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临床试验/DRKS00013657
DRKS00013657已完成4 期

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

niversitätsklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie0 个研究点目标入组 78 人开始时间: 2018年1月11日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
78

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
16 Years 至 60 Years(—)
性别
All

入选标准

  • 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.

排除标准

  • 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)

研究者

发起方
niversitätsklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie

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