Value of intraoperative CT-based navigation systems for operation success and safety in functional endoscopic sinus surgery

Not Applicable

• Conditions: J32; Chronic sinusitis

• Registration Number: DRKS00013508
• Lead Sponsor: Karl Storz SE & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-30
• Study Completion: 2019-12-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Age of 18 years or older; medical indication for functional endoscopic sinus surgery (chronic sinusitis, recurrent acute sinusitis, tumors of the paranasal sinuses with unknown dignity)

Exclusion Criteria

age < 18 years; no medical indication for functional endoscopic sinus surgery; permanent treatment with anticoagulants or inhibitors of thromobocyte function; inherited coagulopathies; chronic pain disease necessitating a permanent treatment with analgetic drugs

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
complication rate (defined as postoperative bleedings, revision surgery, orbital complications and abscesses during the first 14 days after surgery)

Secondary Outcome Measures

Name	Time	Method
operation time; general condition of the patients (one questionnaire for each of the first 5 postoperative days); postoperative pain of the patients (one questionnaire for each of the first 5 postoperative days); benefit of the navigation system during the operation valued by the surgeon (questionnaire for the surgeon); duration of preoperative registration of the navigation system (questionnaire for the surgeon); necessity of Revision surgery during the first 24 months after the first operation