Free Flaps : Should we Propose Them to the Elderly ? | NCT03346928

Studies
Free Flaps : Should we Propose Them to the Elderly ?

NCT03346928

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Nov 20, 2017Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Head and Neck Cancer

Interventions

Head and neck reconstruction

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2012Actual

Primary Completion Date

Jul 31, 2017Actual

Completion Date

Jul 31, 2017Actual

First Submitted Date

Nov 15, 2017

First Submission Date that Met QC Criteria

Nov 17, 2017

First Posted Date

Nov 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2017

Last Update Posted Date

Nov 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction. A retrospective chart review of all patients undergoing head and neck free flap reconstruction was conducted and the overall hospital length of stay and the incidence of perioperative medical and surgical complications were assessed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Head and neck reconstruction	Procedure	Head and neck free flap reconstruction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medical complications	Occurrence of medical complications within one month post-surgery	One month post-surgery

Secondary Outcomes

Measure	Description	Time Frame
Surgical complications	Occurrence of surgical complications within one month post-surgery	One month post-surgery
Hospital length of stay		Approximately 20 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with head and neck cancer undergoing microsurgical free flap reconstruction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Croix-Rousse Hospital, Hospices Civils de Lyon		Lyon			France

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided