Outcomes of Bipolar Electrocautery Tonsillectomy Versus Cold Steel Dissection Pediatric Tonsillectomy

NCT06494839 | Completed

• 1 other identifier: TonsillectomyLHR
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

It was intended to practically establish whether or not the relatively newer technique of tonsillectomy like bipolar electrocautery tonsillectomy has any added benefits in reducing the duration of surgery, blood loss and post-operative pain as compared with conventional cold steel dissection method. This study was done to compare the outcomes of bipolar electrocautery tonsillectomy versus cold steel dissection pediatric tonsillectomy.

Conditions

Tonsillitis

Outcome Measures

Primary Outcomes (3)

• Operative time

  Operative time was measured from the anterior pillar incision to the removal of the mouth gag.

  1 hour

• Blood loss

  Intraoperative blood loss was measured by reading the levels given in the suction bottle at the end of surgery. The weight of dry gauze was subtracted from the wet, considering 1g=1ml.

  up to 24 hours

• Postoperative pain

  Postoperative pain was measured at regular intervals (6-hourly till 24 hours) using the Wong-Baker faces pain rating scale.12 The Wong-Baker faces pain rating scale graded pain as mild (1-3), moderate (4-6), or severe (\>6).

  24 hours

Study Arms (2)

Bipolar electrocautery tonsillectomy group

EXPERIMENTAL

Procedure: Bipolar electrocautery tonsillectomy technique

Cold steel dissection group

EXPERIMENTAL

Procedure: Cold steel dissection technique

Interventions

Bipolar electrocautery tonsillectomy technique PROCEDURE

The BED tonsillectomy procedures were done under general anesthesia, and the patient's position was the same as in the other method. The bipolar machine was adjusted to 30 watts, and a mucosal incision was cauterized with a single straight or stepped bipolar forceps. After carefully cauterizing the tissue, the palatine tonsil was located and removed from the superior to the inferior pole. Most of the identifiable vessels supplying the tonsil were cauterized before being separated from the tonsil. Point coagulation was used to maintain hemostasis. By using point coagulation, hemostasis was maintained. To avoid bias stemming from competence, consultants performed all of these tonsillectomies.

Bipolar electrocautery tonsillectomy group

Cold steel dissection technique PROCEDURE

The cold steel blunt dissection tonsillectomy was carried out under general anesthesia while the patient was in the Rose position and had an endotracheal intubation. The tonsil was retracted medially with a tonsil holding forceps, and in the upper pole, the mucosal incision was made. To protect the tonsillar pillars, a delicate dissection was performed, and the suction tip was used to stop the hemorrhage. The tonsillar fossa was packed with swabs. The other palatine tonsil was then similarly removed. Hemostasis was secured by silk ligation and bipolar electrocautery.

Cold steel dissection group

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients of 5-13 years of age
• Both genders
• With a history of recurrent episodes of tonsillitis in the last year
• Children who had bilaterally enlarged tonsils
• No history of fever or sore throat in the last 4 weeks

You may not qualify if:

• Patients who had enlarged adenoids and required adenotonsillectomy
• Patients who underwent tonsillectomy after quinsy
• With a history of bleeding disorders
• Patients who showed an international normalized ratio (INR) ≥ 1.5

Sponsors & Collaborators

• RESnTEC, Institute of Research: lead

Study Sites (1)

Sir Ganga Ram Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Tonsillitis

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 10, 2024
• Study Start: November 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)