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Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery

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ClinicalTrials.gov Identifier: NCT03175770
Recruitment Status : Unknown
Verified June 2017 by Technische Universität München.
Recruitment status was:  Active, not recruiting
First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:

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.


Condition or disease Intervention/treatment
Radiofrequency Resection Procedure: transoral radiofrequency Resection in Oropharyngeal Tumor Surgery

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : June 1, 2017
Estimated Study Completion Date : June 15, 2017

Group/Cohort Intervention/treatment
Patients with benign or malign tumor in the oropharynx
Patient of 18 years and older with benign or malign tumor in the oropharynx. The resection is done transorally by radiofrequency
Procedure: transoral radiofrequency Resection in Oropharyngeal Tumor Surgery
Patient of 18 years and older with benign or malign tumor in the oropharynx. The resection is done transorally by radiofrequency




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
18 years or older, benign or malign tumor of the oropharynx. the resection must be done transorally
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior radiotherapy or chemotherapy

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): NCT03175770


Locations
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Germany
Department of Ear Nose Throat
Munich, Bayern, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Clemens Heiser, MD department for ENT, Klinikum Rechts der Isar der Technischen Universität München, Ismaninger Straße 22, 81675 München, Germany

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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT03175770     History of Changes
Other Study ID Numbers: 381/14
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases