Time Of Surgery Research Articles

Quantification and Functional Studies of Neutrophilic Cells Identifies Distinct Papilloma Phenotypes.

To characterize the distribution of immune cell subsets within laryngeal papillomas and to study the function of potentially immunosuppressive neutrophilic and regulatory T cells (Tregs). Fresh clinical papilloma specimens were collected at the time of surgery and studied with multiparameter flow cytometry. Papilloma infiltrating neutrophilic cells and Tregs were sorted and studied functionally with ex vivo T cell suppression assays. Flow cytometric analysis of fresh laryngeal papillomas samples from 18 adult patients with recurrent respiratory papillomatosis revealed patterns in immune constituency between patients. Clearly divergent phenotypes based primarily on the degree of neutrophilic and T cell infiltration were identified. Relative neutrophilic cell enrichment and T cell depletion were observed in 50% of samples and neutrophilic cell depletion and T cell enrichment were observed in the others. Greater papilloma neutrophilic cell enrichment was positively associated with the number of clinically indicated interventions required in the 12 months prior to sample collection, linking papilloma neutrophil inflammation to disease severity. Functional assays revealed the ability of both papilloma infiltrating neutrophilic and Tregs to suppress T cell function at roughly equal magnitudes, but substantially increased infiltration of neutrophilic cells compared to Tregs across samples. Neutrophilic cells are an important contributor to immunosuppression within the respiratory papilloma microenvironment. Given these data and the association between greater neutrophilic cell infiltration and lack of clinical response to therapeutic vaccination, additional study of strategies aimed at limiting neutrophilic cell infiltration or function within papillomas is warranted. 4 Laryngoscope, 134:3238-3244, 2024.

Safety and efficacy of capsular tension ring and capsular hook implantation for managing ectopia lentis in Marfan syndrome: real-world study.

To evaluate the safety and efficacy of capsular tension ring and capsular hook (CTR-CH) implantation in Marfan syndrome (MFS) patients with ectopia lentis (EL). Eye and ENT Hospital of Fudan University, Shanghai, China. Retrospective propensity score-matched cohort study. This study included patients with MFS who had in-the-bag intraocular lens (IOL) implantation assisted by CTR-CH or modified CTR (MCTR). The safety analysis focused on the resurgery rate. The efficacy analysis compared the corrected distance visual acuity (CDVA) and the incidence of laser capsulotomy after propensity score matching (PSM). This study encompassed 148 eyes that had the CTR-CH procedure and 162 eyes that received MCTR implantation. In the CTR-CH group, the median age at the time of surgery was 5 years, with a mean follow-up duration of 1.81 ± 0.4 years. 5 eyes (3.38%) required a second surgery because of retinal detachment (2, 1.35%), IOL decentration (2, 1.35%), and CH dislocation (1, 0.68%). The resurgery rate was comparable with that of the MCTR group ( P = .486). After PSM, a total of 108 eyes were recruited in each group. Postoperative CDVA was significantly improved in both groups (both P < .001), but comparable between the groups ( P = .057). The posterior capsular opacification took place earlier ( P = .046) while the anterior capsular opacification required laser capsulotomy at a later stage ( P = .037) compared with the MCTR group. The CTR-CH procedure was a feasible, safe, and efficient approach for managing EL in patients with MFS.

РОБОТ-АССИСТИРОВАННЫЕ ОПЕРАЦИИ В ДЕТСКОЙ АБДОМИНАЛЬНОЙ ХИРУРГИИ: ПЕРВОНАЧАЛЬНЫЙ ОПЫТ

Purpose of this research was to apply the possibilities of robot-assisted surgery technology in children with abdominal pathology in terms of assessing feasibility and evaluating postoperative results. Material and methods used: the scientific study was carried out at the Irkutsk Oblast Regional Children's Clinical Hospital (Irkutsk, Russia) in Dec. 2022-June 2023. During this period, 11 robot-assisted procedures were performed on the abdominal organs. The study was conducted within the framework of the Clinical Trials Program for Medical Products approved by the Federal Service for Surveillance in Healthcare of the Russian Federation. All surgical procedures were implemented according to the same principles and patterns that the Authors have gathered previously with the Versius Surgical Robot. In all cases, the three robotic ports were used: a single 12-mm trocar for optics (intervened at the umbilicus) and two 5-mm trocars for robotic arms. Additionally, another 5-mm laparoport was installed for the assistant surgeon to work during the robotic intervention. During the study, patients' perioperative parameters related to data charts, surgical details and both early and long-term outcomes were recorded. Results: the total number of patients involved in robotic interventions on the abdominal organs was 11, 4 (36,4%) boys/7 (63,6%) girls. The mean age at the time of surgery was 10,9±5.1 y/o (Me 12.0 [7.0; 15.0] y/o), mean weight at the time of surgery was 39.7±18.0 kg (Me 43.0 [24.0; 53.8] kg). The distribution of reasons for surgical interventions was as follows: 3 (27,3%) patients with Nissen fundoplication, 3 (27,3%) patients with cholecystectomy, 2 (18,2%) patients with Heller esophagomyotomy with Dor fundoplication, 2 (18,2%) patients with splenic cyst fenestration and a single (9%) patient with enucleation of ovarian teratoma. The mean duration was 100±52.4 min (Me 70.0 [65.0; 122.5] min). None of the operations were accompanied by any intraoperative complications. There were also no conversions into laparoscopic and/or open surgeries. In the long-term period after the operations, the number of significant complications in the form of recurrence of symptoms of the initial disease did not increase, patients showed no digestive problems during the entire follow-up period as well. Conclusion: Russia’s initial experience with robotic-assisted abdominal surgery confirmed that robotics can be safely and effectively used in children. Fundoplication, esophagomyotomy and cholecystectomy are by far the most commonly performed basic interventions in pediatric surgery. Obviously, this is the first stage in the development of robotic abdominal surgery in children hence it would further involve a more complex procedure.

Identifying unstable ramp lesions using ultrasonography.

Patients with suspected ramp lesions on magnetic resonance imaging (MRI) or ultrasonography (US) healed and showed no instability based on intraoperative arthroscopic findings. The purpose of this study was to assess the use of US in evaluating ramp lesions preoperatively and intraoperatively. Eighty-two knees that underwent anterior cruciate ligament (ACL) reconstruction between January 2022 and June 2023 were included to assess the ramp lesion complication rate and instability using arthroscopic findings. The detection rate of ramp lesions using US at the initial visit and preoperatively was also investigated. The test-retest reliability was assessed using the intraclass correlation coefficient and analyzed using two-way random effects and absolute agreement. The patients were divided into two groups based on the presence or absence of ramp lesions, and these data were compared using Student's t-test. Statistical significance was set at p < 0.05. On ultrasound examination, 90.0% of the cases had a ramp lesion at the initial examination, of which 22.2% were poorly delineated on the day of surgery. In the cases where the ramp lesion was unstable at the time of surgery, it could be delineated using US. In the cases where the ramp lesion was stable, it was difficult to delineate the lesion using US. Unstable ramp lesions complicating ACL injuries could be detected using US.

Comparison of the axial growth with multifocal and monofocal intraocular lenses in unilateral pediatric cataract surgery.

To compare axial growth in pediatric cataract patients who underwent multifocal intraocular lens (IOL) implantation without anterior vitrectomy (AV) with that in pediatric patients who underwent monofocal IOL implantation with or without AV. Patients who had unilateral pediatric cataracts and underwent surgery at 3-6years of age from June 6, 2019, to June 30, 2020, at our institution were prospectively analyzed. The patients were categorized into Group A: multifocal IOL implantation with optic capture in Berger's space without AV; Group B: monofocal IOL implantation with optic capture in Berger's space without AV; and Group C: bag-in-the-lens monofocal IOL implantation with AV. Groups A', B' and C' consisted of the fellow eyes from the respective groups. Axial growth and monthly growth rates were compared among the 3 treatment groups, as well as between the treated eyes and the fellow eyes. Thirty-one, 23, and 14 children fulfilling the inclusion criteria, respectively, were included in the final analysis. There were no significant differences in patient age at the time of surgery or preoperative axial length (P > 0.05). After a mean follow-up of 35.57 ± 3.78months, significant differences in the axial growth and the monthly growth rate were observed (P < 0.05), and Group A had the least axial elongation. Comparing treated eyes with fellow eyes, the amount and rate of axial growth were lower in Group A than in Group A' (P < 0.05), no significant differences were found in Group B (P > 0.05), and Group C had greater growth than did Group C' (P < 0.05). The implanting multifocal intraocular lenses and maintenance of vitreous body integrity may be protective factors against excessive axial growth in pediatric cataract patients. Clinical trial registration (prospective study): chiCRT1900023155; 2019-05-14.

