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Quality of Life and Pain After Appendectomy in Children (CAPA-Peds)

2026年6月4日 更新者:Kocaeli City Hospital

Chronic Postoperative Pain After Appendectomy: A Prospective Observational Study

Acute appendicitis is one of the most common emergency general surgical conditions worldwide and represents the leading cause of emergency abdominal surgery in children. In some cases, appendectomy may result in persistent or recurrent pain in the right iliac fossa, which may negatively affect quality of life, particularly in children. The primary aim of this study is to determine the prevalence of chronic pain at the third postoperative month in pediatric patients who underwent appendectomy. The age, sex, body mass index, and comorbidities of patients aged 8-18 years who underwent appendectomy will be recorded. Pain in children who met the inclusion criteria was assessed using the Numeric Rating Scale (NRS). To evaluate the effects of pain on quality of life, the child and parent versions of the Pediatric Quality of Life Inventory (PedsQL) were administered at the third postoperative month. In addition, the Functional Disability Inventory (FDI) was used at the third postoperative month to assess the impact of pain on the patient's functional status.

研究概览

详细说明

Acute appendicitis is one of the most common surgical emergencies in childhood, with appendectomy being the standard and most frequently performed emergency surgical treatment. Although appendectomy is generally considered a safe and routine surgical procedure, various postoperative complications such as surgical site infection, intra-abdominal adhesions, abscess formation, and nerve injury may occur. In addition to these well-known complications, some patients may experience persistent or recurrent pain following surgery. Chronic postsurgical pain (CPSP) is defined as pain that develops or increases in intensity after a surgical procedure and persists beyond the healing process (for longer than 3 months), localized to the surgical site or radiating to the related area. CPSP in children is associated with adverse psychological outcomes such as depressive mood and anxiety, restricted functionality including avoidance of daily activities and decreased school attendance, and poorer health outcomes (1).

After approval from the Local Ethics Committee was obtained, records of children aged 8-18 years who underwent appendectomy, including age, sex, ASA score, and type of surgical procedure, were obtained by reviewing the hospital information system and anesthetic records. The inclusion criteria were defined as children aged 8-18 years, patients classified as ASA I-II, and children who agreed to participate in the study. Patients with an ASA score of 3 or higher, a history of another operation in the right lower quadrant of the abdomen, chronic abdominal pain in the preoperative period, or psychiatric disorders were excluded from the study. At the third postoperative month, patients will be contacted by telephone to assess chronic pain, quality of life, and functional status. The primary endpoint of this study is to determine the prevalence of chronic pain at the third postoperative month in pediatric patients who underwent appendectomy. The secondary endpoints are to investigate the effects of surgical technique and patient characteristics on chronic pain, as well as the impact of chronic pain on quality of life and functional status in pediatric patients.

Pain is defined as "an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage," and is described as a personal experience influenced to varying degrees by biological, psychological, and social factors. Children were asked whether they experienced pain at rest or during exercise. Pain was evaluated using the Verbal Numeric Rating Scale (VNRS). The effects on quality of life at the third postoperative month were assessed using the Pediatric Quality of Life Inventory (PedsQL) parent and child forms, while the impact on functionality was evaluated using the Functional Disability Inventory (FDI).

研究类型

观察性的

注册 (估计的)

231

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Pediatric patients who underwent appendectomy for acute appendicitis at Kocaeli City Hospital will be recruited for this study.

描述

Inclusion Criteria:

Children between the ages of 8-18 years who underwent appendectomy, who had ASA physical status I-II

Exclusion Criteria:

Children who aged under 8 and over 18 years, who had American Society of Anesthesiologists (ASA) physical status III or higher, who had a history of previous surgery in the right lower abdominal quadrant, who had psychiatric disorders, who had preoperative chronic abdominal pain

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Chronic Pain After Appendectomy
大体时间:At the third postoperative month
The prevalence of chronic pain in pediatric patients who underwent appendectomy will be assessed at the third postoperative month using the Numeric Rating Scale NRS. NRS is a widely used measure that requires the patient to rate their pain on a scale from 0 to 10. A score of 0 indicates no pain, scores of 1-3 indicate mild pain, scores of 4-6 indicate moderate pain, and scores of 7 or higher indicate severe pain. The NRS can be used to describe pain intensity in children older than 8 years of age.
At the third postoperative month

次要结果测量

结果测量
措施说明
大体时间
Quality of Life at the Third Postoperative Month
大体时间:Patients will be evaluated at the third postoperative month for chronic pain, quality of life, and functional status. Follow-up assessments will be conducted via telephone interviews.
Quality of life at the third postoperative month will be assessed using the Pediatric Quality of Life Inventory (PedsQL) parent and child forms. PedsQL is a questionnaire used to assess health-related quality of life in children aged 2-18 years. PedsQL questions the areas of physical health, emotional functioning, and social functioning to determine the child's health status and state at school. The minimum score that can be obtained from the scale is 0, and the maximum score is 100. Children with higher total PedsQL scores have better health-related quality of life.
Patients will be evaluated at the third postoperative month for chronic pain, quality of life, and functional status. Follow-up assessments will be conducted via telephone interviews.
Functional Disability After Appendectomy
大体时间:at the third postoperative month

The Functional Disability Inventory (FDI) is a widely used measure for assessing physical functioning and disability in children with chronic pain. The FDI consists of 15 items evaluating difficulty in performing daily activities and has been validated in children with abdominal pain. Total scores ranging from 0 to 60 are computed by summing the ratings for each of the 15 items on the FDI. Higher scores indicate greater perceived functional disability. The range of FDI total scores for each level of disability were:

No/minimal: 0 - 12 Moderate: 13 - 29 High: >30

at the third postoperative month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Ahmet Ergun, MD、Kocaeli City Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年2月25日

研究注册日期

首次提交

2026年5月12日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年6月5日

上次提交的符合 QC 标准的更新

2026年6月4日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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