A Comparative Study of Monopolar Versus Bipolar Electrocautery Post Tonsillectomy Outcomes. (CSMVBET)

This study aims to compare surgical techniques (monopolar and bipolar electrocautery -used during tonsillectomy,a common procedure to remove toonsils.The goal is to determine which method results in less pain and bleeding for patients after surgery .

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Tonsillitis

Detailed Description

To evaluate and compare post operative pain and bleeding outcomesbetween monopolar and bipolar electrocautery technique used dutring tonsillectomy .

Methodology : Total 112 patients were randomly divided into two groups (56 each groups ).Pain was assessed postoperatively and classified as mild ,moderate or severe .

• Study Type: Observational
• Enrollment (Estimated): 74

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75500
      • Indus Hospital Karachi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The frequent patients are children

Description

Inclusion Criteria

• Patients aged between 5 and 40 years.
• Indicated for elective tonsillectomy due to recurrent tonsillitis, obstructive sleep apnea, or chronic tonsillar hypertrophy.
• Medically stable to undergo general anesthesia and surgical procedure.
• Ability to understand and provide informed consent (or parental/guardian consent for minors).
• Willing to complyy with study procedures and follow-up schedule. Exclusion Criteria
• History of bleeding disorders (e.g., hemophilia, thrombocytopenia).
• Use of anticoagulants or antiplatelet therapy within 7 days prior to surgery.
• Known allergy or adverse reaction to anesthesia agents used in the procedure.
• Previous tonsillar surgery or peritonsillar abscess drainage.
• Severe comorbidities that may interfere with surgery or recovery (e.g., uncontrolled diabetes, heart failure).
• Patients with craniofacial abnormalities affecting the airway.
• Inability to understand or comply with study requirements.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain and bleeding in patient undergone tonsillectomy	Postoperative Bleeding: Occurrence of postoperative reactionary and secondary bleeding Reactionary bleeding: If bleeding occurs within the first 24 hours after surgery. Secondary bleeding: If bleeding occurs beyond 24 hours within 7-10 days after surgery. Pain: Pain will be evaluated by Visual analog score on 1st postoperative day,3rd postoperative day and 7th post operative, visual analog score will be 0 (no pain)1 to 3 (mild),3 to 6(moderate),6 to 9 (severe),10(worst).	24 hours after surgery and beyond 24 hours

Collaborators and Investigators

• Sponsor: Indus Hospital and Health Network

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: September 19, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: MVBETO
• Other Study ID Numbers: IHHN_IRB_2024_12_021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No