AzTrials
AzTrials

AppendicitisNCT04688463

Evaluation of Pressure Algometry in the Clinical Assessment of Acute Abdominal Pain in Children

An observational study of Appendicitis and Diagnoses Disease, run by University of Manitoba.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In this retrospective observational case study, the investigators review the clinical experience with pressure-pain algometry in children with suspected appendicitis. The investigators hypothesized that algometry can discriminate children with appendicitis from children without appendicitis and aimed to determine the… Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Appendicitis, Diagnoses Disease, Pediatric ALL
How many people
427 participants
Where
No sites listed yet
Study dates
1 Jan 2000to 15 Jun 2006
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 2 to 17 years
  • All sexes
  • Child

Study population: -included participants have had acute abdominal pain ≤ 7 days, and suspected appendicitis based on standard history and physical exam; consecutive participant sampling

Who may be able to join

  • all children referred with abdominal pain from January 2000 to June 2006 to one surgeon on the pediatric general surgery service at the Health Sciences Centre (HSC)-Children's Hospital in Winnipeg.

Who cannot join

  • children with abdominal pain > 7 days
  • children with abdominal pain due to other surgical or medical conditions

About this study

In this retrospective observational case study, the investigators review the clinical experience with pressure-pain algometry in children with suspected appendicitis. The investigators hypothesized that algometry can discriminate children with appendicitis from children without appendicitis and aimed to determine the diagnostic accuracy of algometry, compared to ultrasound imaging and clinical assessment.

Read the detailed description

As a retrospective cohort study, participants include all children referred with abdominal pain from January 2000 to June 2006 to one surgeon (R.P.) on the pediatric general surgery service at the Health Sciences Centre (HSC)-Children's Hospital in Winnipeg. The HSC-Children's Hospital is the only pediatric surgery centre within a radius of 600 km. All included participants have had acute abdominal pain ≤ 7 days, and suspected appendicitis based on standard history and physical exam. Standard appendicitis treatments were used: analgesia, antibiotics, operation. The Research Ethics Board of the University of Manitoba approved the study and reporting of the findings (H2003:104).

The investigators use standard clinical, laboratory, diagnostic imaging procedures for appendicitis diagnosis. The final diagnosis is defined by:

  • pathology report indicating transmural inflammation, or
  • from the surgeon's report when pathology was unavailable, or
  • by discharge diagnosis in non-operated patients.

Appendix rupture is defined by the presence of pus and full-thickness perforation of the appendix wall or abscess formation at operation or on pathology examination. The appendix condition is classified as normal, non-perforated or perforated; all other pathologies at operation are recorded. Treatments, complications and morbidity are tabulated.

Clinical Measures

All patient demographics, clinical presentation details, and results of laboratory testing (WBC) are collated. From this, the components of the Alvarado and Samuel pediatric appendicitis scores (PAS) are calculated retrospectively for comparison purposes and not used in patient management. Time intervals are calculated from the date and time entries in the clinical record. Results of diagnostic abdominal imaging (U/S, CT, plain x-rays) are based on recorded verbal or, if available, official written reports at the time of patient management decision. Equivocal imaging results are deemed negative. The reasons why algometry was not done are tabulated and the number of patients who reached or exceeded the maximum algometer readout (≥4 kg)

Algometry Device and Procedure:

The principal investigator (PI) designed and produced in 1983 a simple, lightweight, aluminum-Teflon®, pocket-size, calibrated spring-gauge algometer, similar to a tire gauge, that was used for all measurements. The PI used this routinely in his clinical work.

Children were first familiarized with the algometer and allowed to hold and play with it. The device head was then depressed with increasing force to the child's unencumbered mid-forearm to simulate the abdominal examination and algometry procedure. Children were instructed to indicate with their preferred 'signal' (e.g. 'now', 'ow!', or squeezing the examiner's fingers) when the sensation of pressure changed to a sensation of discomfort or pain. Pressure-pain threshold (PPT) is defined as the minimum force (in kilograms) applied via the algometer to produce discomfort. Lower PPT readings imply greater tenderness. All measurements were obtained and recorded by the Principal Investigator. Algometry was a standard tool used by the PI in all clinical practice.

