Comparison of peritoneal interposition flaps and sealants for prevention of lymphocele after robotic radical prostatectomy and pelvic lymph node dissection: a systematic review, meta-analysis, Bayesian network meta-analysis, and meta-regression.

Lymphocele is one of the most common complications after radical prostatectomy. Multiple authors have proposed the use of vessel sealants or peritoneal interposition techniques as preventive interventions. This study aimed to aggregate and analyze the available literature on different interventions which seek to prevent lymphocele through a Bayesian Network. A systematic review was performed to identify prospective studies evaluating strategies for lymphocele prevention after robot assisted laparoscopic prostatectomy + pelvic lymph node dissection. Data was inputted into Review Manager 5.4 for pairwise meta-analysis. Data was then used to build a network in R Studio. These networks were used to model 200,000 Markov Chains via MonteCarlo sampling. The results are expressed as odds ratios (OR) with 95% credible intervals (CrI). Meta-regression was used to determine coefficient of change and adjust for pelvic lymph node dissection extent. Ten studies providing data from 2211 patients were included. 1097 patients received an intervention and 1114 patients served as controls. Interposition with fenestration had the lowest risk of developing a lymphocele (OR 0.14 [0.04, 0.50], p = 0.003). All interventions, except sealants or patches, had significant decreased odds of lymphocele rates. Meta-analysis of all the included studies showed a decreased risk of developing a lymphocele (OR 0.42 [0.33, 0.53], p < 0.00001) for the intervention group. Perivesical fixation and interposition with fenestration appear to be effective interventions for reducing the overall incidence of lymphocele.

Lymphocele Outcomes After Renal Transplantations Performed by an Experienced Surgeon: Is Meticulously Performed Surgery and Experience Adequate to Prevent Lymphocele?

BACKGROUND The purpose of the present study was to analyze the rate of lymphoceles in kidney transplant operations meticulously performed by the same senior surgeon. MATERIAL AND METHODS The present study included 315 patients who were operated on in our organ transplantation center and followed up in the polyclinic after July 2013. The patients were retrospectively divided into 2 groups: patients with and without lymphocele. Symptomatic lymphocele (SL) has been defined as symptomatic fluid collection around the graft that necessitates an intervention for the graft or patient. RESULTS Lymphocele was observed in 82 (26%) patients. An intervention was needed in 16 (5.1%) of these cases. Demographic data such as age and sex of both groups were similar. Lymphocele cases were mostly asymptomatic, with a size <6 cm (75.6%). However, intervention was needed in 16 (75%) of the patients with a size ≥6 cm that were symptomatic. The length of time on dialysis in the pretansplant period was shorter in the group that developed lymphocele, and a lower rate of graft loss was observed in these patients. No statistically significant difference was found between the 2 groups in terms of rejection rates, serum albumin/globulin levels, and development of de novo DSA. CONCLUSIONS The risk factors reported in the literature related with lymphocele formation were not found to be statistically significant in our study. Complications, except lymphocele, were observed less frequently, but lymphocele formation was encountered in our patients despite meticulous surgery.

The Association of a Peritoneal Interposition Flap With Lymphocele Formation After Pelvic Lymph Node Dissection During Robotic-assisted Laparoscopic Radical Prostatectomy: A Systematic Review and Meta-analysis.

OBJECTIVE: To conduct a systematic review and meta-analysis to evaluate the association of a peritoneal interposition flap (PIF) with lymphocele formation following robotic-assisted laparoscopic radical prostatectomy (RALP) with pelvic lymph node dissection. METHODS: We conducted a systematic search of MEDLINE, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials through August 30, 2023, to identify randomized and nonrandomized studies comparing RALP with pelvic lymph node dissection with and without PIF. A random effects meta-analysis was then performed to evaluate the associations of PIF with 90-day postoperative outcomes. RESULTS: Five randomized controlled trials (RCTs) and four observational studies, including a total of 2941 patients, were included. The use of PIF was associated with a reduced risk of 90-day symptomatic lymphocele formation after RALP when examining only RCTs (pooled odds ratios [OR] 0.44, 95% CI 0.28-0.69; I2 =3%) and both RCTs and observational studies (OR 0.35, 95% CI 0.22-0.56; I2 =17%). Similarly, use of PIF was associated with a reduced risk of 90-day any lymphocele formation (OR 0.40, 95% CI 0.28-0.56, I2 =39%). There were no statistically significant differences in postoperative complications between the two groups (OR 0.89; 95% CI 0.69-1.14; I2 =20%). CONCLUSION: Use of the PIF is associated with an approximately 50% reduced risk of symptomatic and any lymphocele formation within 90-days of surgery, and it is not associated with an increase in postoperative complications.

