Vascular Clips for Preventing Lymphocele and Symptomatic Lymphocele in Patients With Gynecologic Malignancies After Laparoscopic Pelvic Lymphadenectomy.

STUDY OBJECTIVE: To evaluate the effectiveness of using vascular clips to seal targeted lymphatics in gynecological malignancies for the prevention of postoperative pelvic lymphocele and symptomatic lymphocele after laparoscopic pelvic lymphadenectomy. DESIGN: Retrospective analysis. SETTING: Single-center academic hospital. PATIENTS: In total, 217 patients with gynecological malignancies were included. INTERVENTIONS: Patients were classified into two groups: group 1 (vascular clips were used to seal the targeted lymphatics) and group 2 (electrothermal instruments were used to seal the targeted lymphatics). The patients were followed up 4-6 weeks after surgery to evaluate the incidence of lymphoceles by ultrasound or CT. Symptomatic lymphoceles are defined as those that cause infection, deep vein thrombosis with or without swelling of the extremities, edema (swelling) of the extremities or perineum, hydronephrosis, and/or moderate to severe pain. MEASUREMENTS AND MAIN RESULTS: One hundred and thirteen patients were enrolled in group 1, and 104 patients were enrolled in group 2. Lymphoceles were observed in 46 (21.2%) patients. Fewer lymphoceles occurred in group 1 than in group 2 (8 [7.1%] vs. 38 [36.5%], p <.001). The percentage of significantly sized lymphoceles was lower in group 1 than that in group 2 (4 [3.5%] vs. 30 [28.8%], p <.001]. Symptomatic lymphoceles occurred in 18 patients (8.3%), and only one (1.0%) occurred in group 1, while 17 (16.3%) occurred in group 2 (p <.001). A multivariate analysis revealed that vascular clips were the only independent factor for preventing lymphocele (OR = 7.65, 95% CI = [3.30-17.13], p <.001) and symptomatic lymphocele (OR = 22.03, 95% CI = [2.84-170.63], p = .003). CONCLUSION: The results indicate that the use of vascular clips may be useful for the prevention of the development of lymphocele and symptomatic lymphocele secondary to pelvic lymphadenectomy performed via laparoscopy.

Japanese expert consensus on the standardization of robot-assisted pelvic lymph node dissection in urological surgery: Extent of pelvic lymph node and surgical technique.

Pelvic lymph node dissection (PLND) is important for accurate staging and prognosis of prostate and/or bladder cancer. Several guidelines recommend extended PLND for patients with these cancers. However, the therapeutic benefits of extended PLND are unclear. One major reason is that the extent of PLND is not clearly defined. Thus, the working group for standardization of robot-assisted PLND, including nine experienced urologists for PLND in Japan, was launched in January 2023 by the Japanese Society of Endourology and Robotics. This study summarized the discussions to define the individual extent of PLND in urological surgery in a consensus meeting among these experienced urologists. The consensus meeting determined the extent of PLND based on arteries (veins) and anatomical membrane structures rather than a vague concept or approach toward PLND. This concept is expected to allow surgeons to implement the same extent of PLND. Finally, after a total of 10 online web conferences were held, we determined the extent of PLND for the obturator lymph node (LN) area, the internal iliac LN area, the external and common iliac LN area, and the presacral LN area according to the above rules. The extent of PLND suggested here currently does not have a clear therapeutic rationale. Therefore, the extent of our proposed PLND is by no means mandatory. We hope our definition of the extent of PLND will be supported by further evidence of therapeutic benefits for urologic cancers.

Comparison of the efficacy and safety of total laparoscopic hysterectomy without and with uterine manipulator combined with pelvic lymphadenectomy for early cervical cancer.

