Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Reconstruction

NCT06599801 | Not Yet Recruiting

• 1 other identifier: SYSKY-2024-710-01
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Squamous Cell Carcinoma (OSCC)

Keywords

Oral Squamous Cell Carcinoma; thoracodorsal artery perforator flap; quality of life; free flap

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

Study Arms (5)

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

Forearm flap group

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

Procedure: Forearm flap reconstruction surgery

Latissimus dorsi flap group

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

Procedure: Forearm flaps reconstruction surgery

Fibula flap group

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

Procedure: Fibula flap reconstruction surgery

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

Interventions

Thoracodorsal artery perforator flap reconstruction surgery PROCEDURE

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

Thoracodorsal artery perforator flap group

Forearm flaps reconstruction surgery PROCEDURE

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

Latissimus dorsi flap group

Anterolateral thigh flap reconstruction surgery PROCEDURE

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

Anterolateral thigh flap group

Fibula flap reconstruction surgery PROCEDURE

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

Fibula flap group

Forearm flap reconstruction surgery PROCEDURE

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

Forearm flap group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen Univerity

Guangzhou, Guangdong, 510120, China

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Youyuan Wang, MD, Ph.D

CONTACT

+8613631333312; Wangyy78@mail.sysu.edu.cn

Liushan Ou, MD

CONTACT

+8681332587; sys_iit@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 30, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)