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.

Study Overview

• Status: Completed
• Conditions: Radiofrequency Resection
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • Munich, Bayern, Germany, 81675
      • Department of Ear Nose Throat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

18 years or older, benign or malign tumor of the oropharynx. the resection must be done transorally

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Prior radiotherapy or chemotherapy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total blood loss,	assessing the blood loss by measuring blood in the suction	intraoperative
tissuesticking	tissuesticking by physician global assessment scale from 1 - 6	intraoperative
coagulation	coagulation by physician global assessment scale from 1 - 6,	intraoperative
Duration of Operation	measuring Duration of Operation in minutes	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zone of coagulation	Zone of coagulation to assess the tissue damage by radiofrequency by a scale 1 - 6,	within one month after the operation
postoperative parameters	woundhealing by Parameters normal, delayed, infection;	within one month after the operations
postoperative pain	postoperative pain by visual analog scale from 0 -10,	within one month after the operations
accuracy of section	accuracy of section assessed by a scale from 1 - 6	within one month after the operations
status of resection	assessment of status of resection by assessing the margins of resection for Tumor scale from 1 - 6,	within one month after the operations
postoperative dysfunctions by descriptive name of scale	postoperative dysfunctions by descriptive scale from 1 -10	within one month after the operations

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Clemens Heiser, MD, department for ENT, Klinikum Rechts der Isar der Technischen Universität München, Ismaninger Straße 22, 81675 München, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 15, 2017

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Oropharyngeal Neoplasms
• Other Study ID Numbers: 381/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No