Refractory ConstipationNCT07291661
The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation
A study testing High resolution anorectal manometry using a multiuse water perfused catheter in people with Refractory Constipation and Fecal Incontinence in Children, run by Assiut University at 1 site in Egypt.
Trial summary
This research protocol outlines a two-year descriptive cross-sectional study to investigate the role of high-resolution anorectal manometry (HRAM) in children aged 4-18 years with chronic refractory constipation.The study plans to enroll 54 patients at Ain Shams University Specialized Hospital . Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Refractory Constipation, Fecal Incontinence in Children
- What is being tested?
- High resolution anorectal manometry using a multiuse water perfused catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents aged from 4 to 18 years.
- Participants who have chronic refractory constipation either functional or organic with or without fecal incontinence.
- Cooperative patients.
Who cannot join
- Children aged less than 4 years old.
- Uncooperative patients.
- Children with anal fissures or any painful conditions that interfere with the procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nagla H. Ibrahim, Professor contact
About this study
Official title: The Role of Anorectal Manometry in Diagnosing and Guiding Management of Pediatric Chronic Refractory Constipation
This research protocol outlines a two-year descriptive cross-sectional study to investigate the role of high-resolution anorectal manometry (HRAM) in children aged 4-18 years with chronic refractory constipation.The study plans to enroll 54 patients at Ain Shams University Specialized Hospital . The study aims to identify different patterns of anorectal dysfunction (like dyssynergic defecation or rectal hyposensitivity) using standardized international protocols. A key goal is to determine if these manometry findings can directly guide specific management strategies, such as biofeedback therapy for dyssynergia or botulinum toxin injections for anal hypertension. improving outcomes for children who do not respond to standard constipation therapies.
Read the detailed description
Structural and functional abnormalities of the anorectum or pelvic floor have been observed in constipated children with or without fecal incontinence. Childhood functional constipation accounts for about 95% of cases, while organic causes are less than 5%.
Organic causes include Hirschsprung disease, anorectal malformations, neuromuscular disorders and metabolic causes. Functional constipation can be caused by paradoxical contraction or insufficient relaxation of the pelvic floor muscles, and/or inadequate rectal propulsive forces during defecation. According to the Rome IV criteria, functional constipation is defined separately for infants and toddlers (<4 years) and for children (≥ 4 years).
Anorectal manometry (ARM) is an objective tool used to measure pressure and sensation in the anorectum at rest, during squeezing, and during simulated evacuation. three dimensional high resolution anorectal manometry (3D-HRAM) employs an array of 256 sensors, offering a more detailed assessment of anorectal anatomy and function.
Anorectal manometry is used for the evaluation of chronic constipation by checking rectoanal coordination and rectal sensitivity, and helps exclude structural disorders. It evaluates fecal incontinence by analyzing sphincter function and rectal sensation, identifies sphincter hypertension in functional anorectal pain, and provides preoperative baseline data before surgeries affecting continence or defecation.
Treatment of childhood constipation includes both nonpharmacological approaches (education, dietary modifications, behavioral strategies, biofeedback, and pelvic floor physiotherapy) and pharmacological options (osmotic and stimulant laxatives, probiotics as well as newer medications such as prucalopride and lubiprostone). For children with persistent constipation transanal irrigation, botulinum toxin injections, neuromodulation, and surgical procedures may be considered.
- Being tested
- High resolution anorectal manometry using a multiuse water perfused catheter
- Keywords
- Anorectal manometry, Functional constipation, Pediatric chronic refractory constipation, Fecal incontinence, Biofeedback therapy, Botox injection
- Medical subject headings
- Constipation, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution anorectal manometry using a multiuse water perfused catheterDevice
According to the international anorectal physiology working group recommendations(8):
Stabilization: A 3-minute period after catheter insertion to allow anal tone to return to baseline.
- Rest: Measures basal anal tone over 60 seconds.
