NCT05344781

Brief Summary

Anonymous questionnaire regarding relationship and sexual satisfaction as well as quality of life of stoma patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 7, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

April 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

December 7, 2021

Last Update Submit

April 18, 2022

Conditions

Satisfaction, PatientStoma IleostomyStoma Colostomy

Keywords

Sexual satisfactionstoma patientsrelationship satisfaction

Outcome Measures

Primary Outcomes (2)

  • sexual satisfaction

    Questionnaire regarding sexual satisfaction of participants, multiple choice answers.

    September 2022

  • relationship satisfaction

    Questionnaire regarding relationship satisfaction of participants, multiple choice answers.

    September 2022

Secondary Outcomes (1)

  • satisfaction influences

    September 2022

Study Arms (2)

ileostomy

Patients with ileostomy

Other: Questionnaire

colostomy

Patients with colostomy

Other: Questionnaire

Interventions

QuestionnaireOTHER

Questionnaire regarding relationship and sexual satisfaction

colostomyileostomy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ileostomy or colostomy, regardless of reason

You may qualify if:

  • Ileostomy or Colostomy

You may not qualify if:

  • Disease affecting sexual functioning
  • Disease affecting daily life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient SatisfactionOrgasm

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorSexual Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Silvan Haemmerli

    Klinikum Konstanz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvan Haemmerli, MD

CONTACT

+41796410567silvan.haemmerli@glkn.de

Joerg Glatzle, Prof.

CONTACT

+497531 801 1101joerg.glatze@glkn.de

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

December 7, 2021

First Posted

April 25, 2022

Study Start

April 20, 2022

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share