Comparing Two Different Approaches in Robotic-Assisted Renal Surgery

Renal Tumor Clinical Trial

— PIONEER-OPT  

Official title:

Comparing the Modified Novel Trans-Retro Approach vs Conventional Retroperitoneal Approach in Robotic-Assisted Renal Surgery: An Open Label Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05377632
• Other study ID #: PIONEER-OPTICS
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: May 15, 2024

Study information

• Verified date: March 2023
• Source: Kantonsspital Baden
• Contact: Uwe Bieri, MD
• Phone: +41 79 268 78 37
• Email: uwe.bieri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the novel TR approach is superior to the standard RP approach. The anticipated study outcome is a time saving of at least 30% from first skin incision to detection of the renal artery compared to the conventional RP approach, and also a better workspace perception by the operating surgeon.

Description:

The trans abdominal approach (TA) for total and partial nephrectomy (PN) has been widely adopted due to the easy trocar placement and the good working space. The retroperitoneal approach (RP) has gained popularity because the renal artery is often found fast and the operation remains in an anatomically separated space, making it preferable, especially for patients who underwent abdominal surgery in the past. However, both approaches face difficulties. Trocar placement for RP can be challenging, and the working space often is limited, while TA is impaired in cases of dorsal tumors and dissection of the renal artery can be challenging due to the anatomic localization dorsally to the renal vein. Up until now, no direct systematically and prospective comparison of these two approaches was performed. The overall objective of this trial is to assess if the novel TR approach is superior to the conventional RP approach in performing robotic assisted (partial) nephrectomy. To date, no systematic, prospective, randomised study has been conducted on this topic and described in the literature.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older
• Patient with a renal tumor or non-functionally kidney that is a candidate for robotic assisted surgery (RAS) nephrectomy or partial nephrectomy (PN)
• Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria:

• Renal vein tumor thrombus
• Pregnancy or suspected pregnancy

Related Conditions & MeSH terms

• Kidney Neoplasms
• Renal Tumor

Intervention

Procedure:
• Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)
laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) include bilateral tumors or tumors in a solitary kidney. Relative indications include familial renal cancer syndromes such as Von Hippel-Lindau, hereditary leiomyomatosis, or hereditary papillary renal cell carcinoma. Patients with chronic kidney disease are generally offered nephron sparing surgery for hope of future renal function preservation. This reasoning also applies to those patients with preexisting diseases that may threaten a solitary kidney such as uncontrolled diabetes and hypertension.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baden	Baden	Aargau

Sponsors (2)

Lead Sponsor	Collaborator
Lukas J Hefermehl	Kantonsspital Baden

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of the renal artery	Time from first skin incision to detection of the renal artery [Time in minutes]	During procedure/surgery
Secondary	Operative time	The time from [Skin Incision] to [Skin Closure] in minutes as documented in OR-Management Information System	During procedure/surgery
Secondary	Robot docking time	The time from [Skin Incision] to [robot docking] in minutes as documented in OR-Spreadsheet.	During procedure/surgery
Secondary	Instrument insertion time	The time from [Skin Incision] to [insertion of the last instrument] in minutes as documented in OR-Spreadsheet	During procedure/surgery
Secondary	Off-console time	The time from [Skin Incision] to [start of first instrument movement by console surgeon] in minutes as documented in OR-Spreadsheet	During procedure/surgery
Secondary	Ischemia time	The time from [Placement of clamp on artery] to [Release of clamp] in minutes indicated by the console surgeon documented by the anesthesiologist	During procedure/surgery
Secondary	Surgical conversion to open surgery	Conversion from robotic to open surgery	During procedure/surgery
Secondary	Surgical conversion to radical nephrectomy	Conversion partial to radical nephrectomy	During procedure/surgery
Secondary	Intraoperative blood loss	Volume of blood loss during the surgical procedure in mL	During procedure/surgery
Secondary	Console surgeons perception of Trocar placement and working space	Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)	During procedure/surgery
Secondary	Side assistants perception of Trocar placement and working space	Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)	During procedure/surgery
Secondary	Pain assessment	Assessment of pain level via the Visual Analogue Scale (VAS, 1-10, higher scores mean more pain)	During the hospital stay (up to day 7)
Secondary	Pain Management	Documentation of pain management (according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment)	During the hospital stay (up to day 7)
Secondary	Kidney function via the estimated glomerular filtration rate (eGRF)	Data will be gathered from routine examination, not a mandatory assessment (Lab value read-outs from in the clinical Information System) [ml/min/1,73 m2]	During the hospital stay (up to day 7)
Secondary	Post operative complications	Any Clavien-Dindo I-V post-operative complication (standard classification for complication in surgery	Day 30
Secondary	Length of stay Length of stay	Time from surgery to discharge in days [d]	During the hospital stay (up to day 7)
Secondary	Procedure related readmissions	Readmission that can be linked to the (partial) nephrectomy, binary [Yes/No]	Day 30
Secondary	Procedure related reoperations	Re-operation that can be linked to the partial nephrectomy, binary [Yes/No]	Day 30
Secondary	Comprehensive Complication Index	Any complication that occurred within 30 days post surgery, Scale [from 0 (no complication) to 100 (death)]	Day 30