NCT03346928

Brief Summary

The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 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

October 1, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

4.8 years

First QC Date

November 15, 2017

Last Update Submit

November 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Medical complications

    Occurrence of medical complications within one month post-surgery

    One month post-surgery

Secondary Outcomes (2)

  • Surgical complications

    One month post-surgery

  • Hospital length of stay

    Approximately 20 days

Interventions

Head and neck free flap reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with head and neck cancer undergoing microsurgical free flap reconstruction

You may qualify if:

  • Head and neck cancer
  • Microsurgical free flap reconstruction
  • years of age or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

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

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 20, 2017

Study Start

October 1, 2012

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations