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.
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.
- Conditions
- Appendicitis, Diagnoses Disease, Pediatric ALL
- 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.
Appendicitis
Diagnosis of appendicitis as confirmed at operation
Measured: within 1 week
Appendicitis
Diagnosis of appendicitis by pathology report if available.
Measured: within 1week
Non-Appendicitis
Diagnosis of non-appendicitis by observation only
Measured: Within one (1) week
Pressure-pain algometry
Single measurements taken before final management decision
Measured: Within one (1) week
Pressure-pain algometry
Serial measurements taken before final management decision
Measured: Within one (1) week
Secondary outcomes (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.
- First posted30 Dec 2020
- Study start1 Jan 2000
- Primary completion15 Jun 2006
- Study completion15 Jun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ray Postuma, University of Manitoba
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pressure Algometry in the Clinical Assessment of Acute Abdominal Pain in Children
- ClinicalTrials.gov ID
- NCT04688463
- Acronym / sponsor ID
- H2003:104
- Conditions
- Appendicitis, Diagnoses Disease, Pediatric ALL
- Keywords
- Appendicitis, Children, Diagnosis, Pressure-Pain Algometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 15 Jun 2006 (actual)
- Study completion
- 15 Jun 2006 (actual)
- First posted
- 30 Dec 2020 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Age groups
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- children with abdominal pain > 7 days
- children with abdominal pain due to other surgical or medical conditions
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
Appendicitis
Time frame: within 1 week
Diagnosis of appendicitis as confirmed at operation
Appendicitis
Time frame: within 1week
Diagnosis of appendicitis by pathology report if available.
Non-Appendicitis
Time frame: Within one (1) week
Diagnosis of non-appendicitis by observation only
Pressure-pain algometry
Time frame: Within one (1) week
Single measurements taken before final management decision
Pressure-pain algometry
Time frame: Within one (1) week
Serial measurements taken before final management decision
1 secondary outcome
Complications following appendectomy
Time frame: For one (1) month following operation or observation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.