Are early continence recovery and oncological outcomes influenced by use of different devices in prostatic apex dissection during laparoscopic radical prostatectomy?
Treatment of prostate cancer has evolved considerably in the last decade, especially in terms of minimisation of the negative impacts on erectile function and continence to ensure good quality of life for treated patients. New surgical devices, such as dissectors and haemostatic scalpels, allow precise definition of the surgical field with finer dissection of the anatomic structures, with subsequent reductions in operative times and better oncological and functional outcomes. Although monopolar scissors (MS) are still widely used, radiofrequency (RF) and ultrasound (US) scalpels have been recently introduced in laparoscopic radical prostatectomy (LRP). However, despite the widespread use of these scalpels, few studies have compared these devices in terms of oncological and functional outcomes after radical prostatectomy. The present study aimed to prospectively assess the impact of MS, RF and US scalpels on margin status at apex, and recovery of urinary continence and erectile function in patients undergoing extraperitoneal LRP.
Materials and Methods
A total of 150 men were prospectively enrolled. All patients had a histopathologic diagnosis of prostatic adenocarcinoma, as determined by transperineal ultrasound-guided biopsy after preliminary clinical evaluation involving digital rectal examination (DRE) and assessment of serum prostate-specific antigen (PSA) levels (total PSA, free-PSA, and ratio). The clinical stage of the disease was determined in all patients by abdominopelvic magnetic resonance and whole-body bone scintigraphy.
All patients who met the following preoperative criteria underwent bilateral nerve sparing ELRP: PSA ≤10 ng/mL, life expectancy >10 years, no extraprostatic extension, negative DRE, no more than 2 positive cores per lobe, and a primary Gleason pattern = 3.
Postoperative (90 and 180 days post-ELRP) evaluation of continence was performed for all patients using the International Consultation on Incontinence self-administered Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF), a condition-specific, quality of life questionnaire developed by the International Continence Society (ICS) for patients with urinary incontinence.
After a stratified randomization to control for baseline covariates was made, the patients were randomly assigned, using a computer table generation of random numbers, to group A (RF; n = 50), group B (US; n = 50), or group C (MS; n = 50). In group A, the dissection of the prostatic apex was performed with the use of an RF scalpel (LigaSure-8 generator with LigaSure RF scalpel, vessel-sealing system V 5-mm forceps; Valley Lab, Tyco Healthcare®). In group B, the dissection was performed with the use of a US scalpel (UltraCision Harmonic scalpel generator 300 with 5-mm 36p Harmonic Ace forceps; Ethicon Endo-Surgery, Inc.®), and in group C, the dissection was performed using monopolar scissors (Aesculap, Inc.®). All patients were clinically evaluated 15 and 30 days post-surgery.
Patient age, prostate-specific antigen levels, clinical stage, body mass index (BMI), baseline urinary function, and perioperative data were similar in all groups. Focusing on the intraoperative data, there were no differences regarding the operative times (mean: 155.8 ± 29.3 min; range: 108-202 min) and blood loss (mean 184.6 ± 25.6 mL; range: 157-223 mL) between the groups (p = 0.9433).
Similarly to the overall surgical margin positivity, there were no significant differences between the groups in terms of apical margin positivity, with 3, 1, and 1 patients in groups A, B, and C, respectively, reporting positive apical margins (p = 0.4424).
The mean number of days of catheterization was 6.69, 8.25, and 8.86 days in groups A, B, and C, respectively. Moreover, no differences regarding the functional outcomes evaluated by the ICIQ scores at 1, 3, and 6 months post-surgery were observed. At the 3-month follow-up, the median ICIQ scores were 6, 6.57, and 5.36 in groups A, B, and C, respectively (p = 0.7456), whereas at the 6-month follow-up, they were 3.38, 5.14, and 2.73, respectively (p = 0.1782).
The precise aetiology of post-prostatectomy incontinence remains unknown. The reported incidence rates of urinary incontinence after radical prostatectomy range from 2.5-87.0%, and differ considerably according to the exact definition, follow-up duration, and surgical technique used. There are many known causative factors for the occurrence of post-prostatectomy incontinence, with a number of objective clinical characteristics, the surgical technique used, and the absence or presence of postoperative pelvic floor muscle therapy being the most important ones. In the present study, we demonstrated that the use of RF, US, and cold scissors were similar with respect to operative time, blood loss, and postoperative hospital stay, while a shorter catheterization time was noted in the RF group. Moreover, blood transfusions are rarely required, with only 11/150 patients needing blood transfusions in this study. In addition, in our case series, recovery of continence was reported by 71.7% of patients 3 months postoperatively, reaching 94.7% at the 6-month follow-up. To the best of our knowledge, the present study is the first prospective randomized study focusing on the laparoscopic radical prostatectomy functional outcomes (i.e. early continence recovery) related to the use of different devices during apex dissection and urethral stump preparation.
Most surgeons choose the surgical device based on practical aspects, particularly their confidence with the instrument, its ergonomic features, and, consequently, its simplicity of use. Ideally, the preference of one device over another should firstly depend on technical aspects and objective data.
The LigaSure and UltraCision devices used herein present different technical features. The LigaSure vessel-sealing device uses both electrical energy and pressure to liquefy and reform collagen and elastin in the vessel walls and tissues (up to 7 mm in diameter) to provide haemostasis. The device incorporates feedback control, which automatically terminates energy transmission once a seal has been achieved. In contrast, the UltraCision scalpel uses US technology to denature proteins within vessel walls and tissues (up to 5 mm thick), leading to coagulation. Both the LigaSure device and UltraCision scalpel have been demonstrated to be safe and effective in numerous studies, and both devices have been shown to reduce operative times and make the procedure easier for the surgeon.
Oncological, functional, and operative outcomes are similar between monopolar scissors and radiofrequency and ultrasound scalpels during LRP, with no device demonstrating superiority in terms of continence recovery. In the present study, we demonstrated that the use of RF, US, and cold scissors were similar with respect to operative time, blood loss, and postoperative hospital stay. In our case series, recovery of continence was reported by 71.7% of patients 3 months postoperatively, reaching 94.7% at the 6-month follow-up. This is the first study in the literature focusing on continence recovery with respect to different scalpels used in LRP, and our findings confirm the efficacy and safety of these devices.
1. Vora AA, Dajani D, Lynch JH, Kowalczyk KJ. Anatomic and technical considerations for optimizing recovery of urinary function during robotic-assisted radical prostatectomy. Curr Opin Urol. 2013;23(1):78-87.
2. Ficarra V, Novara G, Rosen RC, Artibani W, Carroll PR, Costello A, Menon M, Montorsi F, Patel VR, Stolzenburg JU, Van der Poel H, Wilson TG, Zattoni F, Mottrie A: Systematic review and meta-analysis of studies reporting urinary continence recovery after robot-assisted radical prostatectomy. Eur Urol 2012; 62(3): 405-417.
3. Yang BS, Ye DW, Peng JY, Yao XD, Zhang SL, Dai B, Zhang HL, Shen YJ, Zhu Y, Zhu YP, Shi GH: Analysis of risk factors for urinary continence after radical prostatectomy. Zhonghua Yi Xue Za Zhi. 2011 Aug 30;91(32):2239-42.Argomenti: cancro della prostata