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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013508

Enrollment

100

Registered

2017-11-30

Start date

2017-09-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J32

Interventions

Group 1: endonasal endoscopic paranasal Sinus surgery using the established navigation system STORZ NAV1 optical Group 2: endonasal endoscopic paranasal Sinus surgery using the new navigation system S

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactMaximilian Linxweiler

Universitätsklinikum des SaarlandesKlinik für HNO-Heilkunde

maximilian.linxweiler@uks.eu+496841-1622984

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026