Functional Constipation in ChildrenPhase 4NCT07180680
Preliminary Results of Laparoscopic Assisted Transanal Proximal Rectosigmoidectomy Combined With Malone Antegrade Continence Enema for the Management of Intractable Functional Constipation in Children
A Phase 4 study testing laparoscopic assisted transanal proximal rectosigmoidectomy in people with Functional Constipation in Children, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Technique for surgical management of intractable functional constipation Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Functional Constipation in Children
- What is being tested?
- laparoscopic assisted transanal proximal rectosigmoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jan 2025
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged four years or older with intractable functional constipation
- Documented BMP failure, defined as persistent fecal impaction, chronic dependence on laxatives, or intolerance to enemas despite prolonged conservative therapy.
Who cannot join
- Patients with a history of abdominal surgery or
- Identifiable organic causes for constipation and soiling (e.g., Hirschsprung's disease, anorectal malformations, or metabolic disorders) .
Trial locations and contacts
1 site in 1 country.
About this study
Technique for surgical management of intractable functional constipation
Read the detailed description
Background: Intractable functional constipation (IFC) in children poses a significant clinical challenge when standard medical interventions are unsuccessful. The laparoscopic-assisted transanal proximal rectosigmoidectomy (LATPRS) procedure is a surgical option that combines the precision of laparoscopic techniques with the functional benefits of transanal dissection.
Patients and methods: A prospective trial was conducted at Al-Azhar pediatric surgery departments from January 2022 to January 2025, with a focus on children diagnosed with IFC. Each participant underwent LATPRS combined with a Malone Antegrade continence enema (MACE). The comprehensive data collection process included patient demographics, surgical details, postoperative recovery, complications, and functional outcomes. These data were recorded and subsequently analysed. Furthermore, a validated symptom severity (SS) scoring system and the Pediatric Quality of Life Inventory (PedsQoL) were employed to assess outcomes.
- Conditions
- Functional Constipation in Children
- Being tested
- laparoscopic assisted transanal proximal rectosigmoidectomy
- Keywords
- Intractable functional constipation, laparoscopic rectosigmoidectomy, pediatric, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic assisted transanal proximal rectosigmoidectomyProcedure or surgery
using laparoscopy for such procedure in children is unique for this study
| Study group | Role | What they receive |
|---|---|---|
| children diagnosed with IFC | Active comparator | . Each participant underwent LATPRS combined with a Malone Antegrade continence enema (MACE) Receives: Procedure: laparoscopic assisted transanal proximal rectosigmoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
soiling
Number of soiling episodes in pre-operative and post-operative period. Soiling refers to the inadvertent passage of fecal material into inappropriate places, such as underwear or other clothing.
Measured: 3 years
Secondary outcomes (2)
symptoms severity score
The total symptoms severity score ranged from 0, indicating the best outcome, to 65, indicating the worst outcome. These scores comprised individual assessments in the following areas: soiling problems (range = 0--10); delay in defecation (range = 0--10); difficulty and pain associated with stool passage (range = 0--5); intensity of laxative treatment (range = 0--10); child's general health (range = 0--5); behavior related to bowel problems (range = 0--5); overall improvement of symptoms (range = 0--12); and amount of stool detected during abdominal examination (range = 0--8). A score range of 0-21 is classified as mild and considered "well." In contrast, a score range of 22-43 is categorized as moderate, indicating noticeable bowel dysfunction that requires ongoing management. A score ranging from 44-65 is classified as severe, with significant debilitating symptoms indicative of intractable cases
Measured: 3 years
The Pediatric Quality of Life Inventory (The PedsQoL™ questionnaires)
The tool initially created by James W. Varni and colleagues [16], which has received prior validation from the World Health Organization, was employed to evaluate QoL. This is a practical and validated modular tool for assessing health-related quality of life (HRQOL) in children aged 4-18 years (10). The scale evaluates the fundamental aspects of physical, emotional, social, and school functioning in children. The PedsQoL total score ranges from 0 to 92. A score between 0 and 30 is regarded as having a mild impact, indicating good quality of life. In contrast, a score between 31 and 61 suggests a moderate impact with some limitations in physical, emotional, or social functioning. A score from 62 to 92 is considered to have a severe impact, reflecting a significant compromise in quality of life, with notable distress or disability
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Jan 2022
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation in ChildrenStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- Investigators
- Mohamed Abdelmaboud, assistant professor, Principal investigator, Faculty of medicine- Al-Azhar University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180680
- Sponsor's protocol ID
- PedSurg-38Med.Research.0000038
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Preliminary Results of Laparoscopic Assisted Transanal Proximal Rectosigmoidectomy Combined With Malone Antegrade Continence Enema for the Management of Intractable Functional Constipation in Children
- ClinicalTrials.gov ID
- NCT07180680
- Acronym / sponsor ID
- PedSurg-38Med.Research.0000038
- Conditions
- Functional Constipation in Children
- Keywords
- Intractable functional constipation, laparoscopic rectosigmoidectomy, pediatric, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 18 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.
Technique for surgical management of intractable functional constipation
Detailed description
Background: Intractable functional constipation (IFC) in children poses a significant clinical challenge when standard medical interventions are unsuccessful. The laparoscopic-assisted transanal proximal rectosigmoidectomy (LATPRS) procedure is a surgical option that combines the precision of laparoscopic techniques with the functional benefits of transanal dissection.
Patients and methods: A prospective trial was conducted at Al-Azhar pediatric surgery departments from January 2022 to January 2025, with a focus on children diagnosed with IFC. Each participant underwent LATPRS combined with a Malone Antegrade continence enema (MACE). The comprehensive data collection process included patient demographics, surgical details, postoperative recovery, complications, and functional outcomes. These data were recorded and subsequently analysed. Furthermore, a validated symptom severity (SS) scoring system and the Pediatric Quality of Life Inventory (PedsQoL) were employed to assess outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children diagnosed with IFC | Active comparator | Procedure: laparoscopic assisted transanal proximal rectosigmoidectomy. Each participant underwent LATPRS combined with a Malone Antegrade continence enema (MACE) |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children aged four years or older with intractable functional constipation
- Documented BMP failure, defined as persistent fecal impaction, chronic dependence on laxatives, or intolerance to enemas despite prolonged conservative therapy.
Key exclusion criteria (2 listed)
- Patients with a history of abdominal surgery or
- Identifiable organic causes for constipation and soiling (e.g., Hirschsprung's disease, anorectal malformations, or metabolic disorders) .
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 transanal proximal rectosigmoidectomyusing laparoscopy for such procedure in children is unique for this study | Procedure or surgery | children diagnosed with IFC |
Primary outcome
soiling
Time frame: 3 years
Number of soiling episodes in pre-operative and post-operative period. Soiling refers to the inadvertent passage of fecal material into inappropriate places, such as underwear or other clothing.
2 secondary outcomes
symptoms severity score
Time frame: 3 years
The Pediatric Quality of Life Inventory (The PedsQoL™ questionnaires)
Time frame: 3 years
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.
Mohamed Abdelmaboud, assistant professor principal investigator
Faculty of medicine- Al-Azhar University Hospitals
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 transanal proximal rectosigmoidectomy in people with Functional Constipation in Children, 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 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: 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?
soiling (time frame: 3 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.