Schwannian and Perineuriomatous Differentiation in a Series of Giant Congenital Melanocytic Nevi.

Close relationship between melanocytes and neural cells is accepted to reflect their common derivation from the neural crest and tumors combining both elements. We present a series of 10 patients with giant congenital melanocytic nevi (CMN) in which a secondary proliferation (11 lesions) with schwannian and/or perineuriomatous differentiation developed in the course of the disease. The age of the patients (4 male and 6 female) at the time of surgery and histological assessment varied from 3 months to 57 years. Histopathologically, the following subgroups were delineated: (1) nodular/tumoriform "neurotization" in CMN, (2) diffuse neurofibroma-like proliferation within CMN, (3) plexiform neurofibroma-like proliferation within CMN, and (4) diffuse perineuriomatous (hybrid schwannomatous-perineuriomatous) differentiation in CMN. We review the pertinent literature, including the role of recently identified Schwann cell precursors which are believed to represent the nerve-associated state of neural crest-like cells that persists into later developmental stages.

A survey of breastfeeding among women with previous surgery for benign breast disease: a descriptive exploratory study

BackgroundSurgery is the primary treatment for benign breast disease and causes some disruption to the normal physiology of the breast, even when this disruption is localised, it remains unclear whether it affects women’s ability to breastfeed. There are only a few studies describing the experience of breastfeeding in women who have undergone benign breast disease (BBD) surgery.MethodsWe retrospectively analysed data from patients aged 20–40 years in Guangdong, China, who underwent breast lumpectomy for BBD in our department between 01 January 2013 and 30 June 2019, with a follow-up date of 01 February 2022. Patients were included who had a history of childbirth between the time of surgery and the follow-up date. By collecting general information about this group of patients and information about breastfeeding after surgery, we described the breastfeeding outcomes of women of a fertile age who had previously undergone surgery for benign breast disease.ResultsWith a median follow-up of 5.9 years, a total of 333 patients met the inclusion criteria. From the breastfeeding data of the first child born postoperatively, the mean duration of ‘exclusive breastfeeding’ was 5.1 months, and the mean duration of ‘any breastfeeding’ was 8.8 months. The rate of ‘ever breastfeeding’ is 91.0%, which is lower than the national average of 93.7%, while the exclusive breastfeeding rate at six months was 40.8%, was higher than the 29.2% national average. The any breastfeeding rate at 12 months was 30.0%, which was well below the 66.5% national average. The common reason for early breastfeeding cessation was insufficient breast milk. A total of 29.0% of patients who had ever breastfed after surgery voluntarily reduced the frequency and duration of breastfeeding on the operated breast because of the surgery.ConclusionsThere are some impacts of BBD surgery on breastfeeding and some may be psychological. Institutions should provide more facilities for mothers who have undergone breast surgery to help them breastfeed, such as conducting community education on breastfeeding after breast surgery, training professional postoperative lactation consultants in hospitals, and extending maternity leave. Families should encourage mothers to breastfeed with both breasts instead of only the non-operated breast.

Introduction of a new surgical robot platform "hinotori™" in an institution with established da Vinci surgery™ for digestive organ operations.

New platforms for robotic surgery have recently become available for clinical use; however, information on the introduction of new surgical robotic platforms compared with the da Vinci™ surgical system is lacking. In this study, we retrospectively determined the safe introduction of the new "hinotori™" surgical robot in an institution with established da Vinci surgery using four representative digestive organ operations. Sixty-one patients underwent robotic esophageal, gastric, rectal, and pancreatic operations using the hinotori system in our department in 2023. Among these, 22 patients with McKeown esophagectomy, 12 with distal gastrectomy, 11 with high- and low-anterior resection of the rectum, and eight with distal pancreatectomy procedures performed by hinotori were compared with historical controls treated using da Vinci surgery. The console (cockpit) operation time for distal gastrectomy and rectal surgery was shorter in the hinotori group compared with the da Vinci procedure, and there were no significant differences in the console times for the other two operations. Other surgical results were almost similar between the two robot surgical groups. Notably, the console times for hinotori surgeries showed no significant learning curves, determined by the cumulative sum method, for any of the operations, with similar values to the late phase of da Vinci surgery. This study suggests that no additional learning curve might be required to achieve proficient surgical outcomes using the new hinotori surgical robotic platform, compared with the established da Vinci surgery.

