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1.
Ann Surg ; 2024 Jun 13.
Artículo en Inglés | MEDLINE | ID: mdl-38869440

RESUMEN

OBJECTIVE: To investigate fecal incontinence and defecatory, urinary, and sexual functional outcomes after taTME. SUMMARY BACKGROUND DATA: Proctectomy for rectal cancer may result in alterations in defecatory, urinary, and sexual function that persist beyond 12 months. The recent multicenter Phase II taTME trial demonstrated the safety of taTME in patients with stage I-III tumors. METHODS: Prospectively registered self-reported questionnaires were collected from 100 taTME patients. Fecal continence (FIQL, Wexner), defecatory function (COREFO), urinary function (IPSS), and sexual function (FSFI-female, IIEF-male) were assessed preoperatively (PQ), 3-4 months post-ileostomy closure (FQ1), and 12-18 months post-taTME (FQ2). RESULTS: Among 83 patients who responded at all three time points, FIQL, Wexner, and COREFO significantly worsened post-ileostomy closure. Between FQ1 and FQ2, FIQL lifestyle and coping, Wexner, and COREFO incontinence, social impact, frequency, and need for medication significantly improved, while FIQL depression and embarrassment did not change. IPSS did not change relative to preoperative scores. For females, FSFI declined for desire, orgasm, and satisfaction between PQ and FQ1, and did not improve between FQ1 and FQ2. In males, IIEF declined with no change between FQ1 and FQ2. CONCLUSIONS: Although taTME resulted in initial decline in defecatory function and fecal continence, most functional domains improved by 12 months after ileostomy closure, without returning to preoperative status. Urinary function was preserved while sexual function declined without improvement by 18 months post-taTME. Our results address patient expectations and inform shared decision-making regarding taTME.

2.
Colorectal Dis ; 26(6): 1271-1284, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38750621

RESUMEN

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.


Asunto(s)
Anastomosis Quirúrgica , Fuga Anastomótica , Colon , Neoplasias del Recto , Recto , Humanos , Anastomosis Quirúrgica/instrumentación , Anastomosis Quirúrgica/efectos adversos , Anastomosis Quirúrgica/métodos , Fuga Anastomótica/prevención & control , Estudios Prospectivos , Neoplasias del Recto/cirugía , Recto/cirugía , Colon/cirugía , Femenino , Masculino , Resultado del Tratamiento , Ileostomía/instrumentación , Ileostomía/efectos adversos , Ileostomía/métodos , Persona de Mediana Edad , Calidad de Vida , Adulto , Anciano , Proctectomía/efectos adversos , Proctectomía/métodos , Proctectomía/instrumentación , Complicaciones Posoperatorias/prevención & control
3.
Surg Endosc ; 38(5): 2315-2319, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38575829

RESUMEN

INTRODUCTION: The SAGES Guidelines Committee creates evidence-based clinical practice guidelines. Due to existing health disparities, recommendations made in these guidelines may have different impacts on different populations. The updates to our standard operating procedure described herein will allow us to produce well-designed guidelines that take these disparities into account and potentially reduce health inequities. METHODS: This paper outlines updates to the SAGES Guidelines Committee Standard Operating Procedure in order to incorporate issues of heath equity into our guideline development process with the goal of minimizing downstream health disparities. RESULTS: SAGES has developed an evidence-based, standardized approach to consider issues of health equity throughout the guideline development process to allow physicians to better counsel patients and make research recommendations to better address disparities. CONCLUSION: Societies that promote guidelines within their organization must make an intentional effort to prevent the widening of health disparities as a result of their recommendations. The updates to the Guidelines Committee Standard Operating Procedure will hopefully lead to increased attention to these disparities and provide specific recommendations to reduce them.


Asunto(s)
Equidad en Salud , Humanos , Equidad en Salud/normas , Estados Unidos , Sociedades Médicas , Disparidades en Atención de Salud , Guías de Práctica Clínica como Asunto
4.
Surg Endosc ; 38(6): 2939-2946, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38664294

RESUMEN

BACKGROUND: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has long recognized and championed increasing diversity within the surgical workplace. SAGES initiated the Fundamentals of Leadership Development (FLD) Curriculum to address these needs and to provide surgeon leaders with the necessary tools and skills to promote diversity, equity, and inclusion (DEI) in surgical practice. In 2019, the American College of Surgeons issued a request for anti-racism initiatives which lead to the partnering of the two societies. The primary goal of FLD was to create the first surgeon-focused leadership curriculum dedicated to DEI. The rationale/development of this curriculum and its evaluation/feedback methods are detailed in this White Paper. METHODS: The FLD curriculum was developed by a multidisciplinary task force that included surgeons, education experts, and diversity consultants. The curriculum development followed the Analysis, Design, Development, Implementation and Evaluation (ADDIE) instructional design model and utilized a problem-based learning approach. Competencies were identified, and specific learning objectives and assessments were developed. The implementation of the curriculum was designed to be completed in short intervals (virtual and in-person). Post-course surveys used the Kirkpatrick's model to evaluate the curriculum and provide valuable feedback. RESULTS: The curriculum consisted of interactive online modules, an online discussion forum, and small group interactive sessions focused in three key areas: (1) increasing pipeline of underrepresented individuals in surgical leadership, (2) healthcare equity, and (3) conflict negotiation. By focusing on positive action items and utilizing a problem-solving approach, the curriculum aimed to provide a framework for surgical leaders to make meaningful changes in their institutions and organizations. CONCLUSION: The FLD curriculum is a novel leadership curriculum that provided surgeon leaders with the knowledge and tools to improve diversity in three areas: pipeline improvement, healthcare equity, and conflict negotiation. Future directions include using pilot course feedback to enhance curricular effectiveness and delivery.


Asunto(s)
Diversidad Cultural , Curriculum , Liderazgo , Humanos , Sociedades Médicas/organización & administración , Estados Unidos , Cirujanos/educación , Blanco
5.
Surg Endosc ; 38(5): 2320-2330, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38630178

RESUMEN

BACKGROUND: Large language model (LLM)-linked chatbots may be an efficient source of clinical recommendations for healthcare providers and patients. This study evaluated the performance of LLM-linked chatbots in providing recommendations for the surgical management of gastroesophageal reflux disease (GERD). METHODS: Nine patient cases were created based on key questions addressed by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) guidelines for the surgical treatment of GERD. ChatGPT-3.5, ChatGPT-4, Copilot, Google Bard, and Perplexity AI were queried on November 16th, 2023, for recommendations regarding the surgical management of GERD. Accurate chatbot performance was defined as the number of responses aligning with SAGES guideline recommendations. Outcomes were reported with counts and percentages. RESULTS: Surgeons were given accurate recommendations for the surgical management of GERD in an adult patient for 5/7 (71.4%) KQs by ChatGPT-4, 3/7 (42.9%) KQs by Copilot, 6/7 (85.7%) KQs by Google Bard, and 3/7 (42.9%) KQs by Perplexity according to the SAGES guidelines. Patients were given accurate recommendations for 3/5 (60.0%) KQs by ChatGPT-4, 2/5 (40.0%) KQs by Copilot, 4/5 (80.0%) KQs by Google Bard, and 1/5 (20.0%) KQs by Perplexity, respectively. In a pediatric patient, surgeons were given accurate recommendations for 2/3 (66.7%) KQs by ChatGPT-4, 3/3 (100.0%) KQs by Copilot, 3/3 (100.0%) KQs by Google Bard, and 2/3 (66.7%) KQs by Perplexity. Patients were given appropriate guidance for 2/2 (100.0%) KQs by ChatGPT-4, 2/2 (100.0%) KQs by Copilot, 1/2 (50.0%) KQs by Google Bard, and 1/2 (50.0%) KQs by Perplexity. CONCLUSIONS: Gastrointestinal surgeons, gastroenterologists, and patients should recognize both the promise and pitfalls of LLM's when utilized for advice on surgical management of GERD. Additional training of LLM's using evidence-based health information is needed.


Asunto(s)
Inteligencia Artificial , Reflujo Gastroesofágico , Reflujo Gastroesofágico/cirugía , Humanos , Toma de Decisiones Clínicas , Adulto , Guías de Práctica Clínica como Asunto , Masculino
6.
Surg Endosc ; 38(6): 2947-2963, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38700549

RESUMEN

BACKGROUND: When pregnant patients present with nonobstetric pathology, the physicians caring for them may be uncertain about the optimal management strategy. The aim of this guideline is to develop evidence-based recommendations for pregnant patients presenting with common surgical pathologies including appendicitis, biliary disease, and inflammatory bowel disease (IBD). METHODS: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Guidelines Committee convened a working group to address these issues. The group generated five key questions and completed a systematic review and meta-analysis of the literature. An expert panel then met to form evidence-based recommendations according to the Grading of Recommendations Assessment, Development, and Evaluation approach. Expert opinion was utilized when the available evidence was deemed insufficient. RESULTS: The expert panel agreed on ten recommendations addressing the management of appendicitis, biliary disease, and IBD during pregnancy. CONCLUSIONS: Conditional recommendations were made in favor of appendectomy over nonoperative treatment of appendicitis, laparoscopic appendectomy over open appendectomy, and laparoscopic cholecystectomy over nonoperative treatment of biliary disease and acute cholecystitis specifically. Based on expert opinion, the panel also suggested either operative or nonoperative treatment of biliary diseases other than acute cholecystitis in the third trimester, endoscopic retrograde cholangiopancreatography rather than common bile duct exploration for symptomatic choledocholithiasis, applying the same criteria for emergent surgical intervention in pregnant and non-pregnant IBD patients, utilizing an open rather than minimally invasive approach for pregnant patients requiring emergent surgical treatment of IBD, and managing pregnant patients with active IBD flares in a multidisciplinary fashion at centers with IBD expertise.


Asunto(s)
Apendicectomía , Apendicitis , Enfermedades Inflamatorias del Intestino , Laparoscopía , Complicaciones del Embarazo , Humanos , Embarazo , Femenino , Complicaciones del Embarazo/cirugía , Complicaciones del Embarazo/terapia , Laparoscopía/métodos , Apendicitis/cirugía , Enfermedades Inflamatorias del Intestino/cirugía , Apendicectomía/métodos , Enfermedades de las Vías Biliares/cirugía
7.
Surg Endosc ; 38(7): 3703-3715, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38782828

RESUMEN

AIM: The benefits and short-term outcomes of transanal total mesorectal excision (taTME) for rectal cancer have been demonstrated previously, but questions remain regarding the oncologic outcomes following this challenging procedure. The purpose of this study was to analyze the oncologic outcomes following taTME at high-volume centers in the USA. METHODS: This was a multicenter, retrospective observational study of 8 tertiary care centers. All consecutive taTME cases for primary rectal cancer performed between 2011 and 2020 were included. Clinical, histopathologic, and oncologic data were analyzed. Primary endpoints were rate of local recurrence, distal recurrence, 3-year disease recurrence, and 3-year overall survival. Secondary endpoints included perioperative complications and TME specimen quality. RESULTS: A total of 391 patients were included in the study. The median age was 57 years (IQR: 49, 66), 68% of patients were male, and the median BMI was 27.4 (IQR: 24.1, 31.0). TME specimen was complete or near complete in 94.5% of cases and the rates of positive circumferential radial margin and distal resection margin were 2.0% and 0.3%, respectively. Median follow-up time was 30.7 months as calculated using reverse-KM estimator (CI 28.1-33.8) and there were 9 cases (2.5%) of local recurrence not accounting for competing risk. The 3-year estimated rate of disease recurrence was 19% (CI 15-25%) and the 3-year estimated overall survival was 90% (CI 87-94%). CONCLUSION: This large multicenter study confirms the oncologic safety and perioperative benefits of taTME for rectal cancer when performed by experienced surgeons at experienced referral centers.


Asunto(s)
Recurrencia Local de Neoplasia , Neoplasias del Recto , Cirugía Endoscópica Transanal , Humanos , Neoplasias del Recto/cirugía , Neoplasias del Recto/patología , Masculino , Persona de Mediana Edad , Femenino , Estudios Retrospectivos , Anciano , Estados Unidos/epidemiología , Cirugía Endoscópica Transanal/métodos , Recurrencia Local de Neoplasia/epidemiología , Resultado del Tratamiento , Márgenes de Escisión , Proctectomía/métodos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología
8.
Surg Endosc ; 2024 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-38951239

RESUMEN

BACKGROUND: The healthcare system plays a pivotal role in environmental sustainability, and the operating room (OR) significantly contributes to its overall carbon footprint. In response to this critical challenge, leading medical societies, government bodies, regulatory agencies, and industry stakeholders are taking measures to address healthcare sustainability and its impact on climate change. Healthcare now represents almost 20% of the US national economy and 8.5% of US carbon emissions. Internationally, healthcare represents 5% of global carbon emissions. US Healthcare is an outlier in both per capita cost, and per capita greenhouse gas emission, with almost twice per capita emissions compared to every other country in the world. METHODS: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the European Association for Endoscopic Surgery (EAES) established the Sustainability in Surgical Practice joint task force in 2023. This collaborative effort aims to actively promote education, mitigation, and innovation, steering surgical practices toward a more sustainable future. RESULTS: Several key initiatives have included a survey of members' knowledge and awareness, a scoping review of terminology, metrics, and initiatives, and deep engagement of key stakeholders. DISCUSSION: This position paper serves as a Call to Action, proposing a series of actions to catalyze and accelerate the surgical sustainability leadership needed to respond effectively to climate change, and to lead the societal transformation towards health that our times demand.

9.
Ann Surg ; 278(3): 452-463, 2023 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-37450694

RESUMEN

OBJECTIVES: To report the results of a rigorous quality control (QC) process in the grading of total mesorectal excision (TME) specimens during a multicenter prospective phase 2 trial of transanal TME. BACKGROUND: Grading of TME specimens is based on the macroscopic assessment of the mesorectum and standardized through synoptic pathology reporting. TME grade is a strong predictor of outcomes with incomplete (IC) TME associated with increased rates of local recurrence relative to complete or near complete (NC) TME. Although TME grade serves as an endpoint in most rectal cancer trials, in protocols incorporating centralized review of TME specimens for quality assurance, discordance in grading and the management thereof has not been previously described. METHODS: A phase 2 prospective transanal TME trial was conducted from 2017 to 2022 across 11 North American centers with TME quality as the primary study endpoint. QC measures included (1) training of site pathologists in TME protocols, (2) blinded grading of de-identified TME specimen photographs by central pathologists, and (3) reconciliation of major discordance before trial reporting. Cohen Kappa statistic was used to assess agreement in grading. RESULTS: Overall agreement in grading of 100 TME specimens between site and central reviewer was rated as fair, (κ = 0.35; 95% CI: 0.10-0.61; P < 0.0001). Concordance was noted in 54%, with minor and major discordance in 32% and 14% of cases, respectively. Upon reconciliation, 13/14 (93%) major discordances were resolved. Pre versus postreconciliation rates of complete or NC and IC TME are 77%/16% and 7% versus 69%/21% and 10%. Reconciliation resulted in a major upgrade (IC-NC; N = 1) or major downgrade (NC/C-IC, N = 4) in 5 cases overall (5%). CONCLUSIONS: A 14% rate of major discordance was observed in TME grading between the site and central reviewers. The resolution resulted in a major change in final TME grade in 5% of cases, which suggests that reported rates or TME completeness are likely overestimated in trials. QC through a central review of TME photographs and reconciliation of major discordances is strongly recommended.


Asunto(s)
Laparoscopía , Mesocolon , Proctectomía , Neoplasias del Recto , Humanos , Recto/cirugía , Estudios Prospectivos , Neoplasias del Recto/cirugía , Neoplasias del Recto/patología , Proctectomía/métodos , Mesocolon/cirugía , Resultado del Tratamiento , Laparoscopía/métodos
10.
Colorectal Dis ; 25(7): 1469-1478, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37128185

RESUMEN

AIM: Rates of pouch failure after total proctocolectomy with ileal pouch-anal anastomosis (IPAA) range from 5% to 18%. There is little consistency across studies regarding the factors associated with failure, and most include patients who underwent IPAA in the pre-biologic era. Our aim was to analyse a cohort of patients who underwent IPAA in the biologic era at a large-volume inflammatory bowel disease institution to better determine preoperative, perioperative and postoperative factors associated with pouch failure. METHODS: A retrospective cohort analysis was performed with data from an institutional review board approved prospective database with ulcerative colitis or unclassified inflammatory bowel disease patients who underwent total proctocolectomy with IPAA at Mount Sinai Hospital between 2008 and 2017. Preoperative, perioperative and postoperative data were collected and univariate and multivariate analyses were performed to identify factors associated with increased risk of pouch failure. RESULTS: Out of 664 patients included in the study, pouch failure occurred in 41 (6.2%) patients, a median of 23.3 months after final surgical stage. Of these, 17 (41.4%) underwent pouch excision and 24 (58.5%) had diverting ileostomies. The most common indications for pouch failure were Crohn's disease like pouch inflammation (CDLPI) (n = 17, 41.5%), chronic pouchitis (n = 6, 14.6%), chronic cuffitis (n = 5, 12.2%) and anastomotic stricture (n = 4, 9.8%). On multivariate analysis, pre-colectomy biologic use (hazard ratio [HR] 2.25, 95% CI 1.09-4.67), CDLPI (HR 3.18, 95% CI 1.49-6.76) and pouch revision (HR 2.59, 95% CI 1.26-5.32) were significantly associated with pouch failure. CONCLUSIONS: Pouch failure was significantly associated with CDLPI, preoperative biologic use and pouch revision; however, reassuringly it was not associated with postoperative complications.


Asunto(s)
Productos Biológicos , Colitis Ulcerosa , Reservorios Cólicos , Enfermedad de Crohn , Enfermedades Inflamatorias del Intestino , Reservoritis , Proctocolectomía Restauradora , Humanos , Estudios Retrospectivos , Atención Terciaria de Salud , Reservorios Cólicos/efectos adversos , Enfermedades Inflamatorias del Intestino/cirugía , Enfermedades Inflamatorias del Intestino/etiología , Proctocolectomía Restauradora/efectos adversos , Colitis Ulcerosa/cirugía , Colitis Ulcerosa/complicaciones , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/cirugía , Reservoritis/complicaciones , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Inflamación , Centros de Atención Terciaria
11.
Colorectal Dis ; 25(4): 647-659, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36527323

RESUMEN

AIM: The choice of whether to perform protective ileostomy (PI) after anterior resection (AR) is mainly guided by risk factors (RFs) responsible for the development of anastomotic leakage (AL). However, clear guidelines about PI creation are still lacking in the literature and this is often decided according to the surgeon's preferences, experiences or feelings. This qualitative study aims to investigate, by an open-ended question survey, the individual surgeon's decision-making process regarding PI creation after elective AR. METHOD: Fifty four colorectal surgeons took part in an electronic survey to answer the questions and describe what usually led their decision to perform PI. A content analysis was used to code the answers. To classify answers, five dichotomous categories (In favour/Against PI, Listed/Unlisted RFs, Typical/Atypical, Emotions/Non-emotions, Personal experience/No personal experience) have been developed. RESULTS: Overall, 76% of surgeons were in favour of PI creation and 88% considered listed RFs in the question of whether to perform PI. Atypical answers were reported in 10% of cases. Emotions and personal experience influenced surgeons' decision-making process in 22% and 49% of cases, respectively. The most frequently considered RFs were the distance of the anastomosis from the anal verge (96%), neoadjuvant chemoradiotherapy (88%), a positive intraoperative leak test (65%), blood loss (37%) and immunosuppression therapy (35%). CONCLUSION: The indications to perform PI following rectal cancer surgery lack standardization and evidence-based guidelines are required to inform practice. Until then, expert opinion can be helpful to assist the decision-making process in patients who have undergone AR for adenocarcinoma.


Asunto(s)
Neoplasias del Recto , Recto , Humanos , Recto/cirugía , Recto/patología , Ileostomía/efectos adversos , Neoplasias del Recto/patología , Fuga Anastomótica/etiología , Anastomosis Quirúrgica/efectos adversos , Estudios Retrospectivos
12.
Surg Endosc ; 37(9): 6609-6610, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37430124

RESUMEN

The operating room is a substantial source of pollution, with the major carbon hotspots determined by the use of energy, the procurement, and disposal of consumables and the waste of water. Mitigating the environmental impact of human activities, including surgical practice, to slow down the climate change has now become a priority for the future of the planet. There is a significant challenge ahead to enable surgery to halve carbon emissions by 2030 in accordance with the Race to Zero UN-backed global campaign. Both SAGES and EAES have recently recognized the role they have to play in raising awareness among their members about the need to gradually change our practice to achieve a better balance between technological advancement and respect for the environment. Since any global challenge demands a global response, out two societies decided to create a joint Task Force to address the topic of minimally invasive surgery and climate change. We will develop recommendations and share good practices regarding mitigation of climate risk in the practice of MIS. Strategic collaborations with device manufacturers will also be part of our effort to address this challenge. We wish that this alliance between SAGES and EAES, together representing and serving more than 10,000 members, might help the surgeons to evolve and improve their practice, letting sustainable surgery shape our culture.


Asunto(s)
Carbono , Cambio Climático , Humanos
13.
Surg Endosc ; 37(1): 48-61, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-35920906

RESUMEN

BACKGROUND: To date, the optimal management of patients with inflammatory bowel disease (IBD) and flat low-grade dysplasia (fLGD) of the colon or rectum remains controversial. METHODS: A systematic review was reported in accordance with PRISMA 2020 (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Patients diagnosed with fLGD on surveillance endoscopy were pooled from studies published between 2000 and 2020. Advanced neoplasia was defined by the presence of HGD, CRC or small bowel adenocarcinoma detected on subsequent surveillance endoscopy or from examination of resection specimens. We estimated the pooled annual incidence rate of colorectal cancer (CRC) and advanced neoplasia, and the risk factors associated with neoplastic progression. RESULTS: We identified 24 articles and 738 IBD patients were diagnosed with fLGD on endoscopy. Two hundred thirty-six patients (32%) underwent immediate surgery with surgical specimens demonstrating CRC in 8 patients (pooled prevalence, 8.66%; 95% CI 3.58-19.46) and HGD (high grade dysplasia) in 11 patients (pooled prevalence, 13.97%; 95% CI 5.65-30.65). Five hundred-two patients (68%) underwent endoscopic surveillance with 63 patients with fLGD progressing to advanced neoplasia during endoscopic surveillance (38 HGD, 24 CRC and one patient developing small bowel adenocarcinoma). The mean duration of follow-up after fLGD diagnosis was 71 months (10.9-212). The pooled incidence of CRC and advanced neoplasia was 0.5 (95% CI 0.23-0.77) and 1.71 per 100 patient-year (95% CI 0.88-2.54) respectively. The use of corticosteroids and location of fLGD in the distal colon were significantly associated with neoplastic progression. CONCLUSIONS: This study provides a summary incidence rate of CRC and advanced neoplasia in patients with IBD and fLGD to inform surgeons' and endoscopists' decision-making thus reducing potential ineffective treatments.


