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Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
Sponsor: University Hospital, Ghent
Summary
A proposed new tool ('DIPLANN-tool' - Digital Planning in Nephrectomy) for predicting kidney perfusion zones on a segmented 3D model during robot-assisted partial nephrectomy (RAPN) for localized renal cancer demonstrated high accuracy when planning selective clamping (SC) for RAPN. However, the tool's clinical added value still needs to be confirmed. Therefore, a randomized controlled trial using a study and control group is the preferred study design. Experimental group: the use of the DIPLANN-tool + conventional computed tomography (CT) imaging for preoperative planning and perioperative guidance during RAPN. Control group: the use of only conventional CT imaging for preoperative planning and perioperative guidance during RAPN (= current standard of care). The primary endpoint is planning and performing as planned a SC strategy. Secondary endpoints include patients' health, patients' insight and surgeons' benefits.
Official title: Planning Operative Strategy Using a Digital Renal Artery Clamping Tool: a Randomized Controlled Trial Evaluating the DIPLANN 3D Model for Selective Arterial Clamping During Robot-Assisted Partial Nephrectomy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
235
Start Date
2024-06-27
Completion Date
2027-01-01
Last Updated
2025-04-01
Healthy Volunteers
No
Interventions
Pre-operative explanation of the procedure (DIPLANN + CT)
Pre-operative study visit explaining the RAPN procedure using the 3D model / DIPLANN-tool (with or without classical CT imaging). Included in this visit is a pre-operative physical examination (height, weight, abdominal examination), pre-operative blood examination (Hb, creatinin, eGFR) and patient questionnaires regarding patient knowledge, patient anxiety and patient quality of life.
Pre-operative surgical planning (DIPLANN + CT)
Online assessment by surgeon regarding clamping strategy. Assisted by DIPLANN-tool + CT scan.
RAPN (DIPLANN + CT)
Robot-assisted partial nephrectomy surgical procedure. Peri-operative guidance by DIPLANN-tool + CT scan.
Pre-operative explanation of the procedure (CT only)
Pre-operative study visit explaining the RAPN procedure using CT imaging alone. Included in this visit is a pre-operative physical examination (height, weight, abdominal examination), pre-operative blood examination (Hb, creatinin, eGFR) and patient questionnaires regarding patient knowledge, patient anxiety and patient quality of life.
Pre-operative surgical planning (CT only)
Online assessment by surgeon regarding clamping strategy. Assisted by classical CT imaging only.
RAPN (CT only)
Robot-assisted partial nephrectomy surgical procedure. Peri-operative guidance by CT imaging only.
Locations (5)
AZORG
Aalst, Belgium
AZ Sint-Jan
Bruges, Belgium
ZOL
Genk, Belgium
AZ Maria Middelares
Ghent, Belgium
Ghent University Hospital
Ghent, Belgium