Prophylactic Sclerotherapy for Lymphatic Complications After Living Donor Renal Transplant: A Single-Center Experience.

OBJECTIVES: Lymphocele formation after kidney transplant is a common complication that causes significant morbidity. In this study, we aimed to evaluate the safety and effectiveness of intraoperative prophylactic povidone-iodine sclerotherapy through the closed suction drain to prevent lymphocele after kidney transplant. MATERIALS AND METHODS: In this retrospective comparative single-institution study, we compared patients who underwent intraoperative prophylactic povidone-iodine sclerotherapy through the closed suction drain (group A) with patients who did not receive sclerotherapy (group B). Patients were treated between September 2017 and July 2023. Atthe end of the kidney transplant surgery, after the closure of the external oblique muscle layer and before skin closure, 10 mL of 10% povidone-iodine in 40 mL of normal saline were instilled via the closed suction drain and dwelled in the cavity for 30 minutes. RESULTS: During the study period, 300 living-related donor kidney transplants were performed. Prophylactic povidone-iodine sclerotherapy was performed in 150 patients (50%).We noted a significantly lower incidence of lymphorrhea and lymphocele in group A. On postoperative days 1 and 5, we noted a significant reduction in drain output in group A (P < .001). One patient in group A and 5 patients in group B required ultrasonography-guideddrainage andpovidone-iodine sclerotherapy. No sclerotherapy-related complications were reported after a median follow-up of 16 months (range, 3-29 months). CONCLUSIONS: Intraoperative prophylactic povidoneiodine sclerotherapy appears to be an easy, safe, and effective procedure for preventing lymphatic complications after living donor kidney transplant.

Peritoneal Flap for Lymphocele Prophylaxis Following Robotic-assisted Radical Prostatectomy with Lymph Node Dissection: The Randomised Controlled Phase 3 PELYCAN Trial.

BACKGROUND: Symptomatic lymphoceles (SLCs) after transperitoneal robotic-assisted radical prostatectomy with pelvic lymph node dissection (PLND) are common. Evidence from randomised controlled trials (RCTs) on the impact of peritoneal flaps (PFs) on lymphocele (LC) reduction is inconclusive. OBJECTIVE: To show that addition of PFs leads to a reduction of postoperative SLCs. DESIGN, SETTING, AND PARTICIPANTS: An investigator-initiated, prospective, parallel, double-blinded, adaptive, phase 3 RCT was conducted. Recruitment took place from September 2019 until December 2021; 6-month written survey-based follow-up was recorded. Stratification was carried out according to potential LC risk factors (extended PLND, diabetes mellitus, and anticoagulation) and surgeons; 1:1 block randomisation was used. Surgeons were informed about allocation after completion of the last surgical step. INTERVENTION: To create PFs, the ventral peritoneum was incised bilaterally and fixated to the pelvic floor. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was SLCs. Secondary endpoints included asymptomatic lymphoceles (ALCs), perioperative parameters, and postoperative complications. RESULTS AND LIMITATIONS: In total, 860 men were screened and 551 randomised. Significant reductions of SLCs (from 9.1% to 3.7%, p = 0.005) and ALCs (27.2% to 10.3%, p < 0.001) over the follow-up period of 6 mo were observed in the intention-to-treat analysis. Operating time was 11 min longer (p < 0.001) in the intervention group; no significant differences in amount (80 vs 103, p = 0.879) and severity (p = 0.182) of postoperative complications (excluding LCs) were observed. The survey-based follow-up might be a limitation. CONCLUSIONS: This is the largest RCT evaluating PF creation for LC prevention and met its primary endpoint, the reduction of SLCs. The results were consistent among all subgroup analyses including ALCs. Owing to the subsequent reduction of burden for patients and the healthcare system, establishing PFs should become the new standard of care. PATIENT SUMMARY: A new technique-creation of bilateral peritoneal flaps-was added to the standard procedure of robotic-assisted prostatectomy for lymph node removal. It was safe and decreased lymphocele development, a common postoperative complication and morbidity. Hence, it should become a standard procedure.

