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CompletedNCT04326088Updated Mar 30, 2020

Postoperative Complication After Free Flap Reconstruction for Head and Neck Cancer

An observational study in Head and Neck Cancer, Recurrent Cancer and Surgery--Complications, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-03-30.

Sponsored by Chang Gung Memorial Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
2,004
Ages
20 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Head and Neck Cancer
  • Recurrent Cancer
  • Surgery--Complications
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 2,004 is above the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

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

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Who can participate

Ages eligible
20 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • patients with missing or unvalidated data
  • patients less than 20 years old
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
2,004 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherReconstruction group

    Patients with primary tumor which underwent free flap reconstruction group.

  • OtherRecurrent group

    Patients with recurrent tumor which underwent free flap reconstruction group.

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What researchers measure

Primary outcomes

  1. Failure or success flap

    The condition of the reconstruction flap is failure or success.

    Time frame: 2 months after surgery

Secondary outcomes

  1. Complications

    such as wound infection rate, fistula, hematoma, and partial necrosis of the flap

    Time frame: 2 months after surgery

07

Study locations

1 site
  • Kaohsiung Chang Gung Memorial Hospital
    Kaohsiung, 83301, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 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
NCT04326088
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Mar 30, 2020
Start date
Apr 1, 2018
Primary completion
Dec 15, 2018
Completion
Mar 31, 2019
Last update
Mar 30, 2020

Oversight

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 Mar 2020. You cannot join it, but the record below documents what was studied.

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