nopain") and 10 representing the other pain extreme (e.g.,"pain as bad as you can imagine" and "worst pain imag-inable"). 0 point represents "no pain", 1-3 "mild pain", 4-6 "moderate pain", 7-10 "severe pain".

次要结局

  • the effects of chronic pain on quality of life(at the 6th month after appendectomy in pediatric patients)

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Onur Palabiyik

Assistant Professor, Medical Doctor

Sakarya University

研究点 (1)

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