Microsurgery in the Elderly in a Private Practice Setting

Aged Clinical Trial

Official title:

Outcomes of Microsurgical Reconstruction in the Elderly Patient in a Private Practice Setting in México City: Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584723
• Other study ID #: Elderly
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: December 2020
• Source: Hospital Angeles del Pedregal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Microsurgery

Intervention

Other:
• Observation 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

Locations

Country	Name	City	State
Mexico	Hospital Angeles Pedregal	Mexico city	Cdmx

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Angeles del Pedregal

Country where clinical trial is conducted

Mexico, 

Outcome

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