Clinical trial NCT06599801: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Oral Squamous Cell Carcinoma (OSCC)
Keywords: Oral Squamous Cell Carcinoma
thoracodorsal artery perforator flap
quality of life
free flap
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Quality of Life
timeFrame: Postoperative at 1, 3, 6, and 12 months
measure: Postoperative Speech Function
timeFrame: Postoperative at 1, 3, 6, and 12 months
measure: Scar Assessment
timeFrame: Postoperative at 1, 3, 6, and 12 months
measure: Swallowing Function Assessment
timeFrame: Postoperative at 1, 3, 6, and 12 months
Secondary outcomes:
measure: Flap Complication Incidence
timeFrame: Postoperative at 1, 3, 6, and 12 months
measure: Flap Failure Incidence
timeFrame: Postoperative at 1, 3, 6, and 12 months
measure: Postoperative Complications
timeFrame: Postoperative at 1, 3, 6, and 12 months
measure: Patient Bed Rest Duration
timeFrame: Postoperative at 1 months
measure: Flap Pedicle Vein Diameter
timeFrame: Postoperative at 1 day
measure: Flap Pedicle Artery Diameter
timeFrame: Postoperative at 1 day
measure: Flap Pedicle Vessel Separation Length
timeFrame: Postoperative at 1 day
measure: Flap Surgical Operation Time
timeFrame: Postoperative at 1 day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen Univerity
state: Guangdong
Study officials:
References:
citation: 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.
citation: 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.