Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Reconstruction

Official title

The Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Defect Reconstruction: a Retrospective Study

Overview

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 patients's 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.

Interventions

• Procedure Thoracodorsal artery perforator flap reconstruction surgery
  Oral squamous cell carcinoma patients underwent reconstruction with thoracodorsal artery perforator (TDAP) flaps following tumor resection.
• Procedure Forearm flaps reconstruction surgery
  Oral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection
• Procedure Anterolateral thigh flap reconstruction surgery
  Oral squamous cell carcinoma patients received the reconstruction with anterolateral thigh flaps after tumor resection
• Procedure Fibula flap reconstruction surgery
  Oral squamous cell carcinoma patients received the reconstruction with fibula flaps after tumor resection
• Procedure Forearm flap reconstruction surgery
  Oral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection

Primary outcome measures

• Postoperative Quality of Life [Time frame: Postoperative at 1, 3, 6, and 12 months]
• Postoperative Speech Function [Time frame: Postoperative at 1, 3, 6, and 12 months]
• Scar Assessment [Time frame: Postoperative at 1, 3, 6, and 12 months]
• Swallowing Function Assessment [Time frame: Postoperative at 1, 3, 6, and 12 months]

Secondary outcome measures (8)

• Flap Complication Incidence [Time frame: Postoperative at 1, 3, 6, and 12 months]
• Flap Failure Incidence [Time frame: Postoperative at 1, 3, 6, and 12 months]
• Postoperative Complications [Time frame: Postoperative at 1, 3, 6, and 12 months]
• Patient Bed Rest Duration [Time frame: Postoperative at 1 months]
• Flap Pedicle Vein Diameter [Time frame: Postoperative at 1 day]
• Flap Pedicle Artery Diameter [Time frame: Postoperative at 1 day]
• Flap Pedicle Vessel Separation Length [Time frame: Postoperative at 1 day]
• Flap Surgical Operation Time [Time frame: Postoperative at 1 day]

Eligibility criteria

Inclusion criteria

• Patients with oral squamous cell carcinoma who have completed comprehensive imaging examinations before surgery.
• Preoperative pathological biopsy confirmed as oral squamous cell carcinoma.
• Patients with oral squamous cell carcinoma who have completed comprehensive laboratory tests before surgery.
• Patients with oral squamous cell carcinoma who underwent tumor resection and flap reconstruction at our hospital.
• Postoperative pathological diagnosis confirmed as oral squamous cell carcinoma.
• Patients with oral squamous cell carcinoma who attend follow-up visits at 1, 3, 6, and 12 months post-surgery, completing all clinical examinations and questionnaires.

Exclusion criteria

• Patients with oral squamous cell carcinoma who lack imaging data or have artifacts affecting imaging results.
• Patients with oral squamous cell carcinoma who have incomplete laboratory test results from our hospital.
• Patients with oral squamous cell carcinoma with postoperative pathology that remains unclear or cannot be confirmed as oral squamous cell carcinoma.
• Patients with oral squamous cell carcinoma who are unable to attend follow-up visits at 1, 3, 6, and 12 months.
• Patients who do not complete the questionnaires as required during follow-up visits.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Sun Yat-sen Memorial Hospital, Sun Yat-sen Univerity — Guangzhou

Publications

• Min F, Qiu P, Zhu X, Zhou B, Lin Z, Pan C, Wang Y. Modified submandibular mandibulotomy approach versus lip-splitting approach in tongue cancer surgery: a retrospective paired-cohort study. Clin Oral Investig. 2023 Dec 26;28(1):32. doi: 10.1007/s00784-023-05395-3. PMID 38147089
• Zhou B, Liao J, Zhu C, Yuan K, Liu Z, Lin Z, Huang Z, Chen W, Li J, Wang Y. Full cheek defect reconstruction using ALTF versus RFF: Comparison of quality of life, clinical results, and donor site morbidity. Oral Dis. 2020 Sep;26(6):1157-1164. doi: 10.1111/odi.13354. Epub 2020 May 4. PMID 32289869
• Wu F, Xia X, Zhu C, Fu M, Zhu X, Wang J, Lan T, Wang Y. Functional tongue reconstruction using innervated TDAP versus ALT free flaps: a retrospective paired-cohort study. Head Face Med. 2025 Dec 5;22(1):3. doi: 10.1186/s13005-025-00572-z. PMID 41350686

Identifiers

NCT: NCT06599801 · SYSKY-2024-710-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