OBJECTIVE: Some studies have reported that the prognosis of total laparoscopic hysterectomy (TLH) for early-stage cervical cancer (CC) is worse than that of open surgery. And this was associated with the use of uterine manipulator or not. Therefore, this study retrospectively analyzes the efficacy and safety of TLH without uterine manipulator combined with pelvic lymphadenectomy for early-stage CC. METHODS: Fifty-eight patients with CC (stage IB1-IIA1) who received radical hysterectomy from September 2019 to January 2020 were divided into no uterine manipulator (n = 26) and uterine manipulator group (n = 32). Then, clinical characteristics were collected and intraoperative/postoperative related indicators were compared. RESULTS: Patients in the no uterine manipulator group had significantly higher operation time and blood loss than in the uterine manipulator group. Notably, there was no significant difference in hemoglobin change, blood transfusion rate, number of pelvic nodules, anal exhaust time, complications and recurrence rate between the two groups. Additionally, patients in the uterine manipulator group were prone to urinary retention (15.6%) and lymphocyst (12.5%), while the no uterine manipulator group exhibited high probability of bladder dysfunction (23.1%) and urinary retention (15.4%). Furthermore, the 1-year disease-free survival rate and the 1-year overall survival rate were not significantly different between the two groups. CONCLUSION: There was no significant difference in the efficacy and safety of TLH with or without uterine manipulator combined with pelvic lymphadenectomy in the treatment of patients with early-stage CC. However, the latter requires consideration of the negative effects of high operation time and blood loss.

[Research Progress in Preoperative Evaluation of Lymph Node Metastasis of Bladder Cancer].

Bladder cancer is a common malignant tumor of the urinary system.The prognosis of patients with positive lymph nodes is worse than that of patients with negative lymph nodes.An accurate assessment of preoperative lymph node statushelps to make treatmentdecisions,such as the extent of pelvic lymphadenectomy and the use of neoadjuvant chemotherapy.Imaging examination and pathological examination are the primary methods used to assess the lymph node status of bladder cancer patients before surgery.However,these methods have low sensitivity and may lead to inaccuate staging of patients.We reviewed the research progress and made an outlook on the application of clinical diagnosis,imaging techniques,radiomics,and genomics in the preoperative evaluation of lymph node metastasis in bladder cancer patients at different stages.

Robotically assisted augmented reality system for identification of targeted lymph nodes in laparoscopic gynecological surgery: a first step toward the identification of sentinel node : Augmented reality in gynecological surgery.

BACKGROUND: To prove feasibility of multimodal and temporal fusion of laparoscopic images with preoperative computed tomography scans for a real-time in vivo-targeted lymph node (TLN) detection during minimally invasive pelvic lymphadenectomy and to validate and enable such guidance for safe and accurate sentinel lymph node dissection, including anatomical landmarks in an experimental model. METHODS: A measurement campaign determined the most accurate tracking system (UR5-Cobot versus NDI Polaris). The subsequent interventions on two pigs consisted of an identification of artificial TLN and anatomical landmarks without and with augmented reality (AR) assistance. The AR overlay on target structures was quantitatively evaluated. The clinical relevance of our system was assessed via a questionnaire completed by experienced and trainee surgeons. RESULTS: An AR-based robotic assistance system that performed real-time multimodal and temporal fusion of laparoscopic images with preoperative medical images was developed and tested. It enabled the detection of TLN and their surrounding anatomical structures during pelvic lymphadenectomy. Accuracy of the CT overlay was > 90%, with overflow rates < 6%. When comparing AR to direct vision, we found that scores were significatively higher in AR for all target structures. AR aided both experienced surgeons and trainees, whether it was for TLN, ureter, or vessel identification. CONCLUSION: This computer-assisted system was reliable, safe, and accurate, and the present achievements represent a first step toward a clinical study.

An extremely rare disconnection of the external iliac artery and novel collateral remodeling in an endometrial stromal sarcoma woman.

BACKGROUND: Injury to the external iliac artery can have serious consequences and can be extremely challenging for surgeons. Here, we report a patient with bizarre disconnection of the external iliac artery during a laparoscopic operation. CASE PRESENTATION: On May 27, 2020, during a laparoscopic pelvic lymphadenectomy operation to treat endometrial stromal sarcoma, we encountered an unusual anatomy: abnormal disconnection of the left external iliac artery in a 26-year-old female patient. The proximal and distal ends of the left external iliac artery demonstrated old narrowing without active bleeding, and the distance between the two disconnected ends was more than 3 cm. The scenario was surprising to all the staff in the operating theater. After a comprehensive assessment of skin temperature, arterial pulsation and arterial blood flow, a multidisciplinary team determined that collateral circulation of the left lower limb had been established and could meet the blood supply of the lower limbs, which was also confirmed three times by computed tomography angiography and Doppler ultrasound of the blood vessels in the abdomen and lower limbs. Sixteen months after the operation, the patient had no obvious abnormality, and the daily activities of the left lower limb were not affected. Follow-up after treatment for the patient is still in progress. CONCLUSIONS: We describe the details of the whole case of disconnection of the external iliac artery. We hope to summarize the experience and lessons learned through this case and a relevant literature review to improve the safety and orderliness of our future clinical work.

Postoperative lymphocyst formation after pelvic lymphadenectomy for gynecologic cancers: comparison between laparoscopy and laparotomy.

PURPOSE: The goal of this study was to evaluate, using definitive diagnostic criteria, the incidence of lymphocyst formation following pelvic lymphadenectomy for gynecological cancer, and to compare rates between the approaches of laparoscopy and laparotomy. METHODS: We retrospectively reviewed the medical records of all patients who underwent pelvic lymphadenectomy for cervical or endometrial cancer between March of 2010 and March of 2016. We defined a lymphocyst as a circumscribed collection of fluid within the pelvic cavity, with a diameter of 2 cm or more, as diagnosed with ultrasound or computed tomography. RESULTS: During the six-year observational period, a pelvic lymphadenectomy was conducted in 196 women with clinical stage I uterine cancer; 90 cases underwent laparoscopy, 106 underwent laparotomy. The minimally invasive laparoscopic group had a lower estimated blood loss (p < 0.01), shorter hospital stay (p < 0.01). Lymphocysts were observed in 14.4% (13/90) of the laparoscopy cases, and in 15.1% (16/106) of the laparotomy cases which means no significant difference of lymphocyst (p = 1.00). The median size of symptomatic lymphocyst was significantly larger in laparotomy group than in laparoscopy group (4.8 cm v.s. 2.8 cm, median) (p = 0.04). Symptomatic lymphocysts were more common in laparotomy [7/90 (7.8%) vs 14/106 (13.2%) (p = 0.253)]. CONCLUSIONS: In a retrospective analysis with a strict diagnostic criteria, we could find no statistical difference in lymphocyst occurrence between laparoscopy and laparotomy. The median size of the lymphocyst was bigger and lymphocyst was likely to be symptomatic in the laparotomy group.

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.

Fertility-sparing surgery for early-stage cervical cancer: A case series study on the efficacy and feasibility of cervical conization followed by pelvic lymphadenectomy.

OBJECTIVES: To evaluate the oncologic and obstetric outcomes of cervical conization followed by pelvic lymphadenectomy, which is used as a fertility-sparing procedure, in reproductive-aged patients with early-stage cervical cancer. METHODS: We performed a retrospective study of patients with stage IA1-IB1 cervical cancer who underwent cervical conization followed by pelvic lymphadenectomy from 2011 to 2020 at Kumamoto University Hospital. RESULTS: In total, eight patients underwent conization followed by pelvic lymphadenectomy. The median age of the patients was 33 (range: 28-36) years. Four (50.0%) patients were nulliparous. Seven (87.5%) patients were diagnosed with squamous cell carcinoma (87.5%) and one (12.5%) with adenocarcinoma. Five (62.5%), two (25.0%), and one (12.5%) presented with stage IA1, IA2, and IB1 disease, respectively. Five (62.5%) patients had lymphovascular space invasion (LVSI) based on the assessment of specimens obtained via conization. However, none had lymph node metastasis based on pelvic lymphadenectomy. Regarding long-term oncologic outcomes, recurrence was not observed at a median follow-up of 60 (range: 8-107) months. In addition, obstetric outcomes were consistently favorable in terms of achieving pregnancy, preterm delivery, and live birth. During the study period, two patients who actively attempted to conceive had four pregnancies, resulting in full-term deliveries, and one was on her first trimester of pregnancy. CONCLUSION: Cervical conization combined with pelvic lymphadenectomy represents a feasible conservative management for histologically well-selected patients with early-stage cervical cancer. Furthermore, an optimal histopathological evaluation of conization specimens will contribute to decision-making regarding the use of this fertility-sparing procedure.

