Image-guided navigation during robotic soft tissue surgery: a pilot study

Image-guided navigation during robotic soft tissue surgery: a pilot study - Image-guided soft tissue navigation in robotic surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49610

Enrollment

Registered

2020-05-25

Start date

2020-06-01

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

lymfeklieren lymph node surgery Tumor surgery

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: · Patients who are scheduled for open (phase 1) or (robot assisted) laparoscopic (phase 2) soft tissue surgery, · Locally advanced T3 or T4 tumor, local recurrent tumor or lymph node metastasis, · Patients should be suitable for contrast enhanced CT scanning, · A signed informed consent · Patients * 18 years old

Exclusion criteria

Exclusion criteria: - patients with metal implants in the area that needs to be scanned - patients with a pacemaker - pregnancy

Design outcomes

Primary

Measure	Time frame
Feasibility, safety and efficacy of the image-guided navigation system during soft tissue surgery, first in open procedures (safety phase) and secondly in laparoscopic and robot assisted procedures (efficacy phase). Fefasibility will be monitord through successful implementation of the navigation technology during laparoscopic and robot-assisted surgery. Safety will be monitored through registration of complications during surgery related to the use of the technology Efficacy will be monitored throug clinical outcome parameters (I) target(s) removed, (II) radicality of tumor removed, (III) operative morbidity and time to regain functionality of clinically relevant indicators.	—

Measure

Time frame

Feasibility, safety and efficacy of the image-guided navigation system during soft tissue surgery, first in open procedures (safety phase) and secondly in laparoscopic and robot assisted procedures (efficacy phase). Fefasibility will be monitord through successful implementation of the navigation technology during laparoscopic and robot-assisted surgery. Safety will be monitored through registration of complications during surgery related to the use of the technology Efficacy will be monitored throug clinical outcome parameters (I) target(s) removed, (II) radicality of tumor removed, (III) operative morbidity and time to regain functionality of clinically relevant indicators.

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Secondary

Measure	Time frame
Evaluation of the total time needed to perform image guided surgery. To be (additionally) registered en montoring times are (I) time needed to prepare the set-up and perform CBCT-scan, (II) time needed to remove target, (III) total operating time.	—

Countries

Netherlands

Outcome results