Clinical trial NCT05377632: Comparing Two Different Approaches in Robotic-Assisted Renal Surgery
Official title: Comparing the Modified Novel Trans-Retro Approach vs Conventional Retroperitoneal Approach in Robotic-Assisted Renal Surgery: An Open Label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Tumor
Keywords: robotic surgery
renal tumor
Lead sponsor: Kantonsspital Baden
Sponsor class: OTHER
Collaborators: name: Kantonsspital Baden
First posted: 2022-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: detection of the renal artery
timeFrame: During procedure/surgery
Secondary outcomes:
measure: Operative time
timeFrame: During procedure/surgery
measure: Robot docking time
timeFrame: During procedure/surgery
measure: Instrument insertion time
timeFrame: During procedure/surgery
measure: Off-console time
timeFrame: During procedure/surgery
measure: Ischemia time
timeFrame: During procedure/surgery
measure: Surgical conversion to open surgery
timeFrame: During procedure/surgery
measure: Surgical conversion to radical nephrectomy
timeFrame: During procedure/surgery
measure: Intraoperative blood loss
timeFrame: During procedure/surgery
measure: Console surgeons perception of Trocar placement and working space
timeFrame: During procedure/surgery
measure: Side assistants perception of Trocar placement and working space
timeFrame: During procedure/surgery
measure: Pain assessment
timeFrame: During the hospital stay (up to day 7)
measure: Pain Management
timeFrame: During the hospital stay (up to day 7)
measure: Kidney function via the estimated glomerular filtration rate (eGRF)
timeFrame: During the hospital stay (up to day 7)
measure: Post operative complications
timeFrame: Day 30
measure: Length of stay Length of stay
timeFrame: During the hospital stay (up to day 7)
measure: Procedure related readmissions
timeFrame: Day 30
measure: Procedure related reoperations
timeFrame: Day 30
measure: Comprehensive Complication Index
timeFrame: Day 30
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden
state: Aargau
Study officials:
affiliation: Kantonsspital Baden
name: Lukas J Hefermehl, MD
role: PRINCIPAL_INVESTIGATOR
References: