Satisfaction, PatientNCT05344781
Relationship and Sexual Satisfaction of Stoma Patients
An observational study of Satisfaction, Patient and Stoma Ileostomy, run by Klinikum Konstanz.
Trial summary
Anonymous questionnaire regarding relationship and sexual satisfaction as well as quality of life of stoma patients. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Patient, Stoma Ileostomy, Stoma Colostomy
- What is being tested?
- Questionnaire
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2022to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ileostomy or colostomy, regardless of reason
Who may be able to join
- Ileostomy or Colostomy
Who cannot join
- Disease affecting sexual functioning
- Disease affecting daily life
Trial locations and contacts
No sites are listed yet.
About this study
Anonymous questionnaire regarding relationship and sexual satisfaction as well as quality of life of stoma patients.
Read the detailed description
With an anonymous questionnaire relationship, sexual and life satisfaction of stoma patients are investigated. The questionnaire will be made public by support groups and stoma nurses. Analysis of data and publication of sexual and relationship satisfaction of stoma patients.
- Conditions
- Satisfaction, Patient, Stoma Ileostomy, Stoma Colostomy
- Being tested
- Questionnaire
- Keywords
- Sexual satisfaction, stoma patients, relationship satisfaction
- Medical subject headings
- Patient Satisfaction, Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire regarding relationship and sexual satisfaction
| Study group | Role | What they receive |
|---|---|---|
| ileostomy | Patients with ileostomy Receives: Other: Questionnaire | |
| colostomy | Patients with colostomy Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexual satisfaction
Questionnaire regarding sexual satisfaction of participants, multiple choice answers.
Measured: September 2022
relationship satisfaction
Questionnaire regarding relationship satisfaction of participants, multiple choice answers.
Measured: September 2022
Secondary outcomes (1)
satisfaction influences
Questionnaire with multiple choice answers to possible influences of satisfaction
Measured: September 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start20 Apr 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Konstanz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvan Haemmerli, Klinikum Konstanz
- Investigators
- Silvan Haemmerli, Principal investigator, Klinikum Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344781
- Sponsor's protocol ID
- konstanz_001
- Status last verified
- Apr 2022
- First submitted
- 7 Dec 2021
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship and Sexual Satisfaction of Stoma Patients
- ClinicalTrials.gov ID
- NCT05344781
- Acronym / sponsor ID
- konstanz_001
- Conditions
- Satisfaction, Patient, Stoma Ileostomy, Stoma Colostomy
- Keywords
- Sexual satisfaction, stoma patients, relationship satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Klinikum KonstanzUniversity, hospital or other
- Study start
- 20 Apr 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anonymous questionnaire regarding relationship and sexual satisfaction as well as quality of life of stoma patients.
Detailed description
With an anonymous questionnaire relationship, sexual and life satisfaction of stoma patients are investigated. The questionnaire will be made public by support groups and stoma nurses. Analysis of data and publication of sexual and relationship satisfaction of stoma patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ileostomy | – | Other: QuestionnairePatients with ileostomy |
| colostomy | – | Other: QuestionnairePatients with colostomy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ileostomy or colostomy, regardless of reason
Key inclusion criteria (1 listed)
- Ileostomy or Colostomy
Key exclusion criteria (2 listed)
- Disease affecting sexual functioning
- Disease affecting daily life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire regarding relationship and sexual satisfaction | Other | colostomy, ileostomy |
Primary outcome
sexual satisfaction
Time frame: September 2022
Questionnaire regarding sexual satisfaction of participants, multiple choice answers.
relationship satisfaction
Time frame: September 2022
Questionnaire regarding relationship satisfaction of participants, multiple choice answers.
1 secondary outcome
satisfaction influences
Time frame: September 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvan Haemmerli principal investigator
Klinikum Konstanz
Questions about this trial
What is this clinical trial studying?
An observational study of Satisfaction, Patient and Stoma Ileostomy, run by Klinikum Konstanz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvan Haemmerli, MD (+41796410567, silvan.haemmerli@glkn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sexual satisfaction (time frame: September 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.