Asunto(s)
Adenocarcinoma , Neoplasias Colorrectales , Enfermedades Inflamatorias del Intestino , Humanos , Neoplasias Colorrectales/epidemiología , Neoplasias Colorrectales/etiología , Neoplasias Colorrectales/patología , Colonoscopía/efectos adversos , Enfermedades Inflamatorias del Intestino/complicaciones , Enfermedades Inflamatorias del Intestino/epidemiología , Factores de Riesgo , Adenocarcinoma/etiología , Adenocarcinoma/complicaciones
14.
Surg Endosc ; 37(4): 2517-2527, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36918413

RESUMEN

BACKGROUND: Professional medical associations (PMAs) have an essential role in advancing medical care and health. PMAs promote skills training, clinical standards, and other important educational activities. Most often, PMAs are not-for-profit entities that rely upon funding from industry to help cover the costs of these valuable activities. Equally important, innovation and progress in surgery require physician collaboration with industry throughout the product development process. SAGES has opined that, with appropriate Conflict of Interest (COI) disclosure and management processes, PMA educational activities can be both scientifically and ethically sound. METHODS: SAGES has developed and implemented comprehensive and stringent processes for managing potential COI within the organization, at the annual meeting, and in developing educational offerings. This document reviews the SAGES COI processes and results 2009-2021. RESULTS: Implementation of the SAGES COI disclosure and management processes reduced the reported perceived incidence of bias at the annual meeting from 4.4-6.2% (2008-2010) to 1.2-2.2% (2011-2013). Recent comparison of reported disclosures revealed a rise in number of speakers with financial relationships and an increase in reporting of disclosures in presentations without an associated increase in need for conflict resolution by the COI committee. Despite good overall adherence to COI policies, SAGES was recently cited for non-compliance with ACCME standards related to inclusion of faculty with ownership interest. This experience highlighted the potential for discordance in the interpretation of whether disclosures relate to specific CME content. SAGES COI processes have since been updated to reflect the more stringent 2020 ACCME Standards that exclude speakers and planners with ownership interest from any CME activity. CONCLUSIONS: The SAGES experience with disclosure and mitigation of financial relationships highlights the challenges of validating the accuracy of physician disclosures and establishing the relevance of financial relationships to the content of accredited educational activities. SAGES will continue to streamline its COI disclosure process with specific focus on aligning all financial disclosures among the various reporting platforms.


Asunto(s)
Conflicto de Intereses , Médicos , Humanos , Revelación
15.
Surg Endosc ; 37(6): 4877-4884, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36151393

RESUMEN

BACKGROUND: Financial relationships with industry may bias educational content delivered by physicians. SAGES strives to mitigate potential bias, relying on physician self-reporting. Retrospective review of relationships is possible using the Open Payments Database (OPD), a public record of industry-reported payments to US physicians. We aimed to evaluate the effectiveness of the SAGES disclosure process by comparing faculty disclosures to SAGES, faculty disclosures within presentations, and OPD records among speakers at the 2018-2020 SAGES meetings. METHODS: We reviewed all presentations from the SAGES 2018-2020 Annual Meetings. For each invited presentation, all slide-disclosed relationships were recorded. For US physicians, we queried the OPD and recorded relationships ≥ $500 USD in the calendar year prior to presentation. We compared the slide-disclosed relationships with OPD-reported relationships and with those provided to SAGES during the faculty disclosure process. We surveyed a sample of the 2020 annual meeting speakers to analyze potential reasons for discordance. RESULTS: From 2018 to 2020, there were 1,355 invited presentations, of which 1,234 (91%) were available for review. Disclosure slides were present in 1,098 (89%), increasing from 86% in 2018 to 93% in 2020. The proportion of speakers with OPD-reported relationships ≥ $500 increased from 54% in 2018 to 66% in 2020. The total value of OPD relationships decreased from $5.9 million (2018) to $3.3 million (2020) with a concomitant decrease in the proportion with high discordance from 9% in 2018 to 5% in 2020. Among the 2020 speakers with high discordance, the most common explanations for discordance were being unaware of payment or payment outside the 12-month timeframe (55%). CONCLUSIONS: Discordance between financial disclosures reported to SAGES and OPD highlight the need for improvements in the faculty disclosure process. SAGES will continue to streamline this process by incorporating faculty review of their OPD disclosures to ensure all educational programs remain free of commercial bias.


Asunto(s)
Revelación , Médicos , Humanos , Conflicto de Intereses , Bases de Datos Factuales , Docentes
16.
Surg Endosc ; 37(4): 2528-2537, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36862170

RESUMEN

BACKGROUND: As one of the 8 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Masters Program clinical pathways, the Colorectal Pathway aims to deliver educational content for the general surgeon organized along 3 levels of performance (competency, proficiency and mastery) each represented by an anchoring procedure. In this article, the SAGES Colorectal Task Force presents focused summaries of the top 10 seminal articles selected for laparoscopic left/sigmoid colectomy for uncomplicated disease. METHODS: Using a systematic literature search of Web of Science, the most cited articles on laparoscopic left and sigmoid colectomy were identified, reviewed, and ranked by members of the SAGES Colorectal Task Force. Additional articles not identified in the literature search were included if deemed impactful by expert consensus. The top 10 ranked articles were then summarized, including their findings, strengths and limitations with emphasis on relevance and impact in the field. RESULTS: The top 10 articles selected focus on variations in minimally invasive surgical techniques, video demonstrations, stratified approaches for benign and malignant disease as well as assessments of the learning curve. CONCLUSIONS: The selected top 10 seminal articles for laparoscopic left and sigmoid colectomy in uncomplicated disease are considered by the SAGES colorectal task force to be fundamental to the knowledge base of minimally invasive surgeons as they progress to mastery in these procedures.


Asunto(s)
Neoplasias Colorrectales , Laparoscopía , Cirujanos , Humanos , Colon Sigmoide , Colectomía/métodos
17.
Surg Endosc ; 37(1): 669-682, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36195816

RESUMEN

BACKGROUND: Early ileostomy closure (EIC), ≤ 2 weeks from creation, is a relatively new practice. Multiple studies have demonstrated that this approach is safe, feasible, and cost-effective. Despite the demonstrated benefits, this is neither routine practice, nor has it been studied, in North America. This study aimed to assess patient and surgeon perspectives about EIC. METHODS: A mixed-methods, cross-sectional study of patients and surgeons was performed. Rectal cancer survivors from a single institution who underwent restorative proctectomy with diverting loop ileostomy and subsequent closure within the last 5 years were contacted. North American surgeons with high rectal cancer volumes (> 20 cases/year) were included. Surveys (patients) and semi-structured interviews (surgeons) were conducted. Analysis employed descriptive statistics and thematic analysis, respectively. RESULTS: Forty-eight patients were surveyed (mean age 65.1 ± 11.8 years; 54.2% male). Stoma closure occurred after a median of 7.7 months (IQR 4.8-10.9) and 50.0% (24) found it "difficult" or "very difficult" to live with their stoma. Patients considered improvement in quality of life and quicker return to normal function the most important advantages of EIC, whereas the idea of two operations in two weeks being too taxing on the body was deemed the biggest disadvantage. Most patients (35, 72.9%) would have opted for EIC. Surgeon interviews (15) revealed 4 overarching themes: (1) there are many benefits to EIC; (2) specific patient characteristics would make EIC an appropriate option; (3) many barriers to implementing EIC exist; and (4) many logistical hurdles need to be addressed for successful implementation. Most surgeons (12, 80.0%) would "definitely want to participate" in a North American randomized-controlled trial (RCT) on EIC for rectal cancer patients. CONCLUSIONS: Implementing EIC poses many logistical challenges. Both patients and surgeons are interested in further exploring EIC and believe it warrants a North American RCT to motivate a change in practice.


Asunto(s)
Proctectomía , Neoplasias del Recto , Cirujanos , Masculino , Humanos , Persona de Mediana Edad , Anciano , Femenino , Ileostomía/métodos , Complicaciones Posoperatorias , Neoplasias del Recto/cirugía , Proctectomía/métodos
18.
Surg Endosc ; 37(12): 9483-9508, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37700015

