Épisodes

  • "Vagilangelo, Innovation or Exploitation in Women’s Health Deep Dive Podcast"

    "Vagilangelo, Innovation or Exploitation in Women’s Health Deep Dive Podcast"
    Jul 13 2025
    The provided sources, primarily critiques from an OBGYN and health disparities researcher, Dr. Reza Lankarani, highlight significant concerns regarding the Vagilangelo® procedure and the broader landscape of cosmetic gynecology, particularly in the context of medical tourism and training in Arab countries. The central theme revolves around the tension between profit-driven healthcare and patient safety, arguing that the commercialization of uncertainty in women's health is exploitation, not innovation.1. The Vagilangelo® Procedure: Unsubstantiated Claims and Evidence DeficitThe Vagilangelo® procedure, marketed as a revolutionary vaginal rejuvenation technique, aims to restore "natural vaginal angulation" through internal suturing and platelet-rich plasma (PRP) injections. However, the sources assert that its claims are largely unsubstantiated by scientific evidence.Lack of Peer-Reviewed Validation: Despite claims of "77% satisfaction," Dr. Lankarani's critical review notes: "High satisfaction rates cited are anecdotal... Clinical trials comparing it to established methods would significantly strengthen its standing." The procedure lacks "zero randomized controlled trials," "no longitudinal safety data," and "absence of objective outcome measures (e.g., validated sexual function scales)."Unproven Biological Mechanisms: The efficacy of PRP for vaginal sensitivity lacks "tissue-specific evidence," and its growth factor concentrations and injection protocols are not standardized. This "scientific overreach" contrasts with established therapies that have documented effects.Inadequate Structural Correction: Marketing materials state Vagilangelo® provides "less tightening than traditional vaginoplasty," making it unsuitable for significant prolapse or laxity, positioning it as a "solution" for problems it cannot adequately address.Unquantified Risks: Unlike traditional surgeries with documented complication rates (e.g., vaginoplasty stenosis rates: 5–15% at 5 years), Vagilangelo® lacks published data on intraoperative risks, long-term safety, or pain management. The use of internal sutures poses theoretical risks of "urethral/bladder injury" and "nerve damage."2. The Exploitative Ecosystem: Medical Tourism and Predatory TrainingThe sources heavily criticize the "exploitative cosmetic surgery tourism" and "unethically trained practitioners" associated with procedures like Vagilangelo®, particularly targeting vulnerable women in low-resource settings like Bahrain.Medical Tourism's Hidden Costs: Bahrain's experience shows that its tertiary centers absorb significant costs (175,000 USD annually) treating complications from cosmetic tourism, mostly infections and implant failures. "All-inclusive packages" typically exclude meaningful postoperative care, leading to "patient abandonment" and an "economic drain" on local healthcare systems.Unethical Training Paradigms: The rise of "short-course 'fellowships'" (e.g., 3-5 day "certification" programs in Arab countries) enables this crisis. These programs lack "standardized curricula" and bypass the 1-2 years of supervised training required for legitimate surgical fellowships. They are accused of "targeting vulnerable populations" and allowing "underqualified surgeons operating on poor women," which is deemed "ethical malpractice."Commercialization of Insecurity: Vagilangelo® marketing is seen as violating core bioethical principles by prioritizing profit over documented clinical benefit. Patients cannot provide meaningful consent due to a lack of outcome data, and the high cash-pay cost ($3,000+) excludes low-income women who might need functional repair.3. Ethical Violations and Health DisparitiesThe commercialization of procedures without robust evidence is seen as contributing to global health inequity and ethical failures.Autonomy Violation: Patients cannot provide meaningful consent without comprehensive, evidence-based information on risks and benefits.Justice Failure: The high cost excludes low-income women who might benefit more from affordable, evidence-based functional repairs.Beneficence Abandonment: The emphasis on profit over documented clinical benefit is a betrayal of the medical principle of beneficence.Regressive Healthcare Subsidy: Public hospitals bear the burden of complications from offshore cosmetic procedures, effectively subsidizing a profit-driven industry.4. Policy Recommendations: Toward Ethical PracticeThe sources propose a multi-faceted approach to address these issues, emphasizing regulatory harmonization, patient safety integration, and ethical commercialization.Evidence and Regulation Reform: This includes an "immediate moratorium on Vagilangelo® marketing pending RCTs," standardization of outcome measures by professional bodies (e.g., ACOG/FIGO), and "FDA-equivalent oversight of PRP preparation protocols."Training and Equity Measures: Recommendations include a "global ban on <3-month cosmetic surgery 'fellowships'," mandatory ...
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    14 min
  • Vagilangelo, Innovation or Exploitation in Women’s Health?

    Vagilangelo, Innovation or Exploitation in Women’s Health?
    Jul 11 2025
    Authored by Reza Lankarani MD Section 1: IntroductionCosmetic gynecology is a rapidly growing field, fueled by technological advances and increasing societal interest in aesthetic and functional modifications of female genital anatomy. Among these innovations, Vagilangelo® is heavily marketed as a revolutionary, minimally invasive vaginal rejuvenation technique promising to restore the "natural vaginal angle" disrupted by childbirth or aging, with purported benefits in sexual satisfaction and sensitivity.However, beneath its glossy promotional veneer lies a complex web of scientific uncertainties, ethical dilemmas, and health equity challenges. Today, we will dissect these layers with academic rigor and clinical insight to provide you, our listeners, with a nuanced understanding of Vagilangelo®’s place in modern gynecological practice.Section 2: Critical Scientific Weaknesses and Evidence GapsThe most significant issue surrounding Vagilangelo® is the stark absence of rigorous clinical evidence. Unlike well-established vaginal rejuvenation procedures documented in peer-reviewed journals such as The Journal of Sexual Medicine or the American Journal of Obstetrics and Gynecology, Vagilangelo® relies almost exclusively on manufacturer websites and patient testimonials for its claims. There are no Level I to III studies—meaning no randomized controlled trials, cohort studies, or even case series—to definitively prove its efficacy or safety.As Dr. Reza Lankarani, a respected clinical researcher, has emphasized, this lack of high-quality evidence is a glaring flaw that undermines the procedure’s credibility. In contrast, other less invasive modalities such as laser or radiofrequency (RF) therapies for vaginal rejuvenation have at least preliminary clinical data supporting their use.Furthermore, the biological rationale for the use of PRP injections in Vagilangelo® is problematic. Platelet-Rich Plasma has demonstrated efficacy in some medical fields, such as orthopedics, but its role in vaginal tissue regeneration and sensitivity enhancement remains unproven. Scientific literature, including recent studies published in journals like Cells in 2023, highlights the variability in PRP composition, the lack of standardized injection protocols, and conflicting results regarding its benefits for vaginal lubrication or sensitivity.Beyond these biological uncertainties, Vagilangelo® does not adequately address key structural issues. The procedure explicitly avoids correction of pelvic floor musculature or significant ligamentous laxity, which are often involved in pelvic organ prolapse or functional disorders. Marketing materials themselves acknowledge that Vagilangelo® offers less tightening than traditional vaginoplasty—rendering it unsuitable for patients with moderate to severe pelvic floor dysfunction.Finally, the risks associated with Vagilangelo® are frequently downplayed. Although marketed as “non-invasive,” internal suturing near delicate pelvic nerves and organs carries inherent risks such as suture erosion, chronic pain (dyspareunia), and urinary symptoms (dysuria). PRP injections may also cause complications like infection, scarring, or paradoxical pain. Post-procedural care often requires sexual abstinence for several weeks, mirroring surgical aftercare, yet standardized protocols for managing complications are lacking.---Section 3: Comparative Limitations Against Established AlternativesIn the landscape of vaginal rejuvenation, Vagilangelo® occupies an ambiguous niche. It is less invasive than traditional surgical options like vaginoplasty but more invasive than energy-based modalities such as laser or radiofrequency therapies.Energy-based devices have the advantage of inducing collagen remodeling with documented histological evidence and relatively low risk profiles, without the need for suturing. Vaginoplasty, on the other hand, is the gold standard for correcting severe anatomical defects, with decades of outcome and safety data.Vagilangelo® lacks the evidence base, functional scope, and risk-mitigation protocols of these traditional methods. It is neither a substitute for surgery nor a clearly superior alternative to energy-based treatments. This “middle ground” status complicates clinical decision-making and patient counseling.---Section 4: Ethical Concerns and Commercial ExploitationTurning to the ethical dimension, Vagilangelo® raises serious concerns about the commercialization of women’s health insecurities. The procedure is heavily marketed using terms like “revolutionary” and “groundbreaking,” which can create unrealistic expectations among vulnerable populations—particularly postpartum women who may be distressed by natural anatomical changes after childbirth.This marketing strategy violates ethical standards such as the American Medical Association’s Code of Medical Ethics §8.063, which stresses the importance of providing patients with realistic ...
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    2 min
  • GLP-1 Agonists Versus Bariatric Surgery: A Paradigm Shift?

    GLP-1 Agonists Versus Bariatric Surgery: A Paradigm Shift?
    Jul 8 2025

    GLP-1 Agonists Versus Bariatric Surgery: A Paradigm Shift?

    1.1. Host: Obesity and diabetes management are seeing a seismic shift, Dr. Lankarani, with GLP-1 agonists like semaglutide making headlines. Is metabolic surgery becoming obsolete, or do these drugs complement existing surgical interventions?

    1.2. Guest: It's a critical juncture. While GLP-1 drugs offer noninvasiveness and 15–22% weight loss, bariatric surgery still outperforms in durability—delivering over 25% weight loss and diabetes remission in 80% of patients, as shown in STAMPEDE trial's 10-year data, which all these databases gatheredby by Dr Reza Lankarani, General Surgeon and Surgical Innovation Lead, Curator and Founder of Surgical Pioneering Newsletter and Podcast Series.

    1.3. Host: Yet, for some patients—especially those with BMI 30–35 or unwilling to undergo surgery—GLP-1s seem transformative. Real-world studies like SURMOUNT-4 highlight better adherence and lower complication rates. How should clinicians weigh these benefits against surgical options?

    1.4. Guest: Patient selection is key. Surgery addresses metabolic drivers beyond appetite suppression, but GLP-1s provide a cost-effective, accessible route for those at lower risk. The real challenge lies in balancing short-term drug trial data with proven surgical longevity.

    1.5. Host: So, as these therapies evolve, will we see more combination protocols or a clearer division between surgical and pharmacologic candidates?

    1.6. Guest: Combination strategies may soon emerge, particularly as we integrate longer-term GLP-1 outcomes. Ultimately, multidisciplinary teams must tailor approaches based on comorbidities, prior weight loss attempts, and patient preference.

    #generalsurgerycontroversies #surgicalethicsdebates #medicalmalpracticecases #invasivevsminimallyinvasivesurgery #surgicalinnovationcontroversies #patientsafetyinsurgery #surgicalguidelinesdebate #surgeonaccountabilityissues #healthcarepolicysurgery #surgicaltrainingcontroversies #postoperativecomplicationissues #surgicaltechnologydebates #surgeon-patientcommunication #surgicalriskmanagement #recentsurgicalscandals #surgicalPioneering glp-1 agonists #metabolic surgery #obesity management #weight loss strategies #type 2 diabetes treatment #bariatric procedures #gut hormones #semaglutide #liraglutide #wegovy #satiety regulation #appetite control #diabetes and obesity #future of obesity treatment #surgical vs medical obesity options



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    1 min
  • "Top 5 Controversies in General Surgery for 2024–2025"

    "Top 5 Controversies in General Surgery for 2024–2025"
    Jul 7 2025
    Authored by Reza Lankarani, M.D General surgery faces intense debates for 2024–2025, including GLP1 agonists vs. bariatric surgery, bridging anticoagulation in urgent cancer surgery, timing of hip fracture repair in heart failure patients, robotic vs. laparoscopic surgery costs and benefits, and opioid-sparing pain protocols. Key issues revolve around clinical outcomes, evolving technology, cost-effectiveness, patient safety, and ethical challenges in modern surgical care. 1. GLP-1 Agonists Versus Bariatric Surgery: A Paradigm Shift? 1.1. Host: Obesity and diabetes management are seeing a seismic shift, Dr. Lankarani, with GLP-1 agonists like semaglutide making headlines. Is metabolic surgery becoming obsolete, or do these drugs complement existing surgical interventions? 1.2. Guest: It's a critical juncture. While GLP-1 drugs offer noninvasiveness and 15–22% weight loss, bariatric surgery still outperforms in durability—delivering over 25% weight loss and diabetes remission in 80% of patients, as shown in STAMPEDE trial's 10-year data, which all these databases gatheredby by Dr Reza Lankarani, General Surgeon and Surgical Innovation Lead, Curator and Founder of Surgical Pioneering Newsletter and Podcast Series. 1.3. Host: Yet, for some patients—especially those with BMI 30–35 or unwilling to undergo surgery—GLP-1s seem transformative. Real-world studies like SURMOUNT-4 highlight better adherence and lower complication rates. How should clinicians weigh these benefits against surgical options? 1.4. Guest: Patient selection is key. Surgery addresses metabolic drivers beyond appetite suppression, but GLP-1s provide a cost-effective, accessible route for those at lower risk. The real challenge lies in balancing short-term drug trial data with proven surgical longevity. 1.5. Host: So, as these therapies evolve, will we see more combination protocols or a clearer division between surgical and pharmacologic candidates? 1.6. Guest: Combination strategies may soon emerge, particularly as we integrate longer-term GLP-1 outcomes. Ultimately, multidisciplinary teams must tailor approaches based on comorbidities, prior weight loss attempts, and patient preference. 2. Bridging Anticoagulation in Cancer Surgery: Bleeding or Stent Risk? 2.1. Host: Let’s move to urgent cancer surgery in patients with recent coronary stents. The debate over bridging with IV cangrelor versus aspirin alone is intensifying. Where does current evidence stand, and how do we reconcile registry data with randomized trials? 2.2. Guest: Registry data suggest bridging increases bleeding and cost without clear benefit, especially with modern drug-eluting stents lowering thrombosis risk to under 1% after 30 days. The CHAMPION PHOENIX trial did show cangrelor’s rapid reversibility, but at a steep $5,000 per dose. 2.3. Host: Still, in patients with high-risk anatomy, like left main stents, some guidelines support bridging. Is this a case where individualized anatomy and oncology timelines should override blanket protocols? 2.4. Guest: Precisely. While guidelines now favor aspirin-only post 1 month, nuanced decisions must consider stent location, cancer urgency, and patient-specific risks. Value-based care demands we weigh bleeding complications against rare but catastrophic stent thrombosis. 2.5. Host: Do you anticipate consensus shifting as more real-world data accumulates, or will this remain a case-by-case decision? 2.6. Guest: It’s likely to stay individualized, but ongoing registry analyses and RCTs will refine protocols—perhaps with newer reversal agents or tailored risk calculators. 3. Timing Hip Fracture Surgery in Acute Heart Failure Patients 3.1. Host: Hip fractures in frail patients with acute heart failure present a classic timing dilemma. Should we delay surgery for diuresis and stabilization, or proceed immediately to minimize complications like delirium and pneumonia? 3.2. Guest: It's a clinical tightrope. Delay advocates cite quadrupled mortality in unoptimized heart failure, aligning with ACS-TQIP guidelines recommending up to 48 hours for stabilization, especially if oxygen needs and fluid overload are significant. 3.3. Host: Yet, the HIP ATTACK trial supports expedited surgery, showing lower mortality and fewer adverse events with delays under 24 hours. How do teams decide, especially when physiologic status is borderline? 3.4. Guest: Fluid balance thresholds and real-time monitoring are critical. Multidisciplinary protocols, involving cardiology and anesthesia, help stratify who benefits from delay versus urgent operation. Mortality heatmaps increasingly guide these nuanced calls. 3.5. Host: Could AI-driven risk calculators or remote monitoring soon tip the scales by predicting which patients will truly benefit from delay? 3.6. Guest: Absolutely. As decision-support tools mature, they’ll help personalize timing, integrating more granular physiologic data than blanket ...
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    9 min
  • "Effects of the lavage through fistula in treatment of spontaneous esophageal rupture by combined thoracoscopic and gastroscopic management"

    "Effects of the lavage through fistula in treatment of spontaneous esophageal rupture by combined thoracoscopic and gastroscopic management"
    Jul 6 2025

    "Effects of the lavage through fistula in treatment of spontaneous esophageal rupture by combined thoracoscop and gastroscop "

    Reviewed by Reza Lankarani M.D

    --------------------------------

    World Journal of Emergency Surgery

    Published: 07 June 2025

    https://doi.org/10.1186/s13017-025-00630-6

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    This retrospective study (2014-2024, n = 24) evaluates a novel lavage-drainage technique for spontaneous esophageal rupture (SER/Boehhaave's syndrome).

    Patients undergoing VATS debridement/drainage were divided into:

    1. Lavage-Drainage Group (n = 11): Gastroscopically guided placement of a nasogastric tube through the esophageal fistula for continuous irrigation (iodinated saline) + standard thoracic/mediastinal drainage.

    2. Drainage Group (n = 13): Standard VATS debridement/drainage alone.

    No Difference: Operative time, ICU/hospital stay, mechanical ventilation duration.

    The authors conclude that fistula lavage enhances drainage efficiency, reduces inflammation, and improves SER prognosis but requires cost optimization.

    --------------------------------

    Comparison to Recent Literature:

    VATS as Standard: Confirms VATS as the preferred minimally invasive approach for stable SER patients, aligning with consensus (Elliott et al., Surg Endosc 2019; Haverman et al., Surg Endosc 2011).

    Beyond Basic VATS Drainage: Addresses limitations of simple VATS drainage (tube blockage, inadequate clearance) highlighted by Yu et al. (J Int Med Res 2018). The lavage technique offers a solution similar in spirit to "two-tube" methods but with direct fistula access.

    Lavage Concept Supported: Hanajima et al. (J Thorac Dis 2021) also reported success with VATS-guided lavage/drainage (lower mortality, shorter hospital stay in historical controls), providing external validation for the lavage concept, though without the gastroscopic fistula cannulation.

    --------------------------------

    Conclusion & Significance:

    Huang et al. present a promising technical advancement in managing SER. The combined thoracoscopic-gastroscopic lavage-drainage technique demonstrates potential for reducing mortality and severe complications compared to standard VATS drainage alone, particularly in delayed presentations. Its strength lies in directly addressing a key failure mode of traditional drainage (tube blockage) through enhanced debridement and controlled fistula management.

    However, the small, retrospective, single-center nature of the study is a major limitation. The observed benefits, while clinically compelling, require confirmation in larger, prospective, multi-center studies with longer follow-up and detailed cost-effectiveness analyses. This technique represents a valuable addition to the "damage control" armamentarium for SER but should be considered within the context of available expertise and resources due to its complexity and higher initial cost.

    --------------------------------

    Reza Lankarani M.D



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    2 min
  • "Standardizing the Definition of Each Colon Cancer Segment: Delphi Consensus"

    "Standardizing the Definition of Each Colon Cancer Segment: Delphi Consensus"
    Jul 5 2025

    Reviewed by Reza Lankarani M.D

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    Diseases of the Colon & Rectum

    DOI: 10.1097/DCR.0000000000003739

    Published online:June 2025

    ------------------------------------------------------------

    This international Delphi consensus study addresses a critical gap in colorectal oncology: the lack of standardized anatomical definitions for colon cancer segments. Its primary strength lies in its rigorous methodology and global representation. The three-round Delphi process engaged 295 colorectal surgery experts from 28 countries across four continents, ensuring diverse perspectives and high retention rates (91% completed round 2; 89% all three rounds). The structured approach—using a 9-point Likert scale, predefined consensus thresholds (≥70% for strong agreement), iterative refinement, and a final consensus conference—enhances the validity and reliability of the findings. The resulting definitions leverage clinically accessible landmarks (e.g., ileocecal valve for cecum, disappearance of teniae for sigmoid colon) and introduce a practical "10-cm rule" for flexure boundaries, balancing anatomical precision with surgical applicability. Crucially, the study clarifies responsibility: surgeons should define tumor location intraoperatively (98% consensus), challenging current ICD coding priorities.

    However, the study also reveals persistent challenges requiring further resolution. While strong consensus (>90%) was achieved for 7/8 colon segments (cecum to sigmoid), significant geographical discordance emerged regarding the rectosigmoid concept. Experts from the Americas/Europe overwhelmingly supported abolishing the term (75-76% consensus), favoring classification as upper rectal cancer, whereas Asian experts favored retaining it (63% consensus), reflecting entrenched regional guidelines (e.g., Japanese classifications). Additionally, defining overlapping segment tumors achieved only moderate consensus (64%), with the "center of the lesion" approach lacking universal endorsement. These discrepancies highlight the influence of regional practices and underscore that anatomical definitions alone may not resolve all clinical dilemmas, particularly where embryological boundaries (e.g., hindgut vs. midgut) influence treatment paradigms. Future validation correlating these definitions with oncologic outcomes is essential.