Single mid-forearm 'pressure-pain threshold algometry' (PPTA) measurements are used as the patient's background, 'global', non-abdominal discomfort/pain threshold. This was then followed by single PPTA measurements from the centre of each four abdominal quadrants in the following sequence: left lower quadrant, left upper quadrant, right upper quadrant and right lower quadrant. The lower quadrant centre was defined midway between the umbilicus and anterior iliac spines. The upper quadrant centre was defined midway between the umbilicus and mid-costal margins. Algometer depressing velocity (rate) mimicked normal, heuristic palpation velocity (i.e. approximately 1 kg./sec (0.241 kg/cm2/sec or 23.6 kilopascal/sec). From the 5 sites, the investigators define 7 pressure-pain threshold algometric measurements of interest (forearm, left lower quadrant, left upper quadrant, right upper quadrant and right lower quadrant, lowest reading, average reading).

Additional algometry 'mapping' is done when the most tender site apparent on qualitative palpation was outside the standard four abdominal quadrants e.g. suprapubic or flank tenderness. If the algometry measurements and qualitative assessment agreed, patients are classified as 'concordant' versus 'discordant' when no agreement. For purposes of analysis, 'discordant' patients are included with the non-mapped group. The site of these maximal abdominal wall tenderness measurements are then correlated with the location of the inflamed appendix found at operation.

The primary analysis is with baseline algometry readings or the final of serial readings. The algometry readings of non-appendicitis appendectomy patients are grouped with non-appendicitis patients.

When available and appropriate, algometry measures are repeated during the period of diagnostic observation to determine if serial PPTA 'mirrored' the patient's clinical course.

From these algometry measures the following ratios are determined:

  • Abdominal tenderness localizing ratio (ATLR), calculated as the ratio of abdominal tenderness between the least tender (highest PPT) and most tender (or RLQ) quadrants. A higher ATLR indicates a greater degree of tenderness localization within the abdomen; lower ATLR indicates more diffuse tenderness.
  • Global abdominal tenderness localizing ratio (GTLR), calculated as the ratio of the forearm and most tender (or RLQ) quadrant's (lowest PPT) reading. Higher GTLR indicates a greater degree of tenderness localized to the abdomen relative to the patient's global discomfort/pain threshold. Patients thus serve as their own tenderness control.

For analysis of correlation with clinical variables, the Pearson correlation coefficient R2, are calculated between the 7 PPTA's and age, weight (expressed as a percentile), and duration of symptoms, stratified by gender.

To assess the discriminatory power and predictive values of algometry, we randomly split the data into derivation and validation groups, stratify to gender and final diagnosis of appendicitis. Receiver operating characteristic (ROC) analysis is then performed to identify the area under the curve (AUC), sensitivity, specificity, positive and negative predictive values (PPV and NPV) of algometry. The diagnostic accuracy of algometry is compared to ultrasound assessment and clinical diagnosis, again stratified to gender. GraphPad™ is used for all the statistical analysis.

Keywords
Appendicitis, Children, Diagnosis, Pressure-Pain Algometry
Medical subject headings
Appendicitis, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Disease

What is being measured

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

  1. Appendicitis

    Diagnosis of appendicitis as confirmed at operation

    Measured: within 1 week

  2. Appendicitis

    Diagnosis of appendicitis by pathology report if available.

    Measured: within 1week

  3. Non-Appendicitis

    Diagnosis of non-appendicitis by observation only

    Measured: Within one (1) week

  4. Pressure-pain algometry

    Single measurements taken before final management decision

    Measured: Within one (1) week

  5. Pressure-pain algometry

    Serial measurements taken before final management decision

    Measured: Within one (1) week

Secondary outcomes (1)
  1. Complications following appendectomy

    Categorization of all postoperative complication including deaths

    Measured: For one (1) month following operation or observation.

Timeline

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

  1. First posted30 Dec 2020
  2. Study start1 Jan 2000
  3. Primary completion15 Jun 2006
  4. Study completion15 Jun 2006

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
Retrospective
Enrolment
427 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04688463
Sponsor's protocol ID
H2003:104
Status last verified
Dec 2020
First submitted
21 Dec 2020
Last updated
30 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Appendicitis and Diagnoses Disease, run by University of Manitoba.

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 2 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: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Appendicitis (time frame: within 1 week). The study lists 5 primary outcomes in all. 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 30 Dec 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in