Relationship and Sexual Satisfaction of Stoma Patients | NCT05344781

Studies
Relationship and Sexual Satisfaction of Stoma Patients

NCT05344781

Sponsor

Klinikum Konstanz

Status

Unknown status

Last Update Posted

Apr 25, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Satisfaction, Patient
Stoma Ileostomy
Stoma Colostomy

Interventions

Questionnaire

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2022Estimated

Primary Completion Date

Sep 1, 2022Estimated

Completion Date

Oct 1, 2022Estimated

First Submitted Date

Dec 7, 2021

First Submission Date that Met QC Criteria

Apr 18, 2022

First Posted Date

Apr 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2022

Last Update Posted Date

Apr 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ileostomy		Patients with ileostomy	Other: Questionnaire
colostomy		Patients with colostomy	Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Questionnaire regarding relationship and sexual satisfaction	colostomy ileostomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
satisfaction influences	Questionnaire with multiple choice answers to possible influences of satisfaction	September 2022

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ileostomy or Colostomy

Exclusion Criteria:

Disease affecting sexual functioning
Disease affecting daily life

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with ileostomy or colostomy, regardless of reason

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Silvan Haemmerli, MD	Contact	+41796410567		silvan.haemmerli@glkn.de
Joerg Glatzle, Prof.	Contact	+497531 801 1101		joerg.glatze@glkn.de

Overall Officials

Name	Affiliation	Role
Silvan Haemmerli	Klinikum Konstanz	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 18, 2022	Apr 18, 2022	Prot_000.pdf
ICF	No	No	Yes	Informed Consent Form	Apr 18, 2022	Apr 18, 2022	ICF_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D017060	Patient Satisfaction
D009948	Orgasm

Ancestor Terms

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior
D012725	Sexual Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided