Endoscopic Submucosal Resection Turbinoplasty VS Turbinectomy

NCT06310083 | Completed

• 1 other identifier: SMR for Turbinate Hypertrophy
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to compare endoscopic submucosal resection Turbinoplasty and partial inferior turbinectomy regarding clinical and radiological evaluation and its possible complications in the treatment of Chronic inferior turbinate hypertrophy.

Conditions

Turbinate; Hypertrophy Mucous Membrane

Keywords

turbinoplasty; Turbinectomy; Turbinate Hypertrophy; Endoscopy

Outcome Measures

Primary Outcomes (3)

• Nasal Obstruction

  questionnaire entitled Nasal Obstruction Syndrome Evaluation, known as NOSE score is used to evaluate the improvement in nasal obstruction This score has 5 questions about life quality. Each receives a score from 0 to 4 and these are summed up and multiplied by 20. The total NOSE score ranges from 0 to 100

  3 months

• Nasal Discharge

  rhinorrhea conventional visual analogue scale (VAS) is used to evaluate nasal Discharge. Patients were asked to rank their symptoms on a scale of 0-10, with 0 denoting no symptoms and 10 denoting the most severe symptoms, with mild symptoms scoring 0-3, moderate symptoms scoring 4-7, and severe symptoms scoring 8-10

  3 months

• Crustations

  an endoscopic score of "Lund and Kennedy" is used to evaluate postoperative Crustations Grade 0 Absence of crustations Grade 1 Mild crustations: partially filling the nasal cavity Grade 2 Severe crustations: fully filling the nasal cavity

  3 months

Secondary Outcomes (3)

• intra operative blood loss

  intraoperative

• Duration of operation (Minutes )

  intraoperative

• Hyposmia

  3 months

Other Outcomes (4)

• Size Of Anterior part of Turbinate

  Baseline ; 3 months

• Size Of Posterior part of Turbinate

  Baseline ; 3 months

• Space of Anterior nasal Cavity

  Baseline ; 3 months

Study Arms (2)

Submucosal Rescetion Turbinoplasty

ACTIVE COMPARATOR

participants in this group were applied for Endoscopic submucosal resection Turbinoplasty

Procedure: Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy

Partial Inferior Turbinectomy

PLACEBO COMPARATOR

participants in this group were applied for Partial Inferior Turbinectomy

Procedure: Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy

Interventions

Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy PROCEDURE

The study's Participants Were Randomly classified in two groups Interventional Group, applied for Submucosal Resection Turbinoplasty and the controlled group who were applied for Partial Inferior Turbinectomy

Partial Inferior Turbinectomy; Submucosal Rescetion Turbinoplasty

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All patients aged between 18 and 45 years complaining with a minimum 3-month duration of nasal obstruction combined with clinical findings of inferior turbinate hypertrophy

You may not qualify if:

• Patient's Hemoglobin levels are less than 10gm%.
• Patients who were Presented with acute upper respiratory tract infection.
• Patients with other causes of nasal obstruction, e.g.,- allergic nasal polyposis, deviated nasal septum.
• Patients who have nasal tumors.
• Patients who had nasal operations before
• Presence of bleeding disorder.
• Presence of uncontrolled systemic disease.
• During the period of menses

Sponsors & Collaborators

• Ahmed Nabil Selim: lead

Study Sites (1)

Al-Azhar University Hospital of Assiut

Asyut, 17511, Egypt

Location

Related Publications (9)

• Al Awad, M. K., & Ali, M. Y. (2022). Inferior Turbinate Hypertrophy Histopathology in Allergic Rhinitis Patients and in Patients with Deviated Nasal Septum. Egyptian Journal of Ear, Nose, Throat and Allied Sciences, 23(23). https://doi.org/10.21608/ejentas.2022.141170.1518

  BACKGROUND

• Abdullah B, Singh S. Surgical Interventions for Inferior Turbinate Hypertrophy: A Comprehensive Review of Current Techniques and Technologies. Int J Environ Res Public Health. 2021 Mar 26;18(7):3441. doi: 10.3390/ijerph18073441.

  PMID: 33810309 BACKGROUND

• Thamboo, A., Ayoub, N., Maul, X., & Nayak, J. (2021a). The Inferior Turbinate: Role in Normal Respiration and Airway Obstruction. In Current Otorhinolaryngology Reports (Vol. 9, Issue 4, 98 pp. 383-388). Springer Science and Business Media B.V. https://doi.org/10.1007/s40136-021- 00370-6

  BACKGROUND

• Lee KC, Cho JM, Kim SK, Lim KR, Lee SY, Park SS. The Efficacy of Coblator in Turbinoplasty. Arch Craniofac Surg. 2017 Jun;18(2):82-88. doi: 10.7181/acfs.2017.18.2.82. Epub 2017 Jun 26.

  PMID: 28913312 BACKGROUND

• Elshipli NA, El-Sisi HE, El-Fattah AMA, Al-Saddeik MAE. Outcome comparison of submucous resection versus combined submucous diathermy and outfracture for treatment of inferior turbinate hypertrophy. Eur Arch Otorhinolaryngol. 2021 Oct;278(10):3827-3837. doi: 10.1007/s00405-021-06663-2. Epub 2021 Feb 13.

  PMID: 33582852 RESULT

• Thirugnanamani, R., Sahadevan, S., Ramabhadraiah, A. K., Menon P, A., & M Prabhu, R. (2021). Benefits of Turbinectomy vs Turbinoplasty - A Prospective Study. Bengal Journal of Otolaryngology and Head Neck Surgery, 29(2). https://doi.org/10.47210/bjohns.2021.v29i2.435

  RESULT

• Amhimmid, R. H., Mohamed, W., Amin, B., Mohamed, A. M., & Odabasha, A. E. (2022). Endoscopic Inferior Turbinoplasty Versus Radiofrequency Ablation for Treatment of Inferior Turbinate Hypertrophy. In The Egyptian Journal of Hospital Medicine (Vol. 88). https://ejhm.journals.ekb.eg/

  RESULT

• Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21.

  PMID: 7574265 RESULT

• Easa SH, Farghaly TM, Elswaby ESS, Selim A. Endoscopic Submucosal Resection Turbinoplasty and Partial Inferior Turbinectomy for Management of Inferior Turbinate Hypertrophy: A Randomized Clinical Trial. Indian J Otolaryngol Head Neck Surg. 2024 Dec;76(6):5080-5090. doi: 10.1007/s12070-024-04926-y. Epub 2024 Aug 8.

  PMID: 39559133 DERIVED

Study Officials

• Sabry H Easa, MD

  Al-Azhar University Hospital of Assiut

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The surgeons performed the nasal surgery and evaluating postoperative measurable outcomes was blinded about cases who were subjected to Endoscopic submucosal resection Turbinoplasty
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of otorhinolaryngology

Model Details: A total of 40 patients were enrolled in the study. The patients were randomly classified into two groups, with 20 in each group. Group A (study group): who applied for Endoscopic submucosal resection Turbinoplasty. Group B (control group): Who applied for partial inferior turbinectomy.

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: February 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

EG (1)