DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy) (DOSTILCU)

Prospective, Monocentric, Single Arm, Observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

Prospective, monocentric, single arm, observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

Study Overview

• Status: Completed
• Conditions: Kidney Cancer; Nephrolithiasis; Prostate Cancer; Nephritis; Kidney Injury; Hydronephrosis; Congenital Abnormality of Kidney; Kidney Tuberculosis

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.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Germany
  • Offenburg, Germany, 77654
    • Ortenau Klinikum Klinik für Urologie und Kinderurologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Data is collected preoperatively, intraoperatively and until discharge of all consecutive patients fulfilling the inclusion and exclusion criteria in a single site.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of slippage / movement of the clip in relationship to the total number of used clips.	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.	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Adverse events (intra- and postoperative)	Postoperative bleedings; Infections; Urine extravasation in partial nephrectomy; Prolonged urinary catheter drainage in radical prostatectomies; Ileus; Venous thrombo-embolic events; Sepsis; Other	up to discharge from hospital (approximately 10 days post surgery)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative blood loss	Estimated intraoperative blood loss	intraoperatively
Total operative time	Estimated operative time from first cut to last stitch	intraoperatively
Length of hospital stay	Length of patient's stay in hospital after surgery	up to discharge from hospital (approximately 10 days post surgery)
Handling parameters	The handling performance of the clip is assessed on a five point likert scale (very good, good, acceptable, poor) in four different handling aspects	intraoperatively

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Jörg Simon, PD Dr. med., Ortenau KlinikumKlinik für Urologie und Kinderurologie ChefarztEbertplatz 1277654 Offenburg

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 27, 2021
• Primary Completion (ACTUAL): January 26, 2022
• Study Completion (ACTUAL): January 29, 2022

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (ACTUAL): May 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Nephrectomy; Prostatectomy; Laparoscopy; Minimally Invasive Surgical Procedures; Ligation; Ligature of vessels and hollow organs; Marking of anatomic structures for radiological detection
• Additional Relevant MeSH Terms: Infections; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Pathological Conditions, Anatomical; Mycobacterium Infections; Urolithiasis; Urinary Calculi; Calculi; Tuberculosis, Urogenital; Kidney Neoplasms; Congenital Abnormalities; Tuberculosis; Nephritis; Kidney Calculi; Nephrolithiasis; Hydronephrosis; Tuberculosis, Renal
• Other Study ID Numbers: AAG-O-H-2041