Health TrialsbyHealthPanel

Different Techniques for Prevention of Complications After Septoplasty Operation

ConditionSeptoplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-60
SponsorTanta University

About this trial

the aim of the study is to compare complication of trans-nasal quilting sutures, nasal pack and intra intranasal silicon splint in endoscopic septoplasty

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Healthy adult patient of different ages from 16 to 60 year-old with symptomatic deviated nasal septum

Disqualifiers

Patient with nasal polyposis or nasal tumors or patients with sinusitis not responding to medical treatment.

Patient with previous septal operation

Patient who is planned to do partial inferior turbinectomy or turbinoplasty with septoplasty

Patients with contraindications for general surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • septoplasty with nasal packs

    Procedure/Surgery

    Septoplasty to all the patients will be done using general hypotensive anesthesia via cuffed oral endotracheal tube. The patient will be positioned in a slight reverse Trendelenburg position. Local hemostasis will be achieved by injection of lidocaine with epinephrine (1:100000) with placement of topical epinephrine soaked cotton (1:1000) then nasal packs in inserted at the end of operation for prevention of post operative complication

  • septoplasty with intra-nasal silicon splint

    Procedure/Surgery

    Septoplasty to all the patients will be done using general hypotensive anesthesia via cuffed oral endotracheal tube. The patient will be positioned in a slight reverse Trendelenburg position. Local hemostasis will be achieved by injection of lidocaine with epinephrine (1:100000) with placement of topical epinephrine soaked cotton (1:1000) then intra-nasal silicon splint is inserted at the end of operation for prevention of post operative complication

  • septoplasty with trans--septal quilting sutures

    Procedure/Surgery

    Septoplasty to all the patients will be done using general hypotensive anesthesia via cuffed oral endotracheal tube. The patient will be positioned in a slight reverse Trendelenburg position. Local hemostasis will be achieved by injection of lidocaine with epinephrine (1:100000) with placement of topical epinephrine soaked cotton (1:1000) then trans-septal quilting sutures is done at the end of operation for prevention of post operative complication

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: nasal packActive comparator 1 intervention
Group B: intra-nasal silicon splintActive comparator 1 intervention
Group C: trans-septal quilting suturesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

complication of septoplasty

endoscopic assessment of post operative recovery and complication

Time frame
1 week, one month and 3 months postoperatively
2

post operative pain

post operative pain will be assessed via Visual Analogue scale ( VAS ) on scale from 0 to 10 as higher scores mean worse outcome.

Time frame
1 week, 1 month and 3 months postoperatively
3

improvement of nasal symptoms

improvement of nasal symptoms will be assessed by using validated Arabic version of NOSE score from 0 to 4 as higher scores mean worse outcome.

Time frame
1 week, 1 months and 3 months post operatively

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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