Non-therapeutic hysterectomy in Mexican young females with intellectual disability: a problematized reality

Non-therapeutic hysterectomy in girls and adolescents with intellectual disability (ID) is an acceptable practice, even when there is a lack of prescriptive ethical reason. To determine the magnitude of the practice of hysterectomy in girls and adolescents with ID, and explore the emic factors associated with this procedure. Multicenter, intersectoral study with a mixed methods design. The quantitative results showed that 50 of 234 reported hysterectomies corresponded to females with ID. Average age at the time of surgery was 15 ± 2.9 years. Prophylactic abdominal hysterectomy was the most common procedure, and the justifications for it were "fertility control", "menstrual hygiene management", and "risk of sexual abuse". A qualitative analysis of 15 focus groups revealed that parents' main concern was how to manage their daughters' index disease and reproductive health; they perceived menstruation positively; they expressed their fear of dying and leaving them without support, and emphasized fertility control; none of them approved hysterectomy. The bodies that define health policies need to create a new philosophy that avoids the reductionist approach of current biomedical model, which separates (in the health-disease process) our interdependence with other humans.

The Beating Heart of Untapped Business Opportunities for Additive Manufacturing

This article presents two cases that join user-driven innovation and additive manufacturing (AM) to examine latent business opportunities for AM in the medical sector. The first case arose as a response to shortages during the early stages of the covid 19 pandemic. The second case, explored in more depth, came from maker-medical collaboration during preparation for a life-threatening operation. Surgeons, confronted with a patient with a delicate heart condition, collaborated with a prototyping facility to print a realistic 3D model of the patient’s aortic aneurysm. The model allowed the surgeons to first study and then experiment to determine the most effective operation procedure before the actual operation, which shortened the surgery time by approximately 70%. Reducing surgery time creates two forms of value: improving patient outcomes and reducing costs. Shorter times under anesthetic and on cardiopulmonary bypass correlate with better surgical results. Reducing healthcare costs brings broad societal benefits in both publicly and privately funded healthcare systems. We outline a case for makerspaces to capture value by joining their expertise and manufacturing equipment with the needs of nearby healthcare systems for novel business development.

Impact of total parenteral nutrition versus exclusive enteral nutrition on postoperative adverse outcomes in patients with penetrating Crohn's disease undergoing surgical resection: A retrospective cohort study.

Achieving optimal nutritional status in patients with penetrating Crohn's disease (CD) is crucial in preparing for surgical resection. However, there is a dearth of literature comparing the efficacy of total parenteral nutrition (TPN) versus exclusive enteral nutrition (EEN) in optimizing postoperative outcomes. Hence, we conducted a case-matched study to assess the impact of preoperative EEN versus TPN on the incidence of postoperative adverse outcomes, encompassing overall postoperative morbidity and stoma formation, among penetrating CD patients undergoing bowel surgery. From December 1, 2012 to December 1, 2021, a retrospective study was conducted at a tertiary center to enroll consecutive patients with penetrating CD who underwent surgical resection. Propensity score matching (PSM) was utilized to compare the incidence of postoperative adverse outcomes. Furthermore, univariate and multivariate logistic regression analyses were conducted to identify the risk factors associated with adverse outcomes. The study included 510 patients meeting the criteria. Among them, 101 patients in the TPN group showed significant improvements in laboratory indicators at the time of surgery compared to pre-optimization levels. After matching, TPN was increased occurrence of postoperative adverse outcomes (92.2% vs. 64.1%, p = 0.001) when compared to EEN group. In the multivariate analysis, TPN showed a significantly higher odds ratio for adverse outcomes than EEN (OR = 4.241; 95% CI 1.567-11.478; p = 0.004). The study revealed that penetrating CD patients who were able to fulfill their nutritional requirements through EEN exhibited superior nutritional and surgical outcomes in comparison to those who received TPN.

A Comparison of Clinical Outcomes of Colectomies for Pediatric and Adult Patients With Inflammatory Bowel Disease.

