Coblation Versus Suction Diathermy in Pediatric Adenoidectomy

NCT06841432 | Completed DMC

• 1 other identifier: MSCAZASTENT03028
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare two surgical procedures in endoscopic adenoidectomy including Coblation and Suction diathermy . The main questions it aims to answer are: Does the Coblation device have less time, less pain, less postoperative crustation and bad odor, less intraoperative bleeding, and less recurrence? Participants will: will undergo both procedures every day for 6 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms

Conditions

Adenoid Hypertrophy; Adenoidectomy; Coblation Adenoidectomy; Suction Daithermy

Keywords

Endoscopic; Adenoidectomy; adenoid hypertrophy; Pediatric; Suction Diathermy; Coblation

Outcome Measures

Primary Outcomes (3)

• Operative duration

  The procedure, from the initial insertion of the Bowel-Davis mouth gag to the complete removal of the adenoid and the gag, was timed in minutes.

  During the procedure

• Intraopertive blood loss

  Boezaart surgical field grading scale was used to evaluate the intraoperative bleeding

  during the procedures

• Postopertaive Pain

  The Wong-Baker Pain Scale consists of 6 faces depicting different levels of pain. Face 1 represents no pain, Face 2 indicates a little bit of hurt, Face 3 indicates a little more hurt, Face 4 indicates even more hurt, Face 5 indicates a whole lot of hurt, and Face 6 indicates the worst possible hurt, with pain scores ranging from 0 to 10. Both the children and their parents were informed about the purpose of the questionnaires and how to fill them out before the surgery

  Patients reported their pain levels every day before taking any pain medication during the 7 days after their surgery

Secondary Outcomes (4)

• Development of bad breath

  from the end of operation till 2 weeks post operation

• recovery time

  three months post opertaive

• secondary bleeding

  up to one month surgery

• Pre- and post-adenoid size grading

  preintervention (one day before opertaion ) and postintervention (up to three months)

Study Arms (2)

patients who underwent the adenoidectomy using suction diathermy

ACTIVE COMPARATOR

One hundred and five patients underwent a suction diathermy adenoidectomy procedure. The soft palate was gently retracted using two suction catheters, allowing a 70-degree angled endoscope (Storz, Germany) placed in the oropharynx to provide a clear view of the adenoidal tissue and surrounding structures in the nasopharynx. Using a malleable size 10 or 12 French hand-switching suction coagulator, the adenoidal tissue was carefully ablated, starting from the uppermost part. The procedure was completed when the posterior choanae were clearly visible, and the nasopharynx had a smooth, unobstructed appearance. Great care was taken to avoid injuring the Eustachian tube orifice, posterior septum, choanae, inferior turbinate, palate, and posterior pharyngeal wall. Continuous irrigation with saline, either through the mouth or the nose, helped minimize any thermal damage caused by the diathermy machine.

Procedure: adenoidectomy by Suction diathermy

patients who underwent the adenoidectomy using coblation

EXPERIMENTAL

One hundred and five patients underwent a Coblation-assisted adenoidectomy procedure. The child was positioned in Rose's position, which helped retract the soft palate and improve visibility of the nasopharynx. Two soft rubber catheters were inserted into the patient's mouth, with the distal and proximal ends crossed externally and secured with a clamp. The COBLATOR™ II surgery system Model EC8000-01 was used, with a power setting of nine for ablation and five for coagulation. Under general anesthesia, the adenoidectomy was performed using either a 4 mm, 70-degree angled endoscope inserted orally or a zero-degree endoscope inserted through the nose, providing effective visualization of the nasopharynx. After the procedure, hemostasis was achieved by using a combination of the coagulation and ablation modes.

Procedure: adenoidectomy using coblatioion

Interventions

adenoidectomy using coblatioion PROCEDURE

One hundred and five patients underwent a Coblation-assisted adenoidectomy procedure. The child was positioned in Rose's position, which helped retract the soft palate and improve visibility of the nasopharynx. Two soft rubber catheters were inserted into the patient's mouth, with the distal and proximal ends crossed externally and secured with a clamp. The COBLATOR™ II surgery system Model EC8000-01 was used, with a power setting of nine for ablation and five for coagulation. Under general anesthesia, the adenoidectomy was performed using either a 4 mm, 70-degree angled endoscope inserted orally or a zero-degree endoscope inserted through the nose, providing effective visualization of the nasopharynx. After the procedure, hemostasis was achieved by using a combination of the coagulation and ablation modes.

patients who underwent the adenoidectomy using coblation

adenoidectomy by Suction diathermy PROCEDURE

One hundred and five patients underwent a suction diathermy adenoidectomy procedure. The soft palate was gently retracted using two suction catheters, allowing a 70-degree angled endoscope (Storz, Germany) placed in the oropharynx to provide a clear view of the adenoidal tissue and surrounding structures in the nasopharynx. Using a malleable size 10 or 12 French hand-switching suction coagulator, the adenoidal tissue was carefully ablated, starting from the uppermost part. The procedure was completed when the posterior choanae were clearly visible, and the nasopharynx had a smooth, unobstructed appearance. Great care was taken to avoid injuring the Eustachian tube orifice, posterior septum, choanae, inferior turbinate, palate, and posterior pharyngeal wall. Continuous irrigation with saline, either through the mouth or the nose, helped minimize any thermal damage caused by the diathermy machine.

patients who underwent the adenoidectomy using suction diathermy

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• all patients aged 2 to 18 years
• patients who had isolated adenoid hypertrophy
• patients' hemoglobin levels above 10 mg/dl

You may not qualify if:

• those with recent upper respiratory tract infections, evidence of bleeding disorders, serous otitis media, chronic tonsillitis
• those advised against undergoing adenoidectomy after consulting a phoniatrist
• patients with atrophic rhinitis those with nasal obstruction caused by other nasal or paranasal conditions such as inferior turbinate hypertrophy, Choanal atresia, deviated nasal septum, antrochoanal polyps, and other causes of nasal obstruction in children.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Alazhar university Hopital in Assiut

Asyut, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor of otorhinolanrgology at alazhar univeristy hopsital in assiut

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 24, 2025
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

EG (1)