Polyp of Nasal Sinus, Sinusitis
Conditions
Keywords
FREE, Robotic
Brief summary
To evaluate the safety and feasibility of a Foot Controlled Robotic Endoscope Enabled Robot (FREE) in performing functional endoscopic sinus surgery to answer the two key questions: 1. Is the FREE robot feasible to use in patients for endoscopic sinus surgery? 2. Is the FREE robot safe to use in patients for endoscopic sinus surgery?
Detailed description
Through previous cadaver experiments we have demonstrated and experimentally validated a new foot-controlled robotic endoscope holder prototype that allows the surgeon to directly manipulate surgical instruments with both hands at all times. The conducted ex-vivo cadaver test, corroborated the feasibility of the robotic prototype. However the next step requires further clinical trials to evaluate its use in endoscopic sinus surgery in patients that is the purpose of this study
Interventions
DEVICEFREE robot
FREE robot to hold endoscope
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing FESS surgery for benign pathology
Exclusion criteria
* Pregnant/ lactating female patients * Younger than 18 years of age * Cognitive impairment or unable to provide informed consent * Malignant sinus pathologies * Previous endoscopic sinus surgery * Contraindication to general anaesthesia * Untreated active infection * Non-correctable coagulopathy * Emergency Surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion | Intraoperative | The rate of conversions to normal holding of the endoscope |
| Perioperative complications | Within 30 days postoperative | Assessment of perioperative complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical outcomes | Intraoperative and postoperative 2 weeks and 30 days | Operative time |
| Surgical Outcomes | Intraoperative and postoperative 2 weeks and 30 days | Length of stay |
| Quality of life | Within 30 days postoperative | The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Higher scores represent a worse outcome |
Countries
Hong Kong
Outcome results
None listed