Hirschsprung DiseaseNCT03269812
Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease
A study testing laparoscopic assisted pull-through oeration in people with Hirschsprung Disease, run by Assiut University.
Trial summary
To evaluate the outcomes of laparoscopic pull-through concerning constipation, incontinence and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung disease. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Hirschsprung Disease
- What is being tested?
- laparoscopic assisted pull-through oeration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 1 Oct 2019
- 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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 6months to 3 years.
- Both sexes.
- Classic and long segment Hirshsprung.
- Total a ganglionic colon.
- Hirshsprung disease with leveling colostomy
Who cannot join
- Patients <6 months and >3 years.
- Short and Ultra-short Hirshsprung.
- Recurrent cases of Hirshsprung.
- Other contraindication of laparoscopy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease.
To evaluate the outcomes of laparoscopic pull-through concerning constipation, incontinence and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung disease.
Read the detailed description
Hirschsprung,s disease (HD) is a relatively common cause of intestinal obstruction in the newborn[1,2], The main goal in the treatment of patients with Hirschsprung,s disease is to resect the aganglionic segment and pull down the Normo-ganglionic bowel[3]. With the introduction of minimally invasive surgery, classic pull-through techniques were modified and improved with laparoscopy, because of the obvious advantages of laparoscopic-assisted pull-through operations in form of reduced pain and improved cosmoses this approach has gained much popularity[4,5].
- Conditions
- Hirschsprung Disease
- Being tested
- laparoscopic assisted pull-through oeration
- Medical subject headings
- Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic assisted pull-through oerationProcedure or surgery
Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done,
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic operated group | Experimental | Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done, Receives: Procedure: laparoscopic assisted pull-through oeration |
| non laparoscopic operated group | Experimental | Under general anesthesia ,abdominal exploration ,removal of a ganglionic part by soav ,duhamel procedures and trans-anal pull through procedures. Receives: Procedure: laparoscopic assisted pull-through oeration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation
persistace of inablilty to pass stool even after operation and treatment,it is physiological parameter and assisted by asking the mothers of patients about the bowel habits.
Measured: from one to three months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hirschsprung DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hamada Takrouney, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269812
- Sponsor's protocol ID
- laparoscopy in Hirschsprung
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tomuschat C, Zimmer J, Puri P. Laparoscopic-assisted pull-through operation for Hirschsprung's disease: a systematic review and meta-analysis. Pediatr Surg Int. 2016 Aug;32(8):751-7. doi: 10.1007/s00383-016-3910-5. Epub 2016 Jul 1.
PubMed 27369964Taguchi T, Obata S, Ieiri S. Current status of Hirschsprung's disease: based on a nationwide survey of Japan. Pediatr Surg Int. 2017 Apr;33(4):497-504. doi: 10.1007/s00383-016-4054-3. Epub 2017 Jan 5.
PubMed 28058486
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease.
- ClinicalTrials.gov ID
- NCT03269812
- Acronym / sponsor ID
- laparoscopy in Hirschsprung
- Conditions
- Hirschsprung Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 1 Sep 2017 (actual)
- 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 outcomes of laparoscopic pull-through concerning constipation, incontinence and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung disease.
Detailed description
Hirschsprung,s disease (HD) is a relatively common cause of intestinal obstruction in the newborn[1,2], The main goal in the treatment of patients with Hirschsprung,s disease is to resect the aganglionic segment and pull down the Normo-ganglionic bowel[3]. With the introduction of minimally invasive surgery, classic pull-through techniques were modified and improved with laparoscopy, because of the obvious advantages of laparoscopic-assisted pull-through operations in form of reduced pain and improved cosmoses this approach has gained much popularity[4,5].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic operated group | Experimental | Procedure: laparoscopic assisted pull-through oerationUnder general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done, |
| non laparoscopic operated group | Experimental | Procedure: laparoscopic assisted pull-through oerationUnder general anesthesia ,abdominal exploration ,removal of a ganglionic part by soav ,duhamel procedures and trans-anal pull through procedures. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age from 6months to 3 years.
- Both sexes.
- Classic and long segment Hirshsprung.
- Total a ganglionic colon.
- Hirshsprung disease with leveling colostomy
Key exclusion criteria (4 listed)
- Patients <6 months and >3 years.
- Short and Ultra-short Hirshsprung.
- Recurrent cases of Hirshsprung.
- Other contraindication of laparoscopy
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 |
|---|---|---|
| laparoscopic assisted pull-through oerationUnder general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done, | Procedure or surgery | laparoscopic operated group, non laparoscopic operated group |
Primary outcome
Constipation
Time frame: from one to three months after operation
persistace of inablilty to pass stool even after operation and treatment,it is physiological parameter and assisted by asking the mothers of patients about the bowel habits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Background: PubMed 27369964Tomuschat C, Zimmer J, Puri P. Laparoscopic-assisted pull-through operation for Hirschsprung's disease: a systematic review and meta-analysis. Pediatr Surg Int. 2016 Aug;32(8):751-7. doi: 10.1007/s00383-016-3910-5. Epub 2016 Jul 1.
- Background: PubMed 28058486Taguchi T, Obata S, Ieiri S. Current status of Hirschsprung's disease: based on a nationwide survey of Japan. Pediatr Surg Int. 2017 Apr;33(4):497-504. doi: 10.1007/s00383-016-4054-3. Epub 2017 Jan 5.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic assisted pull-through oeration in people with Hirschsprung Disease, run by Assiut University.
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 5 inclusion and 4 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 1 Sep 2017. 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 Mohammed Hamada Takrouney (+201009321033, m.takrouney1988@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation (time frame: from one to three months after operation). 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 NCT03269812, which also lists 2 linked publications.
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 1 Sep 2017.