NCT07265531

Brief Summary

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 .

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jul 2025Jul 2026

Study Start

First participant enrolled

July 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

December 5, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

September 19, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

MVBETO

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The frequent patients are children

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indus Hospital Karachi

Karachi, Sindh, 75500, Pakistan

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
10 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Dureshahwar

Study Record Dates

First Submitted

September 19, 2025

First Posted

December 5, 2025

Study Start

July 20, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 5, 2025

Record last verified: 2025-09

Locations