Chronic Pain, PostoperativeCAPA-PedsNCT07629362
Quality of Life and Pain After Appendectomy in Children
An observational study of Chronic Pain, Postoperative and Quality of Life, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Postoperative, Quality of Life, Functional Ability
- How many people
- 231 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2026to 25 Apr 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patients who underwent appendectomy for acute appendicitis at Kocaeli City Hospital will be recruited for this study.
Who may be able to join
- Children between the ages of 8-18 years who underwent appendectomy, who had ASA physical status I-II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli City Hospital
Kocaeli, İzmit, 41000
Ahmet Ergun, MD, +90 262-225-2700, aergunndrum@gmail.com
About this study
Official title: 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.
Read the detailed description
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).
- Conditions
- Chronic Pain, Postoperative, Quality of Life, Functional Ability, Appendectomy, Numerical Rating Scale
- Keywords
- chronic pain, appendectomy, FDI, PedsQL
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the third postoperative month
Secondary outcomes (2)
Quality of Life at the Third Postoperative Month
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.
Measured: 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
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
Measured: at the third postoperative month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start2 Nov 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion25 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 231 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmet Ergun, MD, Study director, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629362
- Sponsor's protocol ID
- 2026-55
- Acronym
- CAPA-Peds
- Status last verified
- Nov 2026
- First submitted
- 12 May 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39909546Palabiyik 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.
PubMed 33680224
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Postoperative Pain After Appendectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07629362
- Acronym / sponsor ID
- CAPA-Peds / 2026-55
- Conditions
- Chronic Pain, Postoperative, Quality of Life, Functional Ability, Appendectomy, Numerical Rating Scale
- Keywords
- chronic pain, appendectomy, FDI, PedsQL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 2 Nov 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 25 Apr 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients who underwent appendectomy for acute appendicitis at Kocaeli City Hospital will be recruited for this study.
Key inclusion criteria (1 listed)
- Children between the ages of 8-18 years who underwent appendectomy, who had ASA physical status I-II
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic Pain After Appendectomy
Time frame: 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.
2 secondary outcomes
Quality of Life at the Third Postoperative Month
Time frame: 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
Time frame: at the third postoperative month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Results publication: PubMed 39909546Rosenbloom 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.
- Results publication: PubMed 33680224Palabiyik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmet Ergun, MD study director
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, Postoperative and Quality of Life, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Ergun, MD (+90-262-225-2700, aergunndrum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Pain After Appendectomy (time frame: At the third postoperative month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07629362, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.