Comparison of Tonsillectomy Outcomes Using LigaSure Device-Assisted Technique Versus Conventional Method

Comparison of the efficacy, complications, and clinical outcomes of two techniques, LigaSure and cold dissection, in tonsillectomy surgery.

The present study is a phase 3, single-blind, controlled clinical trial with two parallel groups . Thirty eligible individuals will be randomly assigned to each group using random blocks

Sixty eligible patients referred to the clinic of Baqiyatallah Hospital, will be randomly divided into two groups: cold dissection and LigaSure. Intervention group: Tonsillectomy surgery is performed using LigaSure. Control group: Tonsillectomy is performed using cold dissection. patients do not know which group they have been assigned to, but they were informed about both methods beforehand and entered the study with full consent. Since they are under anesthesia, they are unaware of how their surgery was performed. Additionally, the treatment outcome assessor and the data analyst will be blinded to the study hypothesis.

Inclusion criteria: Patients older than 3 years and younger than 16 years who are candidates for tonsillectomy surgery; have provided consent for the procedure; undergoing tonsillectomy for the first time. Exclusion criteria: Patients who have a history of incomplete tonsil surgery, have coagulation disorders, or withdraw from continued cooperation during the study.

Tonsillectomy surgery is performed using LigaSure. Control group: Tonsillectomy is performed using cold dissection. In this method, the tonsil and its capsule are separated from the surrounding tissues using a dissector, detached from the lower pole, and the tonsil is removed.

Pain intensity at the surgical site (pharynx) based on the Visual Analogue Scale (VAS)

Random allocation will be performed using the random blocking method (four-block blocks). The possible blocks are as follows: 1- AABB, 2- ABAB, 3- BABA, 4- BBAA, 5- BAAB, 6- ABBA. At this stage, numbers (1 to 6) will be randomly selected using a random number table, and this process will be repeated 15 times until the sample size is reached

Patients do not know which group they have been assigned to, but they were informed about both methods beforehand and entered the study with full consent. Since they are under anesthesia, they are unaware of how their surgery was performed. Additionally, the outcome assessor and the data analyst are blinded to the study hypothesis.

Due to patient confidentiality and privacy considerations, we have not received permission from the ethics committee to share individual patient data