Preliminary Results of Laparoscopic Assisted Transanal Proximal Rectosigmoidectomy Combined With Malone Antegrade Continence Enema for the Management of Intractable Functional Constipation in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-01-01

Brief Summary

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Technique for surgical management of intractable functional constipation

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Detailed Description

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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

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Functional Constipation in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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children diagnosed with IFC

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

Group Type ACTIVE_COMPARATOR

laparoscopic assisted transanal proximal rectosigmoidectomy

Intervention Type PROCEDURE

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

Interventions

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laparoscopic assisted transanal proximal rectosigmoidectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Children aged four years or older with intractable functional constipation
2. Documented BMP failure, defined as persistent fecal impaction, chronic dependence on laxatives, or intolerance to enemas despite prolonged conservative therapy.

Exclusion Criteria

1. Patients with a history of abdominal surgery or
2. Identifiable organic causes for constipation and soiling (e.g., Hirschsprung's disease, anorectal malformations, or metabolic disorders) .

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No