Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Reconstruction

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Thoracodorsal artery perforator flap reconstruction surgery

    Procedure/Surgery

    Oral squamous cell carcinoma patients underwent reconstruction with thoracodorsal artery perforator (TDAP) flaps following tumor resection.

  • Forearm flaps reconstruction surgery

    Procedure/Surgery

    Oral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection

  • Anterolateral thigh flap reconstruction surgery

    Procedure/Surgery

    Oral squamous cell carcinoma patients received the reconstruction with anterolateral thigh flaps after tumor resection

  • Fibula flap reconstruction surgery

    Procedure/Surgery

    Oral squamous cell carcinoma patients received the reconstruction with fibula flaps after tumor resection

  • Forearm flap reconstruction surgery

    Procedure/Surgery

    Oral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection

Treatment groups

217 Participants
are divided into 5 treatment groups
Group A: Anterolateral thigh flap group1 intervention
Group B: Forearm flap group1 intervention
Group C: Latissimus dorsi flap group1 intervention
Group D: Fibula flap group1 intervention
Group E: Thoracodorsal artery perforator flap group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Postoperative at 1, 3, 6, and 12 months
2

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.

Time frame
Postoperative at 1, 3, 6, and 12 months
3

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.

Time frame
Postoperative at 1, 3, 6, and 12 months
4

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.

Time frame
Postoperative at 1, 3, 6, and 12 months

Secondary outcomes

1

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.

Time frame
Postoperative at 1, 3, 6, and 12 months
2

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.

Time frame
Postoperative at 1, 3, 6, and 12 months
3

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.

Time frame
Postoperative at 1, 3, 6, and 12 months
4

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.

Time frame
Postoperative at 1 months

Other outcomes

Sponsors and contacts

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