Malnutrition is Not a Risk Factor for Free Flap Failure i... | NCT04069650

Studies
Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity

NCT04069650

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Free Flap Reconstruction

Interventions

Free flap

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

Aug 2019

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

Feb 1, 2018Actual

Primary Completion Date

May 31, 2018Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Aug 23, 2019

First Submission Date that Met QC Criteria

Aug 23, 2019

First Posted Date

Aug 28, 2019Actual

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

Aug 23, 2019

Last Update Posted Date

Aug 28, 2019Actual

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

Free flap reconstruction consists in replacing tissular defect from one body part by another tissu harvested in a distant site. Microsurgery has to be performed to restore vascularization.

Free flaps are now the gold standard in complex reconstruction. While reliable with a success rate superior to 95 %, a failure takes a heavy burden on the patient. Many risk factors have been highlitghted in free flap failure for head and neck microvascular reconstruction.

Among them, malnutrition is still debated. This is a retrospective cohort study comparing complications occurrence between two groups. One group with normal nutritionnal status, the other with malnutrition. Between january 2008 and january 2018, 70 patients who underwent oral cavity reconstruction using free flap were included. This is the first study known to date which uses clinical and biological variables to determine the nutritionnal status.

Malnutrition is not associated with a higher risk for free flap failure in the oral cavity.

Detailed Description

Not provided

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

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
None-malnutrition		normal nutritionnal status	Procedure: Free flap
Malnutrition		weight loss was superior to 5% in the past month; a weight loss was superior to 10% in the past 6 months; a BMI was inferior to 18,5 kg/m² (if age inferior to 70 years old) or inferior to 21 kg/m² (if age superior to > 70 years old) - a serum albumin level inferior to 30g/L (if age inferior to 70 years old) or inferior to <35g/L (if age superior to 70 years old).	Procedure: Free flap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Free flap	Procedure	Free flap reconstruction of the oral cavity	Malnutrition None-malnutrition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major complication occurency	in the first-month post-operative period, complications leading to flap loss	1 month

Secondary Outcomes

Measure	Description	Time Frame
Minor complication occurency	in the first-month post-operative period, complications NOT leading to flap loss	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

every consenting patients undergoing free flap reconstruction of the oral cavity

Exclusion Criteria:

unable to give consent

Accepts Healthy Volunteers

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 undergoing free flap reconstruction of the oral cavity

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Dijon Bourgogne		Dijon		21000	France

Intervention Browse Module

MeSH Terms

ID	Term
D058752	Free Tissue Flaps

Ancestor Terms

ID	Term
D013524	Surgical Flaps
D019738	Surgically-Created Structures
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided