Hirschsprungs DiseaseNCT02342457
Electrophysiological Activity of the Anorectum in Children Suspected of Hirschsprung Disease
A study testing Child suspected of Hirschsprung disease in people with Hirschsprungs Disease, run by Rabin Medical Center.
Trial summary
Children with chronic constipation, suspected of having hirschsprungs disease, who are admitted for rectal biopsy will be included in the study. During the procedure, electrophysiological reading from the site chosen for biopsy will be done. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Hirschsprungs Disease
- What is being tested?
- Child suspected of Hirschsprung disease
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2017
- Phase
- Interventional
- 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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient admitted for rectal biopsy, by clinical decision, so that Hirschsprungs disease may be diagnosed or ruled out
Who cannot join
- None
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Elactrophysiological Response of the Colon, in Normal Bowel, and Large Bowel Lacking Ganglia in Children With Suspected Hirschsprungs Disease.
Children with chronic constipation, suspected of having hirschsprungs disease, who are admitted for rectal biopsy will be included in the study. During the procedure, electrophysiological reading from the site chosen for biopsy will be done. Correlation between electrophysiological data and histopathology will be analyzed.
Read the detailed description
Hirschsprungs disease is found in 1:5000 newborns, the disease is caused by aganglionosis of the colon, leading to severe constipation and possible bowel obstruction. The diagnosis is based on leveling biopsies taken from the rectum and colon. Treatment is supportive if complications had arisen, and surgical for definitive correction of the pathophysiological condition which is the cause of the disease. Currently, clinicians rely on histopathology, for diagnosing the disease, and planning surgical correction. The main goal of Surgical treatment will be the creation of a continuous patent and innervated bowel, in which effective propulsive peristalsis is taking place. This is achieved by resection of aganglionic colon, and anastomosis of normal colon with normal ganglia, to anus. Today surgeons await histopathology report for the diagnosis of Hirschsprungs disease, and frozen section biopsies taken when in surgery to ascertain the level of ganglionated bowel.
In this study the investigators aim to correlate electrophysiological reading, from colon suspected of Hirschsprungs disease. If correlation is found, or a specific pattern which is diagnostic of the disease may be found, the electrophysiological study may offer a new way of diagnosing the disease, which is not invasive and allows prompt diagnosis in contrast to histopathology which is time consuming. A reliable electrophysiological study for Hirschsprungs disease may be helpful in early and correct diagnosis, with a noninvasive procedure as compared to a biopsy of the colonic wall. Children with chronic constipation, suspected of having hirschsprungs disease, who are admitted for rectal biopsy will be included in the study. During the procedure, electrophysiological reading from the site chosen for biopsy will be done. Correlation between electrophysiological data and histopathology will be analyzed. The actual reading will be carried out by a custom made electrode by GAELTEC DEVICES LTD : DUNVEGAN : ISLE OF SKYE : SCOTLAND.
- Conditions
- Hirschsprungs Disease
- Being tested
- Child suspected of Hirschsprung disease
- Medical subject headings
- Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child suspected of Hirschsprung diseaseDevice
Also called Electrophysiological study of the rectum in children
Children admitted for rectal biopsy, due to chronic constipation and suspected of Hirschsprungs disease, will undergo electrophysiological reading from the rectal inner wall, at thechosen site for biopsy before biopsy is performed. Histopathology and readings will be analyzed for corelation
| Study group | Role | What they receive |
|---|---|---|
| Child suspected of Hirschsprung disease | Experimental | Children admitted for biopsy, so that Hirschsprungs desease may be ruled out or diagnosed, whom are planned for rectal biopsy, by clinical decision. Receives: Device: Child suspected of Hirschsprung disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristic electrophysiologic curve for aganglionated bowel
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hirschsprungs DiseaseStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naftali Freud, Rabin Medical Center
- Investigators
- Enrique Freud, MD, Principal investigator, Schneider medical center of Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342457
- Sponsor's protocol ID
- 0274-13-RMC
- Status last verified
- Jan 2015
- First submitted
- 3 Dec 2014
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Marin AM, Rivarola A, Garcia H. Electromyography of the rectum and colon in Hirschsprung's disease. J Pediatr Surg. 1976 Aug;11(4):547-552. doi: 10.1016/s0022-3468(76)80010-3.