    Over۷all, this study provides a much-needed, methodologically robust foundation for standardizing colon segment definitions globally, enhancing registry data comparability and research validity. Its key limitation is unresolved regional divergence on the rectosigmoid junction and overlapping lesions, indicating areas for targeted interdisciplinary research integrating anatomical, molecular, and outcome data.

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    Reza Lankarani M.D

    #colonanatomy #coloncancersegments #colorectalanatomy #ascendingcolon #descendingcolon #transversecolon #sigmoidcolon #taeniacoli #cecum #largeintestineanatomy #colonsegmentdefinitions #colorectalcancerstaging #intestinalsegmentpathology #colonsegmenteducation #gastrointestinalanatomy



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    2 min
  • "Homocysteine a novel biomarker for predicting irreversible transmural intestinal necrosis in patients with adhesive small bowel obstruction"

    "Homocysteine a novel biomarker for predicting irreversible transmural intestinal necrosis in patients with adhesive small bowel obstruction"
    Jul 3 2025

    Reviewed by Reza Lankarani M.D

    ------------------------------------------------------------

    Published: 24 June 2025

    https://doi.org/10.1186/s13017-025-00632-4

    World Journal of Emergency Surgery

    ------------------------------------------------------------

    This prospective observational study by Zhu et al. (2025) investigates serum homocysteine (HCY) as a predictor of irreversible transmural intestinal necrosis (ITIN) in patients with adhesive small bowel obstruction (ASBO). The study demonstrates that elevated HCY levels are strongly associated with ITIN, outperforming established biomarkers and radiological signs in diagnostic accuracy.

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    Below is a critical assessment of its key strengths:

    1. Methodologically Sound & Clinically Focused: The study excels in addressing the critical need for timely bowel necrosis detection in ASBO. Its prospective design, adherence to clinical guidelines (Bologna), clear outcome definition (pathology/surgery-confirmed ITIN), rigorous patient selection (n=221), and appropriate statistical analyses (multivariable regression, ROC curves) ensure robust and reliable findings.

    2. Superior Biomarker Performance & Practical Utility: HCY demonstrates exceptional diagnostic power for ITIN, significantly outperforming standard biomarkers (endotoxin, Hs-CRP, PCT) and clinical signs (like peritonitis, especially in the elderly):

    ●High Accuracy: Outstanding AUC (0.9253), sensitivity (89.71%), and specificity (83.08%).

    ■Clinical Advantages: Test is rapid (<3h), inexpensive (ELISA), avoids radiation, and has a high PPV (91.18%). The established cutoff (15.53 µmol/L) aligns with known hyperhomocysteinemia thresholds.

    ●High-Value Application: Particularly effective in elderly patients (≥65 yrs) where classic signs like peritonitis are often absent (only 29.41%).

    ■Potential to Improve Care: Monitoring HCY could prevent unnecessary surgeries (reducing complications) and dangerous delays in operating on necrotic bowel, potentially lowering mortality. Extremely high HCY (>35.5 µmol/L) correlated with 30-day mortality in elderly surgical patients, adding prognostic value.

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    In conclusion, this study provides compelling and methodologically robust evidence that serum HCY is a highly sensitive, specific, rapid, and cost-effective biomarker for predicting ITIN in ASBO. Its superior performance compared to current standards (including CT and other biomarkers) and its particular utility in high-risk elderly populations represent a significant potential advance in the management of this common surgical emergency.

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    Reza Lankarani MD

    #homocysteine #intestinalnecrosis #biomarker #transmuralnecrosis #guthealth #intestinalischemia #inflammationmarkers #intestinaldisease #earlydiagnosis #medicalbiomarkers #digestivehealth #clinicalresearch #vascularhealth #intestinaldamage #necrosisprediction



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    2 min
  • “Prospective Sensory Outcomes for Targeted Nipple-areolaComplex Reinnervation in Gender-affirming Double IncisionMastectomy With Free Nipple Grafting’

