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A retrospective analysis of risk factors for flap crisis and construction of a predictive model

A retrospective analysis of risk factors for flap crisis after head and neck tumor resection and free flap repair and construction of a predictive model

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126357
Enrollment
Unknown
Registered
2026-06-08
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Tumor, Flap Crisis

Interventions

Flap Crisis Group:None
No Flap Crisis Group:None

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Positive Group: (1) Patients who underwent radical oral cancer surgery (including tongue cancer, buccal cancer, gingival cancer, etc.) combined with flap reconstruction (such as anterolateral thigh flap, forearm flap, pectoralis major myocutaneous flap, etc.) in the Department of Oral and Maxillofacial Surgery of our hospital between June 2020 and June 2025; (2) Postoperative flap crisis (manifested as changes in flap color, decreased temperature, prolonged or absent capillary refill time, flap swelling or atrophy, etc.) occurred, and secondary surgery (such as flap exploration, partial flap resection, vascular re-anastomosis, etc.) was required after conservative treatment (e.g., warming, antispasmodics, anticoagulation, etc.) proved ineffective; (3) Complete clinical data were available, including patient demographics, preoperative examination results, surgical details, postoperative care, and follow-up records. 2. Negative Group: (1) Patients who underwent radical oral cancer surgery (including tongue cancer, buccal cancer, gingival cancer, etc.) combined with flap reconstruction (such as anterolateral thigh flap, forearm flap, pectoralis major myocutaneous flap, etc.) in the Department of Oral and Maxillofacial Surgery of our hospital between June 2020 and June 2025; (2) Complete clinical data were available, including patient demographics, preoperative examination results, surgical details, postoperative care, and follow-up records.

Exclusion criteria

Exclusion criteria: 1. Patients with severe functional failure of vital organs such as the heart, liver, or kidneys, who cannot tolerate secondary surgery; 2. Patients who underwent secondary surgery due to tumor recurrence, metastasis, or other unrelated reasons; 3. Patients with severely incomplete clinical data, where critical information cannot be obtained; 4. Patients who required repeated reoperations due to flap crisis — only data from the first surgery performed for flap crisis will be included.

Design outcomes

Primary

MeasureTime frame
Duration of the operation;Blood loss;Blood transfusion volume;History of radiotherapy and chemotherapy for tumors and related surgical history;Blood pressure;Blood glucose;Flap size and type;Hemoglobin;Platelets; Fibrinogen;DD dimer;Albumin;Potassium;sensitivity, specificity, negative predictive value, positive predictive value;

Secondary

MeasureTime frame
Chronic diseases such as hypertension, coronary heart disease and diabetes;History of smoking and drinking;Tumor size, type and stage;

Countries

China

Contacts

Public ContactChen Jie

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

chenjie.1011@163.com+86 180 1976 5266

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026