- Squeeze: Records anal pressure during voluntary contraction. Three 5-second squeezes are performed.
- Long Squeeze: Evaluates anal pressure and fatigue during a single sustained 30-second contraction.
- Cough: Assesses reflex anal pressure changes during two single coughs.
- Push: Measures pressure changes during simulated defecation. Three 15-second pushes are performed.
- RAIR (Rectoanal Inhibitory Reflex): Tests reflex anal relaxation after rapid rectal balloon distension, starting with at least 30 mL.
Rectal Sensory Test: Measures rectal sensitivity by recording balloon volumes at three thresholds: first constant sensation, desire to defecate, and maximum tolerated volumes.
- Balloon Expulsion: time required to expel the balloon.
| Study group | Role | What they receive |
|---|---|---|
| High resolution anorectal manometry using multiuse water perfused catheter | Other | Solar™ GI High Resolution Anorectal Manometry with multiuse water perfused catheter Receives: Device: High resolution anorectal manometry using a multiuse water perfused catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of anorectal manometry abnormalities in children with chronic refractory constipation, with or without fecal incontinence.
We will measure resting anal pressure, squeeze pressure, changes in rectoanal pressure during cough and during stimulated defecation, rectoanal inhibitory reflex (RAIR), and rectal sensation thresholds (first sensation, urge, maximum tolerable volume) using High resolusion anorectal manometry(HRAM) .
Abnormalities will be categorized as:
- Impaired or absent RAIR
- Abnormal resting or squeeze sphincter pressure (outside age-adjusted norms)
- Rectal sensory dysfunction (hyposensitivity or hypersensitivity)
- Presence of dyssynergic defecation. And will be reported as counts and percentages.
Measured: Baseline
Secondary outcomes (1)
Guiding Management of Chronic Refractory Constipation in Children Using Anorectal Manometry Findings.
Classification of anorectal manometry patterns-including dyssynergic defecation, rectal hyposensitivity, and elevated resting anal sphincter pressure-and documentation of the number of participants assigned to different management strategies including (biofeedback therapy, botulinum toxin injection) according to these findings.
Patients with manometry parameters showing dyssennergic defecation or rectal hyposensitivity will receive biofeedback sessions. While Participants with manometry parameters showing high anal canal resting pressure will have botulinium toxin injections.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Refractory ConstipationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A descriptive cross-sectional study
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mohamed Abd Elaal Ahmed, Assiut University
- Investigators
- Naglaa H. Ibrahim, Professor, Study director, Assiut University- Faculty of medicineNaglaa S. Mohamed, A. professor, Study chair, Assiut University- Faculty of medicineRehab I. Hassan, Lecturer, Study chair, Assiut University- Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291661
- Sponsor's protocol ID
- Anorectal manometry
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poojari VS, Mirani S, Shetty NS, Shah I. Evaluation of constipation in children using high-resolution anorectal manometry. Trop Doct. 2021 Oct;51(4):527-531. doi: 10.1177/00494755211030362. Epub 2021 Jul 16.
PubMed 34270377Rao SSC, Tetangco EP. Anorectal Disorders: An Update. J Clin Gastroenterol. 2020 Aug;54(7):606-613. doi: 10.1097/MCG.0000000000001348.
PubMed 32692116Carrington EV, Scott SM, Bharucha A, Mion F, Remes-Troche JM, Malcolm A, Heinrich H, Fox M, Rao SS; International Anorectal Physiology Working Group and the International Working Group for Disorders of Gastrointestinal Motility and Function. Expert consensus document: Advances in the evaluation of anorectal function. Nat Rev Gastroenterol Hepatol. 2018 May;15(5):309-323. doi: 10.1038/nrgastro.2018.27. Epub 2018 Apr 11.
PubMed 29636555Koppen IJN, Vriesman MH, Saps M, Rajindrajith S, Shi X, van Etten-Jamaludin FS, Di Lorenzo C, Benninga MA, Tabbers MM. Prevalence of Functional Defecation Disorders in Children: A Systematic Review and Meta-Analysis. J Pediatr. 2018 Jul;198:121-130.e6. doi: 10.1016/j.jpeds.2018.02.029. Epub 2018 Apr 12.
PubMed 29656863
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Anorectal Manometry in Diagnosing and Guiding Management of Pediatric Chronic Refractory Constipation
- ClinicalTrials.gov ID
- NCT07291661
- Acronym / sponsor ID
- Anorectal manometry
- Keywords
- Anorectal manometry, Functional constipation, Pediatric chronic refractory constipation, Fecal incontinence, Biofeedback therapy, Botox injection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Dec 2025 (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.
This research protocol outlines a two-year descriptive cross-sectional study to investigate the role of high-resolution anorectal manometry (HRAM) in children aged 4-18 years with chronic refractory constipation.The study plans to enroll 54 patients at Ain Shams University Specialized Hospital . The study aims to identify different patterns of anorectal dysfunction (like dyssynergic defecation or rectal hyposensitivity) using standardized international protocols. A key goal is to determine if these manometry findings can directly guide specific management strategies, such as biofeedback therapy for dyssynergia or botulinum toxin injections for anal hypertension. improving outcomes for children who do not respond to standard constipation therapies.
Detailed description
Structural and functional abnormalities of the anorectum or pelvic floor have been observed in constipated children with or without fecal incontinence. Childhood functional constipation accounts for about 95% of cases, while organic causes are less than 5%.
Organic causes include Hirschsprung disease, anorectal malformations, neuromuscular disorders and metabolic causes. Functional constipation can be caused by paradoxical contraction or insufficient relaxation of the pelvic floor muscles, and/or inadequate rectal propulsive forces during defecation. According to the Rome IV criteria, functional constipation is defined separately for infants and toddlers (<4 years) and for children (≥ 4 years).
Anorectal manometry (ARM) is an objective tool used to measure pressure and sensation in the anorectum at rest, during squeezing, and during simulated evacuation. three dimensional high resolution anorectal manometry (3D-HRAM) employs an array of 256 sensors, offering a more detailed assessment of anorectal anatomy and function.
Anorectal manometry is used for the evaluation of chronic constipation by checking rectoanal coordination and rectal sensitivity, and helps exclude structural disorders. It evaluates fecal incontinence by analyzing sphincter function and rectal sensation, identifies sphincter hypertension in functional anorectal pain, and provides preoperative baseline data before surgeries affecting continence or defecation.
Treatment of childhood constipation includes both nonpharmacological approaches (education, dietary modifications, behavioral strategies, biofeedback, and pelvic floor physiotherapy) and pharmacological options (osmotic and stimulant laxatives, probiotics as well as newer medications such as prucalopride and lubiprostone). For children with persistent constipation transanal irrigation, botulinum toxin injections, neuromodulation, and surgical procedures may be considered.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A descriptive cross-sectional study
| Arm | Type | Receives |
|---|---|---|
| High resolution anorectal manometry using multiuse water perfused catheter | Other | Device: High resolution anorectal manometry using a multiuse water perfused catheterSolar™ GI High Resolution Anorectal Manometry with multiuse water perfused catheter |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children and adolescents aged from 4 to 18 years.
- Participants who have chronic refractory constipation either functional or organic with or without fecal incontinence.
- Cooperative patients.
Key exclusion criteria (3 listed)
- Children aged less than 4 years old.
- Uncooperative patients.
- Children with anal fissures or any painful conditions that interfere with the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High resolution anorectal manometry using a multiuse water perfused catheterAccording to the international anorectal physiology working group recommendations(8): Stabilization: A 3-minute period after catheter insertion to allow anal tone to return to baseline. * Rest: Measures basal anal tone over 60 seconds. * Squeeze: Records anal pressure during voluntary contraction. Three 5-second squeezes are performed. * Long Squeeze: Evaluates anal pressure and fatigue during a single sustained 30-second contraction. * Cough: Assesses reflex anal pressure changes during two single coughs. * Push: Measures pressure changes during simulated defecation. Three 15-second pushes are performed. * RAIR (Rectoanal Inhibitory Reflex): Tests reflex anal relaxation after rapid rectal balloon distension, starting with at least 30 mL. Rectal Sensory Test: Measures rectal sensitivity by recording balloon volumes at three thresholds: first constant sensation, desire to defecate, and maximum tolerated volumes. · Balloon Expulsion: time required to expel the balloon. | Device | High resolution anorectal manometry using multiuse water perfused catheter |
Primary outcome
Identification of anorectal manometry abnormalities in children with chronic refractory constipation, with or without fecal incontinence.
Time frame: Baseline
We will measure resting anal pressure, squeeze pressure, changes in rectoanal pressure during cough and during stimulated defecation, rectoanal inhibitory reflex (RAIR), and rectal sensation thresholds (first sensation, urge, maximum tolerable volume) using High resolusion anorectal manometry(HRAM) . Abnormalities will be categorized as: * Impaired or absent RAIR * Abnormal resting or squeeze sphincter pressure (outside age-adjusted norms) * Rectal sensory dysfunction (hyposensitivity or hypersensitivity) * Presence of dyssynergic defecation. And will be reported as counts and percentages.
1 secondary outcome
Guiding Management of Chronic Refractory Constipation in Children Using Anorectal Manometry Findings.
Time frame: Baseline
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 18 Dec 2025.
- Background: PubMed 34270377Poojari VS, Mirani S, Shetty NS, Shah I. Evaluation of constipation in children using high-resolution anorectal manometry. Trop Doct. 2021 Oct;51(4):527-531. doi: 10.1177/00494755211030362. Epub 2021 Jul 16.
- Background: PubMed 32692116Rao SSC, Tetangco EP. Anorectal Disorders: An Update. J Clin Gastroenterol. 2020 Aug;54(7):606-613. doi: 10.1097/MCG.0000000000001348.
- Background: PubMed 29636555Carrington EV, Scott SM, Bharucha A, Mion F, Remes-Troche JM, Malcolm A, Heinrich H, Fox M, Rao SS; International Anorectal Physiology Working Group and the International Working Group for Disorders of Gastrointestinal Motility and Function. Expert consensus document: Advances in the evaluation of anorectal function. Nat Rev Gastroenterol Hepatol. 2018 May;15(5):309-323. doi: 10.1038/nrgastro.2018.27. Epub 2018 Apr 11.
- Background: PubMed 29656863Koppen IJN, Vriesman MH, Saps M, Rajindrajith S, Shi X, van Etten-Jamaludin FS, Di Lorenzo C, Benninga MA, Tabbers MM. Prevalence of Functional Defecation Disorders in Children: A Systematic Review and Meta-Analysis. J Pediatr. 2018 Jul;198:121-130.e6. doi: 10.1016/j.jpeds.2018.02.029. Epub 2018 Apr 12.
- 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.
Nagla H. Ibrahim, Professor contact
Naglaa H. Ibrahim, Professor study director
Assiut University- Faculty of medicine
Naglaa S. Mohamed, A. professor study chair
Assiut University- Faculty of medicine
Rehab I. Hassan, Lecturer study chair
Assiut University- Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High resolution anorectal manometry using a multiuse water perfused catheter in people with Refractory Constipation and Fecal Incontinence in Children, run by Assiut University at 1 site in Egypt.
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 3 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: opening soon, as of the sponsor's last update on 18 Dec 2025. 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 Egypt. 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 Yasser M. Abd Elaal, Master (+201021356722, Yasser.mohamed412@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of anorectal manometry abnormalities in children with chronic refractory constipation, with or without fecal incontinence. (time frame: Baseline). 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 NCT07291661, which also lists 4 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 18 Dec 2025.