Background: Crohn's disease (CD) and ulcerative colitis (UC) are prevalent in adult and pediatric populations, but their differences are not well studied using national data. We compared the clinical outcomes of these patients using the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) databases.Methods: Colectomy cases for CD and UC, the 2 major forms of inflammatory bowel disease (IBD), were compared between adult and pediatric patients using the 2017-2019 ACS NSQIP databases. Various clinical factors were analyzed, with postoperative complications being the primary outcome of interest.Results: We identified 542 pediatric and 5174 adult CD patients and 360 pediatric and 1292 adult UC patients. Adults with CD or UC were more likely to be on steroids preoperatively (CD: 60.15% vs 24.54%; UC: 65.63% vs 51.39%). Children with IBD were more likely to have preoperative transfusions (CD: 1.48% vs .33%; UC: 8.33% vs .62%), systemic inflammatory response syndrome (CD: 3.51% vs .93%; UC: 12.78% vs 3.10%), or sepsis (CD: 1.85% vs .66%; UC: 1.39% vs .31%). Unplanned reoperations were more common among pediatric patients in both disease states compared to adults (CD: 6.27% vs 4.10%; UC: 11.11% vs 4.26%), with P-values for all factors described as ≤.02. Multivariate logistic regression found pediatric age to be associated with higher odds of needing a reoperation among UC patients but not CD patients.Conclusion: Pediatric patients were sicker at the time of surgery, and those with either disease were more likely to require a reoperation within 30days.

Comparison of Speech Outcomes Between Speech Therapy Only and Double-Opposing Z-Plasty Combined With Speech Therapy in Patients With Submucous Cleft Palate.

The purpose of this study was to compare speech outcomes in patients with submucous cleft palate (SMCP) between speech therapy alone and double-opposing Z-plasty (DOZ) combined with speech therapy. The subjects were 67 patients with SMCP (overt type, 45 males, 22 females), who were divided into the observation group (n=18), the speech therapy group (n=24; duration, 17.8mo), and the DOZ and speech therapy (DOZ-speech therapy) group (n=25; median age at DOZ, 5.3 years, duration, 18.6mo). The median age at initial and final speech assessments were 3 and 5 years. After age, sex, syndromic status, duration of speech therapy, surgery timing, and speech outcomes were investigated, statistical analysis was performed. After tailored interventions, both isolated and non-isolated SMCP patients experienced significant improvements in speech outcomes, including nasal emission, hypernasality, compensatory articulation, and unintelligible speech. Since comparable improvements were observed, there were no significant differences in the final assessments regardless of initial speech issues between the speech therapy group and the DOZ-speech therapy group (all P>0.05). In the DOZ-speech therapy group, the rate of achieving "socially acceptable" speech was 92.3% in isolated cases and 90% in non-isolated cases. Multivariate analysis revealed that DOZ showed a tendency to reduce hypernasality, compensatory articulation, and "unintelligible" speech; syndromic or developmental conditions influenced outcomes in nasal emission and hypernasality; and initial hypernasality and compensatory articulation were correlated with outcomes. Therefore, DOZ surgery could be recommended to resolve hypernasality and compensatory articulation in SMCP patients before speech issues worsen.

Effect of Sublay Preventive Mesh for Terminal Colostomy on Symptoms and Quality of Life in Patients With Parastomal Hernia: A Post-Hoc Analysis of the GRECCAR 7 Cohort.

Recent randomized clinical trials and meta-analyses confirm that the use of a prophylactic mesh doesn't significantly reduce the parastomal hernia rate. Data about the benefits of these meshes concerning the symptoms of the parastomal hernia lack in the existing literature. The aim of this study was to perform a post-hoc analysis of the patients presenting parastomal hernia from the GRECCAR 7 randomized clinical trials cohort on whether the presence or absence of the mesh influenced the symptoms, the quality of life and complications of patients with parastomal hernias. We studied the parastomal hernia related symptoms among the two groups of the GRECCAR 7 randomized clinical trial, with or without prophylactic mesh at the time of the index surgery. Data were retrospectively extracted and analyzed from the GRECCAR 7 database. Patients diagnosed with a parastomal hernia during the two years of the GRECCAR 7 study. Several prospectively collected data about the symptoms were studied among this population. We also studied the average interval between parastomal hernia repair surgery and both index surgery and diagnosis of parastomal hernia. Among the 199 patients included in the GRECCAR study, 36 patients (35.6%) were diagnosed with clinical and/or radiological parastomal hernia in the non-mesh group at 2 years follow-up and 33 (33.7%) in the mesh group, without statistically significant difference (p = 0.89). None of the studied symptoms showed any statistically significant difference between the groups. This study relies on a relatively small number of patients, and although data were prospectively collected, we lacked some details about the categorization of the parastomal hernias. We believe that the use of a prosthetic mesh in a sublay position to prevent parastomal hernia in terminal end colostomy patients should no longer be recommended. See Video Abstract.

