Effects of different nasal septum splint removal times on patient satisfaction and postoperative results after septoplasty and septorhinoplasty

Phase 4

• Conditions: J34.2; Q30.8; M95.0; J34.8; Deviated nasal septum; Other congenital malformations of nose; Acquired deformity of nose; Other specified disorders of nose and nasal sinuses

• Registration Number: DRKS00013657
• Lead Sponsor: niversitätsklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie

Brief Summary

There were no significant differences in postoperative complications (infections, wound healing disorders, synechiae, bleeding, septal hematomas, abscesses, perforations). Incrustations were 2.1 times more frequent in the experimental group than in the control group (p = 0.051) and septal hematomas were observed exclusively with longer wearing time (p = 0.05). For all functional measurements and questionnaire scores, no significant discrepancies between the two groups K4 and E8 could be detected in the prospective comparison. Only in the comparison of the total collective from pre- to postoperative a significant improvement (p < 0.001) could be observed for the NOSE and SNOT score and acoustic rhinometry. CONCLUSION: Leaving the foils in place longer had no significant effect on patient satisfaction or objectively measurable postoperative outcomes. Earlier removal of the foils during the inpatient course could reduce the number of necessary physician contacts and relieve the medical staff.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-11
• Study Completion: 2019-04-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Included are all patients with complaints regarding a chronic obstruction of the nasal breathing, that have a septal deviation with or without a bony crooked nose and whose clinical evidence indicates a surgical intervention.

Exclusion Criteria

1. Previous surgeries of the nasal septum (no revision surgeries).
2. Nicotin consumption >1 package/d.
3. Strong allergic Symptoms.
4. Patients with obstructive sleep apnea syndrome.
5. Patients that are not able to let their splints be removed in our clinic on the 4th or 8th postoperative day.
6. Patients with serious underlying medical conditions.
7. nose operations with open accesses (e.g. open SRP)
8. insufficient knowledge of German to fill in the questionnaires independently (SNOT20 GAV, NOSE)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Straightness of the nasal septum and patency of the nose:<br>By means of a simple, clinically practicable staging system and the associated photo documentation the nasal septum should be evaluated preoperatively and six months after the surgery.<br>Furthermore the patency of the nasal passages is examined via rhinomanometry and acoustic rhinometry preoperatively and six months after the surgery in order to objectify the collected data about the septal shape.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction:<br>Using validated questionnaires (SNOT20 GAV, NOSE), patient satisfaction should be recorded preoperatively and six months postoperatively.