Postoperative Complication After Free Flap Reconstruction for Head and Neck Cancer

NCT04326088 | Completed

• 1 other identifier: 201800440B0
• Study Type: observational
• Target: 2,004
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to investigate the outcome of free-flap reconstruction surgery following head and neck cancer resection between primary and recurrent head and neck cancer patients.

Conditions

Head and Neck Cancer; Recurrent Cancer; Surgery--Complications

Outcome Measures

Primary Outcomes (1)

• Failure or success flap

  The condition of the reconstruction flap is failure or success.

  2 months after surgery

Secondary Outcomes (1)

• Complications

  2 months after surgery

Study Arms (1)

head and neck cancer with free flap reconstruction

patients with head and neck cancer who underwent tumor wide excision and primary free flap reconstruction or secondary free flap reconstruction between March 2008 and February 2017

Other: Reconstruction group; Other: Recurrent group

Interventions

Reconstruction group OTHER

Patients with primary tumor which underwent free flap reconstruction group.

head and neck cancer with free flap reconstruction

Recurrent group OTHER

Patients with recurrent tumor which underwent free flap reconstruction group.

head and neck cancer with free flap reconstruction

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

2,004 patients with head and neck cancer who underwent tumor wide excision and primary free flap reconstruction or secondary free flap reconstruction between March 2008 and February 2017. After excluding missing or unvalidated data, 1,700 patients with a total of 1,791 free flap reconstructions (21 patients received double free flap reconstructions) was left in the study.

You may qualify if:

• Patients with head and neck cancer who underwent tumor wide excision and primary free flap reconstruction or secondary free flap reconstruction between March 2008 and February 2017
• Age: 20\~100 years old

You may not qualify if:

• patients with missing or unvalidated data
• patients less than 20 years old

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: April 1, 2018
• Primary Completion: December 15, 2018
• Study Completion: March 31, 2019
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)