The efficacy of peritoneal flap fixation on symptomatic lymphocele formation following robotic-assisted laparoscopic radical prostatectomy with pelvic lymph node dissection: a systematic review and meta-analysis.

BACKGROUND: Pelvic lymphocele is the most common complication after robot-assisted radical prostatectomy (RARP) with pelvic lymph node dissection (PLND), of which symptomatic lymphocele (sLC) ranges up to 10% and is associated with poorer perioperative outcomes. Peritoneal flap fixation (PFF) is a promising intraoperative modification to reduce sLC formation but the clinical evidence failed to reach consistency. MATERIALS AND METHODS: Randomized and nonrandomized comparative studies comparing postoperative sLC occurrence with or without PFF after RARP with PLND were identified through a systematic literature search via MEDLINE/PubMed, Embase, Web of Science, and CENTRAL up to July 2023. Outcome data of sLC occurrence (primary) and major perioperative events (secondary) were extracted. Mean difference and risk ratio with 95% CI were synthesized as appropriate for each outcome to determine the cumulative effect size. RESULTS: Five RCTs and five observatory studies involving 3177 patients were finally included in the qualitative and quantitative analysis. PFF implementation significantly reduced the occurrence of sLC (RR 0.35, 95% CI: 0.24-0.50), and the specific lymphocele-related symptoms, without compromised perioperative outcomes including blood loss, operative time, and major nonlymphocele complications. The strength of the evidence was enhanced by the low risk of bias and low inter-study heterogeneity of the eligible RCTs. CONCLUSION: PFF warrants routine implementation after RARP with PLND to prevent or reduce postoperative sLC formation.

Effect of Peritoneal Interposition Flap to Prevent Symptomatic Lymphoceles in Robot-Assisted Radical Prostatectomy with Pelvic Lymphadenectomy: A Meta-Analysis and Systematic Review.

Background: This systematic review and meta-analysis investigated whether peritoneal interposition flap (PIF) prevent lymphocele formation after robot-assisted radical prostatectomy with extended pelvic lymph node dissection. Materials and Methods: We performed a systematic review and cumulative meta-analysis of the primary outcomes according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, Assessing the Methodological Quality of Systematic Reviews guidelines and risk-of-bias tool. Five databases, including Medline, PubMed, Cochrane Library, Scopus, and Web of Science, were systematically searched. The time frame of the search was set from the creation of the database to February 2023. Results: Meta-analysis of symptomatic lymphoceles (sLCs) rates revealed significant difference between PIF and no PIF group (eight studies pooled; p = 0.005), The sLCs rates account for 2.6% (28/1074) and 7.1% (85/1186) in the PIF and no PIF group, respectively. The resulting odds ratio was 0.34 (95% confidence interval: 0.16-0.73), taking into account the heterogeneity of these studies (Q = 14.32, p = 0.05; I2 = 51%). Conclusion: PIF is an effective intraoperative modification on the prevention or reduction of sLC, which is worthy of further clinical promotion. Systematic Review Registration: National Institute for Health and Care Research, identifier CRD42022364461.

Efficacy of octreotide to reduce lymphorrhea and prevent lymphocele after pelvic lymph node excision in gynecological malignancies.

