Quality of LifeNCT04579744
Postoperative Quality of Life in Treated Patients With Human Adjuvant Disease
An observational study of Quality of Life and Granuloma, Foreign-Body, run by Hospital Angeles del Pedregal at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Quality of Life, Granuloma, Foreign-Body
- What is being tested?
- EuroQol 5D questionnaire
- How many people
- 11 participants
- Where
- 1 siteMexico
- Study dates
- 27 May 2020to 15 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- History of antidepressant use during the follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Quality of Life, Granuloma, Foreign-Body
- Being tested
- EuroQol 5D questionnaire
- Keywords
- human adjuvant disease, quality of life, Reconstructive surgery
- Medical subject headings
- Granuloma, Foreign-Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuroQol 5D questionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 31.09 months (range 6 - 96)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start27 May 2020
- Primary completion15 Aug 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Angeles del Pedregal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, javier lopez, Hospital Angeles del Pedregal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579744
- Sponsor's protocol ID
- QoL in HAD
- Status last verified
- Oct 2020
- First submitted
- 29 Sep 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Quality of Life in Surgically Treated Patients With Human Adjuvant Disease: Case Series
- ClinicalTrials.gov ID
- NCT04579744
- Acronym / sponsor ID
- QoL in HAD
- Conditions
- Quality of Life, Granuloma, Foreign-Body
- Keywords
- human adjuvant disease, quality of life, Reconstructive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hospital Angeles del PedregalUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- History of antidepressant use during the follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EuroQol 5D questionnaireEuroQol 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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Granuloma, Foreign-Body, run by Hospital Angeles del Pedregal at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life: EuroQuality Of Life-5Dimensions (time frame: 31.09 months (range 6 - 96)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.