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1.
Ann Surg ; 280(3): 414-423, 2024 Sep 01.
Article in English | MEDLINE | ID: mdl-38860374

ABSTRACT

OBJECTIVE: To examine the renoprotective effects of metabolic surgery in patients with established chronic kidney disease (CKD). BACKGROUND: The impact of metabolic surgery compared with glucagon-like peptide-1 receptor agonists (GLP-1RA) in patients with established CKD has not been fully characterized. METHODS: Patients with obesity (body mass index ≥30 kg/m 2 ), type 2 diabetes, and baseline estimated glomerular filtration rate (eGFR) 20-60 mL/min/1.73 m² who underwent metabolic bariatric surgery at a large US health system (2010-2017) were compared with nonsurgical patients who continuously received GLP-1RA. The primary end point was CKD progression, defined as a decline of eGFR by ≥50% or to <15 mL/min/1.73 m 2 , initiation of dialysis, or kidney transplant. The secondary end point was the incident kidney failure (eGFR <15 mL/min/1.73 m 2 , dialysis, or kidney transplant) or all-cause mortality. RESULTS: 425 patients, including 183 patients in the metabolic surgery group and 242 patients in the GLP-1RA group, with a median follow-up of 5.8 years (IQR, 4.4-7.6), were analyzed. The cumulative incidence of the primary end point at 8 years was 21.7% (95% CI: 12.2-30.6) in the surgical group and 45.1% (95% CI: 27.7 to 58.4) in the nonsurgical group, with an adjusted hazard ratio of 0.40 (95% CI: 0.21 to 0.76), P =0.006. The cumulative incidence of the secondary composite end point at 8 years was 24.0% (95% CI: 14.1 to 33.2) in the surgical group and 43.8% (95% CI: 28.1 to 56.1) in the nonsurgical group, with an adjusted HR of 0.56 (95% CI: 0.31 to 0.99), P =0.048. CONCLUSIONS: Among patients with type 2 diabetes, obesity, and established CKD, metabolic surgery, compared with GLP-1RA, was significantly associated with a 60% lower risk of progression of kidney impairment and a 44% lower risk of kidney failure or death. Metabolic surgery should be considered as a therapeutic option for patients with CKD and obesity.


Subject(s)
Bariatric Surgery , Diabetes Mellitus, Type 2 , Renal Insufficiency, Chronic , Adult , Aged , Female , Humans , Male , Middle Aged , Diabetes Mellitus, Type 2/complications , Disease Progression , Glomerular Filtration Rate , Glucagon-Like Peptide-1 Receptor/agonists , Obesity/complications , Renal Insufficiency, Chronic/complications , Retrospective Studies
2.
Surg Endosc ; 38(3): 1406-1413, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38168731

ABSTRACT

BACKGROUND: Recurrent laryngeal nerve (RLN) injury after thyroidectomy is relatively common. Locating the RLN prior to thyroid dissection is paramount to avoid injury. We developed a fluorescence imaging system that permits nerve autofluorescence. We aimed to determine the sensitivity and specificity of fluorescence imaging at detecting the RLN relative to thyroid and other background tissue and compared it to white light. METHODS: In this prospective study, 65 patients underwent thyroidectomy from January to April 2022 (16 bilateral thyroid resections) using white and fluorescent light. Fluorescence intensity [relative fluorescence units (RFU)] was recorded for RLN, thyroid, and background. RFU mean, minimum, and maximum values were calculated using Image J software. Thirty randomly selected pairs of white and fluorescent light images were independently reviewed by two examiners to compare RLN detection rate, number of branches, and length and minimum width of nerves visualized. Parametric and nonparametric statistical analysis was performed. RESULTS: All 81 RNLs observed were visualized more clearly under fluorescence (mean intensity, µ = 134.3 RFU) than either thyroid (µ = 33.7, p < 0.001) or background (µ = 14.4, p < 0.001). Forest plots revealed no overlap between RLN intensity and that of either other tissue. Sensitivity and specificity for RLN were 100%. All 30 RLNs and all 45 nerve branches were clearly visualized under fluorescence, versus 17 and 22, respectively, with white light (both p < 0.001). Visible nerve length was 2.5 × as great with fluorescence as with white light (µ = 1.90 vs. 0.76 cm, p < 0.001). CONCLUSIONS: In 65 patients and 81 nerves, RLN detection was markedly and consistently enhanced with autofluorescence neuro-imaging during thyroidectomy, with 100% sensitivity and specificity.


Subject(s)
Recurrent Laryngeal Nerve Injuries , Thyroidectomy , Humans , Thyroidectomy/adverse effects , Thyroidectomy/methods , Prospective Studies , Recurrent Laryngeal Nerve/diagnostic imaging , Recurrent Laryngeal Nerve/surgery , Thyroid Gland , Recurrent Laryngeal Nerve Injuries/etiology , Recurrent Laryngeal Nerve Injuries/prevention & control
3.
Surg Endosc ; 2024 Oct 23.
Article in English | MEDLINE | ID: mdl-39443379

ABSTRACT

BACKGROUND: Esophageal cancer remains a significant global health challenge. Several treatment modalities were explored in randomized controlled trials (RCTs) in recent decades. This study evaluates the robustness of RCTs focusing on esophageal cancer treatment using the fragility index (FI) and reverse fragility index (RFI). METHODS: A systematic review of RCTs studying different treatment modalities for esophageal cancer from 2000 to 2023 was conducted. The FI and RFI were utilized to gauge the robustness of statistically significant and non-significant outcomes, respectively. The FI represents the minimal number of patient outcomes that would need to alter to overturn a trial's statistical significance, while RFI indicates the minimal changes required to achieve significance in non-significant results. RESULTS: Out of 4028 studies retrieved, 21 RCTs were included for final analysis. The studies spanned 2001 to 2023 with a mean followup of 66 months (range, 29-108 months) and median number of patients of 194 (range, 45-802). The most common treatment modalities examined in these studies were neoadjuvant chemoradiotherapy (n = 7, 33.3%), neoadjuvant chemotherapy (n = 4, 19.0%), and neoadjuvant immunotherapy (n = 2, 9.5%). Only 5 studies (23.8%) had a statistically significant primary outcome result with a median FI of 6 (IQR, 2.5-8.5). Non-significant primary outcomes were seen in 16 studies (76.2%) with a median RFI of 4 (IQR 1-11) and lost to followup of 0 (IQR 0-4). In the study with the highest FI (10), the FI was lower than the number of patients lost to followup (13). CONCLUSION: Our findings demonstrate that most RCTs on esophageal cancer treatments did not report significant primary outcomes. The few studies that reported significant results had a low fragility index, suggesting a vulnerability in their findings.

4.
Surg Endosc ; 38(10): 6026-6032, 2024 Oct.
Article in English | MEDLINE | ID: mdl-39110219

ABSTRACT

BACKGROUND: Surgical treatments of refractory gastroparesis include pyloromyotomy and gastric electrical stimulator (GES). It is unclear if patients may benefit from a combined approach with concomitant GES and pyloromyotomy. METHODS: Retrospective cohort analysis of all patients with refractory gastroparesis treated with GES implantation with and without concomitant pyloromyotomy at Cleveland Clinic Florida from January 2003 to January 2023. Primary endpoint was efficacy (clinical response duration and success rate) and secondary endpoints included safety (postoperative morbidity) and length of stay. Success rate was defined as the absence of one of the following reinterventions during follow-up: Roux-en-Y gastric bypass (RYGB), pyloromyotomy, GES removal. RESULTS: During a period of 20 years, 134 patients were treated with GES implantation. Three patients with history of previous surgical pyloromyotomy or RYGB were excluded from the analysis. Median follow-up was 31 months (IQR 10, 72). Forty patients (30.5%) had GES with pyloromyotomy, whereas 91 (69.5%) did not have pyloromyotomy. Most of the patients had idiopathic (n = 68, 51.9%) or diabetic (n = 58, 43.3%) gastroparesis. Except for preoperative use of opioids (47.5 vs 14.3%; p < 0.001), patient's characteristics were similar in both groups. There were no significant differences between the two groups in terms of overall postoperative complications (17.5% vs 14.3%; p = 0.610), major postoperative complications (0% vs 2.2%; p = 1), and length of stay (2(IQR 1, 2) vs 2(IQR 1, 3) days; p = 0.068). At 5 years, success rate was higher in patients with than without pyloromyotomy however not statistically significant (82% versus 62%, p = 0.066). Especially patients with diabetic gastroparesis seemed to benefit from pyloromyotomy during GES (100% versus 67%, p = 0.053). In an adjusted Cox regression, GES implantation without pyloromyotomy was associated with a 2.66 times higher risk of treatment failure compared to GES implantation with pyloromyotomy (HR 2.66, 95% CI 1.03-6.94, p = 0.044). CONCLUSION: Pyloromyotomy during GES implantation for gastroparesis seems to be associated with a longer clinical response with similar postoperative morbidity and length of hospital stay than GES without pyloromyotomy. Patient with diabetic gastroparesis might benefit from a combination of GES implantation and pyloromyotomy.


Subject(s)
Electric Stimulation Therapy , Gastroparesis , Pyloromyotomy , Humans , Gastroparesis/surgery , Retrospective Studies , Female , Male , Pyloromyotomy/methods , Electric Stimulation Therapy/methods , Middle Aged , Adult , Treatment Outcome , Combined Modality Therapy , Length of Stay/statistics & numerical data , Postoperative Complications/etiology , Postoperative Complications/epidemiology , Gastric Bypass/methods
5.
Surg Endosc ; 2024 Oct 04.
Article in English | MEDLINE | ID: mdl-39365468

ABSTRACT

INTRODUCTION: Obesity is a major risk factor for idiopathic intracranial hypertension (IIH). Effective therapeutics for preventing disease progression and alleviating symptoms are limited. This study aims to examine the effects of bariatric surgery on clinical outcomes of IIH. METHODS: We retrospectively collected data from the medical record of 97 patients with obesity and an existing diagnosis of IIH who underwent primary bariatric surgery at the Cleveland Clinic health system in the USA between 2005 and 2023. Pre- and postoperative data on presence of symptoms and clinical markers of IIH (headaches, visual field defects, papilledema, visual symptoms), intracranial pressure, and usage of IIH medications were compared. RESULTS: A total of 97 patients (98% female, median age 46.7 years, median BMI 48.3 kg/m2) with IIH who underwent bariatric surgery including Roux-en-Y gastric bypass (n = 66, 68%), sleeve gastrectomy (n = 27, 27.8%), and gastric banding (n = 4, 4.1%) were analyzed. In a median follow-up time of 3.0 years, the median total weight loss was 24% (interquartile range, 13-33%). There was a significant improvement in headache, papilledema, visual field deficits, and visual symptoms after bariatric surgery. The mean lumbar opening pressure before and after bariatric surgery was 34.8 ± 8.2 cm CSF and 24.2 ± 7.6 cm CSF, respectively, with a mean reduction of 10.7 cm CSF (95% confidence interval, 4.7 to 16.6), p = 0.003. The dosage of acetazolamide and topiramate, as well as the number of medications taken for IIH, decreased significantly after bariatric surgery (p < 0.001). CONCLUSION: For patients who have obesity, bariatric surgery is a viable treatment modality for alleviation or improvement of symptoms of IIH.

6.
Colorectal Dis ; 25(4): 717-727, 2023 04.
Article in English | MEDLINE | ID: mdl-36550093

ABSTRACT

AIM: Few data are available regarding the management of anorectal abscess in patients with leukopenia. The aim of this study was to investigate the impact of leukopenia among patients undergoing incision and drainage for anorectal abscess. METHOD: A retrospective review of the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database identified patients from 2015 to 2020. Perianal fistulas and supralevator abscesses were excluded. Patients were grouped based on white blood cell (WBC) count: WBC < 4.5 cells/µl, WBC = 4.5-11.0 cells/µl and WBC > 11.0 cells/µl. The 30-day overall complications and outcomes were compared using regression models, accounting for demographics and comorbidities. RESULTS: Ten thousand two hundred and forty (70.3% male) patients were identified. Univariate analysis showed that, compared with patients with leukocytosis (WBC > 11.0 cells/µl) and normal WBC count (WBC = 4.5-11.0 cells/µl), patients with leukopenia (WBC <4.5 cells/µl) had higher rates of overall (p < 0.001), pulmonary (p < 0.001) and haematological complications (p < 0.001). They also had higher rates of readmission (p < 0.001), reoperation (p = 0.005), discharge to a care facility (p = 0.003), increased length of hospital stay (p = 0.004) and death (p < 0.001). Multivariable analysis identified leukopenia as an independent risk factor for overall complications [odds ratio (OR) 2.31, 95% CI 1.65-3.24; p < 0.001], pulmonary complications (OR 5.65, 95% CI 1.88-16.97; p = 0.002), haematological complications (OR 4.30, 95% CI 2.94-6.28; p < 0.001), unplanned readmission (OR 2.20, 95% CI 1.43-3.40; p < 0.001), reoperation (OR 1.80, 95% CI 1.10-2.93; p = 0.019) and death (OR 2.77, 95% CI 1.02-7.52; p = 0.046). Discharge to a care facility and length of stay were not significant on multivariable analysis. CONCLUSION: Leukopenia is associated with increased risk for pulmonary and haematological complications, readmissions, reoperations, discharge to a care facility and death after incision and drainage for anorectal abscess.


Subject(s)
Anus Diseases , Leukopenia , Humans , Male , Female , Abscess/etiology , Abscess/surgery , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Risk Factors , Anus Diseases/surgery , Retrospective Studies , Leukopenia/epidemiology , Leukopenia/etiology , Patient Readmission , Drainage
7.
Ann Surg ; 275(4): 685-691, 2022 04 01.
Article in English | MEDLINE | ID: mdl-33214476

ABSTRACT

BACKGROUND: In recent decades, the use of near-infrared light and fluorescence-guidance during open and laparoscopic surgery has exponentially expanded across various clinical settings. However, tremendous variability exists in how it is performed. OBJECTIVE: In this first published survey of international experts on fluorescence-guided surgery, we sought to identify areas of consensus and nonconsensus across 4 areas of practice: fundamentals; patient selection/preparation; technical aspects; and effectiveness and safety. METHODS: A Delphi survey was conducted among 19 international experts in fluorescence-guided surgery attending a 1-day consensus meeting in Frankfurt, Germany on September 8th, 2019. Using mobile phones, experts were asked to anonymously vote over 2 rounds of voting, with 70% and 80% set as a priori thresholds for consensus and vote robustness, respectively. RESULTS: Experts from 5 continents reached consensus on 41 of 44 statements, including strong consensus that near-infrared fluorescence-guided surgery is both effective and safe across a broad variety of clinical settings, including the localization of critical anatomical structures like vessels, detection of tumors and sentinel nodes, assessment of tissue perfusion and anastomotic leaks, delineation of segmented organs, and localization of parathyroid glands. Although the minimum and maximum safe effective dose of ICG were felt to be 1 to 2 mg and >10 mg, respectively, there was strong consensus that determining the optimum dose, concentration, route and timing of ICG administration should be an ongoing research focus. CONCLUSIONS: Although fluorescence imaging was almost unanimously perceived to be both effective and safe across a broad range of clinical settings, considerable further research remains necessary to optimize its use.


