AgedNCT04584723
Microsurgery in the Elderly in a Private Practice Setting
An observational study of Aged and Microsurgery, run by Hospital Angeles del Pedregal at 1 site in Mexico.
Trial summary
This study reports the experience in free tissue transfer in the elderly population by a single surgeon in the private practice setting in Mexico city and the potential criticism that could arise from adverse events in lower-volume practice situations will be addressed. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged, Microsurgery
- What is being tested?
- Observation of flap survival and complications
- How many people
- 17 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2020to 30 Oct 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 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients more than 65 years old, with indications for a free flap reconstruction.
Who may be able to join
- Elderly population, defined as more than 65 years old
- Patients underwent to free flap microsurgical procedures.
- Complete files
- Patient acceptance to participate
Who cannot join
- Lost follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Microsurgical Reconstruction in the Elderly Patient in a Private Practice Setting in México City: Case Series
This study reports the experience in free tissue transfer in the elderly population by a single surgeon in the private practice setting in Mexico city and the potential criticism that could arise from adverse events in lower-volume practice situations will be addressed. Investigator will answer the question about the age as the variable of interest in this series in which age was not a factor in deciding reconstructive methods, and examine complication rates.
Read the detailed description
Investigators will evaluate the outcomes of 17 flaps in 14 patients who required microsurgical reconstruction with free flaps and microvascular vessels anastomosis. All patients more than 65 years old. Demographic data will be reported as: obesity, American Society of Anesthesiology (asa) level, radiotherapy, combined surgery. And the results of investigation will include: Flap survival, local complications, systemic complications, re-interventions, 30-day mortality.
- Conditions
- Aged, Microsurgery
- Being tested
- Observation of flap survival and complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of flap survival and complicationsOther
We will report the flap survival and complications in this population group underwent to microsurgical procedures in a private practice setting
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap survival
Evaluation of success of microsurgical free flap. Flap necrosis or not
Measured: 1 month
Complications
Report the number and type of local and systemic complications in this microsurgical procedures.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 May 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies 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
- 17 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
- NCT04584723
- Sponsor's protocol ID
- Elderly
- Status last verified
- Dec 2020
- First submitted
- 6 Oct 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share, age, American society of anesthesiology (ASA) level, Obesity, radiotherapy associated. And the results of flap survival, type of complications including local and systemic.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Microsurgical Reconstruction in the Elderly Patient in a Private Practice Setting in México City: Case Series
- ClinicalTrials.gov ID
- NCT04584723
- Acronym / sponsor ID
- Elderly
- Conditions
- Aged, Microsurgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hospital Angeles del PedregalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 14 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 reports the experience in free tissue transfer in the elderly population by a single surgeon in the private practice setting in Mexico city and the potential criticism that could arise from adverse events in lower-volume practice situations will be addressed. Investigator will answer the question about the age as the variable of interest in this series in which age was not a factor in deciding reconstructive methods, and examine complication rates.
Detailed description
Investigators will evaluate the outcomes of 17 flaps in 14 patients who required microsurgical reconstruction with free flaps and microvascular vessels anastomosis. All patients more than 65 years old. Demographic data will be reported as: obesity, American Society of Anesthesiology (asa) level, radiotherapy, combined surgery. And the results of investigation will include: Flap survival, local complications, systemic complications, re-interventions, 30-day mortality.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients more than 65 years old, with indications for a free flap reconstruction.
Key inclusion criteria (4 listed)
- Elderly population, defined as more than 65 years old
- Patients underwent to free flap microsurgical procedures.
- Complete files
- Patient acceptance to participate
Key exclusion criteria (1 listed)
- Lost 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 |
|---|---|---|
| Observation of flap survival and complicationsWe will report the flap survival and complications in this population group underwent to microsurgical procedures in a private practice setting | Other | – |
Primary outcome
Flap survival
Time frame: 1 month
Evaluation of success of microsurgical free flap. Flap necrosis or not
Complications
Time frame: 1 month
Report the number and type of local and systemic complications in this microsurgical procedures.
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 8 Dec 2020.
- Individual participant dataSharing planned: Undecided. We will share, age, American society of anesthesiology (ASA) level, Obesity, radiotherapy associated. And the results of flap survival, type of complications including local and systemic.
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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 Aged and Microsurgery, 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 4 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 8 Dec 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?
Flap survival (time frame: 1 month). The study lists 2 primary outcomes in all. 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 8 Dec 2020.