Deviation from the Protocol of a Randomized Clinical Trial Comparing On-Clamp versus Off-Clamp Laparoscopic Partial Nephrectomy (CLOCK II Laparoscopic Study): A Real-Life Analysis

被引:10
|
作者
Bove, Pierluigi [1 ,2 ]
Bertolo, Riccardo [1 ]
Sandri, Marco [3 ]
Cipriani, Chiara [1 ]
Leonardo, Costantino [4 ]
Parma, Paolo [5 ]
Falsaperla, Mario [6 ]
Veneziano, Domenico [7 ]
Celia, Antonio [8 ]
Mari, Andrea [9 ]
Minervini, Andrea [9 ]
Antonelli, Alessandro [10 ,11 ]
机构
[1] San Carlo di Nancy Hosp, Urol Dept, Rome, Italy
[2] Tor Vergata Univ Rome, Dept Surg, Urol Unit, Rome, Italy
[3] Univ Brescia, Big & Open Data Innovat Lab BODaI Lab, Brescia, Italy
[4] Univ Roma La Sapienza, Dept Urol, Rome, Italy
[5] Osped Carlo Poma Mantova, Dept Urol, Mantua, Italy
[6] ARNAS Garibaldi Hosp, Dept Urol, Catania, Italy
[7] OO Riuniti BMM, Dept Urol & Kidney Transplantat, Reggio Di Calabria, Italy
[8] San Bassiano Hosp, Dept Urol, Bassano Del Grappa, Italy
[9] Univ Florence, Careggi Hosp, Dept Urol, Florence, Italy
[10] Univ Brescia, Spedali Civili Hosp, Unit Urol, Brescia, Italy
[11] Univ Verona, Azienda Osped Univ Integrata Verona, Dept Urol, Verona, Italy
来源
JOURNAL OF UROLOGY | 2021年 / 205卷 / 03期
关键词
nephrectomy; kidney neoplasms; laparoscopy; surgical instruments; NEPHRON-SPARING SURGERY; RENAL TUMORS; OUTCOMES;
D O I
10.1097/JU.0000000000001417
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Purpose: We assess factors/additional morbidities related to the conversion of clamping approach during off-clamp vs on-clamp laparoscopic partial nephrectomy in the setting of a randomized study. Materials and Methods: Consecutive candidates for laparoscopic partial nephrectomy from 6 institutions were randomized to on-clamp or off-clamp surgery. The present study analyzed 1) off-clamp arm patients, comparing the procedures finalized per protocol without artery clamping (off-clamp) to those needing renal artery clamping (shift-on-clamp) and 2) on-clamp arm patients, comparing the procedures finalized with artery clamping (on-clamp) to those completed without clamping (shift-off-clamp). Results: A total of 123 patients were randomized to on-clamp and 126 to off-clamp surgery. Of the off-clamp patients 41 (32.5%) converted to on-clamp. Of the on-clamp patients 70 (56.9%) completed surgery without clamping the renal artery due to subjective intraoperative decision of the surgeon. Tumor size was greater in shift-on-clamp vs off-clamp cases (4 vs 3, p=0.002). Conversely, tumor size (3.7 vs 3 cm, p=0.002) and R.E.N.A.L. nephrometry score (6 vs 5, p=0.038) were lower in shift-off-clamp cases. Shift-on-clamp cases had longer operative times and greater changes in estimated glomerular filtration rate on postoperative day 1. Shift-off-clamp cases had shorter operative times. A higher proportion of patients who completed on-clamp surgery per protocol had a greater than 25% drop in estimated glomerular filtration rate on postoperative day 1 (29.4%) compared to smaller changes (10.3%, p=0.009) in estimated glomerular filtration rate. Increasing tumor size and complete endophytic growth pattern predicted shift-on-clamp while preventing shift-off-clamp. Body mass index above 28 predicted shift-off-clamp. Conclusions: The likelihood of shift-on/off-clamp relies on tumor size/complexity. The intraoperative need to convert the planned strategy seemed harmless on postoperative course. An advantage in terms of early functional outcomes does exist when avoiding artery clamping.
引用
收藏
页码:678 / 684
页数:7
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