Randomized Clinical Trial Comparing On-clamp Versus Off-clamp Laparoscopic Partial Nephrectomy for Small Renal Masses (CLOCK II Laparoscopic Study): A Intention-to-treat Analysis of Perioperative Outcomes
Background: Recent randomized trials (RCTs) in the field of robotic partial nephrectomy (PN) showed no significant differences in perioperative outcomes between the off- and on-clamp approaches. Objective: To compare the perioperative outcomes of on- versus off-clamp pure laparoscopic PN (LPN). Desi...
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2022-12-01
|
| Series: | European Urology Open Science |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666168322021280 |
| _version_ | 1797989595795685376 |
|---|---|
| author | Riccardo Bertolo Pierluigi Bove Marco Sandri Antonio Celia Luca Cindolo Chiara Cipriani Mario Falsaperla Costantino Leonardo Andrea Mari Paolo Parma Alessandro Veccia Domenico Veneziano Andrea Minervini Alessandro Antonelli |
| author_facet | Riccardo Bertolo Pierluigi Bove Marco Sandri Antonio Celia Luca Cindolo Chiara Cipriani Mario Falsaperla Costantino Leonardo Andrea Mari Paolo Parma Alessandro Veccia Domenico Veneziano Andrea Minervini Alessandro Antonelli |
| author_sort | Riccardo Bertolo |
| collection | DOAJ |
| description | Background: Recent randomized trials (RCTs) in the field of robotic partial nephrectomy (PN) showed no significant differences in perioperative outcomes between the off- and on-clamp approaches. Objective: To compare the perioperative outcomes of on- versus off-clamp pure laparoscopic PN (LPN). Design, setting, and participants: A multi-institutional analysis of the on- versus off-clamp approach during LPN in the setting of an RCT (CLOCK II trial; ClinicalTrials.gov NCT02287987) was performed. Intervention: Off- versus on-clamp LPN. Outcome measurements and statistical analysis: Baseline patient and tumor variables, and peri- and postoperative data were collected. Randomized allocation with a 1:1 ratio was assigned. Surgical strategy for managing the renal pedicle was dictated by the study protocol. In the off-clamp arm, the renal artery had to remain unclamped for the duration of the whole procedure. Reporting the intention-to-treat analysis is the purpose of the study. Results and limitations: The study recruited 249 patients. Of them, 123 and 126 were randomized and allocated into the on- and off-clamp treatment groups, respectively. Treatment groups were comparable at baseline after randomization with respect to patients’ demographics, comorbidities, renal function, and tumor size and complexity. A univariable analysis found no differences in the perioperative outcomes between the groups, including median (interquartile range) estimated blood loss (150 [100–200] vs 150 [100–250] ml, p = 0.2), grade ≥2 complication rate as classified according to the Clavien-Dindo system (5.7% vs 4.8%, p = 0.6), and positive surgical margin rate (8.2% vs 3.5% for the on- vs off-clamp group, p = 0.1). No differences were found in terms of the 1st (81.3 [66.7–94.3] vs 85.3 [71.0–97.7] ml/min, p = 0.2) and 5th postoperative days estimated glomerular filtration rate (83.3 [70.5–93.7] vs 83.4 [68.6–139.3] ml/min, p = 0.2). A multivariable analysis found each +1 increase in RENAL score corresponded to an increase in the protection from the occurrence of complications (odds ratio [OR] 0.72, 95% confidence interval [CI] 0.54–0.97, p = 0.034), while each +1 cm increase in tumor size corresponded to an increase in the risk of blood transfusion (OR 1.39, 95% CI 1.14–1.70, p = 0.001). Conclusions: In the setting of an RCT, no differences were found in the perioperative and early functional outcomes between on- and off-clamp LPN. Patient summary: In this study, we investigated, by means of a randomized trial, whether avoiding the clamping of renal artery during laparoscopic resection of renal mass is able to translate into benefits. We found no differences in terms of safety, efficacy, and renal function from the standard approach, which includes arterial clamping. |
| first_indexed | 2024-04-11T08:22:55Z |
| format | Article |
| id | doaj.art-ea670c401e7e4e0d8b45e3dde90d0bdd |