Clinical outcomes of radiofrequency ablation using a radiofrequency needle device for varicose ulcer: A non-randomized controlled prospective study.

To evaluate the short-term clinical outcomes of radiofrequency ablation (RFA) using a radiofrequency (RF) needle device for varicose ulcers. From September 2020 to September 2021, a total of 80 patients with varicose ulcers were included in this study. Based on the different surgical methods, the patients were divided into RF group and control groups, with 40 cases in each group. In the RF group, RFA was performed using an RF needle device and foam sclerotherapy was used for superficial veins. The control group was treated with conventional high-ligation stripping. The surgical data, hospitalization data, clinical efficacy, and postoperative complications of two groups were compared. Meanwhile, the correlation between RBC, HB, HCT, and ulcer healing time was analyzed. Compared to the control group, RF group had shorter surgery time, duration in the hospital, and less intraoperative bleeding (p < .05). The VCSS and CIVIQ scores in RF group were significantly higher than that in control group (p < .05). The healing time of ulcers was shorter in the RF group (x2 = 19.766, p = .000). The RF group had fewer postoperative complications. There was a positive correlation between RBC, HB, and HCT, and ulcer healing time (p < .05). The use of the RF needle device for RFA to treat patients with varicose ulcers showed acceptable short-term clinical outcomes with less incidence of trauma, faster recovery, and fewer complications.

Tip-apex distance as a risk factor for cut-out in cephalic double-screw nailing of intertrochanteric femur fractures.

Proximal femur fractures treatment can involve anterograde nailing with a single or double cephalic screw. An undesirable failure for this fixation is screw cut-out. In a single-screw nail, a tip-apex distance (TAD) greater than 25 mm has been associated with an increased risk of cut-out. The aim of the study was to examine the role of TAD as a risk factor in a cephalic double-screw nail. A retrospective study was conducted on 112 patients treated for intertrochanteric femur fracture with a double proximal screw nail (Endovis BA2; EBA2) from January to September 2021. The analyzed variables were age, sex, BMI, comorbidities, fracture type, side, time of surgery, quality of reduction, pre-existing therapy with bisphosphonate for osteoporosis, screw placement in two different views, and TAD. The last follow-up was at 12 months. Logistic regression was used to study the potential factors of screw cut-out, and receiver operating characteristic curve to identify the threshold value. A total of 98 of the 112 patients met the inclusion criteria. Overall, 65 patients were female (66.3%), the mean age was 83.23 years (SD 7.07), and the mean follow-up was 378 days (SD 36). Cut-out was observed in five patients (5.10%). The variables identified by univariate analysis with p < 0.05 were included in the multivariate logistic regression model were screw placement and TAD. The TAD was significant with an odds ratio (OR) 5.03 (p = 0.012) as the screw placement with an OR 4.35 (p = 0.043) in the anteroposterior view, and OR 10.61 (p = 0.037) in the lateral view. The TAD threshold value identified was 29.50 mm. Our study confirmed the risk factors for cut-out in the double-screw nail are comparable to those in the single screw. We found a TAD value of 29.50 mm to be associated with a risk of cut-out in double-screw nails, when good fracture reduction is granted. This value is higher than the one reported with single-screw nails. Therefore, we suggest the role of TAD should be reconsidered in well-reduced fractures treated with double-screw intramedullary nail.

A pilot study of early PET and biomarker dynamics in patients with stage 2 and 3 triple negative breast cancer treated with neoadjuvant response-adapted chemotherapy with pembrolizumab (NeoADAPT).