Treatment of Early-Stage Gynecological Cancer-Related Lower Limb Lymphedema by Lymphaticovenular Anastomosis-The Triple Incision Approach.

Background and Objectives: Lower extremity lymphedema (LEL) is one of the most relevant chronic and disabling sequelae after gynecological cancer therapy involving pelvic lymphadenectomy (PL). Supermicrosurgical lymphaticovenular anastomosis (LVA) is a safe and effective procedure to treat LEL, particularly indicated in early-stage cases when conservative therapies are insufficient to control the swelling. Usually, preoperative assessment of these patients shows patent and peristaltic lymphatic vessels that can be mapped throughout the limb to plan the sites of skin incision to perform LVA. The aim of this study is to report the efficacy of our approach based on planning LVA in three areas of the lower limb in improving early-stage gynecological cancer-related lymphedema (GCRL) secondary to PL. Materials and Methods: We retrospectively reviewed the data of patients who underwent LVA for the treatment of early-stage GCRL following PL. Patients who had undergone groin dissection were excluded. Our preoperative study based on indocyanine green lymphography (ICG-L) and color doppler ultrasound (CDU) planned three incision sites located in the groin, in the medial surface of the distal third of the thigh, and in the upper half of the leg, to perform LVA. The primary outcome measure was the variation of the mean circumference of the limb after surgery. The changes between preoperative and postoperative limbs' measures were analyzed by Student's t-test. p values < 0.05 were considered significant. Results: Thirty-three patients were included. In every patient, three incision sites were employed to perform LVA. A total of 119 LVA were established, with an average of 3.6 for each patient. The mean circumference of the operated limb showed a significant reduction after surgery, decreasing from 37 cm ± 4.1 cm to 36.1 cm ± 4.4 (p < 0.01). Conclusions: Our results suggest that in patients affected by early-stage GCRL secondary to PL, the placement of incision sites in all the anatomical subunits of the lower limb is one of the key factors in achieving good results after LVA.

[Morbidity of extended pelvic lymphadenectomy during robot-assisted laparoscopic prostatectomy for localized cancer prostate]. / Morbidité du curage ganglionnaire pelvien étendu au cours de la prostatectomie totale laparoscopique robot assistée.

OBJECTIVES: To assess the morbidity specific of extended pelvic lymphadenectomy during robot-assisted laparoscopic radical prostatectomy in a 8 year retrospective study. MATERIAL: We carried out a single-center, single-surgeon retrospective study on 342 consecutive patients who underwent a robot-assisted laparoscopic radical prostatectomy and extended pelvic lymphadenectomy, from July 2010 to March 2018. Postoperative complications were recorded up to 3 months after the operation. RESULTS: Thirty (8.8%) patients had at least one complication related to lymphadenectomy including 1 vascular injury (0.3%), 7 injuries of the obturator nerve (2%), 5 venous thromboembolic complications (1.5%) including 4 pulmonary embolisms, 10 symptomatic lymphoceles (2.9%) and 8 lymphoedemas (2.3%). Of these complications, 13 were classified Clavien 1 (43.3%), 8 Clavien 2 (26.7%), 7 Clavien 3a (23.3%) and 2 Clavien 3b (6.7%). In univariate analysis a high age (P=0.04), high BMI (P<0.01) and pT stage (P=0.02) were significantly associated with complication whereas in multivariate analysis, only age (P=0.02) and BMI (P<0.01) lived were. In univariate analysis high BMI (P=0.04) and lymph node involvement (P=0.04) were associated with lymphatic complication. We did not find any other specific risk factor for the other complications. CONCLUSION: With 8.8% of overall complications related to lymphadenectomy and 5% of complication classified Clavien grade 2 or higher, extended pelvic lymphadenectomy was not very morbid. Age and BMI were risk factors for a overall complication. BMI and lymph node involvement were risk factors for lymphatic complications. LEVEL OF PROOF: 4.

Rise and fall of total mesorectal excision with lateral pelvic lymphadenectomy for rectal cancer: an updated systematic review and meta-analysis of 11,366 patients.

