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Pilot study on the time saving of key manipulations in minimally invasive ear surgery by robot assisted technology

Pilot study on the time saving of key manipulations in minimally invasive ear surgery by robot assisted technology

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033076
Enrollment
Unknown
Registered
2020-05-19
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

Conductive hearing loss

Interventions

robotic-assisted group:Robot-assisted grommet insertion and ossicular bone replacement
manual group:Manual grommet insertion and ossicular replacement

Sponsors

Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 60 Years

Inclusion criteria

Inclusion criteria: a) ASA I-II level; b) Aged 3-60 years; c) Starting from December 1, 2019, the patient intends to be selected in our hospital for grommet insertion and ossicular bone replacement d) Laboratory indicators of infection and systemic conditions are normal: WBC count (4.0 ~ 10.0) x 10^9 / L; Neutrophil percentage of 50-70%; Platelet count (100 ~ 300) x 10^9 / L; Procalcitonin < 0.5ug / L The total bilirubin level is within the normal range (3.4 ~ 17.1 µmol / L); ALT/AST is within 2.5 times of normal value (0 ~ 40U / L); Serum muscle plasma is in the normal range (44-133umol / L). e) Subjects participated in the study voluntarily and signed informed consent.

Exclusion criteria

Exclusion criteria: a) Previous systemic diseases (heart, nervous system, kidney, liver or coagulation system); b) Patients who do not follow this protoco; c) Patients who refuse to participate for any reason; d) Patients whose condition changes during the operation and who need to change the procedure.

Design outcomes

Primary

MeasureTime frame
Operating time for key steps (grommet insertion, ossicular implantation);

Secondary

MeasureTime frame
Robot-assisted surgery experience score;Intraoperative complications;Postoperative infection rate;Postoperative treatment effect;

Countries

China

Contacts

Public ContactJia Huan

Department of Otolaryngology, Head & Neck Surgery, Shanghai Ninth People’s Hospital, affiliated to Shanghai Jiaotong University School of Medicine

huan_jia_orl@163.com+86 18019790827

Outcome results

None listed

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