NCT04068415

Brief Summary

Develop a risk assessment scale for constipation of hospitalized patients to identify at an early stage high-risk individuals and to implement the appropriate means of prevention.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
516

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

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

May 6, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2014

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

August 22, 2019

Last Update Submit

August 26, 2019

Conditions

Constipation

Keywords

Hospitalized patients

Outcome Measures

Primary Outcomes (1)

  • Constipation yes/no

    Less than a saddle in the first 4 days and prescription of laxatives

    On the 4th day of hospitalization

Interventions

Constipation risk assessment scaleOTHER

questionnaires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in services where constipation is a major concern : orthopedic surgery (Bordeaux), plastic surgery (Bordeaux), medical cardiology (Bordeaux) and internal medicine (Limoges).

You may qualify if:

  • Male or female 18 years or older
  • Swallowing, drinking and eating
  • Hospitalized in one of the participating services
  • Hospitalized for a period of at least 4 days
  • Able to give informed consent and answer questions about his or her lifestyle

You may not qualify if:

  • Patient with major constipation at baseline (no stool for at least 6 days)
  • History of intestinal surgery during the 10 days preceding the study,
  • Hospitalized in palliative care or bed identified palliative care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Valérie BERGER, Mrs

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

May 6, 2012

Primary Completion

April 16, 2014

Study Completion

April 16, 2014

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share