Congenital Abnormality of Kidney, Hydronephrosis, Kidney Cancer, Kidney Injury, Kidney Tuberculosis, Nephritis, Nephrolithiasis, Prostate Cancer
Conditions
Keywords
Ligature of vessels and hollow organs, Marking of anatomic structures for radiological detection, Ligation, Prostatectomy, Nephrectomy, Minimally Invasive Surgical Procedures, Laparoscopy
Brief summary
Prospective, monocentric, single arm, observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
Detailed description
The objective of this observational study is to collect systematically and proactively data regarding the Aesculap® DS Titanium Ligation Clip under daily clinical practice when used in urology in different indications. The hypothesis of this study is that this event, slippage / movement of the clip, is extremely rare through the design if used in accordance with the Instructions for Use (IfU). The observed rate through the total number of clips might be a valuable parameter and could influence future research. Furthermore, this study is one of the PMCF measures which enable the manufacturer to monitor the safety and performance of the Aesculap® DS Titanium Ligation Clips. The products bear the CE-marking and are routinely used within this institution for the above-mentioned procedures.
Interventions
None listed
Sponsors
Aesculap AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: Inclusion Criteria: * Planned Da Vinci radical prostatectomy using DS Titanium Ligation Clips (according to the IfU) - OR * Planned laparoscopic nephrectomy using Titanium Ligation Clip (according to the IfU) - OR * Planned Da Vinci partial nephrectomy using Titanium Ligation Clip (according to the IfU) * Patient's written informed consent * Age ≥ 18 years * Intraoperative Usage of DS Titanium Ligation Clips (according to the IfU) Exclusion:
Exclusion criteria
• None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of slippage / movement of the clip in relationship to the total number of used clips. | Intraoperatively | Slippage / movement of the Aesculap® DS Titanium Ligation Clip is an observable slippage, movement, or rotation after the clip was successfully applied and the application forceps was removed. The number of observed slippage / movement of the clip will be documented on the CRF, the clip size, step of the procedure and further measures were necessary, i.e. removal of the clip or application of another clip, will be documented. In the end the rate will be brought in relationship to the overall number of applied clips. Thus, the number of applied clips is documented, for each clip size. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse events (intra- and postoperative) | up to discharge from hospital (approximately 10 days post surgery) | * Postoperative bleedings * Infections * Urine extravasation in partial nephrectomy * Prolonged urinary catheter drainage in radical prostatectomies * Ileus * Venous thrombo-embolic events * Sepsis * Other |
Other
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss | intraoperatively | Estimated intraoperative blood loss |
| Total operative time | intraoperatively | Estimated operative time from first cut to last stitch |
| Length of hospital stay | up to discharge from hospital (approximately 10 days post surgery) | Length of patient's stay in hospital after surgery |
| Handling parameters | intraoperatively | The handling performance of the clip is assessed on a five point likert scale (very good, good, acceptable, poor) in four different handling aspects |
Countries
Germany
Outcome results
None listed