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

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ClinicalTrials.gov Identifier: NCT02818647
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Berke Ozucer, Gaziosmanpasa Taksim Research and Education Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Tonsillitis Tonsillectomy Tonsillar Hypertrophy Procedure: Tonsillectomy

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Cold Dissection Technique and Needle Monopolar Electrocautery Tonsillectomy
Study Start Date : June 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Change of postoperative Pain [ Time Frame: Postoperative first 10 days ]
    Visual Analogue Scale will be used to evaluate the change in postoperative pain



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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818647


Contacts
Contact: Berke özücer, MD 905309635939 berkeozucer@gmail.com
Contact: Mehmet E Dinc, MD 905065426492 dremredinc@hotmail.com

Locations
Turkey
Gaziosmanpasa Taksim Research and Education Hospital, Department of Otorhinolaryngology Recruiting
Istanbul, Gaziosmanpasa, Turkey, 00000
Contact: Berke Ozucer, MD    90-530-963-5939    berkeozucer@gmail.com   
Contact: Emre M Dinc, MD    905065426492    dremredinc@hotmail.com   
Gaziosmanpasa Taksim Research and Education Hospital, Recruiting
Istanbul, Turkey, 00000
Contact: Berke Ozucer, MD    90-530-963-5939    berkeozucer@gmail.com   
Sponsors and Collaborators
Gaziosmanpasa Taksim Research and Education Hospital

Publications:

Responsible Party: Berke Ozucer, Otolaryngologist, Medical Doctor, Gaziosmanpasa Taksim Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02818647     History of Changes
Other Study ID Numbers: TONSIL
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Berke Ozucer, Gaziosmanpasa Taksim Research and Education Hospital:
tonsillectomy
electrocautery
postoperative pain
visual analogue scale

Additional relevant MeSH terms:
Hypertrophy
Tonsillitis
Pathological Conditions, Anatomical
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases