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

4 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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).

Type d'étude

Observationnel

Inscription (Estimé)

231

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Chronic Pain After Appendectomy
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Quality of Life at the Third Postoperative Month
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Directeur d'études: Ahmet Ergun, MD, Kocaeli City Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

25 février 2027

Dates d'inscription aux études

Première soumission

12 mai 2026

Première soumission répondant aux critères de contrôle qualité

4 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

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Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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