Skin Staining After Injection of Superparamagnetic Iron Oxide for Sentinel Lymph Node Dissection: A Retrospective Study of Two Protocols for Injection and Long-Term Follow-Up.

OBJECTIVE: Sentinel lymph node (SLN) dissection is a highly accurate surgical procedure allowing detection of lymph node invasion in patients with clinically negative axilla in early breast cancer. Superparamagnetic iron oxide (SPIO) is a marker used during SLN procedure, allowing the same detection rate as isotopes (Tc-99). A drawback of SPIO is skin staining that can occur around the injection site. The goal of this retrospective study was to assess the frequency of skin staining after oncological breast surgery with SPIO, and the impact of two different injection protocols on the rate of skin staining. MATERIALS AND METHODS: Data from breast cancer patients undergoing magnetic tracer SLN detection (SLND) procedure in a single department between 2020 and 2022 was reviewed. Injection protocol P1 consisted of retro-areolar injection of Magtrace 0.8 mL. Injection protocol P2, consisted of retro-tumoral injection with 1 mL. Presence of skin staining was assessed at day 10 after surgery. The evolution and satisfaction of the patients was assessed at six and 12 months. RESULTS: In total 175 sentinel lymph node biopsy procedures were performed (P1: 141/P2: 34), consisting of breast conservative surgery (BCS) (P1: 70%/P2: 53%) or mastectomy (P1: 30%/P2: 47%) with SLN. SLN detection rate was 97.7%. Skin staining was reported in 23% and occurred more often after BCS (31.6%) compared to mastectomy (6.8%). When BCS was performed, peritumoral injection was associated with a decreased risk of skin staining compared with retro-areolar injection (22.2% vs. 33.3%, respectively). When present skin staining persisted for 12 months, but most of the patients described only a slight discomfort. The low rate of discoloration after mastectomy, as previously reported, can be explained by the removal of skin and glandular tissue in which the tracer accumulates. Less skin staining in P2 may be because of a shorter interval between injection and surgery and the removal of the excess of SPIO during the lumpectomy. CONCLUSION: SPIO injection is a safe surgical technique. After mastectomy, the rate of discoloration was low. Despite the persistent skin discoloration in 58.6% in our study, patient satisfaction was high. Deeper injection, reduced doses, massage of the injection site and peritumoral injection may reduce skin staining.

Early surgical outcomes of 550 consecutive patients treated for benign gynecological conditions by transvaginal natural orifice transluminal endoscopic surgery.

INTRODUCTION: Evidence about intra- and postoperative complication rates related to transvaginal natural orifice transluminal endoscopic surgery (vNOTES) for benign gynecological conditions is still limited. We report and analyze data from a large cohort of patients operated in a single institution during 3.5 years. MATERIAL AND METHODS: To evaluate the safety and feasibility of vNOTES for benign gynecological indications, we performed a single-center observational study reporting and analyzing perioperative outcomes of 550 consecutive patients operated between 2020 and 2024. RESULTS: Of the 550 included patients, 365 (66.4%) underwent a vNOTES hysterectomy, 167 (30.4%) a procedure limited to the adnexa, and 18 (3.3%) other interventions, including myomectomy, pelvic adhesiolysis, post-hysterectomy pelvic hematoma drainage, pelvic organ prolapse repair, and appendectomy. The mean age was 49.4 ± 12.2 years, and the mean BMI was 26.2 ± 5.8 kg/m2. The total complication rate was 6.5% (36 cases), of which 2.7% (15 cases) were intraoperative complications and 4.0% (22 cases) were postoperative complications. Patients presented postoperative complications classified as Clavien-Dindo (CD) grade I in 4 cases (0.7%), grade II in 10 cases (1.8%), and grade III in 8 cases (1.5%). We observed no CD grade IV and V complications. Three patients (0.5%) were rehospitalized for postoperative complications management. The conversion rate was 1.6%, with nine cases of conversion to conventional laparoscopy and none to laparotomy. CONCLUSIONS: The application of vNOTES appears safe and feasible for most benign gynecological surgeries. Our study focused on surgical complications and demonstrated a profile similar to those reported in previous studies.

Sexual quality of life and postoperative deep dyspareunia after vNOTES benign adnexal procedures.

