- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07629362
Quality of Life and Pain After Appendectomy in Children (CAPA-Peds)
Chronic Postoperative Pain After Appendectomy: A Prospective Observational Study
Přehled studie
Postavení
Detailní popis
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).
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Ahmet Ergun, MD
- Telefonní číslo: +90-262-225-2700
- E-mail: aergunndrum@gmail.com
Studijní místa
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-
İzmit
-
Kocaeli, İzmit, Turecko (Türkiye), 41000
- Kocaeli City Hospital
-
Kontakt:
- Ahmet Ergun, MD
- Telefonní číslo: +90 262-225-2700
- E-mail: aergunndrum@gmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Chronic Pain After Appendectomy
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Quality of Life at the Third Postoperative Month
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Ahmet Ergun, MD, Kocaeli City Hospital
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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