| institution | Directory Open Access Journal |
| issn | 2666-1683 |
| language | English |
| last_indexed | 2024-04-11T08:22:55Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | European Urology Open Science |
| spelling | doaj.art-ea670c401e7e4e0d8b45e3dde90d0bdd2022-12-22T04:34:52ZengElsevierEuropean Urology Open Science2666-16832022-12-01467581Randomized Clinical Trial Comparing On-clamp Versus Off-clamp Laparoscopic Partial Nephrectomy for Small Renal Masses (CLOCK II Laparoscopic Study): A Intention-to-treat Analysis of Perioperative OutcomesRiccardo Bertolo0Pierluigi Bove1Marco Sandri2Antonio Celia3Luca Cindolo4Chiara Cipriani5Mario Falsaperla6Costantino Leonardo7Andrea Mari8Paolo Parma9Alessandro Veccia10Domenico Veneziano11Andrea Minervini12Alessandro Antonelli13Urology Department, San Carlo di Nancy Hospital, Rome, Italy; Corresponding author. “San Carlo di Nancy” Hospital – GVM Care & Research, Via Aurelia 275, 00165 Rome, Italy. Tel. +390639976504.Urology Department, San Carlo di Nancy Hospital, Rome, Italy; Urology Unit, Department of Surgery, Tor Vergata University of Rome, Rome, ItalyData Methods and System Statistical Laboratory, University of Brescia, Brescia, ItalyDepartment of Urology, San Bassiano Hospital, Bassano Del Grappa, ItalyDepartment of Urology, Villa Stuart Private Hospital, Rome, ItalyUrology Department, San Carlo di Nancy Hospital, Rome, ItalyDepartment of Urology, ARNAS Garibaldi Hospital, Catania, ItalyDepartment of Urology, La Sapienza University of Rome, Rome, ItalyDepartment of Urology, Careggi Hospital, University of Florence, Florence, ItalyDepartment of Urology, Ospedale “Carlo Poma” Mantova, Mantova, ItalyUnit of Urology, Spedali Civili Hospital, University of Brescia, Brescia, ItalyDepartment of Urology and Kidney Transplantation, O.O. Riuniti BMM, Reggio Calabria, ItalyDepartment of Urology, Azienda Ospedaliera Universitaria Integrata of Verona, University of Verona, Verona, ItalyUnit of Urology, Spedali Civili Hospital, University of Brescia, Brescia, Italy; Department of Urology, Azienda Ospedaliera Universitaria Integrata of Verona, University of Verona, Verona, ItalyBackground: Recent randomized trials (RCTs) in the field of robotic partial nephrectomy (PN) showed no significant differences in perioperative outcomes between the off- and on-clamp approaches. Objective: To compare the perioperative outcomes of on- versus off-clamp pure laparoscopic PN (LPN). Design, setting, and participants: A multi-institutional analysis of the on- versus off-clamp approach during LPN in the setting of an RCT (CLOCK II trial; ClinicalTrials.gov NCT02287987) was performed. Intervention: Off- versus on-clamp LPN. Outcome measurements and statistical analysis: Baseline patient and tumor variables, and peri- and postoperative data were collected. Randomized allocation with a 1:1 ratio was assigned. Surgical strategy for managing the renal pedicle was dictated by the study protocol. In the off-clamp arm, the renal artery had to remain unclamped for the duration of the whole procedure. Reporting the intention-to-treat analysis is the purpose of the study. Results and limitations: The study recruited 249 patients. Of them, 123 and 126 were randomized and allocated into the on- and off-clamp treatment groups, respectively. Treatment groups were comparable at baseline after randomization with respect to patients’ demographics, comorbidities, renal function, and tumor size and complexity. A univariable analysis found no differences in the perioperative outcomes between the groups, including median (interquartile range) estimated blood loss (150 [100–200] vs 150 [100–250] ml, p = 0.2), grade ≥2 complication rate as classified according to the Clavien-Dindo system (5.7% vs 4.8%, p = 0.6), and positive surgical margin rate (8.2% vs 3.5% for the on- vs off-clamp group, p = 0.1). No differences were found in terms of the 1st (81.3 [66.7–94.3] vs 85.3 [71.0–97.7] ml/min, p = 0.2) and 5th postoperative days estimated glomerular filtration rate (83.3 [70.5–93.7] vs 83.4 [68.6–139.3] ml/min, p = 0.2). A multivariable analysis found each +1 increase in RENAL score corresponded to an increase in the protection from the occurrence of complications (odds ratio [OR] 0.72, 95% confidence interval [CI] 0.54–0.97, p = 0.034), while each +1 cm increase in tumor size corresponded to an increase in the risk of blood transfusion (OR 1.39, 95% CI 1.14–1.70, p = 0.001). Conclusions: In the setting of an RCT, no differences were found in the perioperative and early functional outcomes between on- and off-clamp LPN. Patient summary: In this study, we investigated, by means of a randomized trial, whether avoiding the clamping of renal artery during laparoscopic resection of renal mass is able to translate into benefits. We found no differences in terms of safety, efficacy, and renal function from the standard approach, which includes arterial clamping.http://www.sciencedirect.com/science/article/pii/S2666168322021280Partial nephrectomyRenal neoplasmLaparoscopyOff-clampClamplessIschemia |
| spellingShingle | Riccardo Bertolo Pierluigi Bove Marco Sandri Antonio Celia Luca Cindolo Chiara Cipriani Mario Falsaperla Costantino Leonardo Andrea Mari Paolo Parma Alessandro Veccia Domenico Veneziano Andrea Minervini Alessandro Antonelli Randomized Clinical Trial Comparing On-clamp Versus Off-clamp Laparoscopic Partial Nephrectomy for Small Renal Masses (CLOCK II Laparoscopic Study): A Intention-to-treat Analysis of Perioperative Outcomes European Urology Open Science Partial nephrectomy Renal neoplasm Laparoscopy Off-clamp Clampless Ischemia |
| title | Randomized Clinical Trial Comparing On-clamp Versus Off-clamp Laparoscopic Partial Nephrectomy for Small Renal Masses (CLOCK II Laparoscopic Study): A Intention-to-treat Analysis of Perioperative Outcomes |
| title_full | Randomized Clinical Trial Comparing On-clamp Versus Off-clamp Laparoscopic Partial Nephrectomy for Small Renal Masses (CLOCK II Laparoscopic Study): A Intention-to-treat Analysis of Perioperative Outcomes |
| title_fullStr | Randomized Clinical Trial Comparing On-clamp Versus Off-clamp Laparoscopic Partial Nephrectomy for Small Renal Masses (CLOCK II Laparoscopic Study): A Intention-to-treat Analysis of Perioperative Outcomes |
| title_full_unstemmed | Randomized Clinical Trial Comparing On-clamp Versus Off-clamp Laparoscopic Partial Nephrectomy for Small Renal Masses (CLOCK II Laparoscopic Study): A Intention-to-treat Analysis of Perioperative Outcomes |
| title_short | Randomized Clinical Trial Comparing On-clamp Versus Off-clamp Laparoscopic Partial Nephrectomy for Small Renal Masses (CLOCK II Laparoscopic Study): A Intention-to-treat Analysis of Perioperative Outcomes |
| title_sort | randomized clinical trial comparing on clamp versus off clamp laparoscopic partial nephrectomy for small renal masses clock ii laparoscopic study a intention to treat analysis of perioperative outcomes |
| topic | Partial nephrectomy Renal neoplasm Laparoscopy Off-clamp Clampless Ischemia |
| url | http://www.sciencedirect.com/science/article/pii/S2666168322021280 |
| work_keys_str_mv | AT riccardobertolo randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT pierluigibove randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT marcosandri randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT antoniocelia randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT lucacindolo randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT chiaracipriani randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT mariofalsaperla randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT costantinoleonardo randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT andreamari randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT paoloparma randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT alessandroveccia randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT domenicoveneziano randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT andreaminervini randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes AT alessandroantonelli randomizedclinicaltrialcomparingonclampversusoffclamplaparoscopicpartialnephrectomyforsmallrenalmassesclockiilaparoscopicstudyaintentiontotreatanalysisofperioperativeoutcomes |