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Completed

NCT Number: NCT07180680

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

Technique for surgical management of intractable functional constipation

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Key information

Conditions

Functional Constipation in Children

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

pediatric surgery departments- Al-Azhar University Hospitals

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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) .

Treatment and study plan

laparoscopic assisted transanal proximal rectosigmoidectomy

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. symptoms severity score

    Time frame: 3 years

    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

  2. The Pediatric Quality of Life Inventory (The PedsQoL™ questionnaires)

    Time frame: 3 years

    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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 18, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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