Viewing Study NCT06599801



Ignite Creation Date: 2024-10-26 @ 3:40 PM
Last Modification Date: 2024-10-26 @ 3:40 PM
Study NCT ID: NCT06599801
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-05

Brief Title: Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Reconstruction
Sponsor: None
Organization: None

Study Overview

Official Title: The Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Defect Reconstruction a Retrospective Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this study is to retrospectively compare different types of free flaps to determine the most suitable free flap for functional reconstruction in oral squamous cell carcinoma patients following tumor resection The main questions it aims to answer are

Do the clinical characteristics of the thoracodorsal artery perforator flap differ from those of other types of flaps Does the thoracodorsal artery perforator flap result in better clinical outcomes compared to other types of flaps After reconstruction with the thoracodorsal artery perforator flap do patients have better quality of life speech function and scar healing compared to other types of flaps Investigators will retrospectively compare the thoracodorsal artery perforator flap with other types of flaps such as the anterolateral thigh flap forearm flap latissimus dorsi flap and fibula flap to explore the most suitable free flap for facial defect reconstruction in oral squamous cell carcinoma patients

Participants are oral squamous cell carcinoma patients who previously underwent facial defect reconstruction with different types of flaps Participants have completed relevant questionnaires at 1 3 6 and 12 months post-surgery The data will be scored and assessed by the investigators
Detailed Description: Oral squamous cell carcinoma OSCC severely impacts patientss quality of life QoL The combined treatment approach of surgery radiation and chemotherapy can lead to oral function impairments including swallowing and speech difficulties Postoperatively patients may also experience physical emotional and functional sequelae resulting in a significant decline in their QoL

Functional maxillofacial defect repair has become a mainstream approach in surgical reconstruction The thoracodorsal artery perforator TDAP flap is increasingly favored by oral and maxillofacial surgeons due to its advantages of fewer complications favorable tissue characteristics and easy access to the latissimus dorsi nerve making it the preferred option for maxillofacial defect reconstruction

Postoperative QoL has become an important indicator for evaluating the prognosis of OSCC In successful cases of OSCC surgery patients may still experience a decline in QoL due to postoperative complications oral function impairments and aesthetic issues leading to a suicide rate much higher than that of other cancer patients Compared to traditional free flaps the TDAP flap has less conspicuous donor site scarring which is hidden under the posterior axillary fold thus offering significant advantages in aesthetics Additionally the motor nerve of the TDAP flap helps achieve functional reconstruction of the maxillofacial area improving the postoperative QoL for OSCC patients

In this retrospective study the investigators will collect clinical data from 217 OSCC patients who underwent different free flap reconstructions at the Oral and Maxillofacial Surgery Department of Sun Yat-sen Memorial Hospital from January 2020 to December 2023 The investigators will assess the QoL speech ability and scarring of patients using the Washington Quality of Life Scale Speech Disorder Index Scale and Vancouver Scar Scale The goal is to evaluate the repair and reconstruction outcomes of the TDAP flap in OSCC patients and to identify the most suitable flap choice for OSCC patients at this stage

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None