Pediatric DisorderNCT06419998
Transanal Versus Laparoscopic-assisted Transanal Through in the Management of Hirschsprung's Disease
A study testing Group A: Pure transanal endorectal pull-through (TAERPT) and Group B: Laparoscopic-assistance endorectal pull-through (LAERPT) in people with Pediatric Disorder and Hirschprung's Disease, run by Egyptian Biomedical Research Network at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) in pediatric patients presented with Hirschsprung's Disease between 3 months and 18 years old. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Pediatric Disorder, Hirschprung's Disease
- What is being tested?
- Group A: Pure transanal endorectal pull-through (TAERPT) and Group B: Laparoscopic-assistance endorectal pull-through (LAERPT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Dec 2023
- 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
- Pediatric patients with age range between 3 months and 18 years old presented with Hirschsprung's Disease who were confirmed to have this condition by contrast enema and/or rectal biopsy.
Who cannot join
- Patients with previous colostomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One Stage Transanal Versus One Stage Laparoscopic-assisted Transanal Endorectal Pull-through in the Management of Hirschsprung's Disease in Pediatric Age Group; A Retrospective Study.
The goal of this clinical trial is to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) in pediatric patients presented with Hirschsprung's Disease between 3 months and 18 years old.
The main questions our study aims to answer are:
Read more
- Does post-operative continence differs between the two groups?
- Does post-operative constipation differs between the two groups?
- Does post-operative soiling differs between the two groups
- Does post-operative enterocolitis differs between the two groups?
- Do post-operative complications differ between the two groups? If there is a comparison group: Researchers will compare between pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) to see if there is a difference in post-operative continence, constipation, soiling, enterocolitis or complications.
Participants will be divided into two groups; 40 patients will be treated by TAERPT and included in Group A and 30 patients will be treated by LAERPT and included in Group B.
Read the detailed description
Introduction: One-stage treatment of endorectal pull-through for Hirschsprung's disease could be approached through a complete transanal approach or with the assistance of laparoscopy. Our study aims to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT). Material \& methods: This retrospective study included 70 pediatric patients presented with Hirschsprung's Disease to Elshatby University Hospital. 40 patients were treated by TAERPT and included in Group A and 30 patients were treated by LAERPT and included in Group B. The two groups were compared as regards the operative data as well as the post-operative outcomes including the time of passage of stools, time of tolerating oral feeding, the duration of hospital stay, and the development of any early postoperative complications. Also, the number of bowel habits, constipation, enterocolitis, abdominal distension, anastomotic stricture, and continence were assessed.
- Conditions
- Pediatric Disorder, Hirschprung's Disease
- Being tested
- Group A: Pure transanal endorectal pull-through (TAERPT), Group B: Laparoscopic-assistance endorectal pull-through (LAERPT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: Pure transanal endorectal pull-through (TAERPT)Procedure or surgery
Patients of Group A will be treated totally by pure transanal endorectal pull-through without the assistance of laparoscopy
Group B: Laparoscopic-assistance endorectal pull-through (LAERPT)Procedure or surgery
Patients of Group B will be treated transanal endorectal pull-through but with the assistance of laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Pediatric patients presented with Hirschsprung's disease treated by pure transanal endorectal pull-through (TAERPT) Receives: Procedure: Group A: Pure transanal endorectal pull-through (TAERPT) |
| Group B | Active comparator | Pediatric patients presented with Hirschsprung's disease treated by laparoscopic-assistance endorectal pull-through (LAERPT) Receives: Procedure: Group B: Laparoscopic-assistance endorectal pull-through (LAERPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative continence
The two groups will be compared according to post-operative continence whether continent or incontinent by using Abbreviated Baylor Social Continence Scale. the sore ranges from 0 to 24 with the minimum score revealing an excellent result and the highest score revealing the worst result. (Excellent = 0-5, Good = 7-12, Fair = 13-18, Poor = 19-24)
Measured: One post-operative year
Post-operative constipation
The two groups will be compared according to post-operative constipation whether present or not
Measured: One post-operative year
Post-operative soiling
The two groups will be compared according to post-operative soiling whether present or not
Measured: One post-operative year
Post-operative enterocolitis
The two groups will be compared according to post-operative enterocolitis whether present or not
Measured: One post-operative year
Post-operative complications
The two groups will be compared according to post-operative complications whether present or not
Measured: One post-operative year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Jan 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
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 Pediatric DisorderStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Ahmed Elrouby, Egyptian Biomedical Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419998
- Sponsor's protocol ID
- 0306356
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elrouby A, Shehata S, Waheeb S, Khairi A, AbdAl-Aziz D, Looka B. One stage transanal versus one stage laparoscopic-assisted transanal endorectal pull-through in managing Hirschsprung's disease in pediatric age group; a retrospective study. BMC Surg. 2025 Feb 8;25(1):59. doi: 10.1186/s12893-025-02768-1.
