Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.
1 other identifier
interventional
15
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2022
CompletedFirst Posted
Study publicly available on registry
March 25, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedMarch 25, 2022
March 1, 2022
2 years
March 6, 2022
March 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Primary Reconstruction of intraoral defects by use of Lateral Arm Free Flap.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \. Small defect post excision can be closed directly 2. medically unfit patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, 71511, Egypt
Related Publications (1)
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.
PMID: 11352423BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
hassan harby
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
March 6, 2022
First Posted
March 25, 2022
Study Start
June 1, 2022
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
March 25, 2022
Record last verified: 2022-03