OBJECTIVE: This study aimed to investigate the impact of vNOTES on postoperative sexual dysfunction in patients undergoing adnexal procedures. METHODS: We analyzed data from patients who underwent vNOTES adnexal surgeries for benign conditions between May 2020 and May 2023. The primary outcome was the presence of new postoperative deep dyspareunia (DD) or other sexual dysfunctions, which were assessed through a phone survey conducted 6 to 24 months after surgery. Secondary outcomes included surgical feasibility, operative times, complications rate, and postoperative pain evaluation. RESULTS: We included 103 patients for primary and secondary outcomes and 111 patients for secondary outcomes analysis only. Newly postoperative DD was reported by three patients (2.9%), remained present at 12 postoperative months in one case (1.0%), and spontaneously disappeared in two cases (1.9%) after four and 10 postoperative months, respectively. In the remaining 100 patients (97.1%), no new DD or other sexual function disorders were reported after surgery. vNOTES procedures were successfully performed in all cases, with a mean operative time of 38.2 ± 19.6 min and a conversion rate to conventional laparoscopy of 0.9%. No significant complication was observed. CONCLUSION: This study suggests a very limited risk of developing postoperative sexual dysfunction after vNOTES benign adnexal procedures.

Utero-ovarian transposition before pelvic radiation in a patient with rectal cancer: a case report and systemic literature review.

Objective: To describe a case of utero-ovarian transposition (UOT) before pelvic radiation in a patient with rectal cancer and provide a systematic literature review on all reported cases of UOT. Methods: We performed a prospective collection and revision of clinical, intraoperative, and postoperative data from a patient who underwent UOT. In addition, a systematic review of the literature available to date on all cases of UOT was realized, and 14 patients from 10 articles were included. Results: We reported the case of a 28-year-old nulligravida patient who was diagnosed with a low-grade rectal adenocarcinoma and underwent neoadjuvant chemoradiotherapy, followed by transanal total mesorectal excision (TaTME). Before starting neoadjuvant oncological therapies, the patient underwent laparoscopic UOT. The intervention was performed without complications, and the patient received neoadjuvant oncological treatments as planned. TaTME and uterus repositioning were completed six weeks after the end of radiotherapy. No complications were observed during the first 9 postoperative months. Adequate utero-ovarian perfusion was assessed by Doppler ultrasound, cervicovaginal anastomosis appeared to have healed correctly, and the patient experienced menstrual bleeding. Data from the literature review of all reported cases of UOT were presented and discussed. Conclusions: UOT represents a valuable option to preserve fertility in patients requiring pelvic radiotherapy. This study provides additional evidence on the feasibility and safety of performing UOT.

SENOSI Confocal Microscopy: A New and Innovating Way to Detect Positive Margins in Non-Palpable Breast Cancer?

In Switzerland, breast cancer is the leading cancer among women, with breast-conserving surgery (BCS) being the preferred treatment for small tumors. The margin status post-surgery is a critical predictor of local recurrence. Achieving negative margins remains a challenge, leading to re-excision in 20-30% of cases. Traditional methods like intraoperative examination palpation and radiography have limitations in assessing excised margins. This study introduces the Histolog® Scanner, a confocal microscopy tool, as a potential solution. It provides real-time images of tissue architecture, allowing for rapid and accurate assessment of excised margins. Our research compared the Histolog® Scanner with standard per-operative radiography in patients with non palpable breast cancer. Preliminary results indicate that the Histolog® Scanner offers a reliable and time-efficient method for margin assessment, suggesting its potential for clinical integration.

Impact of Uterine Weight and Shape on vNOTES Hysterectomy: Analysis of 238 Consecutive Cases.

STUDY OBJECTIVE: To compare the perioperative outcomes of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomies for different uterine weights and shapes. DESIGN: Observational study. SETTING: Swiss teaching hospital. PATIENTS: Women who underwent vNOTES hysterectomy for benign conditions between May 2020 and July 2023 (N = 238). Patients were divided into 4 subgroups depending on uterus weight and shape. Uteri weighting <280 g were classified as type 0. Uteri weighting ≥280 g were categorized as type 1 (no vascular pedicle displacement), type 2 (cranial displacement of adnexal vascular pedicles), and type 3 (displacement of uterine arteries). INTERVENTIONS: All women underwent vNOTES hysterectomies. We compared perioperative outcomes for the 4 subgroups. MEASUREMENT AND MAIN RESULTS: We classified 168 patients (70.6%) as uterus type 0, 33 patients (13.9%) as type 1, 24 patients (10.1%) as type 2, and 13 patients (5.4%) as type 3. Mean uterine weight was 135.8 ± 59.5 g in type 0, 398.0 ± 167.3 g in type 1, 603.5 ± 217.9 g in type 2, and 661.7 ± 281.6 g in type 3. Operative time in type 0 (65.1 ± 30.9 minutes) and type 1 (65.1 ± 24.0 minutes) was shorter than in type 2 (102.3 ± 60.0 minutes) and type 3 (115.2 ± 40.3 minutes). Blood losses were more significant in type 2 (158.5 ± 212.0 mL) and type 3 (158.5 ± 110.7 mL) than in type 0 (85.6 ± 113.5 mL). No difference in the rate of total complications among groups was observed (8.3%, 3.0%, 12.5%, and 15.4% in types 0, 1, 2, and 3, respectively). CONCLUSION: The displacement of the vascular pedicles seems associated with longer operative time and more blood loss and could represent a marker for technical difficulty in vNOTES hysterectomy. However, it does not influence the perioperative complication rate.