PubMed 39922991
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Stage Transanal Versus One Stage Laparoscopic-assisted Transanal Endorectal Pull-through in the Management of Hirschsprung's Disease in Pediatric Age Group; A Retrospective Study.
- ClinicalTrials.gov ID
- NCT06419998
- Acronym / sponsor ID
- 0306356
- Conditions
- Pediatric Disorder, Hirschprung's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 17 May 2024 (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.
The goal of this clinical trial is to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) in pediatric patients presented with Hirschsprung's Disease between 3 months and 18 years old.
The main questions our study aims to answer are:
- Does post-operative continence differs between the two groups?
- Does post-operative constipation differs between the two groups?
- Does post-operative soiling differs between the two groups
- Does post-operative enterocolitis differs between the two groups?
- Do post-operative complications differ between the two groups? If there is a comparison group: Researchers will compare between pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) to see if there is a difference in post-operative continence, constipation, soiling, enterocolitis or complications.
Participants will be divided into two groups; 40 patients will be treated by TAERPT and included in Group A and 30 patients will be treated by LAERPT and included in Group B.
Detailed description
Introduction: One-stage treatment of endorectal pull-through for Hirschsprung's disease could be approached through a complete transanal approach or with the assistance of laparoscopy. Our study aims to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT). Material \& methods: This retrospective study included 70 pediatric patients presented with Hirschsprung's Disease to Elshatby University Hospital. 40 patients were treated by TAERPT and included in Group A and 30 patients were treated by LAERPT and included in Group B. The two groups were compared as regards the operative data as well as the post-operative outcomes including the time of passage of stools, time of tolerating oral feeding, the duration of hospital stay, and the development of any early postoperative complications. Also, the number of bowel habits, constipation, enterocolitis, abdominal distension, anastomotic stricture, and continence were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Group A: Pure transanal endorectal pull-through (TAERPT)Pediatric patients presented with Hirschsprung's disease treated by pure transanal endorectal pull-through (TAERPT) |
| Group B | Active comparator | Procedure: Group B: Laparoscopic-assistance endorectal pull-through (LAERPT)Pediatric patients presented with Hirschsprung's disease treated by laparoscopic-assistance endorectal pull-through (LAERPT) |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients with age range between 3 months and 18 years old presented with Hirschsprung's Disease who were confirmed to have this condition by contrast enema and/or rectal biopsy.
Key exclusion criteria (1 listed)
- Patients with previous colostomy.
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 |
|---|---|---|
| Group A: Pure transanal endorectal pull-through (TAERPT)Patients of Group A will be treated totally by pure transanal endorectal pull-through without the assistance of laparoscopy | Procedure or surgery | Group A |
| Group B: Laparoscopic-assistance endorectal pull-through (LAERPT)Patients of Group B will be treated transanal endorectal pull-through but with the assistance of laparoscopy | Procedure or surgery | Group B |
Primary outcome
Post-operative continence
Time frame: One post-operative year
The two groups will be compared according to post-operative continence whether continent or incontinent by using Abbreviated Baylor Social Continence Scale. the sore ranges from 0 to 24 with the minimum score revealing an excellent result and the highest score revealing the worst result. (Excellent = 0-5, Good = 7-12, Fair = 13-18, Poor = 19-24)
Post-operative constipation
Time frame: One post-operative year
The two groups will be compared according to post-operative constipation whether present or not
Post-operative soiling
Time frame: One post-operative year
The two groups will be compared according to post-operative soiling whether present or not
Post-operative enterocolitis
Time frame: One post-operative year
The two groups will be compared according to post-operative enterocolitis whether present or not
Post-operative complications
Time frame: One post-operative year
The two groups will be compared according to post-operative complications whether present or not
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 21 May 2024.
- Derived from this study: PubMed 39922991Elrouby A, Shehata S, Waheeb S, Khairi A, AbdAl-Aziz D, Looka B. One stage transanal versus one stage laparoscopic-assisted transanal endorectal pull-through in managing Hirschsprung's disease in pediatric age group; a retrospective study. BMC Surg. 2025 Feb 8;25(1):59. doi: 10.1186/s12893-025-02768-1.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: Pure transanal endorectal pull-through (TAERPT) and Group B: Laparoscopic-assistance endorectal pull-through (LAERPT) in people with Pediatric Disorder and Hirschprung's Disease, run by Egyptian Biomedical Research Network at 1 site in Egypt.
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 1 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 21 May 2024. 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 Egypt. 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?
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?
Post-operative continence (time frame: One post-operative year). The study lists 5 primary outcomes in all. 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 NCT06419998, 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 May 2024.