Microsurgery in the Elderly in a Private Practice Setting

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.

Study Overview

• Status: Completed
• Conditions: Aged; Microsurgery
• Intervention / Treatment: Other: Observation of flap survival and complications

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 Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Mexico
  • Cdmx
    • Mexico city, Cdmx, Mexico, 01330
      • Hospital Angeles Pedregal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

• Lost follow up

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flap survival	Evaluation of success of microsurgical free flap. Flap necrosis or not	1 month
Complications	Report the number and type of local and systemic complications in this microsurgical procedures.	1 month

Collaborators and Investigators

• Sponsor: Hospital Angeles del Pedregal

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ELDERLY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No