BiZact Tonsillectomy in the Pediatric Population

October 25, 2023 updated by: Ronald Vilela, Baylor College of Medicine

BiZact Tonsillectomy

This study has been designed to evaluate how effective the Bizact tonsillectomy device is in reducing operating time and complications that occur after surgery. This device operates in a different way than the standard device that is used for most tonsillectomies. In 2019, a study was conducted in 186 children and adults using this device in tonsillectomies. Results showed lower blood loss and shortened time in surgery. However, the rate for bleeding as a complication after surgery was the same as other procedures that are used in tonsillectomy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Tonsillectomy is the second most common pediatric surgical procedure, with more than 280,000 performed in children under the age of 15 in the United States in 2010. The most common indications for tonsillectomy in children include recurrent infections and obstructive sleep apnea. While tonsillectomy in the pediatric population is generally safe and well-tolerated, post-operative complications are not uncommon, with post-operative pain, respiratory compromise, and post-tonsillectomy hemorrhage being chief among them.

Post-operative pain has been described as the main morbidity associated with tonsillectomy and is often ineffectively controlled. Pain beyond the initial 24-hour post-operative period has been noted to be worse with the use of electrocautery when compared to cold-knife dissection and snare tonsillectomy, perhaps attributable to the high levels of heat (400 °C to 600 °C) applied directly to the tonsillar area. Yet electrocautery remains one of the most frequently utilized tools due to its hemostatic effects through vessel coagulation at the time of dissection. Still, a recent large meta-analysis reported the rates of primary post-tonsillectomy hemorrhage (bleeding within the first 24 hours) at 2.4% and secondary post-tonsillectomy hemorrhage (beyond 24 hours) at 2.6%, suggesting that bleeding after tonsillectomy remains a relatively common occurrence. The search for a methodology that improves post-operative pain without increasing the risk of post-operative hemorrhage remains an active area of research.

Coblation, which creates an ionized plasma layer by passing a bipolar radio-frequency current through a medium of saline, offers another approach. The saline irrigation results in much less heat when compared to monopolar cautery, measuring approximately 40°C to 70°C. Coblation can be used in both subcapsular and intracapsular fashion. Subcapsular tonsillectomy with coblation has demonstrated a minimal decrease in pain, and may result in slightly higher rates of post-operative hemorrhage.

It has been pointed out that bipolar cautery could result in lower thermal injury and reduced blood loss, however tonsillectomy using traditional bipolar forceps leads to longer operative times. One group found that the use of BiClamp, a bipolar vascular sealing device originally designed for thyroidectomy, provided decreased operative times and less intraoperative bleeding compared to electrocautery. They noted, however, instances of posterior pillar perforation, which they attributed to curvature of the device that was designed for thyroid surgery, making dissection of the superior pole more difficult. Medtronic has now developed a similar device designed for use in tonsillectomy with a curved jaw meant to follow the contour of the tonsillar bed. In its marketing material for the recently developed BiZact , Medtronic describes a bipolar device that continuously measures the impedance of clamped tissue, adjusting energy levels in real-time and automatically stopping energy delivery when a seal is established. Their literature suggests the device permanently seals vessels up to 3mm with less thermal damage, resulting in less intraoperative blood loss, more efficient procedures, and possibly less pain.

In a pilot study of 186 patients, intraoperative blood loss was shown to be <1ml of blood loss in 71 cases (38.2%) and between 1 and 10ml of blood loss in 81 cases (43.5%). Post-operative hemorrhage rate of 4.3% is similar to rates described by other studies. BiZact tonsillectomy allows for a shortened operative time with a median time of 5.1 minutes. Other studies have shown other techniques to have a time duration of 21.6 minutes (electrocautery), 20.20 minutes (coblator), and 16.14 minutes (microdebrider).

