Hirschsprung DiseasePhase 4NCT07186647
Laparoscopic-Assisted Transanal Pull-Through for Hirschsprung Disease in Pediatric:Short and Intermediate Outcomes of Two Different Techniques
A Phase 4 study testing laparoscopic-assisted Swenson-like (LASwL) and laparoscopic-assisted Soave (LASo) in people with Hirschsprung Disease, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Compare the functional and surgical outcomes of laparoscopic-assisted Swenson-like (LASwL) and laparoscopic-assisted Soave (LASo) pull through in children with HD. Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Hirschsprung Disease
- What is being tested?
- laparoscopic-assisted Swenson-like (LASwL) and laparoscopic-assisted Soave (LASo)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 Aug 2024
- Phase
- Phase 4
- 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 month to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants and children diagnosed with Hirschsprung's disease (HD) at the Department of Pediatric Surgery, Al-Azhar University Hospitals, from September 2020 to August 2024
Who cannot join
- Patients with ultrashort or total colonic aganglionosis and those who had previously undergone pull-through procedures
Trial locations and contacts
1 site in 1 country.
About this study
Compare the functional and surgical outcomes of laparoscopic-assisted Swenson-like (LASwL) and laparoscopic-assisted Soave (LASo) pull through in children with HD.
Read the detailed description
A prospective, randomized study was conducted involving 80 patients diagnosed with HD at Al-Azhar University Hospitals over a 48-month period from September 2020 to August 2024. Participants were randomly allocated to the LASwL (Group A) or LASo (Group B). The primary outcome was the postoperative bowel function score. Secondary outcomes included operative time, blood loss, duration of hospital stay, and incidence of postoperative Hirschsprung-associated enterocolitis (HAEC).
- Conditions
- Hirschsprung Disease
- Being tested
- laparoscopic-assisted Swenson-like (LASwL), laparoscopic-assisted Soave (LASo)
- Keywords
- Hirschsprung Disease, Laparoscopy, Swenson, Soave, Pediatrics
- 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 Swenson-like (LASwL)Procedure or surgery
Following port placement, laparoscopic exploration was performed to evaluate the spastic colonic segment and transitional zone. An aperture was created in the sigmoid mesentery, and the sigmoid colon was mobilized. The proximal ganglionic bowel was mobilized while preserving the marginal arcades. The peritoneal reflection was sharply incised to facilitate dissection and mobilization of the aganglionic rectum. The procedure diverged between the two groups at this juncture: LASwl group: The rectum below the peritoneal reflection was dissected circumferentially up to a level 2 cm above the anal verge . LASo group: The rectum below the peritoneal reflection was minimally mobilized (within 1 cm of the peritoneal reflection). Following laparoscopic dissection, the ports were left in situ, and the position was adjusted for transanal dissection of the remaining rectum.
laparoscopic-assisted Soave (LASo)Procedure or surgery
Transanal endorectal procedure was conducted according to the standard technique described by De la Torre-Mondragon and Ortega-Salgado [12]. A circular incision was made in the mucosa, and mucosectomy was performed. The muscle sleeve was cut, connecting the two dissection planes circularly . After keeping the muscular cuff as short as possible, a longitudinal incision was made posteriorly. Then, the bowel was extracted, and the anastomosis was performed as described above.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 20 patients with HD Receives: Procedure: laparoscopic-assisted Swenson-like (LASwL) |
| Group B | Active comparator | 20 patients with HD Receives: Procedure: laparoscopic-assisted Soave (LASo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative bowel function score
This assessment evaluated the ability to hold back defecation, the ability to feel or report the urge to defecate, the frequency of defecation, soiling accidents, constipation, and social issues. Most items are scored on a 0-3 scale, while defecation frequency is scored 1-2, resulting in a maximum total score of 20. A higher score indicates better bowel function, with Scores ranged from 17-20 (excellent), 12-16 (good), 9-11 (fair), and less than 8 (poor)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Sep 2020
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
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 Al-Azhar 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelmaboud, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186647
- Sponsor's protocol ID
- Ped. -Surg.-77MED.-Research-00
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic-Assisted Transanal Pull-Through for Hirschsprung Disease in Pediatric:Short and Intermediate Outcomes of Two Different Techniques
- ClinicalTrials.gov ID
- NCT07186647
- Acronym / sponsor ID
- Ped. -Surg.-77MED.-Research-00
- Conditions
- Hirschsprung Disease
- Keywords
- Hirschsprung Disease, Laparoscopy, Swenson, Soave, Pediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 22 Sep 2025 (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.
Compare the functional and surgical outcomes of laparoscopic-assisted Swenson-like (LASwL) and laparoscopic-assisted Soave (LASo) pull through in children with HD.
Detailed description
A prospective, randomized study was conducted involving 80 patients diagnosed with HD at Al-Azhar University Hospitals over a 48-month period from September 2020 to August 2024. Participants were randomly allocated to the LASwL (Group A) or LASo (Group B). The primary outcome was the postoperative bowel function score. Secondary outcomes included operative time, blood loss, duration of hospital stay, and incidence of postoperative Hirschsprung-associated enterocolitis (HAEC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A prospective, randomized study
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: laparoscopic-assisted Swenson-like (LASwL)20 patients with HD |
| Group B | Active comparator | Procedure: laparoscopic-assisted Soave (LASo)20 patients with HD |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants and children diagnosed with Hirschsprung's disease (HD) at the Department of Pediatric Surgery, Al-Azhar University Hospitals, from September 2020 to August 2024
Key exclusion criteria (1 listed)
- Patients with ultrashort or total colonic aganglionosis and those who had previously undergone pull-through procedures
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 Swenson-like (LASwL)Following port placement, laparoscopic exploration was performed to evaluate the spastic colonic segment and transitional zone. An aperture was created in the sigmoid mesentery, and the sigmoid colon was mobilized. The proximal ganglionic bowel was mobilized while preserving the marginal arcades. The peritoneal reflection was sharply incised to facilitate dissection and mobilization of the aganglionic rectum. The procedure diverged between the two groups at this juncture: LASwl group: The rectum below the peritoneal reflection was dissected circumferentially up to a level 2 cm above the anal verge . LASo group: The rectum below the peritoneal reflection was minimally mobilized (within 1 cm of the peritoneal reflection). Following laparoscopic dissection, the ports were left in situ, and the position was adjusted for transanal dissection of the remaining rectum. | Procedure or surgery | Group A |
| laparoscopic-assisted Soave (LASo)Transanal endorectal procedure was conducted according to the standard technique described by De la Torre-Mondragon and Ortega-Salgado [12]. A circular incision was made in the mucosa, and mucosectomy was performed. The muscle sleeve was cut, connecting the two dissection planes circularly . After keeping the muscular cuff as short as possible, a longitudinal incision was made posteriorly. Then, the bowel was extracted, and the anastomosis was performed as described above. | Procedure or surgery | Group B |
Primary outcome
postoperative bowel function score
Time frame: 2 years
This assessment evaluated the ability to hold back defecation, the ability to feel or report the urge to defecate, the frequency of defecation, soiling accidents, constipation, and social issues. Most items are scored on a 0-3 scale, while defecation frequency is scored 1-2, resulting in a maximum total score of 20. A higher score indicates better bowel function, with Scores ranged from 17-20 (excellent), 12-16 (good), 9-11 (fair), and less than 8 (poor)
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 29 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing laparoscopic-assisted Swenson-like (LASwL) and laparoscopic-assisted Soave (LASo) in people with Hirschsprung Disease, run by Al-Azhar University 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 29 Sep 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
postoperative bowel function score (time frame: 2 years). 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 Sep 2025.