RESUMEN

BACKGROUND: Transanal TME (taTME) combines abdominal and transanal dissection to facilitate sphincter preservation in patients with low rectal tumors. Few phase II/III trials report long-term oncologic and functional results. We report early results from a North American prospective multicenter phase II trial of taTME (NCT03144765). METHODS: 100 patients with stage I-III rectal adenocarcinoma located ≤ 10 cm from the anal verge (AV) were enrolled across 11 centers. Primary and secondary endpoints were TME quality, pathologic outcomes, 30-day and 90-day outcomes, and stoma closure rate. Univariable regression analysis was performed to assess risk factors for incomplete TME and anastomotic complications. RESULTS: Between September 2017 and April 2022, 70 males and 30 females with median age of 58 (IQR 49-62) years and BMI 27.8 (IQR 23.9-31.8) kg/m2 underwent 2-team taTME for tumors located a median 5.8 (IQR 4.5-7.0) cm from the AV. Neoadjuvant radiotherapy was completed in 69%. Intersphincteric resection was performed in 36% and all patients were diverted. Intraoperative complications occurred in 8% including 3 organ injuries, 2 abdominal and 1 transanal conversion. The 30-day and 90-day morbidity rates were 49% (Clavien-Dindo (CD) ≥ 3 in 28.6%) and 56% (CD ≥ 3 in 30.4% including 1 mortality), respectively. Anastomotic complications were reported in 18% including 10% diagnosed within 30 days. Higher anastomotic risk was noted among males (p = 0.05). At a median follow-up of 5 (IQR 3.1-7.4) months, 98% of stomas were closed. TME grade was complete or near complete in 90%, with positive margins in 2 cases (3%). Risk factors for incomplete TME were ASA ≥ 3 (p = 0.01), increased time between NRT and surgery (p = 0.03), and higher operative blood loss (p = 0.003). CONCLUSION: When performed at expert centers, 2-team taTME in patients with low rectal tumors is safe with low conversion rates and high stoma closure rate. Mid-term results will further evaluate oncologic and functional outcomes.


Asunto(s)
Laparoscopía , Proctectomía , Neoplasias del Recto , Cirugía Endoscópica Transanal , Masculino , Femenino , Humanos , Persona de Mediana Edad , Recto/cirugía , Recto/patología , Estudios Prospectivos , Cirugía Endoscópica Transanal/métodos , Neoplasias del Recto/patología , Proctectomía/métodos , Laparoscopía/métodos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/patología , Resultado del Tratamiento
19.
Surg Endosc ; 37(12): 9001-9012, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37903883

RESUMEN

BACKGROUND: Variation exists in practice pertaining to bowel preparation before minimally invasive colorectal surgery. A survey of EAES members prioritized this topic to be addressed by a clinical practice guideline. OBJECTIVE: The aim of the study was to develop evidence-informed clinical practice recommendations on the use of bowel preparation before minimally invasive colorectal surgery, through evidence synthesis and a structured evidence-to-decision framework by an interdisciplinary panel of stakeholders. METHODS: This is a collaborative project of EAES, SAGES, and ESCP. We updated a previous systematic review and performed a network meta-analysis of interventions. We appraised the certainty of the evidence for each comparison, using the GRADE and CINeMA methods. A panel of general and colorectal surgeons, infectious diseases specialists, an anesthetist, and a patient representative discussed the evidence in the context of benefits and harms, the certainty of the evidence, acceptability, feasibility, equity, cost, and use of resources, moderated by a GIN-certified master guideline developer and chair. We developed the recommendations in a consensus meeting, followed by a modified Delphi survey. RESULTS: The panel suggests either oral antibiotics alone prior to minimally invasive right colon resection or mechanical bowel preparation (MBP) plus oral antibiotics; MBP plus oral antibiotics prior to minimally invasive left colon and sigmoid resection, and prior to minimally invasive right colon resection when there is an intention to perform intracorporeal anastomosis; and MBP plus oral antibiotics plus enema prior to minimally invasive rectal surgery (conditional recommendations); and recommends MBP plus oral antibiotics prior to minimally invasive colorectal surgery, when there is an intention to localize the lesion intraoperatively (strong recommendation). The full guideline with user-friendly decision aids is available in https://app.magicapp.org/#/guideline/LwvKej . CONCLUSION: This guideline provides recommendations on bowel preparation prior to minimally invasive colorectal surgery for different procedures, using highest methodological standards, through a structured framework informed by key stakeholders. Guideline registration number PREPARE-2023CN045.


Asunto(s)
Catárticos , Neoplasias Colorrectales , Humanos , Catárticos/uso terapéutico , Cuidados Preoperatorios/métodos , Antibacterianos/uso terapéutico , Colon Sigmoide , Infección de la Herida Quirúrgica
20.
Clin Colon Rectal Surg ; 36(5): 342-346, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-37564340

RESUMEN

The paucity of gender diversity in the biotech and medical/surgical technology fields remains a persistent challenge. Over the course of history, advancements have been made; however, women remain underrepresented in these sectors from the entry level to the leadership and corporate positions. Similarly, there is a notable lack of women-led startup teams obtaining funding from venture capitalists and fewer women-led teams submitting and securing patents. We will discuss current data surrounding the lack of gender diversity in these fields, explore parallels specifically between the lack of women in surgical specialties and science, technology, engineering, and mathematics (STEM) pathways, and how this translates to the lack of women in the surgical and medical technology industry. We will also offer examples of the real-world ramifications of product development by teams not representative of the population. Lastly, we will offer recommendations and action items for companies, STEM educators, individuals, and allies that will continue to aid in improving gender diversity in the industry.

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