Subject(s)
Indocyanine Green , Sentinel Lymph Node , Consensus , Delphi Technique , Humans , Optical Imaging/methods
8.
Surg Endosc ; 36(3): 1999-2005, 2022 03.
Article in English | MEDLINE | ID: mdl-33835251

ABSTRACT

BACKGROUND: During surgery, surgeons must accurately localize nerves to avoid injuring them. Recently, we have discovered that nerves fluoresce in near-ultraviolet light (NUV) light. The aims of the current study were to determine the extent to which nerves fluoresce more brightly than background and vascular structures in NUV light, and identify the NUV intensity at which nerves are most distinguishable from other tissues. METHODS: We exposed sciatic nerves within the posterior thigh in five 250-300 gm Wistar rats, then observed them at four different NUV intensity levels: 20%, 35%, 50%, and 100%. Brightness of fluorescence was measured by fluorescence spectroscopy, quantified as a fluorescence score using Image-J software, and statistically compared between nerves, background, and both an artery and vein by unpaired Student's t tests with Bonferroni adjustment to accommodate multiple comparisons. Sensitivity, specificity, and accuracy were calculated for each NUV intensity. RESULTS: At 20, 35, 50, and 100% NUV intensity, fluorescence scores for nerves versus background tissues were 117.4 versus 40.0, 225.8 versus 88.0, 250.6 versus 121.4, and 252.8 versus 169.4, respectively (all p < 0.001). Fluorescence scores plateaued at 50% NUV intensity for nerves, but continued to rise for background. At 35%, 50%, and 100% NUV intensity, a fluorescence score of 200 was 100% sensitive, specific, and accurate identifying nerves. At 100 NUV intensity, artery and vein scores were 61.8 and 60.0, both dramatically lower than for nerves (p < 0.001). CONCLUSIONS: At all NUV intensities ≥ 35%, a fluorescence score of 200 is 100% accurate distinguishing nerves from other anatomical structures in vivo.


Subject(s)
Ultraviolet Rays , Animals , Rats , Rats, Wistar
9.
Surg Endosc ; 36(6): 4079-4089, 2022 06.
Article in English | MEDLINE | ID: mdl-34694489

ABSTRACT

BACKGROUND: Nerve visualization and the identification of other neural tissues during surgery is crucial for numerous reasons, including the prevention of iatrogenic nerve and neural structure injury and facilitation of nerve repair. However, current methods of intra-operative nerve detection are generally expensive, unproven, and/or technically challenging. Recently, we have documented, in both in vivo animal models and ex vivo human tissue, that nerves autofluorescence when viewed in near-ultraviolet light (NUV). In this paper, we describe our use of nerve autofluorescence to facilitate the visualization of nerves and other neural tissues intra-operatively in 17 patients undergoing a range of surgical procedures. METHODS: Employing the same prototype axon imaging system previously documented to markedly enhance nerve visualization in both in vivo animal and ex vivo human models, surgical fields were observed in 17 patients under both white and NUV light during parotid tumor resection (n = 3), thyroid tumor resection (n = 7), and surgery for peripheral nerve and spinal tumors and injury (n = 7). RESULTS: In all 17 patients, the intra-operative use of the imaging system both was feasible and markedly enhanced the localization of all neural tissues throughout their course within the surgical field. All 17 procedures were successful and devoid of any peri-operative complications or post-operative neurological deficits. CONCLUSIONS: Intra-operatively visualizing auto-fluorescent peripheral nerves and other neural tissues under NUV light is feasible in human patients across a range of clinical scenarios and appears to appreciably enhance nerve and other neural tissue visualization. Controlled studies to explore this technology further are needed.


Subject(s)
Thyroidectomy , Ultraviolet Rays , Animals , Humans , Neurosurgical Procedures , Technology , Thyroid Gland/surgery , Thyroidectomy/adverse effects
10.
J Card Surg ; 37(7): 2187-2190, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35451064

ABSTRACT

Extracorporeal membrane oxygenation (ECMO) has been adopted to support patients with acute severe cardiac or pulmonary failure that is potentially reversible and unresponsive to conventional management. Mesenteric ischemia (MI) can present as a life-threatening complication in patients receiving veno-arterial echocardiogram (ECHO) support. Due to the nature and acuity of these conditions, determining adequate perfusion upon surgical intervention is challenging for the operating surgeon, especially in cardiogenic shock (CS) patients on ECMO support persenting low arterial pulsatility. Indocyanine green fluorescent angiography (ICG-FA) has proven to be useful for real-time assessment of vascular perfusion, which may help determine the extent of bowel ischemia in patients receiving ECMO support. The case report here-in presented, breaks the paradigm of performing non-cardiac surgical procedures on ECMO support via a pioneering visual aid technique. LEARNING OBJECTIVE: ICG-FA is a promising visual intraoperatory technique providing real-time feedback for the adequate identification and assessment of target tissue/organs. The high morbidity and mortality rates associated to MI and CS-particularly when concomitantly present-hinders salvage surgical therapy. The use of ECMO provides hemodynamic stability This case report highlights the importance of adequate surgical intervention under extracorporeal life support in the presence of both CS and MI. To the authors' knowledge, this is the first report of application of ICG-FA to evaluate mesenteric perfusion in a patient receiving ECMO support.


Subject(s)
Extracorporeal Membrane Oxygenation , Shock, Cardiogenic , Angiography/adverse effects , Extracorporeal Membrane Oxygenation/methods , Hemodynamics , Humans , Perfusion/adverse effects , Retrospective Studies , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/etiology , Shock, Cardiogenic/surgery
11.
JAMA ; 327(24): 2423-2433, 2022 06 28.
Article in English | MEDLINE | ID: mdl-35657620

ABSTRACT

Importance: Obesity increases the incidence and mortality from some types of cancer, but it remains uncertain whether intentional weight loss can decrease this risk. Objective: To investigate whether bariatric surgery is associated with lower cancer risk and mortality in patients with obesity. Design, Setting, and Participants: In the SPLENDID (Surgical Procedures and Long-term Effectiveness in Neoplastic Disease Incidence and Death) matched cohort study, adult patients with a body mass index of 35 or greater who underwent bariatric surgery at a US health system between 2004 and 2017 were included. Patients who underwent bariatric surgery were matched 1:5 to patients who did not undergo surgery for their obesity, resulting in a total of 30 318 patients. Follow-up ended in February 2021. Exposures: Bariatric surgery (n = 5053), including Roux-en-Y gastric bypass and sleeve gastrectomy, vs nonsurgical care (n = 25 265). Main Outcomes and Measures: Multivariable Cox regression analysis estimated time to incident obesity-associated cancer (a composite of 13 cancer types as the primary end point) and cancer-related mortality. Results: The study included 30 318 patients (median age, 46 years; median body mass index, 45; 77% female; and 73% White) with a median follow-up of 6.1 years (IQR, 3.8-8.9 years). The mean between-group difference in body weight at 10 years was 24.8 kg (95% CI, 24.6-25.1 kg) or a 19.2% (95% CI, 19.1%-19.4%) greater weight loss in the bariatric surgery group. During follow-up, 96 patients in the bariatric surgery group and 780 patients in the nonsurgical control group had an incident obesity-associated cancer (incidence rate of 3.0 events vs 4.6 events, respectively, per 1000 person-years). The cumulative incidence of the primary end point at 10 years was 2.9% (95% CI, 2.2%-3.6%) in the bariatric surgery group and 4.9% (95% CI, 4.5%-5.3%) in the nonsurgical control group (absolute risk difference, 2.0% [95% CI, 1.2%-2.7%]; adjusted hazard ratio, 0.68 [95% CI, 0.53-0.87], P = .002). Cancer-related mortality occurred in 21 patients in the bariatric surgery group and 205 patients in the nonsurgical control group (incidence rate of 0.6 events vs 1.2 events, respectively, per 1000 person-years). The cumulative incidence of cancer-related mortality at 10 years was 0.8% (95% CI, 0.4%-1.2%) in the bariatric surgery group and 1.4% (95% CI, 1.1%-1.6%) in the nonsurgical control group (absolute risk difference, 0.6% [95% CI, 0.1%-1.0%]; adjusted hazard ratio, 0.52 [95% CI, 0.31-0.88], P = .01). Conclusions and Relevance: Among adults with obesity, bariatric surgery compared with no surgery was associated with a significantly lower incidence of obesity-associated cancer and cancer-related mortality.


