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CompletedNCT04579744Updated Oct 9, 2020

Postoperative Quality of Life in Treated Patients With Human Adjuvant Disease

An observational study in Quality of Life and Granuloma, Foreign-Body, sponsored by Hospital Angeles del Pedregal. Completed at 1 site in Mexico. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-10-09.

Sponsored by Hospital Angeles del Pedregal · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
11
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Quality of Life
  • Granuloma, Foreign-Body

Keywords

  • human adjuvant disease
  • quality of life
  • Reconstructive surgery
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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.

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

Exclusion Criteria:

  • History of antidepressant use during the follow up
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
11 participants (actual)
Patient registry
No

Interventions

  • OtherEuroQol 5D questionnaire

    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.

05

What researchers measure

Primary outcomes

  1. Quality of life: EuroQuality Of Life-5Dimensions

    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.

    Time frame: 31.09 months (range 6 - 96)

06

Study locations

1 site
  • Hospital Angeles Pedregal
    Mexico City, Cdmx 10700, Mexico
07

References and documents

Individual participant data

Plan to share: Undecided — 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

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04579744
Lead sponsor
Hospital Angeles del Pedregal
Responsible party
javier lopez (Principal investigator, Plastic and reconstructive surgeon staff, MBA, FACS, Hospital Angeles del Pedregal) — Principal investigator
First posted
Oct 8, 2020
Start date
May 27, 2020
Primary completion
Aug 15, 2020
Completion
Sep 15, 2020
Last update
Oct 9, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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