The Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Defect Reconstruction: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Postoperative Quality of Life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Postoperative Quality of Life
时间窗: Postoperative at 1, 3, 6, and 12 months
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 Speech Function
时间窗: Postoperative at 1, 3, 6, and 12 months
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.
Scar Assessment
时间窗: Postoperative at 1, 3, 6, and 12 months
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.
Swallowing Function Assessment
时间窗: Postoperative at 1, 3, 6, and 12 months
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.
次要结局
- Flap Complication Incidence(Postoperative at 1, 3, 6, and 12 months)
- Flap Failure Incidence(Postoperative at 1, 3, 6, and 12 months)
- Postoperative Complications(Postoperative at 1, 3, 6, and 12 months)
- Patient Bed Rest Duration(Postoperative at 1 months)
- Flap Pedicle Vein Diameter(Postoperative at 1 day)
- Flap Pedicle Artery Diameter(Postoperative at 1 day)
- Flap Pedicle Vessel Separation Length(Postoperative at 1 day)
- Flap Surgical Operation Time(Postoperative at 1 day)