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Completed

NCT Number: NCT03175770

Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery

In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.

Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.

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Key information

Conditions

Radiofrequency Resection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ear Nose Throat

Munich, Bavaria, 81675, Germany

About this study

In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.

Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years and older benign or malign tumor of the oropharynx tumor must be resectable transorally

Exclusion criteria

  • Prior radiotherapy or chemotherapy

Treatment and study plan

transoral radiofrequency Resection in Oropharyngeal Tumor Surgery

Procedure

Patient of 18 years and older with benign or malign tumor in the oropharynx. The resection is done transorally by radiofrequency

Primary outcomes

  1. total blood loss,

    Time frame: intraoperative

    assessing the blood loss by measuring blood in the suction

  2. tissuesticking

    Time frame: intraoperative

    tissuesticking by physician global assessment scale from 1 - 6

  3. coagulation

    Time frame: intraoperative

    coagulation by physician global assessment scale from 1 - 6,

  4. Duration of Operation

    Time frame: intraoperative

    measuring Duration of Operation in minutes

Secondary outcomes

  1. Zone of coagulation

    Time frame: within one month after the operation

    Zone of coagulation to assess the tissue damage by radiofrequency by a scale 1 - 6,

  2. postoperative parameters

    Time frame: within one month after the operations

    woundhealing by Parameters normal, delayed, infection;

  3. postoperative pain

    Time frame: within one month after the operations

    postoperative pain by visual analog scale from 0 -10,

  4. accuracy of section

    Time frame: within one month after the operations

    accuracy of section assessed by a scale from 1 - 6

  5. status of resection

    Time frame: within one month after the operations

    assessment of status of resection by assessing the margins of resection for Tumor scale from 1 - 6,

  6. postoperative dysfunctions by descriptive name of scale

    Time frame: within one month after the operations

    postoperative dysfunctions by descriptive scale from 1 -10

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 5, 2017
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.