SurgeryFast-trackNCT02350088
Fast-track Surgery in the Treatment of Hirschsprung's Disease
A study testing probiotics in people with Surgery, run by Tongji Hospital at 1 site in China.
Trial summary
To evaluate the safety and efficacy of Hirschsprung's disease Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Surgery
- What is being tested?
- probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2016
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- surgical treatment for Hirschsprung's disease
- The first procedure for Hirschsprung's disease
- Age<14 years
Who cannot join
- conservative treatment for Hirschsprung's disease
- The reoperation for Hirschsprung's disease
- Age>14 years
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Zhi Li, MD PhD, 13387664883, lizhimdphd@163.com
About this study
To evaluate the safety and efficacy of Hirschsprung's disease
Read the detailed description
The patients are divided into two groups：fast-track surgery combined with laparoscope group and laparoscope with traditional managements group.Postoperative recovery,hospital stay,hospital cost and complcations were compared.
- Conditions
- Surgery
- Being tested
- probiotics, placebo
- Keywords
- fast-track surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsDrug
Also called Bifico
probiotics
placeboDrug
Also called Bifico
placebo
| Study group | Role | What they receive |
|---|---|---|
| Fast-track Surgery | Active comparator | probiotics,oral,b.i.d. Receives: Drug: probiotics |
| Traditional Group | Active comparator | placebo,oral,b.i.d. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with recovery of boewl movements
Measured: one year
Secondary outcomes (1)
Duration of the hospital stay
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Principal investigator, Jiexiong Feng, Tongji Hospital
- Investigators
- Zhi Li, MD PhD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350088
- Sponsor's protocol ID
- Tongji Fast-track surgery
- Acronym
- Fast-track
- Status last verified
- Jan 2015
- First submitted
- 17 Jan 2015
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast-track Surgery in the Treatment of Hirschsprung's Disease
- ClinicalTrials.gov ID
- NCT02350088
- Acronym / sponsor ID
- Fast-track / Tongji Fast-track surgery
- Conditions
- Surgery
- Keywords
- fast-track surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 29 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.
To evaluate the safety and efficacy of Hirschsprung's disease
Detailed description
The patients are divided into two groups：fast-track surgery combined with laparoscope group and laparoscope with traditional managements group.Postoperative recovery,hospital stay,hospital cost and complcations were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast-track Surgery | Active comparator | Drug: probioticsprobiotics,oral,b.i.d. |
| Traditional Group | Active comparator | Drug: placeboplacebo,oral,b.i.d. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- surgical treatment for Hirschsprung's disease
- The first procedure for Hirschsprung's disease
- Age<14 years
Key exclusion criteria (3 listed)
- conservative treatment for Hirschsprung's disease
- The reoperation for Hirschsprung's disease
- Age>14 years
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 |
|---|---|---|
| probioticsAlso: Bificoprobiotics | Drug | Fast-track Surgery |
| placeboAlso: Bificoplacebo | Drug | Traditional Group |
Primary outcome
number of participants with recovery of boewl movements
Time frame: one year
1 secondary outcome
Duration of the hospital stay
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
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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.
Zhi Li, MD PhD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics in people with Surgery, 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 3 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: status not confirmed, as of the sponsor's last update on 29 Jan 2015. 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 Zhi Li, MD PhD (+8613387664883, lizhimdphd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with recovery of boewl movements (time frame: one year). 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 29 Jan 2015.