Lateral Arm Free Flap for Reconstruction of the Oral Cavi... | NCT05296811

Studies
Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.

NCT05296811

Sponsor

hassan harby mohamed

Status

Unknown status

Last Update Posted

Mar 25, 2022Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Oral Cancer

Interventions

Lateral Arm Free Flap

Countries

Egypt

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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Estimated

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Jun 1, 2024Estimated

First Submitted Date

Mar 6, 2022

First Submission Date that Met QC Criteria

Mar 16, 2022

First Posted Date

Mar 25, 2022Actual

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

Mar 16, 2022

Last Update Posted Date

Mar 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 excision of oral cancers causes extensive impairment of the oral cavity soft tissue. Complete excision of the tumors is vital, and the reconstruction of the resected area influences not only the postoperative recovery period of patients but also physiological functions such as swallowing, phonation function ,daily activities and psychosocial impact.

Oral and maxillofacial surgeons are faced with the task of reconstructing the affected area to reduce these problems as much as possible.

In 1982, Song introduced the lateral arm flap (LAF). Since this time, its used in surgical repairs of oral defects, But the specific subject of publications generally restricted to a small number of cases.

LAF is a thin and pliable flap with consistent anatomy and a high success rate. It is also claimed that there is no risk of vascular compromise to the arm

Detailed Description

reconstruction of oral , head and neck defects with Lateral Arm Free Flap

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lateral Arm Free Flap	Procedure	Primary Reconstruction of intraoral defects by use of Lateral Arm Free Flap.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early detection of recurrence	reconstruction of defects in head and neck post surgical excision by lateral arm free flap and early detection of recurrence by CT neck.	3 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients post glossectomy.
Patients post maxillectomy with malignant maxillary swelling with no distant metastases.
All patients which defect after surgery for head and neck neoplasia.

Exclusion Criteria:

1. Small defect post excision can be closed directly 2. medically unfit patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
hassan harby	Contact	0101261001		harby1990hassan@gmail.com

Overall Officials

Name	Affiliation	Role
hassan harby	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University		Asyut		71511	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11352423	Background	Nahabedian MY, Deune EG, Manson PN. Utility of the lateral arm flap in head and neck reconstruction. Ann Plast Surg. 2001 May;46(5):501-5. doi: 10.1097/00000637-200105000-00008.

ID	Term
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009059	Mouth Diseases