Feasibility and safety of vNOTES for gynecological procedures in obese patients.

INTRODUCTION: This study aimed to determine the feasibility and safety of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) to treat benign and malign gynecological conditions in obese patients. MATERIAL AND METHODS: We analyzed data from 79 obese patients with a body mass index (BMI) > 30 Kg/m2 operated by vNOTES for gynecological conditions between May 2020 and April 2023. The primary outcome was the feasibility of performing the surgery as initially planned. Data were presented for subgroups of patients with obesity class I (BMI 30.1 - 34.9 Kg/m2), class II (BMI 35.0 - 39.9 Kg/m2), and class III (BMI ≥ 40.0 Kg/m2). RESULTS: Patients presented obesity class I in 39 cases (49.4 %), class II in 27 cases (34.2 %), and class III in 13 cases (16.4 %). Fifty-two patients (65.8 %) underwent vNOTES hysterectomy, 26 patients (32.9 %) underwent procedures limited to the adnexa, and 1 patient (1.3 %) underwent myomectomy. The conversion rate was 0 %, 11.1 %, and 7.7 % in obesity class I, II, and III, respectively. Intraoperative bladder injury was observed in 1 case (1.3 %) and rectal serosal tear in 2 cases (2.5 %). Postoperatively, we observed 3 cases (3.8 %) of wound infection, 2 cases (2.5 %) of cystitis, and 1 case (1.3 %) of deep vein thrombosis. DISCUSSION: This study demonstrated the feasibility and safety of performing gynecological vNOTES procedures in obese patients. However, obesity could be associated with longer and more complex interventions, especially in obesity class II and III patients.

Association of Axillary Dissection With Systemic Therapy in Patients With Clinically Node-Positive Breast Cancer.

Importance: The role of axillary lymph node dissection (ALND) to determine nodal burden to inform systemic therapy recommendations in patients with clinically node (cN)-positive breast cancer (BC) is currently unknown. Objective: To address the association of ALND with systemic therapy in cN-positive BC in the upfront surgery setting and after neoadjuvant chemotherapy (NACT). Design, Setting, and Participants: This was a prospective, observational, cohort study conducted from August 2018 to June 2022. This was a preplanned study within the phase 3 randomized clinical OPBC-03/TAXIS trial. Included were patients with confirmed cN-positive BC from 44 private, public, and academic breast centers in 6 European countries. After NACT, residual nodal disease was mandatory, and a minimum follow-up of 2 months was required. Exposures: All patients underwent tailored axillary surgery (TAS) followed by ALND or axillary radiotherapy (ART) according to TAXIS randomization. TAS removed suspicious palpable and sentinel nodes, whereas imaging-guidance was optional. Systemic therapy recommendations were at the discretion of the local investigators. Results: A total of 500 patients (median [IQR] age, 57 [48-69] years; 487 female [97.4%]) were included in the study. In the upfront surgery setting, 296 of 335 patients (88.4%) had hormone receptor (HR)-positive and Erb-B2 receptor tyrosine kinase 2 (ERBB2; formerly HER2 or HER2/neu)-negative disease: 145 (49.0%) underwent ART, and 151 (51.0%) underwent ALND. The median (IQR) number of removed positive lymph nodes without ALND was 3 (1-4) nodes compared with 4 (2-9) nodes with ALND. There was no association of ALND with the proportion of patients undergoing adjuvant chemotherapy (81 of 145 [55.9%] vs 91 of 151 [60.3%]; adjusted odds ratio [aOR], 0.72; 95% CI, 0.19-2.67) and type of systemic therapy. Of 151 patients with NACT, 74 (51.0%) underwent ART, and 77 (49.0%) underwent ALND. The ratio of removed to positive nodes was a median (IQR) of 4 (3-7) nodes to 2 (1-3) nodes and 15 (12-19) nodes to 2 (1-5) nodes in the ART and ALND groups, respectively. There was no observed association of ALND with the proportion of patients undergoing postneoadjuvant systemic therapy (57 of 74 [77.0%] vs 55 of 77 [71.4%]; aOR, 0.86; 95% CI, 0.43-1.70), type of postneoadjuvant chemotherapy (eg, capecitabine: 10 of 74 [13.5%] vs 10 of 77 [13.0%]; trastuzumab emtansine-DM1: 9 of 74 [12.2%] vs 11 of 77 [14.3%]), or endocrine therapy (eg, aromatase inhibitors: 41 of 74 [55.4%] vs 36 of 77 [46.8%]; tamoxifen: 8 of 74 [10.8%] vs 6 of 77 [7.8%]). Conclusion: Results of this cohort study suggest that patients without ALND were significantly understaged. However, ALND did not inform systemic therapy recommendations.