TPS624 Background: In patients with triple negative breast cancer (TNBC) the addition of pembrolizumab to neoadjuvant chemotherapy has improved pathologic complete response rates (pCR) and 5-year event free survival (EFS). Patients with TNBC who achieve a pCR have a significantly lower risk of recurrence compared to those with residual disease (RD). However, pCR can only be assessed at the time of surgery after completion of 6 months of intensive chemo-immunotherapy, associated with up to 77% high-grade treatment-related toxicity. Identifying pCR early on is imperative in developing optimized and individualized treatments, however, there are no predictive biomarkers. Studies in HER2-positive breast cancer have shown that early fluorodeoxyglucose positron emission tomography (FDG-PET) changes soon after initiation of neoadjuvant treatment can help predict the pathological outcomes at the time of surgery and also the risk of recurrence. Emerging data also support that clearance of circulating tumor DNA (ctDNA) during neoadjuvant treatment may be associated with higher rates of pCR. We thus designed a study to determine the association of early FDG-PET changes and ctDNA clearance with pCR in early-stage TNBC. Methods: NeoADAPT is a phase 2, open label, single center clinical trial including adult patients with previously untreated clinical stage 2 or 3 TNBC. Participants will receive 4 cycles of neoadjuvant paclitaxel/carboplatin with pembrolizumab (TC/pembro), per standard-of-care (SOC). An FDG-PET will be performed at baseline and after 1 cycle. A breast MRI will be performed at baseline and after completion of 4 cycles of treatment. Patients with a complete clinical response (cCR) will proceed to surgery and will forgo more neoadjuvant treatment. Patients with clinical RD on MRI will complete SOC neoadjuvant therapy with 4 cycles of doxorubicin/cyclophosphamide (AC) with pembro prior to surgery. If RD is identified after surgery, adjuvant therapy will be determined by the treating oncologist, which may include pembro with AC (if not given prior), capecitabine, etc. The primary objective is to evaluate if lack of decrease in maximum FDG-PET standard uptake value of lean body mass (SULmax) by less than 40% after 1 cycle of neoadjuvant treatment correlates with RD at the time of surgery (i.e. determining the negative predictive value of FDG-PET). Additional key endpoints include ctDNA clearance, evaluation of pCR and cCR rates in the treatment population and EFS. Distributions of percent reduction in SULmax will be compared between pCR and no-pCR groups using the Wilcoxon rank sum test. Receiver operating characteristic (ROC) curve analysis will be performed to estimate the ability of FDG-PET SULmax reduction and cCR by MRI in predicting pCR at surgery. Clinical trial information: NCT06245889 .

Concurrent hyperthermic intraperitoneal chemotherapy and intraoperative radiotherapy with cytoreductive surgery in patients with rectal cancer with peritoneal carcinomatosis.

e15571 Background: Rectal cancer (RC) is often associated with peritoneal carcinomatosis (PC). Hyperthermic intraperitoneal chemotherapy (HIPEC) and intraoperative radiotherapy (IORT) have been shows to reduce recurrence and effectively treat PC across several cancers. However, little evidence is available regarding the concurrent use of HIPEC and IORT alongside cytoreductive surgery (CRS) in the literature. Methods: We retrospectively reviewed the medical records of RC patients with PC who received HIPEC plus IORT during CRS at the King Faisal Specialist Hospital and Research Centre. Demographic data, PC index (PCI), completeness of cytoreduction (CC), and tumor staging were collected. Overall survival (OS) was calculated from the time of surgery until death or last follow-up. Recurrence-free survival (RFS) was calculated from the time of surgery until recurrence or last follow-up. Unadjusted hazard ratios (HR) were used to determine the impact of parameters on OS or RFS. Results: 17 patients were included in our analysis. Basic demographic data can be found in Table 1. The most common operation performed was rectosigmoid resection in 7 (41.2%) patients, followed by low anterior resection in 6 (35.3%). The pT stage was T0 in 1 (5.9%), T4a in 7 (41.2%), and T4b in 9 (52.9%). The pN stage was N0 in 11 (64.7%), N1a in 1 (5.9%), N1b in 2 (11.8%), N1c in 2 (11.8%), and N2b in 1 (5.9%). There was positive resection margin in 2 patients. The PCI was ≤6 in 15 (88.2%), and the CC score was 0-1 in all patients. No patients had intraoperative complications. 12 (70.6%) received mitomycin C, 4 (23.5%) received cisplatin and mitomycin C, and one patient received a reduced dose of mitomycin C due to old age. 2 (11.8%) patients received two doses of IORT. 11 (64.7%) patients had postoperative complications, of which all were Clavein-Dindo grades 1-3b. Recurrence occurred in 11 (64.7%). The median OS was not reached, and the median RFS was 12 months. There were no parameters associated with OS. Male gender (HR: 7.7, 95% CI: 1.4-57.3), pM1 (HR: 4.5, 95% CI; 1.2-18.1), and perineural invasion (HR: 6.5, 95% CI: 1.2-49.3) were associated with poor RFS in univariate analysis. Conclusions: Incorporating HIPEC and IORT into CRS may be an effective treatment strategy for RC patients. Presence of distant metastasis and perineural invasion can be predictors of rapid recurrence. [Table: see text]

