Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.
Primary Purpose
Oral Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lateral Arm Free Flap
Sponsored by
About this trial
This is an interventional treatment trial for Oral Cancer
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
Sites / Locations
- Assiut University
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05296811
Brief Title
Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.
Official Title
Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
hassan harby mohamed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Lateral Arm Free Flap
Intervention Description
Primary Reconstruction of intraoral defects by use of Lateral Arm Free Flap.
Primary Outcome Measure Information:
Title
Early detection of recurrence
Description
reconstruction of defects in head and neck post surgical excision by lateral arm free flap and early detection of recurrence by CT neck.
Time Frame
3 month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hassan harby
Phone
0101261001
Email
harby1990hassan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hassan harby
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71511
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
11352423
Citation
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.
Results Reference
background
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Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.
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