The role of lateral lymph node dissection (LLND) during total mesorectal excision (TME) for rectal cancer is still controversial. Many reviews were published on prophylactic LLND in rectal cancer surgery, some biased by heterogeneity of overall associated treatments. The aim of this systematic review and meta-analysis is to perform a timeline analysis of different treatments associated to prophylactic LLND vs no-LLND during TME for rectal cancer. METHODS: A literature search was performed in PubMed, SCOPUS and WOS for publications up to 1 September 2020. We considered RCTs and CCTs comparing oncologic and functional outcomes of TME with or without LLND in patients with rectal cancer. RESULTS: Thirty-four included articles and 29 studies enrolled 11,606 patients. No difference in 5-year local recurrence (in every subgroup analysis including preoperative neoadjuvant chemoradiotherapy), 5-year distant and overall recurrence, 5-year overall survival and 5-year disease-free survival was found between LLND group and non LLND group. The analysis of post-operative functional outcomes reported hindered quality of life (urinary, evacuatory and sexual dysfunction) in LLND patients when compared to non LLND. CONCLUSION: Our publication does not demonstrate that TME with LLND has any oncological advantage when compared to TME alone, showing that with the advent of neoadjuvant therapy, the advantage of LLND is lost. In this review, the most important bias is the heterogeneous characteristics of patients, cancer staging, different neoadjuvant therapy, different radiotherapy techniques and fractionation used in different studies. Higher rate of functional post-operative complications does not support routinely use of LLND.

Laparoscopic repair of segmental obturator nerve injury defect using an artificial nerve conduit: A case report.

Obturator nerve injury is an uncommon complication frequently associated with pelvic gynecologic or urologic cancer surgery. It can lead to disability or adversely affect quality of life. Large segmental defects are particularly difficult to manage as the limited mobility of the nerve prevents tension-free direct end-to-end anastomosis. A 36-year-old woman with cervical cancer underwent sentinel lymph node biopsy, laparoscopic radical hysterectomy, and bilateral adnexectomy. During the procedure, the sentinel lymph node (right obturator node) adherent to the obturator nerve was resected together with the nerve segment leaving a 3 cm defect. Immediate laparoscopic obturator nerve repair was performed using an artificial nerve conduit leading to successful recovery. We report this unique case due to rarity of large segmental obturator nerve defects and present laparoscopic nerve repair with artificial nerve conduits as a useful treatment alternative of these important injuries, without nerve donor site morbidity.

Robotic surgical staging of lymphadenectomy during pregnancy - case report.

OBJECTIVE: We aim to present a case of a 43-year-old patient dia-gnosed with cervical adenocarcinoma in the 15th week of pregnancy, who underwent robotically-assisted staging in a laparoscopic pelvic lymphadenectomy. Further therapeutic approach was based on the results of subsequent lymph node histopathologic assessment. CONCLUSION: In pregnant women with cervical cancer, robot-assisted laparoscopic lymphadenectomy is a method of choice for surgical staging.

Digital anatomic study of the ureter relative to bifurcation of the common iliac artery in females.

INTRODUCTION: Laparoscopic salpingo-oophorectomy and pelvic lymphadenectomy place the ureter at risk. Although traditional anatomic studies indicate that ureters generally cross over the common iliac artery in the pelvic inlet, the view is often different during surgery. Hence, digital three-dimensional models have been utilized to solve this conundrum. Our study aimed to evaluate the anatomic relation between the iliac artery and the ureter in the pelvic inlet. MATERIAL AND METHODS: A medical image processing system processed data collected from 129 female patients, and digital 3D models of the iliac artery and ureter were used to study their anatomic relation. Left- and right-side data were compared using Pearson's χ2 analysis. RESULTS: Two different anatomic relations were found immediately posterior to the ureter: Common iliac arteries were present in 33.2% and external iliac arteries in 76.8%. The mean distances from the point at which the ureter crossed over the iliac artery until the bifurcation of the artery was 8.8 ± 12.2 mm in the left pelvis and 12.4 ± 10.8 mm in the right pelvis - different from that of the traditional anatomic study. CONCLUSION: In the future, these models and digital anatomical data could help avoid surgical complications.