PubMed 787484
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Elactrophysiological Response of the Colon, in Normal Bowel, and Large Bowel Lacking Ganglia in Children With Suspected Hirschsprungs Disease.
- ClinicalTrials.gov ID
- NCT02342457
- Acronym / sponsor ID
- 0274-13-RMC
- Conditions
- Hirschsprungs Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Jan 2015 (estimated)
- 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.
Children with chronic constipation, suspected of having hirschsprungs disease, who are admitted for rectal biopsy will be included in the study. During the procedure, electrophysiological reading from the site chosen for biopsy will be done. Correlation between electrophysiological data and histopathology will be analyzed.
Detailed description
Hirschsprungs disease is found in 1:5000 newborns, the disease is caused by aganglionosis of the colon, leading to severe constipation and possible bowel obstruction. The diagnosis is based on leveling biopsies taken from the rectum and colon. Treatment is supportive if complications had arisen, and surgical for definitive correction of the pathophysiological condition which is the cause of the disease. Currently, clinicians rely on histopathology, for diagnosing the disease, and planning surgical correction. The main goal of Surgical treatment will be the creation of a continuous patent and innervated bowel, in which effective propulsive peristalsis is taking place. This is achieved by resection of aganglionic colon, and anastomosis of normal colon with normal ganglia, to anus. Today surgeons await histopathology report for the diagnosis of Hirschsprungs disease, and frozen section biopsies taken when in surgery to ascertain the level of ganglionated bowel.
In this study the investigators aim to correlate electrophysiological reading, from colon suspected of Hirschsprungs disease. If correlation is found, or a specific pattern which is diagnostic of the disease may be found, the electrophysiological study may offer a new way of diagnosing the disease, which is not invasive and allows prompt diagnosis in contrast to histopathology which is time consuming. A reliable electrophysiological study for Hirschsprungs disease may be helpful in early and correct diagnosis, with a noninvasive procedure as compared to a biopsy of the colonic wall. Children with chronic constipation, suspected of having hirschsprungs disease, who are admitted for rectal biopsy will be included in the study. During the procedure, electrophysiological reading from the site chosen for biopsy will be done. Correlation between electrophysiological data and histopathology will be analyzed. The actual reading will be carried out by a custom made electrode by GAELTEC DEVICES LTD : DUNVEGAN : ISLE OF SKYE : SCOTLAND.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Child suspected of Hirschsprung disease | Experimental | Device: Child suspected of Hirschsprung diseaseChildren admitted for biopsy, so that Hirschsprungs desease may be ruled out or diagnosed, whom are planned for rectal biopsy, by clinical decision. |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patient admitted for rectal biopsy, by clinical decision, so that Hirschsprungs disease may be diagnosed or ruled out
Key exclusion criteria (2 listed)
- None
- -
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 |
|---|---|---|
| Child suspected of Hirschsprung diseaseAlso: Electrophysiological study of the rectum in childrenChildren admitted for rectal biopsy, due to chronic constipation and suspected of Hirschsprungs disease, will undergo electrophysiological reading from the rectal inner wall, at thechosen site for biopsy before biopsy is performed. Histopathology and readings will be analyzed for corelation | Device | Child suspected of Hirschsprung disease |
Primary outcome
Characteristic electrophysiologic curve for aganglionated bowel
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
- Background: PubMed 787484Marin AM, Rivarola A, Garcia H. Electromyography of the rectum and colon in Hirschsprung's disease. J Pediatr Surg. 1976 Aug;11(4):547-552. doi: 10.1016/s0022-3468(76)80010-3.
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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.
Enrique Freud, MD principal investigator
Schneider medical center of Israel
Questions about this trial
What is this clinical trial studying?
A study testing Child suspected of Hirschsprung disease in people with Hirschsprungs Disease, run by Rabin Medical Center.
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: status not confirmed, as of the sponsor's last update on 21 Jan 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrique Freud, MD (+972-3-9253737, freuden@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristic electrophysiologic curve for aganglionated bowel (time frame: 2 years). 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 NCT02342457, which also lists 1 linked publication.
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 21 Jan 2015.