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Introduction/Background*SENTIX is a prospective cohort multicentric international study on sentinel lymph node (SLN) biopsy without pelvic lymph node dissection (PLND) in patients with early-stage cervical cancer. SLN frozen section (FS) and pathological ultrastaging were mandatory by the protocol. Samples from SLN were reviewed centrally for pathological assessment quality control. Only sites experienced in SLN biopsy technique could join the trial.MethodologyIn total, 47 sites from 18 countries participated in the trial. Patients with FIGO 2009 stages T1A1/LVSI+ – T1B1 (<4 cm or ≤ 2 cm for fertility sparing), with common tumour types and no suspicious lymph nodes on imaging were registered in the trial. Patients remained in the trial after the surgery if SLN were detected on both sides of the pelvis and if SLN were negative on FS histological evaluation. Blue dye, radioactive tracer, indocyanine green or their combinations were all eligible tracers for SLN detection. Intraoperative SLN pathological processing consisted of SLN examination in one randomly selected slice. SLN ultrastaging protocol included a complete processing of all SLN tissue in slices of 2 mm thickness, 2 sections in 150 μm from each block until no tissue left, one stained with H&E and second examined immunohistochemically.Result(s)*Altogether 733 patients were registered until Sentix enrolment closure in October 2020, 83 patients were excluded (table 1) and 650 patients was analysed. Patients` characteristics are shown in table 1. Bilateral SLN detection rate reached 95%. FS detected macrometastases (MAC) in 44 cases and micrometastasis (MIC) in 4 cases. SLN ultrastaging found additional 9 cases with MAC, 26 with micrometastases (MIC) and all 19 cases with isolated tumor cells (ITC). Sensitivity of FS was 83.0% for the detection of MAC, 57.8% for pN1 status (MAC or MIC) and 47.1% for any type of SLN involvement (MAC, MIC, ITC). Table 2.Abstract 950 Table 1Patient’s characteristics (N=733)Abstract 950 Table 2SLN status assessed by frozen section and final ultastaging (N=650)Conclusion*High bilateral detection rate of 95% was achieved in Sentix sites experienced in the SLN biopsy technique. Intraoperative pathological assessment of SLN failed to detect majority of MIC (86.7%), all cases with ITC and 42.2% with pN1 (MIC or MAC).

Introduction/BackgroundThe quality of pathological assessment is of pivotal importance in the management of cervical cancer patients if pelvic lymph node dissection (PLND) is to be replaced by sentinel lymph node (SLN) biopsy only.MethodologyThe aim was to report the results of the quality control of pathological SLN assessment in the group of 300 patients treated per protocol. All specimens and full pathology reports from at least two patients per site were reviewed centrally in Prague. SLN ultrastaging protocol included a complete processing of all SLN tissue in slices of 2 mm thickness, 2 sections in 150 µm from each block until no tissue left, one stained with H&E and second examined immunohistochemically. The findings were classified as: Minor (minor protocol deviations), Major (additional sections completed at central pathology), or Critical (deviations could not have been fixed at central pathology). In the case of Major or Critical findings, sites were requested to submit all samples from all additional patients for the second-round assessment.ResultsSamples from 77 cases from 36 sites with at least 1 patient treated per protocol were submitted for the central reading. Minor findings were identified in 27% of cases, Major in 30%, and Critical in 4%. Samples from 18 patients were submitted for the second control round; 9 were without deviations 7 had Minor, 2 Major, and 1 Critical findings. One site was prematurely closed due to repeated Critical findings. The most frequent deviations included incompletely processed SLN (36/95) and a lower number of immunohistochemical staining (31/95).ConclusionMajor deviations from the SLN protocol were identified in 33% of sites and 31% of samples. These deviations can impact detection of small metastases and, consequently, the safety of the SLN concept. Central pathology reading allowed for substantial improvement of SLN pathological assessment during the trial.Disclosure Acknowledgements: This work was supported by a grant from the Czech Research Council (No 16-31643A). None of the authors declare a conflict of interest.

We describe a case of injury of the small intestine in a patient who underwent placement of Align R retropubic urethral support system (BARD). Absence of characteristic symptoms of the bowel injury and peritonitis led to a rapid development of sepsis, multiple organ failure, and death. Although the placement of midurethral sling is a minimally invasive surgery, good diagnostic skills, proper evaluation of indications, safe performance of the procedure, and thorough postsurgical monitoring are paramount for safe and effective outcome of the surgery.

Introduction/BackgroundIn the presented case report we discuss the necessity of immediate treatment of obturator nerve damage in pelvic lymphadenectomy in the light of new surgical procedures in oncogynecology, while considering the abilities and possibilities of the self-repair of damaged peripheral nerves.MethodologyCase report.ResultsBetween 2011 and 2018 we performed 482 pelvic lymphadenectomy procedures. 470 cases (97.5%) were laparotomies. In 4 cases obturator nerve was injured (0.8%). In 3 patients, the injury occurred during the laparotomy and the nerve was immediately sutured without any subsequent functional deficiency. We present a case of nerve injury during laparoscopic lymphadenectomy where we did not proceed with the immediate treatment. Despite this, the patient suffered no sensitive or functional impairment, either after surgery or 6 months later. Laparoscopic staging was done due to an early stage ovarian carcinoma in a 67-year-old woman. During the right-sided pelvic lymphadenectomy, the obturator nerve was completely transected. Procedure was completed without further complications however immediate endoscopic treatment of the nerve injury was not possible. After some discussion we forgo the idea of immediate laparotomy. Since the patient did not experience any clinical signs of nerve damage, even after postoperative recovery, we definitely abandoned the idea of treating damaged nerve surgically. We have documented this complication on video.ConclusionImmediate treatment and its technique, delayed suture or conservative procedure for obturator nerve injury can all yield to the favourite functional outcome. In our case, we have abandoned the idea of nerve suture after laparoscopic lymphadenectomy and the patient showed no clinical signs of nerve damage.DisclosureNothing to disclose.

