Complications of TreatmentNCT02212054
A Trial on Treatments of Hirschsprung Allied Disease
A study testing conservative and operative in people with Complications of Treatment and Complication of Surgical Procedure, run by Tongji Hospital at 1 site in China.
Trial summary
The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Complications of Treatment, Complication of Surgical Procedure, Megacolon, Not Hirschsprung
- What is being tested?
- conservative and operative
- 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
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 1 Dec 2025
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- hard or firm stools for twice or less per week
- a predicting score of less than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96
Who cannot join
- functional constipation
- a predicting score of more than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pediatric Surgery
Wuhan, Hubei, 430000
About this study
Official title: A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Children With Hirschsprung Allied Disease
The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease
Read the detailed description
The present study was designed to compare the efficacy of conservative treatment,such as anal dilatation, colonic lavage and so on, to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease
- Conditions
- Complications of Treatment, Complication of Surgical Procedure, Megacolon, Not Hirschsprung
- Being tested
- conservative, operative
- Medical subject headings
- Megacolon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservativeBehavioural
anal dilatation; colonic lavage; oral probiotic
operativeProcedure or surgery
one stage pull through radical colectomy
| Study group | Role | What they receive |
|---|---|---|
| conservative & operative treatment | Experimental | anal dilation; colon lavage; probiotics Receives: Behavioral: conservative |
| operative treatment | Active comparator | one stage pull- through radical colectomy Receives: Procedure: operative |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of defecation frequency
the changes of defecation frequency at 6~12 months after treatment
Measured: 6~12 months
Secondary outcomes (3)
stool pattern
stool pattern as hard stool or loose stool
Measured: 6~12 months
controlling stool ability
whether patients' controlling stool ability is better or not after treatment
Measured: 6~12 months
complications
complications were suffered by patients or not
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 posted8 Aug 2014 (estimated)
- Study start1 May 2020 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of TreatmentStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Jiexiong, Tongji Hospital
- Investigators
- Qi T Zhu, PhD, Principal investigator, department of pediatric surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212054
- Sponsor's protocol ID
- 101
- Status last verified
- Mar 2020
- First submitted
- 6 Aug 2014
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. 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 Children With Hirschsprung Allied Disease
- ClinicalTrials.gov ID
- NCT02212054
- Acronym / sponsor ID
- 101
- Conditions
- Complications of Treatment, Complication of Surgical Procedure, Megacolon, Not Hirschsprung
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Aug 2014 (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 children with Hirschsprung allied disease
Detailed description
The present study was designed to compare the efficacy of conservative treatment,such as anal dilatation, colonic lavage and so on, to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservative & operative treatment | Experimental | Behavioral: conservativeanal dilation; colon lavage; probiotics |
| operative treatment | Active comparator | Procedure: operativeone stage pull- through radical colectomy |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- hard or firm stools for twice or less per week
- a predicting score of less than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96
Key exclusion criteria (2 listed)
- functional constipation
- a predicting score of more than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96
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 |
|---|---|---|
| conservativeanal dilatation; colonic lavage; oral probiotic | Behavioural | conservative & operative treatment |
| operativeone stage pull through radical colectomy | Procedure or surgery | operative treatment |
Primary outcome
the change of defecation frequency
Time frame: 6~12 months
the changes of defecation frequency at 6~12 months after treatment
3 secondary outcomes
stool pattern
Time frame: 6~12 months
controlling stool ability
Time frame: 6~12 months
complications
Time frame: 6~12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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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.
Qi T Zhu, PhD principal investigator
department of pediatric surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conservative and operative in people with Complications of Treatment and Complication of Surgical Procedure, run by Tongji Hospital at 1 site in China.
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 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 11 Mar 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiong J Feng, MD,PhD (0086-27-83665309, 31699788@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of defecation frequency (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 11 Mar 2020.