    “Prospective Sensory Outcomes for Targeted Nipple-areolaComplex Reinnervation in Gender-affirming Double IncisionMastectomy With Free Nipple Grafting’
    Jun 29 2025
    Reviewed by Reza Lankarani M.DVolume 282, Number 1, July 2025DOI: 10.1097/SLA.0000000000006192Annals of SurgerySummary:This prospective cohort study by Remy et al. (2025) presents a significant contribution to gender-affirming surgery by rigorously evaluating the novel technique of Targeted Nipple-Areola Complex Reinnervation (TNR) during double-incision mastectomy with free nipple grafting (FNG). The primary strength lies in its comprehensive, prospective design, meticulously tracking sensory outcomes (quantitative monofilament testing and patient-reported questionnaires) in 25 patients (50 mastectomies) at multiple time points up to 12 months postoperatively. This longitudinal approach robustly demonstrates that TNR facilitates restoration of NAC and chest sensation to baseline within 3 months, with significant *improvement* over baseline observed at 12 months – a finding with profound implications for patient quality of life. Furthermore, the study provides crucial, previously unavailable anatomical data on intercostal nerves (ICNs), confirming comparable axon/fascicle counts across branches (3rd-6th lateral ICNs) and establishing a median of 2 nerves utilized per mastectomy. The analysis linking surgical technique to outcomes is particularly valuable; it conclusively shows that direct coaptation of ≥2 ICN branches to the NAC yields superior and faster sensory recovery compared to using allografts alone or coapting only a single branch.Methods:Twenty-five patients (50 mastectomies) were prospectively enrolled between 2021 and 2022. Data collected included demographics, surgical technique, and axon/fascicle counts from a subset of patients (n=15). Quantitative sensory evaluation was performed using Semmes-Weinstein monofilaments preoperatively and at 1, 3, 6, 9, and 12 months postoperatively. Qualitative patient-reported questionnaires on sensation, pain, and satisfaction were also administered at various postoperative time points. The study evaluated the influence of intraoperative nerve anatomy, axon and fascicle counts, and nerve repair techniques (direct coaptation vs. allograft) on sensory outcomes.Results:A median of 2 ICN branches were found and used per mastectomy.Preoperatively, a higher Body Mass Index (BMI \ge30 g) and mastectomy weight (\ge800 g) were associated with significantly worse sensation.Postoperatively, NAC sensation was initially worse at 1 month but comparable to preoperative values at 3, 6, and 9 months, and significantly better at 12 months. Chest sensation followed a similar trend, becoming significantly better at 12 months.Direct coaptation of the ICN to the NAC resulted in significantly better NAC sensation compared to using allografts only.Utilizing two or more ICN branches for direct coaptation led to superior sensory outcomes compared to a single branch.At 12 months postoperatively, 95.6% of patients had equal or improved NAC monofilament values, and 100% had equal or improved chest skin sensation.Patient-reported outcomes showed good subjective return of sensory functions, with 88% of patients reporting a return of some degree of erogenous sensation at 12 months post-surgery.Nipple hypersensitivity decreased over time, from 42% at 3 months to 8.0% at 12 months. Chronic pain was reported in 32% of patients throughout the study period, decreasing to 10% at 12 months, while phantom pain was absent at 12 months.It demonstrates TNR effectively restored NAC and chest sensation within 3 months postoperatively. The study concluded that using multiple ICN branches and direct coaptation techniques yielded the best sensory outcomes.Key findings include:• Restoration of sensation : 95.6% of patients showed equal or improved NAC sensation at 12 months compared to preoperative baseline, with 88% reporting erogenous sensation recovery.• Technical advantages : Direct coaptation of ≥2 intercostal nerve (ICN) branches yielded superior sensory outcomes compared to allograft-only techniques.• Reduced chronic pain : Only 10% of patients reported chest pain at 12 months, significantly lower than historical rates (27.3%) post-GAM.• Anatomic insights : Axon and fascicle counts across ICN branches were comparable, suggesting flexibility in donor nerve selection, though the 4th and 5th ICNs were most consistently viable.The study underscores TNR’s potential to mitigate common postoperative complications of GAM, including sensory loss, phantom pain, and chronic neuropathic discomfort.Strengths:Innovative Technique Evaluation : This is the first prospective study to quantify sensory recovery following TNR in GAM, addressing a critical gap in gender-affirming surgical outcomes. Prior work focused on oncologic breast reconstruction 17–20, leaving GAM-specific reinnervation understudied.Prospective Design: The prospective nature of the study provides a higher level of evidence compared to retrospective reviews, allowing for systematic data collection and follow-up.Comprehensive ...
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    2 min