Quality of Life After Wide Surgical Excision in Patients With Hidradenitis Suppurativa

October 11, 2017 updated by: Tobias Kisch, University Hospital Schleswig-Holstein
Patients undergoing wide surgical excision of their hidradenitis suppurativa areas are asked by telephone about their quality of life by standard questionnaires (WHOQOL-BREF, DLQI, Skindex, MHF, FLQA-d) and their sexual function (FSFI, IIEF).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • University of Schleswig-Holstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with hidradenitis suppurativa that were treated in 2013 in Fachklinik Hornheide, Germany, by wide excision of their infected skin areas.

Description

Inclusion Criteria:

  • Hidradenitis suppurativa that was wide excised in 2013 in Fachklinik Hornheide
  • Agreed to retrospective analysis and questionnaires

Exclusion Criteria:

  • Non-compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (WHOQOL-BREF)
Time Frame: 2 years postop
Quality of Life is checked by WHOQOL-BREF
2 years postop
Quality of Life (DLQI)
Time Frame: 2 years postop
Quality of Life is checked by DLQI
2 years postop
Quality of Life (FLQA-d)
Time Frame: 2 years postop
Quality of Life is checked by FLQA-d
2 years postop
Quality of Life (Skindex)
Time Frame: 2 years postop
Quality of Life is checked by Skindex
2 years postop

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual Function
Time Frame: 2 years postop
Sexual Function is checked by IIEF (male) and FSFI (female)
2 years postop
Demographic Parameters
Time Frame: 2 years postop
Patients' history
2 years postop
Smoking
Time Frame: 2 years postop
Smoking
2 years postop
Weight and height
Time Frame: 2 years postop
Weight and height
2 years postop
Wound assessment
Time Frame: 2 years postop
Localization, Hurley Stage, pain before operation
2 years postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Collaborators

Fachklinik Hornheide an der Universität Münster

Investigators

  • Study Director: Tobias Kisch, MD, University of Schleswig-Holstein, Campus Lübeck, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2015

Primary Completion (Actual)

April 15, 2017

Study Completion (Actual)

April 15, 2017

Study Registration Dates

First Submitted

April 11, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

November 1, 2015

Study Record Updates

Last Update Posted (Actual)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-015
  • U1111-1176-0162 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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