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Randomized Controlled Trial
. 2025 Mar 5;43(1):148.
doi: 10.1007/s00345-025-05518-3.

Impact of peritoneal bladder flap in robot-assisted radical prostatectomy patients on lymphoceles: a prospective randomised trial

Randi M Pose  1 , S Knipper  2 , B Beyer  3 , L Hohenhorst  4 , A Haese  4 , H Heinzer  4 , G Salomon  4 , T Steuber  4   5 , L Budäus  4 , D Tilki  4   5 , H Isbarn  2 , T Maurer  4   5 , P Tennstedt  4 , M Graefen  4 , U Michl  4
Affiliations
Randomized Controlled Trial

Impact of peritoneal bladder flap in robot-assisted radical prostatectomy patients on lymphoceles: a prospective randomised trial

Randi M Pose et al. World J Urol. .

Abstract

Objective: To test the impact of fixing a peritoneal flap of the bladder to the plexus Santorini as final step of robot-assisted radical prostatectomy (RARP) to reduce the incidence of symptomatic lymphoceles and postoperative complications.

Patients and methods: A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent RARP with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention. Secondary endpoints were total lymphocele rate, other complications ≥ grade IIIa according to Clavien-Dindo and continence rates within one year after RARP.

Results: Overall, between June 2017 and October 2019, 531 patients were randomised to the MT and 549 to the control arm. There were no differences in both arms with respect to age at surgery, PSA, BMI, prostate volume, surgical time, blood loss, and time to removal of the catheter. Overall, in median 14 lymph nodes were dissected and 337 (32%) patients had a lymphocele. There was no statistically significant difference in lymphoceles requiring intervention (7.2% in MT-group versus 8.8% in control group, p = 0.4). There was no difference in continence rates and other complications between the two groups after one-year-follow-up.

Conclusions: There was no significant reduction in symptomatic lymphoceles observed when using the Michl-technique. Lymphoceles remain a significant complication post lymph node dissection in RARP patients.

Keywords: Complication; Lymphocele; Pelvic lymph node dissection; Prostate cancer; Prostatectomy.

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Conflict of interest statement

Declarations. Ethical approval: In accordance with federal and institutional guidelines, all men signed an institutional review board-approved, protocol-specific informed consent form before study entry. The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Anonymised data was used. All patients agreed on data collection by informed consent. Competing interests: The authors declare no competing interests.

References

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