AIM: To study the efficacy of octreotide to reduce lymphorrhea and prevent lymphocele after pelvic lymph node excision in gynecological malignancies. METHODS: Patients with more than 200 mL of lymph drained per day until postoperative day 3 after pelvic lymph node excision were enrolled. Of the 75 patients, 36 were managed by conservative methods without the injection of octreotide, and the other 39 patients were treated with the injection of octreotide. The treated group was injected with 0.1 mg octreotide q8h for 5 days, starting on postoperative day 3. The drainage tube was removed when the amount of drained lymph decreased to 100 mL per day. The age, BMI, operation time, removed lymph nodes, amount of lymph, duration of drain placement, proportion of patients with lymphocele and complications between these two group were compared. RESULTS: The total and mean daily amount of lymph produced per patient was significantly lower in the octreotide-treated group than in the untreated group. The duration of drain placement was shorter in the octreotide group than in the untreated group. The proportion of patients with lymphocele in the treatment group was lower than that in the untreated group. CONCLUSIONS: The injection of octreotide is effective to reduce lymphorrhea and prevent lymphocele after pelvic lymph node excision in gynecological malignancies.

Is advanced bipolar v anced bipolar vessel sealing de essel sealing device really eff eally effective in decreasing the pelvic lymphocele ratio in open surgery for endometrial cancer?

BACKGROUND: We aim to show pelvic lymphocele (PL) rates in patients who were operated for endometrial cancer (EC) and underwent systematic paraaortic bilateral pelvic lymph node dissection (PABPLND) with advanced bipolar vessel sealing device (ABVSD). METHODS: The medical files of all patients who underwent open surgery for EC between January 2017 and December 2021 were retrospectively analyzed. One hundred three patients who operated with the diagnosis of high-intermediate and high-risk endometrial cancer were included. Systematic PABPLND was performed with total abdominal hysterectomy with or without bilateral salpingo-oophorectomy during surgery to all patients. All operations were performed by same three surgeons who were expert in their field. While the lymph packages were removed during surgical dissection, the distal afferent and proximal efferent lymphatic channels were sealed with LigaSure™ blunt tip sealer/divider (Medtronic, Covidien, USA). The patients were scanned with computed tomography (CT) between 8 and 12 weeks postoperatively. Lymphocele diagnosis was confirmed by radiologists and largest diameter was recorded. Clinical-pathological findings of all patients were recorded. RESULTS: Mean age and body mass index (BMI) of all participants were 58.6 ±10.2 years and 28.1± 5.6 kg/m2 . The most histopathological findings were endometrioid type (84.5%) and grade 2 (44.2%) ECs. The pelvic lymphocele (PL) was detected with CT in 24 of 103 patients at 8 to 12 weeks postoperatively. Only two PL patients were symptomatic. The first patient had symptoms of pelvic fullness and compression while the second patient had infected image. PL was located to right pelvic area in first case while the second was located on the vaginal cuff. DISCUSSION: The dissection and sealing of major lymph vessels were achieved during the removal of all lymph packages with LigaSure™ blunt tip laparoscopic sealer/divider. The use of advanced bipolar systems can reduce the formation of PL in lymph node dissection in endometrial cancer.

[Fluorescence-guided Lymph Vessel Sealing in Systematic Nodal Dissection: a New Surgical Technique to Prevent Lymphorrhea and Lymphocele.] / Fluoreszenzgesteuerte Lymphgefäßversiegelung bei der systematischen Lymphknotendissektion zur Vermeidung von Lymphfisteln und Lymphozelen.

INTRODUCTION: The primary morbidities of inguinal and axillary systematic nodal dissection are lymphatic fistulas and seromas. Intraoperative fluorescence imaging-guided sealing of lymph vessels may prevent these postoperative complications. METHODS: Indocyanine dye was injected intracutaneously into the distal limb before the beginning of the lymphadenectomy. Systematic nodal dissection was performed according to standard protocols. Near-infrared imaging was applied throughout the procedure and real-time fluorescence-guided lymph vessel sealing was performed. RESULTS: Fluorescence-guided lymph vessel sealing was implemented in three patients undergoing axillary systematic lymph node dissection. No adverse events occurred following fluorescence dye injection. All patients could be discharged free of wound complications. CONCLUSION: Fluorescence-guided lymph vessel sealing might be a promising new technique for preventing lymphatic fistulas and lymphocele after systematic lymphadenectomy.

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

BACKGROUND: 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. OBJECTIVE: 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. DESIGN, SETTING, AND PARTICIPANTS: 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. SURGICAL PROCEDURE: 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. MEASUREMENTS: 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. RESULTS AND LIMITATIONS: 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). CONCLUSIONS: 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. PATIENT SUMMARY: 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.

The Results of Peritoneal Re-Approximation Methods on Symptomatic Lymphocele Formation in Robot-Assisted Laparoscopic Radical Prostatectomy and Extended Pelvic Lymphadenectomy.

INTRODUCTION: To evlauate role of peritoneal re-approximation methods in the prevention of symphtomatic lymphocele formation in patients underwent transperitoneal robot-assisted laparoscopic prostatectomy (tRALP) and extendeded pelvic lympadenoctomy (ePLND). MATERIALS AND METHODS: Between January 2016 and April 2020, 120 consecutive patients who were administered anterior t-RALP and ePLND were analyzed retrospectively. In group 1 (n = 40), peritoneal approximation was not performed after t-RALP and ePLND application, peritoneal half re-approximation was performed in group 2 (n=40), and peritoneal full re-approximation was performed in group 3 (n=40). Operative parameters and symptomatic lymphocele rates were compared between the groups. RESULTS: There was no statistically significant difference between the groups in terms of mean age, body mass index and prostatespecific antigen levels, Gleason score on biopsy, D'amico risk groups, the mean number of lymph nodes removed, Clavien-Dindo complication grade and mean duration of the surgery. Patients with symptomatic lymphocele in Group 1, Group 2, and Group 3 were found to be 2 (5%), 3 (7.5%) and 5 (12.5%), respectively. There was no statistically significant difference between the groups in terms of symptomatic lymphocele formation. CONCLUSION: Half or full closure of the peritoneum does not affect the symptomatic lymphocele formation in patients who underwent tRALP and ePLND.

Prevention of lymphocele or seroma after mastectomy and axillary lymphadenectomy for breast cancer: systematic review and meta-analysis.

Seroma or lymphocele remains the most common complication after mastectomy and lymphadenectomy for breast cancer. Many different techniques are available to prevent this complication: wound drainage, reduction of the dead space by flap fixation, use of various types of energy, external compression dressings, shoulder immobilization or physical activity, as well as numerous drugs and glues. We searched MEDLINE, clinicaltrials.gov, Cochrane Library, and Web of Science databases for publications addressing the issue of prevention of lymphocele or seroma after mastectomy and axillary lymphadenectomy. Quality was assessed using Hawker's quality assessment tool. Incidence of seroma or lymphocele were collected. Fifteen randomized controlled trials including a total of 1766 patients undergoing radical mastectomy and axillary lymphadenectomy for breast cancer were retrieved. The incidence of lymphocele or seroma in the study population was 24.2% (411/1698): 25.2% (232/920) in the test groups and 23.0% (179/778) in the control groups. Neither modification of surgical technique (RR 0.86; 95% CI [0.72, 1.03]) nor application of a medical treatment (RR 0.96; 95% CI [0.72, 1.29]) was effective in preventing lymphocele. On the contrary, decreasing the drainage time increased the risk of lymphocele (RR 1.88; 95% CI [1.43, 2.48). There was no publication bias but the studies were of medium to low quality. To conclude, despite the heterogeneity of study designs, drainage appears to be the most effective technique, although the overall quality of the data is low.

