NCT07180680

Brief Summary

Technique for surgical management of intractable functional constipation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

September 12, 2025

Last Update Submit

September 24, 2025

Conditions

Functional Constipation in Children

Keywords

Intractable functional constipationlaparoscopic rectosigmoidectomypediatricquality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (2)

  • symptoms severity score

    3 years

  • The Pediatric Quality of Life Inventory (The PedsQoL™ questionnaires)

    3 years

Study Arms (1)

children diagnosed with IFC

ACTIVE COMPARATOR

. Each participant underwent LATPRS combined with a Malone Antegrade continence enema (MACE)

Procedure: laparoscopic assisted transanal proximal rectosigmoidectomy

Interventions

laparoscopic assisted transanal proximal rectosigmoidectomyPROCEDURE

using laparoscopy for such procedure in children is unique for this study

children diagnosed with IFC

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

pediatric surgery departments- Al-Azhar University Hospitals

Cairo, Egypt

Location

Study Officials

  • Mohamed Abdelmaboud, assistant professor

    Faculty of medicine- Al-Azhar University Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of pediatric surgery

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 18, 2025

Study Start

January 1, 2022

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations

EG(1)