Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Reconstruction

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Oral Squamous Cell Carcinoma (OSCC)
• Intervention / Treatment: Procedure: Anterolateral thigh flap reconstruction surgery; Procedure: Forearm flap reconstruction surgery; Procedure: Forearm flaps reconstruction surgery; Procedure: Fibula flap reconstruction surgery; Procedure: Thoracodorsal artery perforator flap reconstruction surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 217

Contacts and Locations

• Study Contact: Name: Liushan Ou, MD; Phone Number: +8681332587; Email: sys_iit@163.com
• Study Contact Backup: Name: Youyuan Wang, MD, Ph.D; Phone Number: +8613631333312; Email: Wangyy78@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen Univerity
      • Contact: Liushan Ou, MD; Phone Number: +8681332587; Email: sys_iit@163.com
      • Contact: Youyuan Wang, MD, Ph.D; Phone Number: +8613631333312; Email: wufan43@mail2.sysu.edu.cnWangyy78@mail.sysu.edu.cn
      • Principal Investigator: Youyuan Wang, MD, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any patient with oral squamous cell carcinoma undergoing reconstruction with thoracodorsal artery perforator flap, anterolateral thigh flap, forearm flap, latissimus dorsi flap, or fibula flap at Sun Yat-sen Memorial Hospital of Sun Yat-sen University from January 2020 to June 2023 will be included. Descriptive statistics will be generated for all outcome measures. Statistical analysis will be conducted using SPSS software version 23.0.

Description

Inclusion Criteria:

1. Patients with oral squamous cell carcinoma who have completed comprehensive imaging examinations before surgery.
2. Preoperative pathological biopsy confirmed as oral squamous cell carcinoma.
3. Patients with oral squamous cell carcinoma who have completed comprehensive laboratory tests before surgery.
4. Patients with oral squamous cell carcinoma who underwent tumor resection and flap reconstruction at our hospital.
5. Postoperative pathological diagnosis confirmed as oral squamous cell carcinoma.
6. 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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anterolateral thigh flap group; Oral squamous cell carcinoma patients received the reconstruction with anterolateral thigh 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
Forearm flap group; Oral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection	Procedure: Forearm flap reconstruction surgery; Oral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection
Latissimus dorsi flap group; Oral squamous cell carcinoma patients received the reconstruction with latissimus dorsi flaps after tumor resection	Procedure: Forearm flaps reconstruction surgery; Oral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection
Fibula flap group; Oral squamous cell carcinoma patients received the reconstruction with Fibula flaps after tumor resection	Procedure: Fibula flap reconstruction surgery; Oral squamous cell carcinoma patients received the reconstruction with fibula flaps after tumor resection
Thoracodorsal artery perforator flap group; Oral squamous cell carcinoma patients received the reconstruction with Thoracodorsal artery perforator flaps after tumor resection	Procedure: Thoracodorsal artery perforator flap reconstruction surgery; Oral squamous cell carcinoma patients underwent reconstruction with thoracodorsal artery perforator (TDAP) flaps following tumor resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Quality of Life	The investigators applied the University of Washington Quality of Life (UW-QOL) questionnaire to evaluate the participants' appearance, functional outcomes and emotional well-being. This included scores for pain, appearance, activity, comfort, swallowing, chewing, speech, shoulder function, taste, saliva, emotion, anxiety and the overall total score. According to the UW-QOL version 4 questionnaire, each domain is scored on a scale from 0 to 100, with higher scores indicating a better quality of life.	Postoperative at 1, 3, 6, and 12 months
Postoperative Speech Function	The investigators evaluated postoperative speech function using the 30-item Speech Handicap Index (SPI) questionnaire. This questionnaire employs a 5-point Likert scale with the following response categories: "never" (0 points), "almost never" (1 point), "sometimes" (2 points), "almost always" (3 points), and "always" (4 points). The total SPI score ranges from 0 to 120 and includes two subscales: psychosocial function and speech function, each consisting of 14 items. Lower scores indicate better speech function.	Postoperative at 1, 3, 6, and 12 months
Scar Assessment	The investigators applied the Vancouver Scar Scale (VSS) questionnaire to evaluate the participants' scars at the donor site. This included scores for the pigmentation (score from 0-3), thickness (score from 0-3), blood supply (score from 0-5) and texture (score from 0-3) of the scar at donor site. According to the VSS questionnaire, a lower score indicates a better outcome with the similar appearance like normal, however a higher score indicates an abnormal appearance and contracture.	Postoperative at 1, 3, 6, and 12 months
Swallowing Function Assessment	The investigators applied the NIH Swallowing Safety Scale (NIH-SSS) questionnaire to evaluate the participants' swallowing function. The total score of NIH-SSS ranges from 0 to 10 points, with each score reflecting a different level of swallowing safety. A score of 0 indicates completely safe swallowing with no signs of aspiration or difficulty, while a score of 10 represents the most severe aspiration or swallowing impairment, potentially requiring urgent intervention.	Postoperative at 1, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flap Complication Incidence	The rate at which the blood supply to the flap suddenly interrupts or significantly decreases postoperatively, leading to ischemia or necrosis of the flap.	Postoperative at 1, 3, 6, and 12 months
Flap Failure Incidence	The rate at which the flap fails to survive and heal due to insufficient blood supply, infection, technical issues, or other complications, resulting in partial or complete necrosis of the flap.	Postoperative at 1, 3, 6, and 12 months
Postoperative Complications	Includes complications at the recipient site (hematoma, infection, wound dehiscence, and fistula), complications at the donor site (hematoma, infection, and wound dehiscence), and lower limb venous thrombosis.	Postoperative at 1, 3, 6, and 12 months
Patient Bed Rest Duration	The time a patient spends completely resting in bed postoperatively, during which the patient is unable to move independently or can only perform necessary bedside activities with the assistance of caregivers.	Postoperative at 1 months
Flap Pedicle Vein Diameter	The investigators used a Micro-Vessel Caliper to measure the cross-sectional diameter of the vein in the flap pedicle during flap-harvesting surgery.	Postoperative at 1 day
Flap Pedicle Artery Diameter	The investigators used a Micro-Vessel Caliper to measure the cross-sectional diameter of the artery in the flap pedicle during flap-harvesting surgery.	Postoperative at 1 day
Flap Pedicle Vessel Separation Length	The maximum distance that can be separated between the point where the flap's blood supply vessel (artery or vein) enters the flap and the furthest point of its branching.	Postoperative at 1 day
Flap Surgical Operation Time	The total time spent on the flap procedure, including the time for designing the flap, harvesting the flap, shaping the flap, and placing and securing the flap.	Postoperative at 1 day

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; free flap; Oral Squamous Cell Carcinoma; thoracodorsal artery perforator flap
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: SYSKY-2024-710-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect participants' privacy, the data may include sensitive information such as personal identification or health status. If IPD is needed, please contact the project investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No