Prospective evaluation of the breast microbiome and tumor microenvironment-related biomarkers of response to neoadjuvant systemic therapy in triple negative breast cancer.

TPS615 Background: Predictive biomarkers of response to combination chemotherapy and immune-checkpoint inhibitors are urgently needed to tailor treatment recommendations for patients with early-stage triple negative breast cancer (eTNBC). Our group has demonstrated that tumour-associated microbiota in primary breast tumours represent promising and novel candidate biomarkers for patients with breast cancer. We aim to prospectively interrogate the breast cancer microbiome and tumour microenvironment (TME) of eTNBC treated with neoadjuvant chemo-immunotherapy, and correlate with clinical outcome. Methods: Trial design: This prospective translational biomarker study is enrolling patients with eTNBC suitable for standard neoadjuvant systemic therapy followed by definitive surgery. The primary objective is to evaluate the change in breast cancer microbiome composition pre- and post-therapy. Secondary objectives include correlation of the breast microbiome with pathologic complete response (pCR) and survival outcomes, tumor infiltrating lymphocytes (TILs), PDL-1 and immune subset analysis, extracellular vesicles analysis and analysis of gut microbiome. Tumor tissue samples will be collected at baseline (mandatory research biopsy) and at the time of surgery. Microbiome evaluation will be conducted using metagenomic sequencing to assess changes in the relative abundance of microbial taxa. Blood and stool samples will be collected and analysed at baseline, on-treatment, at the time of surgery and post-operatively for secondary endpoints. Statistical analysis: Hierarchical clustering of samples based on relative abundance of the operational taxonomic units (OTUs) with sample composition at family and genus level will be performed. Alpha Diversity (Shannon Diversity Index) and Beta Diversity (Jaccard Similarity Index) will be analysed. Principal component analysis (PCA) and Random Forest analysis will be performed for classification and clustering analysis. Comparison of taxa or functions between clinical cohorts will be performed (two tailed Z test) and corrected using the false discovery rate to determine Q-values. Thirty patients will be recruited over 18-24 months. Current status: This University College Cork sponsored trial received ethics approval from the CREC in January 2024 and recruitment is ongoing. Those interested can contact uccctg@ucc.ie. This trial will provide a deeper insight into the potential role of the local breast microbiome as a predictive biomarker for response to neoadjuvant therapy in patients with eTNBC. The results will guide further studies exploring optimal immunomodulatory combinations for the treatment of TNBC and may provide evidence regarding future therapeutic targeting of the breast cancer microbiome.

25-GAUGE VERSUS 27-GAUGE VITRECTOMY FOR MANAGEMENT OF VITREORETINAL DISEASES: A Large Prospective Randomized Trial.

To compare the safety and performance clinical outcomes of the 27-gauge (G) two-dimensional cutting vitrectomy probe versus a standard 25-G probe for retinal procedures. In this large randomized prospective study, all candidates for epiretinal membrane or macular hole surgery were randomized to the 27-G group or 25-G group. Outcome measures included surgery time, changes in best-corrected distance visual acuity, intraocular pressure, and central macular thickness between baseline and 1-month and 3-month follow-up time points. Moreover, intraoperative and postoperative complications were evaluated as well as the rate of sutureless vitrectomy. A total of 463 patients were included in this study, 227 patients in the 27-G group and 236 patients in the 25-G group. A similar total surgery time was found between both groups ( P = 0.0911). Similar best-corrected distance visual acuity and central macular thickness changes were observed between baseline and the 1-month and 3-month follow-up visits. No significant differences were reported in intraoperative and postoperative complications rates. The rate of sutureless vitrectomy was 96.5% for the 27-G group and 91.1% for the 25-G group ( P = 0.0170). These results suggest that 27-G vitrectomy probe is similar to 25-G probe in surgery time and complications, while decreasing the need for vitrectomy sutures.