Postoperative Quality of Life in Treated Patients With Human Adjuvant Disease

October 7, 2020 updated by: javier lopez, Hospital Angeles del Pedregal

Postoperative Quality of Life in Surgically Treated Patients With Human Adjuvant Disease: Case Series

This study aims to describe the quality of life in patients submitted to surgical excision of the adjuvants and injured surrounding tissue. For this purpose, the EuroQol questionnaire (EQ-5d) facilitates to obtain values of health in the physical, psychological, and social dimensions. It is a standardized non-disease specific instrument to describe and value the health-related quality of life. Although there are only five domains, it has been found to cover the most critical dimensions of quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

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

  • Mexico
    • Cdmx
      • Mexico City, Cdmx, Mexico, 10700
        • Hospital Angeles Pedregal

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with history of injection of foreign substances as mineral oil or paraffin for cosmetic purposes and who developed human adjuvant disease, characterized for chronic fatigue, myalgias, arthralgias, fever, chronic pain and skin trophic changes due to this foreign substances.

Description

Inclusion Criteria:

  • Diagnosis of human adjuvant disease due to foreign substances injection
  • Treated surgically to remove foreign substance
  • In a private practice setting and treated all by plastic surgeon senior author.

Exclusion Criteria:

  • History of antidepressant use during the follow up

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: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life: EuroQuality Of Life-5Dimensions
Time Frame: 31.09 months (range 6 - 96)
Each EuroQOL-5Dimensions instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding, taking only a few minutes to complete. The questionnaire provides a simple descriptive profile of a respondent's health state. Values of health in the physical, psychological, and social dimensions are investigated. After surgical removal of foreign substances quality of life should have high values.
31.09 months (range 6 - 96)

Collaborators and Investigators

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

Sponsor

Hospital Angeles del Pedregal

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)

May 27, 2020

Primary Completion (Actual)

August 15, 2020

Study Completion (Actual)

September 15, 2020

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QoL in HAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Will share info about overall quality of life, also each score of the 5 domains of EQ-5D. Comparison of results with different methods of surgical removal. Share will be in forums, symposia and article sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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