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A prospective randomized controlled trial: comparison of two different suture methods in HUPPP surgery

A prospective randomized controlled trial: comparison of two different suture methods in HUPPP surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049881
Enrollment
Unknown
Registered
2021-08-10
Start date
2021-09-25
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Obstructive sleep apnea hypopnea syndrome

Interventions

Control group:simple suture
Experimental group:double "8" suture of velopharyngeal muscle

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with moderate to severe OSAHS diagnosed by laboratory polysomnography (PSG) cannot tolerate CPAP therapy; 2. The plane of obstruction is in the oropharynx: the pharyngeal cavity is narrow due to hypertrophic mucosal tissue, the uvula is hypertrophic or too long, the soft palate is too low or too long, the tonsils are hypertrophic or the palate is narrow; 3. Male, aged 18 to 65 years; 4. Patients voluntarily participate in this clinical study and sign the informed consent form; they are willing and able to follow up with the program in a timely manner.

Exclusion criteria

Exclusion criteria: 1. OSAHS patients who have received relevant surgical treatment; 2. Patients with severe craniomaxillofacial deformities (examinations indicate that there is no stenosis in other upper airway regions); 3. Those with scar constitution; 4. Patients with heart failure or central sleep apnea hypopnea syndrome; 5. People with coagulation dysfunction; 6. Mental illness or mental disorder; 7. Chronic obstructive pulmonary disease, asthma, chronic bronchitis and other airway inflammatory diseases and rheumatoid and other systemic diseases; 8. The investigator believes that there are any reasons for not being suitable to participate in the trial.

Design outcomes

Primary

MeasureTime frame
score of assessment scale;

Secondary

MeasureTime frame
Apnea hypopnea index;

Countries

China

Contacts

Public ContactYi Hongliang

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

yihongl@126.com+86 18930172215

Outcome results

None listed

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