Nasal Septum; Deviation, Congenital
Conditions
Brief summary
Comparative study of nasal stents and nasal packing in patients undergoing septoplasty
Detailed description
To investigate the safety and effectiveness of nasal stent in clinical application by comparing and observing the clinical effect and comfort of nasal stent and merocel sponge applied in nasal septoplasty. Methods: patients with nasal septal deviation were selected and randomly divided into nasal stent group (experimental group) and merocel sponge group (control group) according to the packing method. The hemostasis effect, comfort and complications of the two groups were compared during the packing period.
Interventions
DEVICEnasal stents
using nasal stents after septoplasty
DEVICEmerocel
using merocel after septoplasty
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. The subjects voluntarily participate in the experiment and sign the informed consent; 2. Age range from 18 to 70 years old, gender unlimited; 3. With nasal congestion as the chief complaint, CT of sinus suggested deviation of nasal septum with indications of surgery (deviation of nasal septum affects breathing and nasal congestion is serious; High nasal septum deviation affects sinus drainage or causes reflex headache; Nasal septum spine often causes nasal bleeding; Nasal septum deviation affects eustachian tube function); 4. No history of respiratory tract infection and nasal decongestant use within 1 month before the visit; 5. No other treatment was used; 6. ASA grade 1\ 2; 7. Able to communicate well with researchers and follow the requirements of the experiment.
Exclusion criteria
1. There are acute and chronic rhinosinusitis, nasal polyps, benign and malignant tumors and other nasal diseases; 2. History of craniocerebral and nasal surgery; 3. The results of preoperative coagulation function test exceeded 20% of the upper limit of normal value; 4. Patients known to be allergic to test instrument materials; 5. Pregnant or lactating women; 6. Other organoplastic or functional diseases complicated by the subjects limited their participation in the study and could not comply with the follow-up or affect the scientific integrity of the study; 7. Participants who have participated in other clinical trials within the last 1 month; 8. Participants considered unsuitable for this clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective rate of packing | 2days after operation | (1) In the period of nasal tamponade and after the removal of the tamponade instrument (48 h ± 1 h after surgery), the nasal bleeding score was ≤ 2 points; (2) 48 h ± 1 h after the completion of nasal tamponade, the overall discomfort score ≤ 7 points; (3) No septal hematoma and nasal adhesions were confirmed by nasal endoscopy at 30 days ± 5 days after the operation. Nasal tamponade is considered effective when the above 3 criteria are met. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual analog scale（VAS）of comfort | 2days after operation | including nasal congestion, nasal pain, headache, itchy nose sneezing, watery tears, runny nose, nasal reflux, facial swelling, difficulty swallowing, sleep disturbance, dry mouth, and general discomfort. The severity of each symptom was graded using the visual analog scale (VAS) of 0 (none) to10 (unbearable) |
| security | 30days after operation | The incidence of complications and adverse events were used as safety evaluation indexes |
Countries
China
Outcome results
None listed