Outcomes of Bipolar Electrocautery Tonsillectomy Versus Cold Steel Dissection Pediatric Tonsillectomy

NCT ID: NCT06494839

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bipolar electrocautery tonsillectomy group

Group Type: EXPERIMENTAL

Bipolar electrocautery tonsillectomy technique

Intervention Type: 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.

Cold steel dissection group

Group Type: EXPERIMENTAL

Cold steel dissection technique

Intervention Type: 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 The tonsil was retracted medially with a tonsil holding forceps, and in the upper pole, the mucosal incision was made.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.

Interventions

Bipolar electrocautery tonsillectomy technique

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.

Intervention Type: PROCEDURE

Cold steel dissection technique

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RESnTEC, Institute of Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sir Ganga Ram Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

TonsillectomyLHR

Identifier Type: -

Identifier Source: org_study_id