The Results of Peritoneal Re-Approximation Methods on Symptomatic Lymphocele Formation in Robot-Assisted Laparoscopic Radical Prostatectomy and Extended Pelvic Lymphadenectomy

Introduction: To evlauate role of peritoneal re-approximation methods in the prevention of symphtomatic lymphocele formation in patients underwent transperitoneal robot-assisted laparoscopic prostatectomy (tRALP) and extendeded pelvic lympadenoctomy (ePLND). Materials and Methods: Between January 2016 and April 2020, 120 consecutive patients who were administered anterior t-RALP and ePLND were analyzed retrospectively. In group 1 (n = 40), peritoneal approximation was not performed after t-RALP and ePLND application, peritoneal half re-approximation was performed in group 2 (n=40), and peritoneal full re-approximation was performed in group 3 (n=40). Operative parameters and symptomatic lymphocele rates were compared between the groups. Results: There was no statistically significant difference between the groups in terms of mean age, body mass index and prostatespecific antigen levels, Gleason score on biopsy, D'amico risk groups, the mean number of lymph nodes removed, Clavien-Dindo complication grade and mean duration of the surgery. Patients with symptomatic lymphocele in Group 1, Group 2, and Group 3 were found to be 2 (5%), 3 (7.5%) and 5 (12.5%), respectively. There was no statistically significant difference between the groups in terms of symptomatic lymphocele formation. Conclusion: Half or full closure of the peritoneum does not affect the symptomatic lymphocele formation in patients who underwent tRALP and ePLND (AU)

Bilateral Peritoneal Flaps Reduce Incidence and Complications of Lymphoceles after Robotic Radical Prostatectomy with Pelvic Lymph Node Dissection-Results of the Prospective Randomized Multicenter Trial ProLy.

PURPOSE: The purpose of this study was to investigate the effect of a surgically constructed bilateral peritoneal flap (PIF) as an adjunct to robot-assisted radical prostatectomy (RARP) and pelvic lymph node dissection (PLND) on the incidence of lymphoceles. MATERIALS AND METHODS: A total of 530 men with localized prostate cancer underwent a RARP with bilateral extended standardized PLND in a prospective randomized controlled trial. In group A, a PIF was created by suturing the margins of the bladder peritoneum to the ipsilateral endopelvic fascia at 2 points on each side. In group B, no PIF was created. The patients were followed 30 and 90 days after the surgery to assess the incidence, extent and treatment of lymphoceles. RESULTS: Lymphoceles occurred in 22% of group A patients and 33% of group B patients (p=0.008). Symptomatic lymphoceles were observed in 3.3% of group A patients and 8.1% of group B patients (p=0.027). Lymphoceles requiring intervention occurred significantly less frequently in group A patients (1.3%) than in group B patients (6.8%, p=0.002). The median lymphocele size was 4.3 cm in group A and 5.0 cm in group B (p=0.055). No statistically significant differences were observed in minor or major complications unrelated to lymphocele, blood loss, or surgical time between groups A and B. CONCLUSIONS: Bilateral PIFs in conjunction with RARP and PLND significantly reduce the total incidence of lymphoceles, the frequency of symptomatic lymphoceles and the rate of associated secondary interventions.

Clinical Importance of a Peritoneal Interposition Flap to Prevent Symptomatic Lymphoceles after Robot-Assisted Radical Prostatectomy and Pelvic Lymph Node Dissection: A Systematic Review and Meta-Analysis.

BACKGROUND: Robot-assisted radical prostatectomy (RARP) including pelvic lymph node dissection (PLND) is the current state of the art in surgical therapy of localized prostate cancer with intermediate or high risk. PLND in particular is associated with morbidity inherent to this method; the rate of symptomatic lymphoceles (sLCs), for example, ranges up to 10%. OBJECTIVE: Various intraoperative modifications have been developed with the aim of reducing the sLC rate. Based on current studies, a peritoneal interposition flap (PIF) appears to be one of the most effective methods for this purpose. Under the criteria of a systematic review, 5 retrospective studies have been identified until now, 4 of which showed a positive effect of PIF on the sLC rate. RESULTS AND LIMITATIONS: A total of 1,308 patients were included in the aggregated analysis of these 5 studies. The amount of sLCs was 1.3% (8/604) and 5.7% (40/704) in the PIF and standard groups, respectively (p < 0.001). The resulting odds ratio (OR) was 0.23 (95% confidence interval [CI]: 0.05-0.99), taking in-to account a noteworthy heterogeneity of the 5 studies (Q = 9.47, p = 0.05; I2 = 58%). In addition, a prospective randomized and blinded study (Pianoforte trial) with corresponding sLC rates of 8.3% (9/108) versus 9.7% (12/124) (p = 0.820) exists. In this study, the OR was 0.85 (95% CI: 0.34-2.10, p = 0.722). CONCLUSION: Despite positive results from retrospective studies with indirect evidence, the role of the PIF in the reduction of sLC in RARP could not be conclusively assessed yet. The results of the first prospective randomized study do not show a positive effect of PIF, declaring a research gap for further studies with direct evidence.