Trends in use of neoadjuvant systemic therapy in patients with clinically node-positive breast cancer in Europe: prospective TAXIS study (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101).

PURPOSE: The aim of this study was to evaluate clinical practice heterogeneity in use of neoadjuvant systemic therapy (NST) for patients with clinically node-positive breast cancer in Europe. METHODS: The study was preplanned in the international multicenter phase-III OPBC-03/TAXIS trial (ClinicalTrials.gov Identifier: NCT03513614) to include the first 500 randomized patients with confirmed nodal disease at the time of surgery. The TAXIS study's pragmatic design allowed both the neoadjuvant and adjuvant setting according to the preferences of the local investigators who were encouraged to register eligible patients consecutively. RESULTS: A total of 500 patients were included at 44 breast centers in six European countries from August 2018 to June 2022, 165 (33%) of whom underwent NST. Median age was 57 years (interquartile range [IQR], 48-69). Most patients were postmenopausal (68.4%) with grade 2 and 3 hormonal receptor-positive and human epidermal growth factor receptor 2-negative breast cancer with a median tumor size of 28 mm (IQR 20-40). The use of NST varied significantly across the countries (p < 0.001). Austria (55.2%) and Switzerland (35.8%) had the highest percentage of patients undergoing NST and Hungary (18.2%) the lowest. The administration of NST increased significantly over the years (OR 1.42; p < 0.001) and more than doubled from 20 to 46.7% between 2018 and 2022. CONCLUSION: Substantial heterogeneity in the use of NST with HR+/HER2-breast cancer exists in Europe. While stringent guidelines are available for its use in triple-negative and HER2+ breast cancer, there is a need for the development of and adherence to well-defined recommendations for HR+/HER2-breast cancer.

Tailored axillary surgery in patients with clinically node-positive breast cancer: Pre-planned feasibility substudy of TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101).

AIM: We developed tailored axillary surgery (TAS) to reduce the axillary tumor volume in patients with clinically node-positive breast cancer to the point where radiotherapy can control it. The aim of this study was to quantify the extent of tumor load reduction achieved by TAS. METHODS: International multicenter prospective study embedded in a randomized trial. TAS is a novel pragmatic concept for axillary surgery de-escalation that combines palpation-guided removal of suspicious nodes with the sentinel procedure and, optionally, imaging-guided localization. Pre-specified study endpoints quantified surgical extent and reduction of tumor load. RESULTS: A total of 296 patients were included at 28 sites in four European countries, 125 (42.2%) of whom underwent neoadjuvant chemotherapy (NACT) and 71 (24.0%) achieved nodal pathologic complete response. Axillary metastases were detectable only by imaging in 145 (49.0%) patients. They were palpable in 151 (51.0%) patients, of whom 63 underwent NACT and 21 had residual palpable disease after NACT. TAS removed the biopsied and clipped node in 279 (94.3%) patients. In 225 patients with nodal disease at the time of surgery, TAS removed a median of five (IQR 3-7) nodes, two (IQR 1-4) of which were positive. Of these 225 patients, 100 underwent ALND after TAS, which removed a median of 14 (IQR 10-17) additional nodes and revealed additional positive nodes in 70/100 (70%) of patients. False-negative rate of TAS in patients who underwent subsequent ALND was 2.6%. CONCLUSIONS: TAS selectively reduced the tumor load in the axilla and remained much less radical than ALND.

Prepectoral versus subpectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy (OPBC-02/ PREPEC): a pragmatic, multicentre, randomised, superiority trial.

INTRODUCTION: The emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast implant above (prepectoral) or below (subpectoral) the pectoralis major muscle or by using the patients' own tissue (autologous reconstruction). The optimal positioning of the implant prepectoral or subpectoral is currently not clear. Subpectoral implant-based breast reconstruction (IBBR) is still standard care in many countries, but prepectoral IBBR is increasingly performed. This heterogeneity in breast reconstruction practice is calling for randomised clinical trials (RCTs) to guide treatment decisions. METHODS AND ANALYSIS: International, pragmatic, multicentre, randomised, superiority trial. The primary objective of this trial is to test whether prepectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being (chest) compared with subpectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of breast cancer. Secondary objectives will compare prepectoral versus subpectoral IBBR in terms of safety, QoL and patient satisfaction, aesthetic outcomes and burden on patients. Total number of patients to be included: 372 (186 per arm). ETHICS AND DISSEMINATION: This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained for the lead investigator's site by the Ethics Committee 'Ethikkommission Nordwest- und Zentralschweiz' (2020-00256, 26 March 2020). The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs and good publication practice. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories adhering to the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles. TRIAL REGISTRATION NUMBER: NCT04293146.