A Comparative Study of Monopolar Versus Bipolar Electroca... | NCT07265531

Studies
A Comparative Study of Monopolar Versus Bipolar Electrocautery Post Tonsillectomy Outcomes.

NCT07265531

Sponsor

Indus Hospital and Health Network

Status

Active, not recruiting

Last Update Posted

Dec 5, 2025Actual

Enrollment

74Estimated

Phase

Not provided

Conditions

Chronic Tonsillitis

Interventions

Not provided

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2025Actual

Primary Completion Date

May 1, 2026Estimated

Completion Date

Jul 1, 2026Estimated

First Submitted Date

Sep 19, 2025

First Submission Date that Met QC Criteria

Nov 24, 2025

First Posted Date

Dec 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Dec 5, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Dureshahwar Bhurgri, Dr Dureshahwar, Indus Hospital and Health NetworkPrincipal Investigator

Lead Sponsor

Indus Hospital and Health NetworkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

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 .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

74Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

The frequent patients are children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indus Hospital Karachi		Karachi	Sindh	75500	Pakistan