Actively Recruiting

Phase Not Applicable
Age: 16Years - 60Years
All Genders
ID06920368

Comparative Study of Trans-Septal Quilting Sutures, Nasal Pack, and Intranasal Silicon Splint in Endoscopic Septoplasty

Led by Tanta University · Updated on 2025-04-16

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare three different methods used to prevent complications after endoscopic septoplasty, a surgery to correct a deviated nasal septum. The study focuses on trans-nasal quilting sutures, nasal packing, and intranasal silicon splints, examining their effects on post-surgical complications, pain, and nasal symptom improvement. Septoplasty involves removing the deviated cartilage and bone to address the nasal obstruction, but complications like hematoma, abscess, adhesions, and perforation can sometimes occur. All participants will undergo septoplasty under general anesthesia with local hemostasis measures. After the surgery, they will be randomly assigned to receive one of three interventions: nasal packing, intranasal silicon splint, or trans-septal quilting sutures. Each method aims to reduce complications by supporting the septum differently. Nasal packing may cause discomfort and breathing difficulties, silicon splints may lead to sneezing and risk of infection, while quilting sutures avoid nasal cavity blockage and reduce anxiety related to pack removal. Participants will be monitored for complications, pain levels, and nasal symptom improvements at one week, one month, and three months after surgery. The study involves clinical assessments to evaluate these outcomes and compare the three techniques. The total participation lasts at least three months postoperatively, ensuring careful follow-up of recovery and potential side effects.

CONDITIONS

Brief Title

Different Techniques for Prevention of Complications After Septoplasty Operation

Who Can Participate

Age: 16Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adult patients aged 16 to 60 years
  • Symptomatic deviated nasal septum
Not Eligible

You will not qualify if you...

  • Nasal polyposis, nasal tumors, or sinusitis not responding to medical treatment
  • Previous septal surgery
  • Planned partial inferior turbinectomy or turbinoplasty with septoplasty
  • Contraindications for general surgery procedures such as septoplasty surgery under general anesthesia or local hemostasis methods used in this study (e.g., lidocaine with epinephrine injection, topical epinephrine application, or general hypotensive anesthesia)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo septoplasty surgery using one of three techniques to prevent complications: nasal packs, intra-nasal silicon splint, or trans-septal quilting sutures.

1 surgical visit

Post-operative Follow-up

Duration - 3 months

Participants are followed to monitor complications, post-operative pain, and improvement of nasal symptoms after surgery.

Visits at 1 week, 1 month, and 3 months post-operation

Trial Site Locations

Total: 1 location

1

Tanta University Hospitals

Tanta, Egypt

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Research Team

A

Ahmed Yahia Ata, Master

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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