NCT05787093

Brief Summary

Constipation is a frequently encountered problem in childhood, with a prevalence ranging between 1 and 30%. Several studies have proposed pelvic ultrasound, (simple, non-invasive and reproducible) both to define the presence of megarectum, and to follow the answer to treatment, but the real utility remains to be defined, especially in the follow-up.The primary aim of the study is to evaluate whether, in the conventional treatment of functional constipation of the child, the variations of the rectal diameter, measured through the use of the pelvic ultrasound, are a good marker of disease severity and efficacy of the treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 3, 2023

Last Update Submit

March 15, 2023

Conditions

Pediatric Functional Constipation

Outcome Measures

Primary Outcomes (3)

  • primary outcome

    Evaluate whether, in the conventional treatment of functional constipation of the child, the variations of the rectal diameter, measured through the use of the pelvic ultrasound, are a good marker of disease severity and efficacy of the treatment.

    day one

  • primary outcome

    Evaluate whether, in the conventional treatment of functional constipation of the child, the variations of the rectal diameter, measured through the use of the pelvic ultrasound, are a good marker of disease severity and efficacy of the treatment.

    month 2

  • primary outcome

    Evaluate whether, in the conventional treatment of functional constipation of the child, the variations of the rectal diameter, measured through the use of the pelvic ultrasound, are a good marker of disease severity and efficacy of the treatment.

    month 4

Secondary Outcomes (1)

  • Secondary outcome

    day one

Study Arms (2)

pediatric patients accessing for constipation with rectal diameter >3 cm

Device: transabdominal rectal ultrasound

pediatric patients accessing for constipation with rectal diameter <3 cm

Device: transabdominal rectal ultrasound

Interventions

transabdominal rectal ultrasoundDEVICE

transabdominal rectal ultrasound to detect megarectum and evaluate the improvements after medical therapy with macrogol

pediatric patients accessing for constipation with rectal diameter <3 cmpediatric patients accessing for constipation with rectal diameter >3 cm

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients aged 4 years and older with chronic functional constipation

You may qualify if:

  • pediatric patients (between 4 and 18 years of age) accessing the services outpatient or pediatric first aid for constipation (according to Rome IV criteria)
  • rectal diameter superior to 3 cm on the transabdominal echo
  • presence of informed consent to participation in the study by minors and children parents/legal guardians

You may not qualify if:

  • age under 4 years;
  • previous anorectal surgery;
  • suspicion of anamnestic and/or clinical examination of an organic cause of constipation.rectal diameter \&lt; 3 cm on the transabdominal echo
  • absence of informed consent to participation in the study by minors and parents/guardians legal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico universitario agostino gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Central Study Contacts

Valentina giorgio

CONTACT

0630155940valentina.giorgio@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 28, 2023

Study Start

September 1, 2022

Primary Completion

March 1, 2023

Study Completion

September 1, 2024

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

IT(1)