Robotic Vessel Sealer Device for Lymphocele Prevention After Pelvic Lymphadenectomy: Results of a Randomized Trial.

Introduction: Pelvic lymph node dissection (PLND) during robotic prostatectomy is associated with potential complications. The most common complication of PLND is lymphoceles, occurring in up to 50% of patients in studies with screening imaging but usually asymptomatic. We performed a prospective randomized trial to evaluate whether using advanced bipolar energy for PLND via the robotic vessel sealer can prevent lymphoceles. Methods: A total of 120 patients were enrolled in the trial with each patient serving as their own control. Robotic PLND was randomly performed using the vessel sealer on one side and standard PLND using clips on the other side. All patients underwent screening computed tomography scan 3 months postoperatively with radiologists blinded to the assigned technique. Significant lymphoceles were defined as fluid collections ≥3 cm in any plane. Results: Of those enrolled, 114 completed the study. The mean nodal yield was 6.5 nodes, with 3.1 versus 3.4 nodes for vessel sealer side versus standard technique (P = .35), respectively. The mean operative time for PLND was 11.3 versus 11.1 minutes (P = .62), respectively. Twenty-two lymphoceles were identified. Ten occurred on the vessel sealer side versus 12 on the standard side (8.8% versus 10.5%, P = .412). All lymphoceles were asymptomatic. Conclusions: While the robotic advanced bipolar device did not appear to prevent lymphoceles, the vessel sealer also did not increase the rate of lymphoceles compared with a standard technique using clips. Both techniques were equally efficacious, efficient, and safe for PLND such that surgeons who prefer to avoid clips can reasonably use the vessel sealer, although at increased cost. Clinical Trial Registration number: NCT02035475.

Significant reduction of lymphoceles after radical prostatectomy and pelvic lymph node dissection.

OBJECTIVES: To reduce the risk of symptomatic lymphocele (SLC), we present a technique using peritoneal fenestration that allows lymphatic fluid to drain into the abdomen, as SLC formation after open retropubic radical prostatectomy (ORP) with pelvic lymph node dissection (PLND) is a common adverse event. PATIENTS AND METHODS: We identified 1513 patients who underwent ORP with PLND between July 2018 and November 2019. Of those, 307 patients (20.3%) received peritoneal fenestration and 1206 (79.7%) no fenestration. The rate of LCs and the necessity for intervention were analysed by uni- and multivariable logistic regression (MLR) models. A propensity score matching was performed, as well. RESULTS: The median (interquartile range [IQR]) age was 65 (60-70) years. A median (IQR) of 16 (10-22) lymph nodes were dissected, 22 vs 14 lymph nodes in the fenestration vs non-fenestration group (P < 0.001). Overall, 189 patients (12.5%) were diagnosed with a LC after ORP, while 21 patients (6.8%) in the fenestration and 168 (13.9%) in the non-fenestration group had LCs (P = 0.001). In 70 patients (4.7%), LCs required further intervention, categorised as Clavien-Dindo Grade IIIa/b, with a smaller proportion in the fenestration group (2.9% vs 5.0% in the non-fenestration group, P < 0.001). There were no Clavien-Dindo Grade IV or V complications, in particular no abdominal complications in association with peritoneal fenestration observed. In MLR, peritoneal fenestration was associated with a reduced risk of LCs (odds ratio [OR] 0.33, 95% confidence interval [CI] 0.2-0.5; P < 0.001). The risk reduction was also shown after propensity score matching (OR 0.38, 95% CI 0.21-0.68; P = 0.001). The number needed to treat was 14. CONCLUSIONS: Peritoneal fenestration may decrease the rate of SLC after ORP with (extended) PLND. Therefore, it should be part of the operative strategy.

