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AppendicitisNCT03791229

Pain and Discomfort After Appendectomy in Children

An observational study of Appendicitis and Chronic Post-Procedural Pain, run by Sakarya University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Appendectomy is the most common surgical procedure. Chronic abdominal pain is an uncommon complication following appendectomy. It is observed that pediatric patients who have undergone abdominal surgical procedure complained of pain and discomfort in the postoperative period and these complaints may affect quality of… Read more about this study

Who is it for?
Ages 8 to 18 years
Conditions the study is for
Appendicitis, Chronic Post-Procedural Pain
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2018to 30 Apr 2019
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Child, Adult

Study population: Children aged 8-18 years who underwent appendectomy

Who may be able to join

  • Children between the ages of 8-18 years who underwent appendectomy,
  • who had ASA I physical score
  • who agree to participate for this research

Who cannot join

  • Children who aged under 8 and over 18 years,
  • who had ASA II and those with higher physical score,
  • who had previously undergone surgery from the right lower abdomen,
  • who had preoperative pain complaint over 6 month,
  • who had psychiatric disorders,
  • who do not agree to participate

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sakarya University School of Medicine Department of Anesthesiology

    Sakarya, Adapazari, 54100

Other trials in Turkey (Türkiye)

About this study

Official title: The Evaluation of Pain and Discomfort After Appendectomy in Children and Their Effects on Quality of Life

Appendectomy is the most common surgical procedure. Chronic abdominal pain is an uncommon complication following appendectomy. It is observed that pediatric patients who have undergone abdominal surgical procedure complained of pain and discomfort in the postoperative period and these complaints may affect quality of life. We aimed to investigate the presence of postoperative chronic abdominal pain and discomfort in children aged 8-18 years underwent appendectomy and their social and physical effects. The records of children aged 8-18 years who underwent appendectomy, such as age, gender, American Society of Anesthesiology (ASA) classification score, the type of surgical procedure, and anesthetic technique were obtained. Children had inclusions crietrias, pain was assessed using numerical rating scale and their effects on life were assessed Pediatric Quality of Life Inventory parent and child versions questionnaire at sixth months after surgery.

Read the detailed description

Acute appendicitis is a diagnosis with clinical findings, laboratory tests and radiological imaging. The main pathology of appendicitis is usually the onset of the inflammatory process in the appendix vermiformis in the right lower abdomen. If untreated, the inflammatory process may progress to the perforation of the appendix and develop peritonitis. Appendectomy is an emergency surgical procedure for treatments of patients diagnosed with acute appendicitis and is the most common surgical procedure (1). Complications of appendectomy are wound site infection, postoperative intestinal adhesions and obstruction, peritonitis, bleeding, inguinal hernia, and chronic abdominal pain.

It is observed that pediatric patients who have undergone abdominal surgical procedure complained of pain and discomfort in the postoperative period (2). It should be noted that these complaints may affect quality of life. To the best of our knowledge, since there is no study in the literature, we aimed to investigate the presence of postoperative chronic abdominal pain and discomfort in children aged 8-18 years underwent appendectomy and their social and physical effects.

After Local Ethics Committee approval had been obtained, the records of children aged 8-18 years who underwent appendectomy, such as age, gender, American Society of Anesthesiology (ASA) classification score, the type of surgical procedure, and anesthetic technique were obtained from hospital information management system and anesthetic charts. Inclusion criterias were children between the ages of 8-18 years who underwent appendectomy, had ASA I physical score, and those who agree to participate for this research. Children who aged under 8 and over 18 years, had ASA II and those with higher physical score, had previously undergone surgery from the right lower abdomen, had preoperative pain complaint over 6 month, had psychiatric disorders, and whose parents do not agree to participate were excluded in this study. By calling parents, at the 6th month after the surgical procedure, the presence of chronic pain and discomfort were asked via face to face or talking on the phone. The primary endpoint of this study is to investigate the prevalence of chronic pain and discomfort at the 6th month after appendectomy in pediatric patients. The secondary endpoint is to determine the effects of chronic pain on the children's quality of life.

Pain was defined as the presence of intermittent or continuous hurtfully sensation. Discomfort was defined as an abnormal bad feeling. Children were asked whether they felt pain or discomfort while resting, coughing, and exercise. Pain was assessed using verbal numeric rating scale. Their effects on life were assessed Pediatric Quality of Life Inventory parent and child versions questionnaire at sixth months after surgery.

Keywords
Appendectomy, Chronic abdominal pain, Discomfort, Numerical rating scale, Pediatric quality of life inventory
Medical subject headings
Appendicitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of chronic pain

    The primary endpoint of this study is to investigate the prevalence of chronic pain and discomfort. Chronic pain is going to be assessed using numeric rating scale (NRS). The NRS for pain is a unidimensional measure of pain intensity in adults and children. The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "nopain") and 10 representing the other pain extreme (e.g.,"pain as bad as you can imagine" and "worst pain imag-inable"). 0 point represents "no pain", 1-3 "mild pain", 4-6 "moderate pain", 7-10 "severe pain".

    Measured: at the 6th month after appendectomy in pediatric patients

Secondary outcomes (1)
  1. the effects of chronic pain on quality of life

    The secondary endpoint is to determine the effects of chronic pain on the children's quality of life. Pediatric Quality of Life Inventory Parent and Child Versions (PedQL-P and C) is going to apply to children which report chronic pain and discomfort for evaluating their effects on quality of life.

    Measured: at the 6th month after appendectomy in pediatric patients

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2019
  2. Study start1 May 2018
  3. Primary completion31 Mar 2019 (estimated)
  4. Study completion30 Apr 2019 (estimated)

Resources

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
120 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03791229
Sponsor's protocol ID
SAU14113
Status last verified
Jan 2019
First submitted
21 Dec 2018
Last updated
4 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Appendicitis and Chronic Post-Procedural Pain, run by Sakarya University 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Jan 2019. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of chronic pain (time frame: at the 6th month after appendectomy in pediatric patients). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Jan 2019.

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