Introduction/Background*Lower-limb lymphedema (LLL) is a well-recognized adverse outcome of the surgical management of cervical cancer. Recently, sentinel lymph node (SLN) biopsy has emerged as an alternative procedure to systematic pelvic lymphadenectomy (PLND) aiming to decrease the risk of complications, especially LLL development. Our study represents the first prospective analysis of LLL incidence in cervical cancer patients after a uterine procedure with SLN biopsy, without systematic PLND.MethodologyIn a prospective international multicenter trial SENTIX, the group of 150 patients with stage IA1–IB2 cervical cancer treated by uterine surgery with bilateral SLN biopsy was prospectively evaluated using both objective LLL assessments, based on limb volume increase (LVI) between pre- and postoperative measurements, and subjective patient-perceived swelling were conducted in six-month periods over 24-months post-surgery. The characteristics of the patients are summarized in table 1.Result(s)*The cumulative incidence of LLL at 24 months was 17.3% for mild LLL (LVI 10-19%), 9.2% for moderate LLL (LVI 20-39%), while only one patient (0.7%) developed severe LLL (LVI >40%). The median interval to LLL onset was nine months (figure 1). A transient edema resolving without intervention within six months was reported in an additional 22% of patients. Subjective LLL was reported by 10.7% of patients, though only a weak and partial correlation between subjective-report and objective-LVI was found. No risk factor directly related to LLL development was identified.Abstract 114 Figure 1Abstract 114 Figure 2Conclusion*Contrary to the expectations, the replacement of standard PLND by bilateral SLN biopsy in the surgical treatment of cervical cancer does not eliminate the risk of mild to moderate LLL, which develops irrespective of the number of SLN removed.Trial registrationClinicalTrials.gov: NCT02494063FundingThis work was supported by Charles University in Prague (UNCE 204065 and PROGRES Q28/LF1) and by a grant from the Czech Health Research Council (NV19-03-00023). The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.Conflicts of InterestThe authors declare no conflict of interest.

Background and aim: Evidence exists for the pathogenic role of the enteric flora in inflammatory bowel disease. Probiotics contain living microorganisms which exert health effects on the host. We compared the efficacy in maintaining remission of the probiotic preparation Escherichia coli Nissle 1917 and established therapy with mesalazine in patients with ulcerative colitis. Patients and methods: In total, 327 patients were recruited and assigned to a double blind, double dummy trial to receive either the probiotic drug 200 mg once daily (n = 162) or mesalazine 500 mg three times daily (n = 165). The study lasted for 12 months and patients were assessed by clinical and endoscopic activity indices (Rachmilewitz) as well as by histology. The primary aim of the study was to confirm equivalent efficacy of the two drugs in the prevention of relapses. Results: The per protocol analysis revealed relapses in 40/110 (36.4%) patients in the E coli Nissle 1917 group and 38/112 (33.9%) in the mesalazine group (significant equivalence p = 0.003). Subgroup analyses showed no differences between the treatment groups in terms of duration and localisation of disease or pretrial treatment. Safety profile and tolerability were very good for both groups and were not different. Conclusions: The probiotic drug E coli Nissle 1917 shows efficacy and safety in maintaining remission equivalent to the gold standard mesalazine in patients with ulcerative colitis. The effectiveness of probiotic treatment further underlines the pathogenetic significance of the enteric flora.

The relationship between organisms and contaminants may be a two-way interaction: contaminants affecting the biota and the biota affecting the environmental fate and distribution of the contaminants. This may be especially so for sediment-dwelling organisms, because their burrowing and feeding can drastically influence sediment characteristics. The present study looked at the influence of the suspension-feeding stout razor clam Tagelus plebeius on the distribution of crude oil and pyrene in greenhouse mesocosm experiments. Water column turbidity and sediment redox also were monitored during the 15- to 30-day exposures to provide information on the influence of hydrocarbons and the razor clams on environmental conditions. For the experiment with crude oil, sediment was taken from the mesocosms at the end of the experiment, and the hydrocarbon-degradation potential was assessed in incubations with 14C-naphthalene. The experiments used four treatments: hydrocarbons present/absent and razor clams present/absent. Hydrocarbon dosing levels were relatively low (1 mL of oil or 30 mg of pyrene per mesocosm with 22 L of natural sediment and 11 L of seawater). The presence of the razor clams resulted in hydrocarbon concentrations at the sediment surface being 25% lower than in mesocosms without clams. No consistent effects were noted for polycyclic aromatic hydrocarbon (PAH) concentrations in the water column or in subsurface sediment. The naphthalene-degradation potential was elevated for sediment from mesocosms dosed with oil, but the presence of the clams did not affect this potential. The presence of the razor clams resulted in a lowering of water column turbidity, but no effect on sediment redox. The hydrocarbon addition had no effect on turbidity, but sediment redox was lowered. While results show that the presence of the razor clams resulted in a loss of hydrocarbons from the surface sediment, the other results do not provide a clear picture of the underlying mechanisms and the fate of the PAHs lost from the sediment surface. We hypothesize that the loss of surface sediment PAHs was due to burial of surface sediment and possibly bioaccumulation by the clams. While additional research is needed for further insights into underlying mechanisms, the present work demonstrates that the presence of sediment-burrowing suspension feeders decreases hydrocarbon levels in surface sediment. This means that assessments of the impact of an oil spill should pay attention to effects on these organisms and to their influence on the fate and distribution of the spilled oil.