Peritoneal flap for lymphocele prophylaxis following robotic-assisted laparoscopic radical prostatectomy with pelvic lymph node dissection: study protocol and trial update for the randomized controlled PELYCAN study.

BACKGROUND: Data from interventional studies suggest that a peritoneal flap after pelvic lymph node dissection (LND) during laparoscopic, robotic-assisted radical prostatectomy (RARP) may reduce the rate of symptomatic lymphoceles in transperitoneal approach. However, most of these studies are not conducted in a randomized controlled fashion, thus limiting their scientific value. A recent prospective, randomized, controlled trial (RCT) did not show superiority of a peritoneal flap while further trials are lacking. Therefore, the aim of the presented RCT will be to show that creating a peritoneal flap decreases the rate of symptomatic lymphoceles compared to the current standard procedure without creation of a flap. METHODS/DESIGN: PELYCAN is a parallel-group, patient- and assessor-blinded, phase III, adaptive randomized controlled superiority trial. Men with histologically confirmed prostate cancer who undergo transperitoneal RARP with pelvic LND will be randomly assigned in a 1:1 ratio to two groups-either with creating a peritoneal flap (PELYCAN) or without creating a peritoneal flap (control). Sample size calculation yielded a sample size of 300 with a planned interim analysis after 120 patients, which will be performed by an independent statistician. This provides a possibility for early stopping or sample size recalculation. Patients will be stratified for contributing factors for the development of postoperative lymphoceles. The primary outcome measure will be the rate of symptomatic lymphoceles in both groups within 6 months postoperatively. Patients and assessors will be blinded for the intervention until the end of the follow-up period of 6 months. The surgeon will be informed about the randomization result after performance of vesicourethral anastomosis. Secondary outcome measures include asymptomatic lymphoceles at the time of discharge and within 6 months of follow-up, postoperative complications, mortality, re-admission rate, and quality of life assessed by the EORTC QLQ-C30 questionnaire. DISCUSSION: The PELYCAN study is designed to assess whether the application of a peritoneal flap during RARP reduces the rate of symptomatic lymphoceles, as compared with the standard operation technique. In case of superiority of the intervention, this peritoneal flap may be suggested as a new standard of care. TRIAL REGISTRATION: German Clinical Trials Register DRKS00016794 . Registered on 14 May 2019.

Combined pedicled superficial circumflex iliac artery perforator (SCIP) flap with lymphatic tissue preservation and lymphovenous anastomosis (LVA) for defect reconstruction and lymphedema-lymphocele prevention in thigh sarcoma surgery: Preliminary results.

BACKGROUND: Sarcoma surgery often requires large tissue resection to be treated safely. When the tumor is localized in the groin and/or medial thigh, lymphocele and lymphedema are common complications because of the rich lymphatic network present there. The aim of this study is to share the outcome of seven patients who received defect reconstruction in this area with combined pedicled superficial circumflex artery perforator (SCIP) flap with lymphatic tissue preservation and lymphovenous anastomosis (LVA) for prevention of lymphatic complications. PATIENTS AND METHODS: Seven patients who underwent surgical resection of sarcoma in the groin and/or adductors compartment received defect reconstruction with pedicled SCIP flap combined with LVA. For a better dead space obliteration, four of them also received an additional tissue flap: two pedicled deep inferior epigastric perforator flaps and two free anterolateral thigh flaps. Indocyanine green lymphography was performed in all cases to identify the lymphatic pathway, make the preoperative marking and check the patency of the anastomoses. RESULTS: All seven patients were successfully treated reaching a good aesthetic result and a full range of motion. No immediate nor delayed complications such as lymphocele or lymphorrhea and early extremity lymphedema were observed during the follow up (range: 6-9 months; mean: 7.3) and no secondary procedures were required. CONCLUSIONS: The combination of the pedicle SCIP lymphatic tissue transfer with LVA seems to be effective in preventing the development of lymphatic sequelae after large resections in the medial thigh.