Oral Squamous Cell Carcinoma (OSCC)NCT06599801
Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Reconstruction
An observational study of Oral Squamous Cell Carcinoma (OSCC), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC)
- What is being tested?
- Thoracodorsal artery perforator flap reconstruction surgery, Forearm flaps reconstruction surgery and Anterolateral thigh flap reconstruction surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 217 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen Univerity
Guangzhou, Guangdong, 510120
Youyuan Wang, MD, Ph.D, +8613631333312, wufan43@mail2.sysu.edu.cnWangyy78@mail.sysu.edu.cn
Liushan Ou, MD, +8681332587, sys_iit@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Being tested
- Thoracodorsal artery perforator flap reconstruction surgery, Forearm flaps reconstruction surgery, Anterolateral thigh flap reconstruction surgery, Fibula flap reconstruction surgery, Forearm flap reconstruction surgery
- Keywords
- Oral Squamous Cell Carcinoma, thoracodorsal artery perforator flap, quality of life, free flap
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracodorsal artery perforator flap reconstruction surgeryProcedure or surgery
Oral squamous cell carcinoma patients underwent reconstruction with thoracodorsal artery perforator (TDAP) flaps following tumor resection.
Forearm flaps reconstruction surgeryProcedure or surgery
Oral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection
Anterolateral thigh flap reconstruction surgeryProcedure or surgery
Oral squamous cell carcinoma patients received the reconstruction with anterolateral thigh flaps after tumor resection
Fibula flap reconstruction surgeryProcedure or surgery
Oral squamous cell carcinoma patients received the reconstruction with fibula flaps after tumor resection
Forearm flap reconstruction surgeryProcedure or surgery
Oral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection
| Study group | Role | What they receive |
|---|---|---|
| Anterolateral thigh flap group | Oral squamous cell carcinoma patients received the reconstruction with anterolateral thigh flaps after tumor resection Receives: Procedure: Anterolateral thigh flap reconstruction surgery | |
| Forearm flap group | Oral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection Receives: Procedure: Forearm flap reconstruction surgery | |
| Latissimus dorsi flap group | Oral squamous cell carcinoma patients received the reconstruction with latissimus dorsi flaps after tumor resection Receives: Procedure: Forearm flaps reconstruction surgery | |
| Fibula flap group | Oral squamous cell carcinoma patients received the reconstruction with Fibula flaps after tumor resection Receives: 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 Receives: Procedure: Thoracodorsal artery perforator flap reconstruction surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative at 1, 3, 6, and 12 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative at 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 217 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599801
- Sponsor's protocol ID
- SYSKY-2024-710-01
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 38147089Zhou 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.
PubMed 32289869Wu 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.
PubMed 41350686
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Defect Reconstruction: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06599801
- Acronym / sponsor ID
- SYSKY-2024-710-01
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Keywords
- Oral Squamous Cell Carcinoma, thoracodorsal artery perforator flap, quality of life, free flap
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 217 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Anterolateral thigh flap group | – | Procedure: Anterolateral thigh flap reconstruction surgeryOral squamous cell carcinoma patients received the reconstruction with anterolateral thigh flaps after tumor resection |
| Forearm flap group | – | Procedure: Forearm flap reconstruction surgeryOral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection |
| Latissimus dorsi flap group | – | Procedure: Forearm flaps reconstruction surgeryOral squamous cell carcinoma patients received the reconstruction with latissimus dorsi flaps after tumor resection |
| Fibula flap group | – | Procedure: Fibula flap reconstruction surgeryOral squamous cell carcinoma patients received the reconstruction with Fibula flaps after tumor resection |
| Thoracodorsal artery perforator flap group | – | Procedure: Thoracodorsal artery perforator flap reconstruction surgeryOral squamous cell carcinoma patients received the reconstruction with Thoracodorsal artery perforator flaps after tumor resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracodorsal artery perforator flap reconstruction surgeryOral squamous cell carcinoma patients underwent reconstruction with thoracodorsal artery perforator (TDAP) flaps following tumor resection. | Procedure or surgery | Thoracodorsal artery perforator flap group |
| Forearm flaps reconstruction surgeryOral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection | Procedure or surgery | Latissimus dorsi flap group |
| Anterolateral thigh flap reconstruction surgeryOral squamous cell carcinoma patients received the reconstruction with anterolateral thigh flaps after tumor resection | Procedure or surgery | Anterolateral thigh flap group |
| Fibula flap reconstruction surgeryOral squamous cell carcinoma patients received the reconstruction with fibula flaps after tumor resection | Procedure or surgery | Fibula flap group |
| Forearm flap reconstruction surgeryOral squamous cell carcinoma patients received the reconstruction with forearm flaps after tumor resection | Procedure or surgery | Forearm flap group |
Primary outcome
Postoperative Quality of Life
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
8 secondary outcomes
Flap Complication Incidence
Time frame: Postoperative at 1, 3, 6, and 12 months
Flap Failure Incidence
Time frame: Postoperative at 1, 3, 6, and 12 months
Postoperative Complications
Time frame: Postoperative at 1, 3, 6, and 12 months
Patient Bed Rest Duration
Time frame: Postoperative at 1 months
Flap Pedicle Vein Diameter
Time frame: Postoperative at 1 day
Flap Pedicle Artery Diameter
Time frame: Postoperative at 1 day
Flap Pedicle Vessel Separation Length
Time frame: Postoperative at 1 day
Flap Surgical Operation Time
Time frame: Postoperative at 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 38147089Min 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.
- Background: PubMed 32289869Zhou 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.
- Derived from this study: PubMed 41350686Wu 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma (OSCC), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youyuan Wang, MD, Ph.D (+8613631333312, Wangyy78@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Quality of Life (time frame: Postoperative at 1, 3, 6, and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06599801, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.