Hirschsprung DiseaseEarly Phase 1NCT01985646
A Trial on Conservative Treatment for Infants' Hirschsprung Disease
A Early Phase 1 study testing surgery treatment, anal dilation and colonic lavage in people with Hirschsprung Disease, run by Tongji Hospital.
Trial summary
The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in infants with short or normal-segment Hirschsprung disease. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Hirschsprung Disease
- What is being tested?
- surgery treatment, anal dilation and colonic lavage
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Nov 2011
- Phase
- Early Phase 1
- 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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hard or firm stools for twice or less per week
- Age were from newborn to 3 months
- Histochemical acetylcholinesterase reaction (AChE) in rectal mucosa was positive
- The narrowed distal bowel on barium enema was characterized as normal or short-segment Hirschsprung disease with a 24h barium retention
Who cannot join
- Children >3months of age
- Patients presented severe inflammation or malnutrition, unconsciousness, and symptoms of a ruptured hollow viscus
- Barium enema showed long-segment or total colonic aganglionic bowel
About this study
Official title: A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Normal and Short-segment Hirschsprung Disease for Infants
The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in infants with short or normal-segment Hirschsprung disease.
- Conditions
- Hirschsprung Disease
- Being tested
- surgery treatment, anal dilation, colonic lavage, oral probiotic
- Keywords
- Hirschsprung disease, conservative treatment, surgery treatment, infants
- Medical subject headings
- Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery treatmentProcedure or surgery
one staged pull-through left-colectomy
anal dilationBehavioural
anal dilation
colonic lavageBehavioural
colonic lavage
oral probioticDrug
oral probiotic
| Study group | Role | What they receive |
|---|---|---|
| surgery treatment | Experimental | one stage pull through left-colectomy Receives: Procedure: surgery treatment |
| conservative treatment | Experimental | anal dilation, colonic lavage, oral probiotic Receives: Behavioral: anal dilation; Behavioral: colonic lavage; Drug: oral probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of defecation frequence
the changes of defecation frequence at 6~12 months after treatment
Measured: 6~12 months
Secondary outcomes (3)
stool pattern
stool pattern as Forming soft stool or Loose stool
Measured: 6~12 months
controlling defecation ability
whether patients' controlling of defecation be better or not after treatment
Measured: 6~12 months
complications
complications were suffered by patients or not, such as enterolitis, anastomotic stenosis etc.
Measured: 6~12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startOct 2009
- Primary completionNov 2011
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 Tongji HospitalThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiexiong Feng, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985646
- Sponsor's protocol ID
- 001
- Other IDs
- 20090302
- Status last verified
- Nov 2013
- First submitted
- 31 Oct 2013
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Normal and Short-segment Hirschsprung Disease for Infants
- ClinicalTrials.gov ID
- NCT01985646
- Acronym / sponsor ID
- 001
- Conditions
- Hirschsprung Disease
- Keywords
- Hirschsprung disease, conservative treatment, surgery treatment, infants
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2011 (actual)
- First posted
- 15 Nov 2013 (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.
The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in infants with short or normal-segment Hirschsprung disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery treatment | Experimental | Procedure: surgery treatmentone stage pull through left-colectomy |
| conservative treatment | Experimental | Behavioral: anal dilation, Behavioral: colonic lavage, Drug: oral probioticanal dilation, colonic lavage, oral probiotic |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Hard or firm stools for twice or less per week
- Age were from newborn to 3 months
- Histochemical acetylcholinesterase reaction (AChE) in rectal mucosa was positive
- The narrowed distal bowel on barium enema was characterized as normal or short-segment Hirschsprung disease with a 24h barium retention
Key exclusion criteria (3 listed)
- Children >3months of age
- Patients presented severe inflammation or malnutrition, unconsciousness, and symptoms of a ruptured hollow viscus
- Barium enema showed long-segment or total colonic aganglionic bowel
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 |
|---|---|---|
| surgery treatmentone staged pull-through left-colectomy | Procedure or surgery | surgery treatment |
| anal dilationanal dilation | Behavioural | conservative treatment |
| colonic lavagecolonic lavage | Behavioural | conservative treatment |
| oral probioticoral probiotic | Drug | conservative treatment |
Primary outcome
the change of defecation frequence
Time frame: 6~12 months
the changes of defecation frequence at 6~12 months after treatment
3 secondary outcomes
stool pattern
Time frame: 6~12 months
controlling defecation ability
Time frame: 6~12 months
complications
Time frame: 6~12 months
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 15 Nov 2013.
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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?
A Early Phase 1 study testing surgery treatment, anal dilation and colonic lavage in people with Hirschsprung Disease, run by Tongji Hospital.
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 4 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: finished, as of the sponsor's last update on 15 Nov 2013. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the change of defecation frequence (time frame: 6~12 months). 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 15 Nov 2013.