Sentinel node mapping using indocyanine green and near-infrared fluorescence imaging technology for endometrial cancer: A prospective study using a surgical algorithm in Indian patients.

BACKGROUND: Indocyanine green (ICG) fluorescence with high-definition, three-dimensional imaging systems is emerging as the latest strategy to reduce trauma and improve surgical outcomes during oncosurgery. MATERIALS AND METHODS: This is a prospective study involving 100 patients with carcinoma endometrium who underwent robotic-assisted Type 1 pan-hysterectomy, with ICG-directed sentinel lymph node (SLN) biopsy from November 2017 to December 2019. The aim was to assess the feasibility and diagnostic accuracy of SLN algorithm and to evaluate the location and distribution of SLN in pelvic, para-aortic and unusual areas and the role of frozen section. RESULTS: The overall SLN detection rate was 98%. Bilateral detection was possible in 92% of the cases. Right side was detected in 98% of the cases and left side was visualised in 92% of the cases. Complete node dissection was done where SLN mapping failed. The most common location for SLN in our series was obturator on the right hemipelvis and internal iliac on the left hemipelvis. SLN in the para-aortic area was detected in 14% of cases. In six cases, SLN was found in atypical locations, that is pre-sacral area. Eight patients had SLN positivity for metastasis and underwent complete retroperitoneal lymphadenectomy. Comparison of final histopathological report with frozen section reports showed no false negatives. CONCLUSIONS: SLN mapping holds a great promise as a modern staging strategy for endometrial cancer. In our experience, cervical injection was an optimal method of mapping the pelvis. ICG showed a high overall detection rate, and bilateral mapping appears to be a feasible alternative to the more traditional methods of SLN mapping in patients with endometrial cancer. The ICG fluorescence imaging system is simple and safe and may become a standard in oncosurgery in view of its staging and anatomical imaging capabilities. This approach can reduce the morbidity, operative times and costs associated with complete lymphadenectomy while maintaining prognostic and predictive information.

Internal hernia beneath superior vesical artery after pelvic lymphadenectomy for cervical cancer: a case report and literature review.

BACKGROUND: The common complications of radical hysterectomy and pelvic lymphadenectomy usually include wound infection, hemorrhage or hematomas, lymphocele, uretheral injury, ileus and incisional hernias. However, internal hernia secondary to the orifice associated with the uncovered vessels after pelvic lymphadenectomy is very rare. CASE PRESENTATION: We report a case of internal hernia with intestinal perforation beneath the superior vesical artery that occurred one month after laparoscopic pelvic lymphadenectomy for cervical cancer. A partial ileum resection was performed and the right superior vesical artery was transected to prevent recurrence of the internal hernia. CONCLUSIONS: Retroperitonealization after the pelvic lymphadenectomy should be considered in patients with tortuous, elongated arteries which could be causal lesions of an internal hernia.

A prospective multicenter trial on sentinel lymph node biopsy in patients with early-stage cervical cancer (SENTIX).

OBJECTIVE: Sentinel lymph node (SLN) biopsy has been increasingly used in the management of early-stage cervical cancer. It appears in guidelines as an alternative option to systematic pelvic lymphadenectomy. The evidence about safety is, however, based mostly on retrospective studies, in which SLN was combined with systematic lymphadenectomy. MATERIALS AND METHODS: SENTIX is a prospective multicenter trial aiming to prove that less-radical surgery with SLN is non-inferior to treatment with systematic pelvic lymphadenectomy. The primary end point is recurrence rate; the secondary end point is the prevalence of lower-leg lymphedema and symptomatic pelvic lymphocele. The reference recurrence rate was set up conservatively at 7% at 24 months after treatment. With a sample size of 300 patients treated per protocol, the trial is powered to detect a non-inferiority margin of 5% (90% power, p = 0.05) for recurrence rate, 30% reduction in the prevalence of symptomatic lymphocele or lower-leg lymphedema, with reference rates of 30% and 6% at 12 months (p = 0.025, Bonferroni correction). The patients eligible for SENTIX have stage IA1/LVSI+, IA2, IB1 (<2 cm for fertility sparing), with negative LN on pre-operative imaging. Intra-operatively, patients are excluded when there is a failure to detect SLN on both sides of the pelvis in cases of more advanced cancer (stage >IB1), or a positive intra-operative SLN assessment. The quality of SLN pathology evaluation will be assessed by central review. Three interim safety analyses are pre-planned when 30, 60, 150 patients complete 12 months' follow-up. CONCLUSIONS: The first patient was enrolled into the study in June 2016 and, by June 2018, 340 patients had been enrolled. The first analysis of secondary outcomes should be available in 2019 and the oncological outcome of 300 patients at the end of 2021. The trial is registered as a CEEGOG trial (CEEGOG CX-01), ENGOT trial (ENGOT-Cx 2), and at the ClinicalTrials.gov database (NCT02494063).

