NCT04002713

Brief Summary

This study was designed to compare the outcome of the anteromedial thigh (AMT) and anterolateral thigh (ALT) flaps in head and neck cancer reconstruction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,590

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
Last Updated

July 1, 2019

Status Verified

June 1, 2019

Enrollment Period

1 month

First QC Date

June 27, 2019

Last Update Submit

June 27, 2019

Conditions

Reconstructive SurgeryHead and Neck Cancer

Keywords

Anterolateral thigh (ALT)anteromedial thigh (AMT)free flap reconstructionmicrosurgeryhead and neck canceroutcomes

Outcome Measures

Primary Outcomes (1)

  • survival or failure

    The primary free flap outcome was determined as its survival or failure.

    up to 6 months

Secondary Outcomes (1)

  • Complications

    up to 6 months

Study Arms (1)

ALT&AMT free flap reconstruction

Patients who underwent ALT or AMT free flap reconstruction after head and neck cancer surgery between March 1, 2008 and February 28, 2017

Other: ALT flap reconstructionOther: AMT flap reconstruction

Interventions

ALT flap reconstructionOTHER

Patients who underwent ALT free flap reconstruction after head and neck cancer surgery.

ALT&AMT free flap reconstruction
AMT flap reconstructionOTHER

Patients who underwent AMT free flap reconstruction after head and neck cancer surgery.

ALT&AMT free flap reconstruction

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A retrospective study was performed on adult trauma patients from the registered free flap database and electric medical records of Kaohsiung Chang Gung Memorial Hospital, a 2,686-bed medical center in Southern Taiwan.

You may qualify if:

  • Patients who underwent ALT or AMT free flap reconstruction after head and neck cancer surgery between March 1, 2008 and February 28, 2017.

You may not qualify if:

  • Patients whose data were missing will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 1, 2019

Study Start

March 20, 2019

Primary Completion

May 2, 2019

Study Completion

June 3, 2019

Last Updated

July 1, 2019

Record last verified: 2019-06

Locations

TW(1)