Hirschsprung DiseaseNCT07156981
Effects of Physiotherapy in Children With Hirschsprung's Disease
A study testing Physiotherapy in people with Hirschsprung Disease, run by Ankara Yildirim Beyazıt University.
Trial summary
The aim of our study is to investigate the effects of physiotherapy in children with Hirschsprung's disease who have bowel symptoms after surgery. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Hirschsprung Disease
- What is being tested?
- Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 30 Jan 2026
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 5-18 who have undergone surgery for Hirschsprung's disease and have intestinal symptoms, and who come for routine check-ups.
- Volunteering to participate in the study
Who cannot join
- Presence of a congenital and/or chronic disease
- Those with missing assessment parameters
- Having a history of any additional orthopedic, neurological or psychiatric disease that will affect the evaluation parameters
- Loss of sensation
- Mental retardation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of Effects of Physiotherapy in Children With Hirschsprung's Disease
The aim of our study is to investigate the effects of physiotherapy in children with Hirschsprung's disease who have bowel symptoms after surgery.
Read the detailed description
Hirschsprung's disease is a developmental disorder of the enteric nervous system characterized by the absence of ganglion cells in the distal intestine, resulting in functional intestinal obstruction. The treatment applied after diagnosis is surgical. Although individuals with a history of surgery due to Hirschsprung's disease generally have normal bowel and urinary function, it has been reported that they have a higher prevalence of fecal incontinence and constipation and a lower quality of life related to the gastrointestinal system. However, there are few studies evaluating the use of physiotherapy in the management of postoperative bowel symptoms in children with Hirschsprung's disease.
- Conditions
- Hirschsprung Disease
- Being tested
- Physiotherapy
- Medical subject headings
- Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyBehavioural
The treatment program will include patient education, lifestyle recommendations, breathing exercises, pelvic floor muscle training, and stabilization exercises. The treatment program will last for a total of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Other | Physiotherapy program will be performed Receives: Behavioral: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel function
Bowel function will be evaluated with a bowel diary. They will be asked to keep a bowel diary for 1 week, including the number and type of daily stools and the number of incontinent stools.
Measured: before and after treatment (8-week change)
Secondary outcomes (5)
Constipation
Children's constipation will be evaluated with the Rome IV criteria. These criteria include; two or less defecation per week, fecal incontinence at least once a week, history of holding/ delaying the large toilet, painful and difficult bowel movements, presence of large feces in the rectum, presence of a history of large feces that can block the toilet. An increase in the number of symptoms indicates the severity of constipation.
Measured: before and after treatment (8-week change)
Pelvic floor muscle function
Pelvic floor muscle function will be evaluated with palpation form anus. The presence of correct contraction and relaxation of the pelvic floor muscle will be determined.
Measured: before and after treatment (8-week change)
Life quality
Life quality will be assessed with the Pediatric Quality of Life Inventory (PedsQL). The PedsQL consists of 23 items. It are scored between 0-100. The higher the total score of the life quality, the better health-related life quality is perceived.
Measured: before and after treatment (8-week change)
Perception of improvement
Subjective perception of improvement will be assessed as -1 (worse), 0 (no change) and 1 (better).
Measured: after treatment (8-week change)
Compliance with recommendations
Compliance with post-treatment recommendations will be assessed with the Visual Analog Scale (VAS). The VAS is a horizontal line with "0" at one end as "never compliance" and '10' at the other end as "always compliance".
Measured: after treatment (8-week change)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hirschsprung DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156981
- Sponsor's protocol ID
- TABED1/1561/2025
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effects of Physiotherapy in Children With Hirschsprung's Disease
- ClinicalTrials.gov ID
- NCT07156981
- Acronym / sponsor ID
- TABED1/1561/2025
- Conditions
- Hirschsprung Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 5 Sep 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.
The aim of our study is to investigate the effects of physiotherapy in children with Hirschsprung's disease who have bowel symptoms after surgery.
Detailed description
Hirschsprung's disease is a developmental disorder of the enteric nervous system characterized by the absence of ganglion cells in the distal intestine, resulting in functional intestinal obstruction. The treatment applied after diagnosis is surgical. Although individuals with a history of surgery due to Hirschsprung's disease generally have normal bowel and urinary function, it has been reported that they have a higher prevalence of fecal incontinence and constipation and a lower quality of life related to the gastrointestinal system. However, there are few studies evaluating the use of physiotherapy in the management of postoperative bowel symptoms in children with Hirschsprung's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Other | Behavioral: PhysiotherapyPhysiotherapy program will be performed |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children aged 5-18 who have undergone surgery for Hirschsprung's disease and have intestinal symptoms, and who come for routine check-ups.
- Volunteering to participate in the study
Key exclusion criteria (5 listed)
- Presence of a congenital and/or chronic disease
- Those with missing assessment parameters
- Having a history of any additional orthopedic, neurological or psychiatric disease that will affect the evaluation parameters
- Loss of sensation
- Mental retardation
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 |
|---|---|---|
| PhysiotherapyThe treatment program will include patient education, lifestyle recommendations, breathing exercises, pelvic floor muscle training, and stabilization exercises. The treatment program will last for a total of 8 weeks. | Behavioural | Physiotherapy |
Primary outcome
Bowel function
Time frame: before and after treatment (8-week change)
Bowel function will be evaluated with a bowel diary. They will be asked to keep a bowel diary for 1 week, including the number and type of daily stools and the number of incontinent stools.
5 secondary outcomes
Constipation
Time frame: before and after treatment (8-week change)
Pelvic floor muscle function
Time frame: before and after treatment (8-week change)
Life quality
Time frame: before and after treatment (8-week change)
Perception of improvement
Time frame: after treatment (8-week change)
Compliance with recommendations
Time frame: after treatment (8-week change)
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 5 Sep 2025.
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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.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Hirschsprung Disease, run by Ankara Yildirim Beyazıt University.
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 2 inclusion and 5 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 5 Sep 2025. 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?
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 Seyda Toprak Celenay (+90 312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel function (time frame: before and after treatment (8-week change)). 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 5 Sep 2025.