Efficacy of a Fibrin Sealant (Tissucol Duo) for the Preventionof Lymphocele after Laparoscopic Pelvic Lymphadenectomy:A Randomized Controlled Trial.

STUDY OBJECTIVE: To assess the efficacy of Tissucol Duo (Baxter AG, Vienna, Austria) fibrin sealant in decreasing the incidence of lymphocele (LC) after pelvic laparoscopic lymph node dissection using harmonic shears. DESIGN: Randomized controlled trial (Canadian Task Force classification level I). SETTING: Tertiary referral and educational center. PATIENTS: Seventy-four patients randomized to the use of sealant per hemipelvis. INTERVENTION: Fibrin sealant. MEASUREMENTS AND MAIN RESULTS: After bilateral pelvic lymphadenectomy a fibrin sealant was used in 1 hemipelvis but not the other, applied in 41 patients (55.4%) to the left and 33 patients (44.6%) to the right hemipelvis. The primary outcome was the incidence of LC after surgery in symptomatic and asymptomatic patients. Imaging (ultrasound, computed tomography, and magnetic resonance) was performed to detect LC at 3, 6, and 12 months after surgery. Overall, 26 patients (35.1%) developed LC, and 4 were symptomatic (5.4%). Allowing patients to serve as their own treatment group and control, the hemipelvis treated with Tissucol Duo corresponding to the treatment group and that not treated to the control group, LCs were found in 17 (23%) and 14 (19%) cases, respectively, but the difference was not significant. The mean initial LC maximum diameter was 27.1 mm (standard deviaiotn, 35.2), and LCs tended to decrease in size during the first year to a mean of 8.7 mm. CONCLUSION: Application of Tissucol Duo fibrin sealant after laparoscopic pelvic lymphadenectomy using ultrasonic shears does not decrease the occurrence of symptomatic or asymptomatic LC.

A collagen-fibrin patch for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: A randomized clinical trial.

OBJECTIVE: To evaluate the efficacy of a collagen-fibrin patch for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies. METHODS: In a multicenter, randomized, clinical trial, 164 women with pelvic lymphadenectomy were allocated either to bilateral pelvic application of two collagen-fibrin patches or no intervention. Main outcome was efficacy, defined as reduction of symptomatic lymphocele rate diagnosed within four weeks after surgery. Secondary outcomes were asymptomatic lymphoceles and subsequent interventions. Sample size was based on the assumption that application of a collagen-fibrin patch reduces the prevalence of symptomatic lymphoceles by at least 66%. The study was single-blinded, i.e., patients and primary outcome assessors, but not surgeons, were blinded to the treatment allocation. RESULTS: A total of 75 women were randomized to the intervention and 89 to the control group. All women received the allocated intervention. In total, 42 (27.4%) lymphoceles and 8 (5.2%) symptomatic lymphoceles were observed. Symptomatic lymphoceles were observed in 5/68 (7.4%) women in the intervention group and 3/85 (3.5%) women in the control group (p = 0.47). Asymptomatic lymphoceles were observed in 16 (23.5%) women in the intervention group compared to 18 (21.2%) in the control group (p = 0.85). In a multivariate logistic regression model, no independent risk factor for the development of a symptomatic lymphocele was ascertained. DISCUSSION: Intraoperative application of collagen-fibrin patches to the pelvic side walls does not reduce the incidence of symptomatic lymphoceles in women with gynecologic malignancies undergoing pelvic lymphadenectomy.