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The multicenter prospective observational study for evaluating the rate of dysphagia after tongue reconstruction

The multicenter prospective observational study for evaluating the rate of dysphagia after tongue reconstruction - The multicenter prospective observational study for tongue reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000027583
Enrollment
200
Registered
2017-06-01
Start date
2017-09-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Tongue cancer

Interventions

None listed

Sponsors

Oral Pharyngeal Esophageal Operation and Reconstruction Analytical Group (OPERA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Established diagnosis of primary squamous cell carcinoma of tongue. 2) Subtotal or total glossectomy is performed. 3) Tongue reconstruction is performed using free flap transfer. 4) No surgical histories of intraoral reconstruction. 5) Glossectomy is performed without mandibular segmentectomy, or resection of soft palate, or larynx, or skin. 6) No surgical histories for oropharyngeal, or hypopharyngeal, or laryngeal cancer. 7) No surgical histories for esophageal, or gastric cancer. 8) No synchronous advanced cancer histories. 9) No metastases are detected. 10) Radical resection is performed. 11) Age of 20 years, or over 20 years. 12) Written informed consent has been obtained.

Exclusion criteria

Exclusion criteria: 1) ECOG performance status score 2 - 4. 2) Patients with severe condition. 3) Patients who are considered to be ineligible by referring physician.

Design outcomes

Primary

MeasureTime frame
The rate of dysphagia at twelve months after tongue reconstruction

Secondary

MeasureTime frame
The rate of aspiration within twelve months after tongue reconstruction The rate of postoperative complications within twelve months after tongue reconstruction

Countries

Japan

Contacts

Public ContactTakuya Higashino

National Cancer Center Hospital East Department of Plastic and Reconstructive Surgery

higashino-pla@umin.ac.jp04-7133-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026