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Clinical trial protocol for P-NeLoP: a randomized controlled trial comparing the feasibility and outcomes of robot-assisted partial nephrectomy with low insufflation pressure using AirSeal versus standard insufflation pressure (UroCCR no. 85 study).

ABSTRACT: Robot-assisted partial nephrectomy (RAPN) is the standard of care for small, localized kidney tumors. This surgery is conducted within a short hospital stay and can even be performed as outpatient surgery in selected patients. In order to allow early rehabilitation of patients, an optimal control of postoperative pain is necessary. High-pressure pneumoperitoneum during surgery seems to be the source of significant pain during the first hours postoperatively. Our study is a prospective, randomized, multicenter, controlled study which aims to compare post-operative pain at 24 h between patients undergoing RAPN at low insufflation pressure (7 mmHg) and those operated on at standard pressure (12 mmHg) using the AirSeal system.This trial is registered in the US National Library of Medicine Trial Registry (NCT number: NCT05404685).

SUBMITTER: Margue G

PROVIDER: S-EPMC10439590 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Clinical trial protocol for P-NeLoP: a randomized controlled trial comparing the feasibility and outcomes of robot-assisted partial nephrectomy with low insufflation pressure using AirSeal versus standard insufflation pressure (UroCCR no. 85 study).

Margue Gaelle G Bigot Pierre P Ingels Alexandre A Roupret Morgan M Waeckel Thibaut T Long Jean-Alexandre JA Pignot Géraldine G Bensalah Karim K Lang Hervé H Olivier Jonathan J Bruyere Franck F Durand Matthieu M Beauval Jean-Baptiste JB Mallet Richard R Parier Bastien B De La Taille Alexandre A Bernhard Jean-Christophe JC

Trials 20230819 1

Robot-assisted partial nephrectomy (RAPN) is the standard of care for small, localized kidney tumors. This surgery is conducted within a short hospital stay and can even be performed as outpatient surgery in selected patients. In order to allow early rehabilitation of patients, an optimal control of postoperative pain is necessary. High-pressure pneumoperitoneum during surgery seems to be the source of significant pain during the first hours postoperatively. Our study is a prospective, randomize ...[more]

PMID: 37596613

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Project description:ImportanceTechnical skill in complex surgical procedures may affect clinical outcomes, and there is growing interest in understanding the clinical implications of surgeon proficiency levels.ObjectivesTo determine whether surgeon scores representing technical skills of robot-assisted kidney surgery are associated with patient outcomes.Design, setting, and participantsThis quality improvement study included 10 urological surgeons participating in a surgical collaborative in Michigan from July 2021 to September 2022. Each surgeon submitted up to 7 videos of themselves performing robot-assisted partial nephrectomy. Videos were segmented into 6 key steps, yielding 127 video clips for analysis. Each video clip was deidentified and distributed to at least 3 of the 24 blinded peer surgeons from the collaborative who also perform robot-assisted partial nephrectomy. Reviewers rated technical skill and provided written feedback. Statistical analysis was performed from May 2023 to January 2024.Main outcomes and measuresReviewers scored each video clip using a validated instrument to assess technical skill for partial nephrectomy on a scale of 1 to 5 (higher scores indicating greater skill). For all submitting surgeons, outcomes from a clinical registry were assessed for length of stay (LOS) greater than 3 days, estimated blood loss (EBL) greater than 500 mL, warm ischemia time (WIT) greater than 30 minutes, positive surgical margin (PSM), 30-day emergency department (ED) visits, and 30-day readmission.ResultsAmong the 27 unique surgeons who participated in this study as reviewers and/or individuals performing the procedures, 3 (11%) were female, and the median age was 47 (IQR, 39-52) years. Risk-adjusted outcomes were associated with scores representing surgeon skills. The overall performance score ranged from 3.5 to 4.7 points with a mean (SD) of 4.1 (0.4) points. Greater skill was correlated with significantly lower rates of LOS greater than 3 days (-6.8% [95% CI, -8.3% to -5.2%]), EBL greater than 500 mL (-2.6% [95% CI, -3.0% to -2.1%]), PSM (-8.2% [95% CI, -9.2% to -7.2%]), ED visits (-3.9% [95% CI, -5.0% to -2.8%]), and readmissions (-5.7% [95% CI, -6.9% to -4.6%]) (P < .001 for all). Higher overall score was also associated with higher partial nephrectomy volume (β coefficient, 11.4 [95% CI, 10.0-12.7]; P < .001).Conclusions and relevanceIn this quality improvement study on video-based evaluation of robot-assisted partial nephrectomy, higher technical skill was associated with lower rates of adverse clinical outcomes. These findings suggest that video-based evaluation plays a role in assessing surgical skill and can be used in quality improvement initiatives to improve patient care.

Dataset Information

Clinical trial protocol for P-NeLoP: a randomized controlled trial comparing the feasibility and outcomes of robot-assisted partial nephrectomy with low insufflation pressure using AirSeal versus standard insufflation pressure (UroCCR no. 85 study).

Publications

Clinical trial protocol for P-NeLoP: a randomized controlled trial comparing the feasibility and outcomes of robot-assisted partial nephrectomy with low insufflation pressure using AirSeal versus standard insufflation pressure (UroCCR no. 85 study).

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