In off label use of the device at our institution, data from surgeons using the device showed that surgeons perceived a relative improvement in following compared to standard tonsillectomy:

  1. Less perceived thermal heat transfer to surrounding soft tissues
  2. Left perceived blood loss
  3. Superior ease of obtaining timely hemostasis
  4. Faster operative time

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Sub-Investigator:
          • Daniel Chelius, MD
        • Sub-Investigator:
          • Shraddha Mukerji, MD
        • Sub-Investigator:
          • Carol Yi-Chun Liu, MD
        • Sub-Investigator:
          • Matthew D Chelius, MD
        • Sub-Investigator:
          • Sonal Saraiya, MD
        • Sub-Investigator:
          • Jeff Carter
        • Sub-Investigator:
          • Alexis Moisiuc
        • Contact:
          • Ronald Vilela, MD
          • Phone Number: 832-822-3268
        • Contact:
          • Grace Anand, MPH
          • Phone Number: 8328221980

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Tonsil hypertrophy with sleep disordered breathing
  • Recurrent tonsillitis or pharyngitis
  • Tonsil asymmetry or neoplasm
  • Tonsil stones
  • Must be able to take ibuprofen

Exclusion Criteria:

  • Bleeding disorders such as von Willebrand's disease or hemophilia
  • Down's Syndrome or other craniofacial syndromes
  • Revision tonsillectomy cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BiZact
A bipolar electrosurgical device that employs radiofrequency(RF) energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger
Device: BiZact
It has been described as describes a bipolar device that continuously measures impedance of clamped tissue, adjusting energy levels in real time and automatically stopping energy delivery when a seal is established. Their literature suggests the device permanently seals vessels up to 3mm with less thermal damage, resulting in less intraoperative blood loss, more efficient procedures, and possibly less pain
Active Comparator: Standard of care
In electrocautery tonsillectomy (or diathermy) electric current from a radiofrequency generator is passed through the tissue between two electrodes. The resulting high temperature (400º-600ºC) cuts the tissue and simultaneously seals the blood vessels
Procedure: Standard of care
This method would involve removal of tonsils using electrocautery technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency room visits
Time Frame: 2 months
Emergency room visits following tonsillectomy commonly involve poorly controlled pain, dehydration, and post-tonsillectomy hemorrhage. The investigators will tabulate the number of ER visits related to post-operative factors by reviewing charts of tonsillectomy patients two months post-operatively.
2 months
Intra-operative blood loss
Time Frame: Duration of surgery
Intra-operative blood loss will be recorded in milliliters for all patients undergoing tonsillectomy using the BiZact device. Additionally, each surgeon using the Bi-zact device will maintain records of intra-operative blood loss in milliliters for tonsillectomies utilizing standard electrocautery for tonsillectomy.
Duration of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-tonsillectomy hemorrhage
Time Frame: 2 months
Post-tonsillectomy hemorrhage is a known complication of tonsillectomy. The investigators will tabulate the incidence of post-tonsillectomy hemorrhage by reviewing emergency room visits in the post-operative period and through follow-up questionnaires at the first post-operative clinic visit.
2 months
Pain level
Time Frame: 14 days
Patients will be asked to maintain a pain diary. The investigators will ask the parent or caretaker to document the Wong-Baker FACES Pain Rating Scale twice a day for fourteen days.
14 days
Pain medication documentation
Time Frame: 5 days
Post-operative pain protocol at Texas Children's Hospital includes scheduled weight-based doses of ibuprofen every 6 hours for 5 days, acetaminophen every 4-6 hours as needed, and a one-time dose of dexamethasone as needed to be given on post-operative day 3, 4, or 5 for breakthrough pain. Patients are also instructed to use ibuprofen as needed for pain after the first 5 days. Participants will be instructed to maintain accurate records of use of acetaminophen and dexamethasone use, and use of ibuprofen beyond 5 days post-operatively
5 days
Operating time
Time Frame: Duration of procedure
Operative time in minutes will be recorded for all patients undergoing tonsillectomy using the BiZact device. Additionally, each surgeon using the BiZact device will maintain records of operative time using standard electrocautery for tonsillectomy
Duration of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2021

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

November 26, 2020

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-44399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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