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Effectiveness of Transnasal Negative Pressure Therapy in Preventing Pharyngoesophageal Fistula after Total Laryngectomy: A Prospective Multicenter Randomized Controlled Trial

Effectiveness of Transnasal Negative Pressure Therapy in Preventing Pharyngoesophageal Fistula after Total Laryngectomy: A Prospective Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113515
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Pharyngoesophageal Fistula

Interventions

Experimental Group:During total laryngectomy, TNPT was placed in the lower pharynx. After the operation, negative pressure aspiration was continuously performed for one week, with a negative pressure
Control group:The patient was treated surgically in accordance with the conventional procedure of total laryngectomy.

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) The age of participants must be between 18 and 80 years; 2) Due to the needs of the condition, total laryngectomy must be performed; 3) Participants should be in good overall health, able to tolerate general anesthesia and surgery, and the Eastern Cooperative Oncology Group (ECOG) performance status score should not exceed 2; 4) Participants must be willing and able to comply with the visit, treatment plan, and other related research procedures in the study protocol.

Exclusion criteria

Exclusion criteria: 1) At the same time, there are other serious diseases that need to be effectively controlled, such as tuberculosis, leprosy, etc.; 2) Accompanied by severe abnormalities in the functions of important organs such as the heart, brain, and lungs; 3) Do not agree to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Postoperative pharyngocutaneous fistula incidence;

Secondary

MeasureTime frame
Postoperative complication rate;Quality of Life Score;

Countries

China

Contacts

Public ContactZhangwei Hu

The First Affiliated Hospital of Sun Yat-sen University

huzhw9@mail.sysu.edu.cn+86 135 5433 1318

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026