Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery

Radiofrequency Resection Clinical Trial

Official title:

Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175770
• Other study ID #: 381/14
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: June 15, 2017

Study information

• Verified date: March 2020
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 15, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Prior radiotherapy or chemotherapy

Related Conditions & MeSH terms

• Oropharyngeal Neoplasms
• Radiofrequency Resection

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Ear Nose Throat	Munich	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total blood loss,	assessing the blood loss by measuring blood in the suction	intraoperative
Primary	tissuesticking	tissuesticking by physician global assessment scale from 1 - 6	intraoperative
Primary	coagulation	coagulation by physician global assessment scale from 1 - 6,	intraoperative
Primary	Duration of Operation	measuring Duration of Operation in minutes	intraoperative
Secondary	Zone of coagulation	Zone of coagulation to assess the tissue damage by radiofrequency by a scale 1 - 6,	within one month after the operation
Secondary	postoperative parameters	woundhealing by Parameters normal, delayed, infection;	within one month after the operations
Secondary	postoperative pain	postoperative pain by visual analog scale from 0 -10,	within one month after the operations
Secondary	accuracy of section	accuracy of section assessed by a scale from 1 - 6	within one month after the operations
Secondary	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
Secondary	postoperative dysfunctions by descriptive name of scale	postoperative dysfunctions by descriptive scale from 1 -10	within one month after the operations