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CompletedNCT04584723Updated Dec 8, 2020

Microsurgery in the Elderly in a Private Practice Setting

An observational study in Aged and Microsurgery, sponsored by Hospital Angeles del Pedregal. Completed at 1 site in Mexico. Open to participants aged 65 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-08.

Sponsored by Hospital Angeles del Pedregal · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
17
Ages
65 Years to 95 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Aged
  • Microsurgery
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In context

Lead sponsor

Hospital Angeles del Pedregal is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients more than 65 years old, with indications for a free flap reconstruction.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Elderly population, defined as more than 65 years old
  • Patients underwent to free flap microsurgical procedures.
  • Complete files
  • Patient acceptance to participate

Exclusion criteria

Exclusion Criteria:

  • Lost follow up
05

Study design

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

Interventions

  • OtherObservation of flap survival and complications

    We will report the flap survival and complications in this population group underwent to microsurgical procedures in a private practice setting

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What researchers measure

Primary outcomes

  1. Flap survival

    Evaluation of success of microsurgical free flap. Flap necrosis or not

    Time frame: 1 month

  2. Complications

    Report the number and type of local and systemic complications in this microsurgical procedures.

    Time frame: 1 month

07

Study locations

1 site
  • Hospital Angeles Pedregal
    Mexico city, Cdmx 01330, Mexico
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04584723
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 14, 2020
Start date
May 1, 2020
Primary completion
Oct 30, 2020
Completion
Oct 30, 2020
Last update
Dec 8, 2020

Oversight

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

Not currently enrolling

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

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