- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07629362
Quality of Life and Pain After Appendectomy in Children (CAPA-Peds)
Chronic Postoperative Pain After Appendectomy: A Prospective Observational Study
연구 개요
상태
상세 설명
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).
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ahmet Ergun, MD
- 전화번호: +90-262-225-2700
- 이메일: aergunndrum@gmail.com
연구 장소
-
-
İzmit
-
Kocaeli, İzmit, 터키 (Türkiye), 41000
- Kocaeli City Hospital
-
연락하다:
- Ahmet Ergun, MD
- 전화번호: +90 262-225-2700
- 이메일: aergunndrum@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Chronic Pain After Appendectomy
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of Life at the Third Postoperative Month
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Ahmet Ergun, MD, Kocaeli City Hospital
간행물 및 유용한 링크
일반 간행물
- Rosenbloom BN, Frederiksen SD, Wang V, Birnie KA, Park CS, Gordon G, Rasic N, Stinson JN, Rabbitts JA. Prevalence of and recommendation for measuring chronic postsurgical pain in children: an updated systematic review and meta-analysis. Reg Anesth Pain Med. 2025 Feb 5;50(2):132-143. doi: 10.1136/rapm-2024-105697.
- Palabiyik O, Demir G. Chronic Pain after Open Appendectomy and Its Effects on Quality of Life in Children Aged 8-18 Years. Pain Res Manag. 2021 Feb 22;2021:6643714. doi: 10.1155/2021/6643714. eCollection 2021.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
삶의 질에 대한 임상 시험
-
Queens College, The City University of New York모병
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)완전한
-
Swansea University완전한A Bite of ACT' (BOA) 수용전념치료 온라인 심리교육 과정 | 대기자 명단 제어영국
-
Hôpital Léon Bérard완전한
-
Centre Hospitalier Universitaire Dijon완전한
-
Yale-NUS College완전한연구 초점은 SGH Life Center에서 관리하는 비만 관리 설문지에 대한 환자의 반응입니다.싱가포르
-
Scripps Translational Science Institute완전한
-
National Taiwan University Hospital모병수술 부위 감염 | 상처 감염 | 지연된 상처 치유 | ExtraCorporeal Life Support (ECLS) | 바이오필름 관련 감염대만
-
Novartis Pharmaceuticals완전한신경내분비종양 | GI 오리진의 고급 NET | 고급 NET of Lung Origin미국, 콜롬비아, 이탈리아, 대만, 영국, 벨기에, 체코, 독일, 일본, 사우디 아라비아, 캐나다, 네덜란드, 스페인, 대한민국, 레바논, 오스트리아, 중국, 그리스, 남아프리카, 태국, 헝가리, 칠면조, 폴란드, 슬로바키아, 러시아 연방
-
Yale-NUS College완전한