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NCT Number: NCT07156981

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.

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Key information

Conditions

Hirschsprung Disease Colonic Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Megacolon

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Physiotherapy

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Constipation

    Time frame: before and after treatment (8-week change)

    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.

  2. Pelvic floor muscle function

    Time frame: before and after treatment (8-week change)

    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.

  3. Life quality

    Time frame: before and after treatment (8-week change)

    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.

  4. Perception of improvement

    Time frame: after treatment (8-week change)

    Subjective perception of improvement will be assessed as -1 (worse), 0 (no change) and 1 (better).

  5. Compliance with recommendations

    Time frame: after treatment (8-week change)

    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".

Study contacts

Contact information is provided by the study sponsor or research team.

Seyda Toprak Celenay

CONTACT

[email protected]

+90 312 906 1000

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

Investigation of Effects of Physiotherapy in Children With Hirschsprung's Disease

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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