NCT00677508

Brief Summary

We propose to develop parent and child disease-specific instruments to assess health related quality of life (HRQoL) in children with constipation and fecal incontinence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

5.9 years

First QC Date

May 9, 2008

Last Update Submit

April 29, 2020

Conditions

ConstipationFecal Incontinence

Keywords

ConstipationFecal incontinenceQuality of lifeHealth related quality of life

Outcome Measures

Primary Outcomes (1)

  • To develop and validate child and parent questionnaires to assess HRQoL of children with chronic constipation and fecal incontinence.

    2 years

Study Arms (3)

C FR

Children with constipation and fecal incontinence.

C

Children with constipation but without fecal incontinence.

P-C FR

Parents of children with constipation and/or fecal incontinence.

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children will be recruited from the Constipation Clinic at Children's Hospital of Wisconsin, as well as four coolaborating sites.

You may qualify if:

  • Age 2-18 years
  • Child and parents fluent in English
  • Child must meet one of the following criteria;
  • A. Constipation and fecal incontinence: must include 2 or more of the following in a child with insufficient criteria for a diagnosis of IBS (criteria fulfilled at least once per week for at least 2 months before diagnosis in a child over 4 years of age and for at least one month in a child less than 4 years of age):
  • Two or fewer defecations in the toilet per week
  • At least 1 episode of fecal incontinence per week
  • History of retentive posturing or excessive volitional stool retention
  • History of painful or hard bowel movements
  • Presence of a large fecal mass in the rectum
  • History of large diameter stools that may obstruct the toilet
  • B. Constipation predominant IBS: must include the following, once a week for at least 2 months:
  • Abdominal pain/discomfort, associated with 2 of the following:
  • improved with defecation
  • onset associated with 2 or less stools per week
  • onset associated with hard or lump stool
  • +5 more criteria

You may not qualify if:

  • Children with developmental delays and children over 12 years of age who are unable to understand the questionnaires.
  • Associated chronic disease which may have an impact on quality of life such as cerebral palsy, spine deformity or malformations, learning difficulties, severe mental illness, celiac disease, etc.
  • Child and parents not fluent in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

  • Treurniet HF, Essink-Bot ML, Mackenbach JP, van der Maas PJ. Health-related quality of life: an indicator of quality of care? Qual Life Res. 1997 May;6(4):363-9. doi: 10.1023/a:1018435427116.

    PMID: 9248318BACKGROUND

  • Brooks RC, Copen RM, Cox DJ, Morris J, Borowitz S, Sutphen J. Review of the treatment literature for encopresis, functional constipation, and stool-toileting refusal. Ann Behav Med. 2000 Summer;22(3):260-7. doi: 10.1007/BF02895121.

    PMID: 11211851BACKGROUND

  • Youssef NN, Langseder AL, Verga BJ, Mones RL, Rosh JR. Chronic childhood constipation is associated with impaired quality of life: a case-controlled study. J Pediatr Gastroenterol Nutr. 2005 Jul;41(1):56-60. doi: 10.1097/01.mpg.0000167500.34236.6a.

    PMID: 15990631BACKGROUND

MeSH Terms

Conditions

ConstipationFecal Incontinence

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Manu Sood, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Associate Professor

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 14, 2008

Study Start

September 1, 2005

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 30, 2020

Record last verified: 2020-04

Locations

US(1)