Effect of Peritoneal Fixation (PerFix) on Lymphocele Formation in Robot-assisted Radical Prostatectomy with Pelvic Lymphadenectomy: Results of a Randomized Prospective Trial

Symptomatic lymphoceles present the most common complication of robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND). No surgical technique has so far shown success in reducing the incidence rate, but several retrospective studies have shown the beneficial effect of the fixation of the peritoneum.To introduce a modification in the technique of fixing the peritoneum to the pubic bone and to confirm whether this intervention reduces the incidence of lymphoceles.A prospective randomized (1:1) single-center one-sided blind study was conducted in patients with localized prostate cancer (cT1-2cN0M0) indicated for RARP with ePLND operated between December 2019 and June 2021. In the intervention group, the free flap of the peritoneum was fixed to the pubic bone. In the control group, the peritoneal flap was left free without fixation.In the intervention group, the free flap of the peritoneum was fixed to the pubic bone (PerFix) so that lateral holes were left, allowing drainage of lymph from the pelvis into the abdominal cavity, where it would be resorbed. The iliac vessels and obturator fossa remained uncovered by the peritoneum and the bladder.The primary objective was to evaluate the frequency of symptomatic lymphoceles during follow-up. The secondary endpoints were the radiological presence of lymphoceles on computed tomography of the pelvis carried out 6 wk after surgery, the volume of the lymphoceles, and the degree of severe (Clavien-Dindo ≥3) complications.Of the 260 randomized patients, 245 were evaluated in the final analysis-123 in the intervention and 122 in the control group. The median follow-up was 595 d. There were no differences between the groups regarding clinical and pathological variables. The median of 17 nodes removed was the same in both groups (p = 0.961). Symptomatic lymphoceles occurred in 17 patients (6.9%), while in the intervention group these were found in three (2.4%) versus 14 (11.5%) in the control group (p = 0.011). The number of radiologically detected asymptomatic lymphoceles did not differ (p = 0.095). There was no significant difference in lymphocele volume between the two groups (p = 0.118). The rate of serious complications (Clavien 3a and 3b) was 4.8% in the intervention group and 9.1% in the control group (p = 0.587). A multivariate logistic regression model of symptomatic lymphocele occurrence was created with significant factors: body mass index (odds ratio [OR] = 1.1, 95% confidence interval [CI] = [1.03, 1.26], p = 0.012) and intervention (OR = 4.6, 95% CI = [1.28, 16.82], p = 0.02).Fixation of the peritoneum (PerFix) reduced the incidence of symptomatic lymphoceles in RARP with ePLND. We found no difference in the frequency of asymptomatic lymphocele development. The volume of the detected lymphoceles was similar.In this study, we compared the rate of development of postoperative complications using the peritoneal fixation technique with that of a nonfixation control group for robot-assisted radical prostatectomy with extended pelvic lymphadenectomy. Fixation of the peritoneum should obviate the development of severe complications in the postoperative period.