NCT07629362

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2027

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

May 12, 2026

Last Update Submit

June 4, 2026

Conditions

Keywords

chronic painappendectomyFDIPedsQL

Outcome Measures

Primary Outcomes (1)

  • Chronic Pain After Appendectomy

    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

Secondary Outcomes (2)

  • Quality of Life at the Third Postoperative Month

    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

    at the third postoperative month

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli City Hospital

Kocaeli, İzmit, 41000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Pain, PostoperativeChronic Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ahmet Ergun, MD

    Kocaeli City Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

June 5, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 25, 2027

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations