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Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum

10. januar 2016 opdateret af: SHOROOK NA'ARA MD, Rambam Health Care Campus

Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum: A Prospective, Randomized Controlled Trial

In this study the investigators aim to assess whether endoscopic septoplasty is effective at improving patients QOL and reducing postoperative signs and complications.

Primary outcome: To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding variables.

Secondary outcomes:

  1. To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
  2. To evaluate the differences in the operation time between the two different approaches.

Studieoversigt

Detaljeret beskrivelse

Nasal obstruction is one of the most common complaints that the otorhinolaryngologist faces in the daily practice. Deviated nasal septum (DNS) is a very frequently encountered and common cause. It not only causes breathing difficulties but also results in improper aeration of paranasal sinuses predisiposing to sinusitis and also results in drying of mucosa leading to crusting and epistaxis 1,2. DNS can also be accompanied with hypertrophic nasal turbinates causing sleep disturbances and snoring3.

Septoplasty is an accepted and common surgical intervention to improve the nasal airway4 and sleep disturbances3.

Traditional septoplasty procedure involves sum mucosal resection of the anterior septum. The results for long-term symptom relief after traditional septoplasty are contradictory in reviewed publications 5.

In the last two decades the endoscopic Sino nasal surgery has been widely used including endoscopic approach for septoplasty. Endoscopic septoplasty as a minimally invasive technique where the dissection of the nasal septal flap can be limited minimizing trauma. The excellent visualization is presumed to decrease morbidity and post-operative swelling in isolated septal deviation by limiting the excision to the area of deviation 2. Furthermore, diagnosing and treating abnormalities of the lateral wall of the nose at the same sitting is only feasible in the endoscopic approach.

At the time of this study, there are no studies comparing the changes of quality of life in patients undergoing traditional septoplasty Vs endoscopic septoplasty.

The investigators aimed to assess whether endoscopic septoplasty is effective at improving patients QOL and reducing postoperative signs and complications.

Aims

Primary:

1) To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding variables.

Secondary:

  1. To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
  2. To evaluate the differences in the operation time between the two different approaches.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Diagnosis of nasal obstruction and deviated nasal septum with or without hypertrophy of nasal turbinates.
  2. Patient undergoing surgery for repairing the deviated nasal septum.

Exclusion Criteria:

  1. Diagnosis of bilateral acute or chronic rhinosinusitis or nasal polyposis
  2. Patients undergoing endoscopic sinonasal surgery.
  3. Diagnosed with inflammatory (e.g. Wegener's granulomatosis, sarcoidosis) or neoplastic nasal pathology
  4. Diagnosed with systemic conditions affecting the nose e.g. Cystic fibrosis, Kartagener's syndrome
  5. Patients listed for revision surgery
  6. Neoplasms - untreated or under active or recent treatment with chemotherapy or radiotherapy
  7. Unable to give informed consent due to mental impairment
  8. Unable to adhere follow up or treatment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Traditional
a control arm of patients undergoing traditional septoplasty for DNS
septoplasty under direct vision
Eksperimentel: Endoscopic
patients undergoing endoscopic septoplasty.
Endoscopic surgery; septoplasty with or without middle turbenectomy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Quality of life
Tidsramme: Baseline (maximum 3 months before surgery), at 2-3 weeks, and 3-4 months after the surgery.
quality of life will assessed using Sino-Nasal Outcome Test-22 (SNOT-22) scores.
Baseline (maximum 3 months before surgery), at 2-3 weeks, and 3-4 months after the surgery.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2016

Primær færdiggørelse (Forventet)

1. februar 2019

Datoer for studieregistrering

Først indsendt

6. januar 2016

Først indsendt, der opfyldte QC-kriterier

10. januar 2016

Først opslået (Skøn)

13. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 0576-15-RMB

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Intranasal Surgery

Kliniske forsøg med Traditional septoplasty

3
Abonner