Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery

Completed

• Conditions: Radiofrequency Resection
• Interventions: Procedure: transoral radiofrequency Resection in Oropharyngeal Tumor Surgery

• Registration Number: NCT03175770
• Lead Sponsor: Technical University of Munich

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.

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 Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2017-03-16
• Primary Completion: 2017-06-01
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Study Completion: 2017-06-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with benign or malign tumor in the oropharynx	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

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Ear Nose Throat; 🇩🇪 Munich, Bayern, Germany