OBJECTIVE: To determine whether lymphoceles can be prevented after robotic prostatectomy with pelvic lymph node dissection (PLND), we performed a prospective randomized study using an absorbable hemostatic agent (Arista AH). The most common complications of PLND for prostate cancer are related to lymphocele formation, which occur in 30%-50% of patients according to studies that performed screening imaging. Although most are asymptomatic, when intervention is required the cost and morbidity are high. MATERIALS AND METHODS: Of 100 patients enrolled, 88 completed the study. Each patient served as his or her own control, with Arista AH placed over the field of PLND on only one side in a randomized fashion as revealed only after bilateral PLND was completed. All patients underwent screening pelvic computed tomography scan 3 months later, with radiologists blinded to the Arista AH treated side. A significant lymphocele was defined as a fluid collection 3 cm or greater in any plane. RESULTS: The mean lymph node yield was 8.1 nodes. Fourteen lymphoceles were identified. Five occurred on the side where Arista AH was used vs 9 on untreated sides (5.7% vs 10.2%, P = .248). When they occurred, there was no statistically significant difference in lymphocele size between treated and untreated sides (P = .441). No lymphoceles were symptomatic. CONCLUSION: Although the lymphocele rate with Arista AH was 5.7% compared with 10.2% without it, this was not a statistically significant difference potentially because the study was underpowered due to an unusually low baseline rate of lymphoceles. A larger study is warranted to determine whether using a hemostatic agent like Arista AH can prevent lymphoceles.
RCT Entities:
OBJECTIVE: To determine whether lymphoceles can be prevented after robotic prostatectomy with pelvic lymph node dissection (PLND), we performed a prospective randomized study using an absorbable hemostatic agent (Arista AH). The most common complications of PLND for prostate cancer are related to lymphocele formation, which occur in 30%-50% of patients according to studies that performed screening imaging. Although most are asymptomatic, when intervention is required the cost and morbidity are high. MATERIALS AND METHODS: Of 100 patients enrolled, 88 completed the study. Each patient served as his or her own control, with Arista AH placed over the field of PLND on only one side in a randomized fashion as revealed only after bilateral PLND was completed. All patients underwent screening pelvic computed tomography scan 3 months later, with radiologists blinded to the Arista AH treated side. A significant lymphocele was defined as a fluid collection 3 cm or greater in any plane. RESULTS: The mean lymph node yield was 8.1 nodes. Fourteen lymphoceles were identified. Five occurred on the side where Arista AH was used vs 9 on untreated sides (5.7% vs 10.2%, P = .248). When they occurred, there was no statistically significant difference in lymphocele size between treated and untreated sides (P = .441). No lymphoceles were symptomatic. CONCLUSION: Although the lymphocele rate with Arista AH was 5.7% compared with 10.2% without it, this was not a statistically significant difference potentially because the study was underpowered due to an unusually low baseline rate of lymphoceles. A larger study is warranted to determine whether using a hemostatic agent like Arista AH can prevent lymphoceles.
Authors: Giuseppe Magistro; Doan Tuong-Linh Le; Thilo Westhofen; Alexander Buchner; Boris Schlenker; Armin Becker; Christian G Stief Journal: Cent European J Urol Date: 2021-09-09