Comparison of Cold Dissection Technique and Needle Monopolar Electrocautery Tonsillectomy (TONSIL)

August 8, 2016 updated by: Berke Ozucer, Gaziosmanpasa Research and Education Hospital
Patients 13-years-or older who undergo tonsillectomy operation (without another additional surgery) will be enrolled in the study. Randomly, one side is going to be operated with conventional cold-knife technique and hemostasis will be maintained with bipolar diathermy (25-30w). Contralateral tonsil is going to be operated with needle-tip monopolar electrocautery (10-12w) at Blend 1 mode and hemostasis will also be maintained with needle-tip monopolar cautery. Postoperative tonsillar fossa healing and pain is going to be evaluated for both sides separately with Visual Analogue Scale. All operations are going to be performed by a single surgeon and all evaluations are going to be carried out by another surgeon in a totally blinded fashion to avoid possible bias.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Comparison of cold and hot tonsillectomy carried out with needle-point tip monopolar electrocautery: a prospective, randomized, blinded, controlled (paired design) : A Randomized Clinical Trial

Tonsillectomy surgery techniques are basically divided into cold steel knife dissection and other (hot) techniques where surgeons use electrocautery and other contemporary technological devices. Pros / cons of hot and cold techniques have been long researched in the literature. Parameters are: cost, postoperative bleeding rate, postoperative pain. (Leinbach RF) Latest research proved that monopolar electrocautery (EC) is ideal when cost/postoperative bleeding rate ratio is concerned. (Cunningham LC) Although EC presents as a viable option, hot techniques - although providing good advantages - result with a more painful postoperative period. Trade-off with electrosurgery is the heat generated to cut/coagulate the tissue also causes a variable amount of tissue necrosis consequent to thermal injury. This pain is associated with the thermal injury and consequent tissue necrosis. (Hetzler D) Needle electrocautery tips are thinner compared to conventional bovie tip. Their surface area is smaller and according to the study carried out by Farnworth et al. (Farnworth TK) cause reduced thermal injury compared to conventional blade tip.

The investigators' aim in this study is to compare cold-knife dissection + bipolar diathermy tonsillectomy with needle tip EC monopolar cautery. Study design was prospective, randomised, single-blinded and controlled (paired). Either right tonsil was operated with standard-needle electrocautery, contralateral side was operated with cold-technique; or vice-versa. Which side received which treatment was randomly assigned (Aksoy F)

Surgical Technique

Both tonsils were injected with lidocaine and epinephrine infiltration to anterior tonsillar plica before the operation. All surgeries were performed by the primary investigator (BO) under x2.5 loupes. Force 2 Electrosurgical Generator (The Valley Lab, Boulder,CO) was used to power both the monopolar and bipolar electrocautery. Bipolar cautery was used (25-30 Watts) in accordance with the literature. Monopolar electrocautery settings were adjusted to 'Blend 1' which is a summation of the coagluation and cutting waveforms (75% cutting, 25% coagulation). Cut power was adjusted to 10W, whereas coagulation power was set to 12 Watts.

Results and Evaluations

Postoperative tonsillar fossa healing and pain is going to be evaluated for both sides separately with Visual Analogue Scale. All operations are going to be performed by a single investigator and all evaluations are going to be carried out by another investigator in a totally blinded fashion to avoid possible bias. These evaluations are going to be carried out for 10 postoperative days. Tonsillar fossa healing will be evaluated according to scale reported by Magdy EA et al. on first, fifth and tenth postoperative day (Magdy EA). Patients will evaluate their pain 10 (maximum) , 0 (none) based on a Visual Analogue Scale. Results will be calculated as (mean+-SD) and compared statistically for significance with SPSS.

Discussion

A finer tip can give greater precision in dissection and can also affect the dispersion characteristics of the energy used to perform the dissection. The implication of this for tonsillectomy is that greater precision in dissecting the tonsil from the underlying muscle can potentially lead to less post-operative discomfort.

For those surgeons who choose to use an electrocautery technique for tonsillectomy, the greater precision of the needle-tip EC may enhance the results.

Study Type

Interventional

Enrollment (Anticipated)

40

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 Locations

  • Turkey
      • Istanbul, Turkey, 00000
        • Recruiting
        • Gaziosmanpasa Taksim Research and Education Hospital,
    • Gaziosmanpasa
      • Istanbul, Gaziosmanpasa, Turkey, 00000
        • Recruiting
        • Gaziosmanpasa Taksim Research and Education Hospital, Department of Otorhinolaryngology

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

13 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 13-years old and older
  • Informed consent
  • Isolated tonsillectomy (without adenoidectomy, OSAS surgery etc )
  • Tonsillar hypertrophy

Exclusion Criteria:

  • Malignancy suspicion
  • Additional simultaneous surgeries (adenoidectomy, OSAS etc)

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
Active Comparator: COLD-DISSECTION
Cold Dissection Technique
Procedure: Tonsillectomy
Tonsillectomy is the name of the surgery where tonsils are removed via capsullary dissection. There are various techniques and its basically removing the tonsil from its tonsillary fossa and conducting hemostasis with various equipments.
Active Comparator: HOT-DISSECTION
Needle Electrocautery Dissection Technique
Procedure: Tonsillectomy
Tonsillectomy is the name of the surgery where tonsils are removed via capsullary dissection. There are various techniques and its basically removing the tonsil from its tonsillary fossa and conducting hemostasis with various equipments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of postoperative Pain
Time Frame: Postoperative first 10 days
Visual Analogue Scale will be used to evaluate the change in postoperative pain
Postoperative first 10 days

Collaborators and Investigators

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

Sponsor

Gaziosmanpasa Research and Education Hospital

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

June 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

June 19, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TONSIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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