Postoperative Quality of Life in Treated Patients With Human Adjuvant Disease

NCT04579744 | Completed

• 1 other identifier: QoL in HAD
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Quality of Life; Granuloma, Foreign-Body

Keywords

human adjuvant disease; quality of life; Reconstructive surgery

Outcome Measures

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.

  31.09 months (range 6 - 96)

Interventions

EuroQol 5D questionnaire OTHER

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• History of antidepressant use during the follow up

Sponsors & Collaborators

• Hospital Angeles del Pedregal: lead

Study Sites (1)

Hospital Angeles Pedregal

Mexico City, Mexico City, 10700, Mexico

Location

MeSH Terms

Conditions

Granuloma, Foreign-Body

Condition Hierarchy (Ancestors)

Granuloma; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Foreign-Body Reaction; Foreign Bodies; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Plastic and reconstructive surgeon staff, MBA, FACS

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 8, 2020
• Study Start: May 27, 2020
• Primary Completion: August 15, 2020
• Study Completion: September 15, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Locations

ME (1)