Subject(s)
Bariatric Surgery , Neoplasms , Obesity , Adult , Bariatric Surgery/methods , Bariatric Surgery/statistics & numerical data , Cohort Studies , Female , Gastrectomy/methods , Gastrectomy/statistics & numerical data , Gastric Bypass/methods , Gastric Bypass/statistics & numerical data , Humans , Male , Middle Aged , Neoplasms/epidemiology , Neoplasms/etiology , Neoplasms/mortality , Obesity/complications , Obesity/epidemiology , Obesity/mortality , Obesity/surgery , Obesity, Morbid/complications , Obesity, Morbid/epidemiology , Obesity, Morbid/mortality , Obesity, Morbid/surgery , Retrospective Studies , Risk , United States/epidemiology , Weight Loss
12.
Ann Surg ; 274(5): 821-828, 2021 11 01.
Article in English | MEDLINE | ID: mdl-34334637

ABSTRACT

OBJECTIVE: To define "best possible" outcomes for secondary bariatric surgery (BS). BACKGROUND: Management of poor response and of long-term complications after BS is complex and under-investigated. Indications and types of reoperations vary widely and postoperative complication rates are higher compared to primary BS. METHODS: Out of 44,884 BS performed in 18 high-volume centers from 4 continents between 06/2013-05/2019, 5,349 (12%) secondary BS cases were identified. Twenty-one outcome benchmarks were established in low-risk patients, defined as the 75th percentile of the median outcome values of centers. Benchmark cases had no previous laparotomy, diabetes, sleep apnea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, thromboembolic events, BMI> 50 kg/m2 or age> 65 years. RESULTS: The benchmark cohort included 3143 cases, mainly females (85%), aged 43.8 ±â€Š10 years, 8.4 ±â€Š5.3 years after primary BS, with a BMI 35.2 ±â€Š7 kg/m2. Main indications were insufficient weight loss (43%) and gastro-esophageal reflux disease/dysphagia (25%). 90-days postoperatively, 14.6% of benchmark patients presented ≥1 complication, mortality was 0.06% (n = 2). Significantly higher morbidity was observed in non-benchmark cases (OR 1.37) and after conversional/reversal or revisional procedures with gastrointestinal suture/stapling (OR 1.84). Benchmark cutoffs for conversional BS were ≤4.5% re-intervention, ≤8.3% re-operation 90-days postoperatively. At 2-years (IQR 1-3) 15.6% of benchmark patients required a reoperation. CONCLUSION: Secondary BS is safe, although postoperative morbidity exceeds the established benchmarks for primary BS. The excess morbidity is due to an increased risk of gastrointestinal leakage and higher need for intensive care. The considerable rate of tertiary BS warrants expertise and future research to optimize the management of non-success after BS.


Subject(s)
Bariatric Surgery/standards , Benchmarking/standards , Elective Surgical Procedures/standards , Laparoscopy/standards , Obesity, Morbid/surgery , Adult , Female , Follow-Up Studies , Humans , Male , Prospective Studies , Reoperation
13.
Surg Endosc ; 35(12): 7104-7111, 2021 12.
Article in English | MEDLINE | ID: mdl-33782757

ABSTRACT

BACKGROUND: Being able to accurately identify sensory and motor nerves is crucial during surgical procedures to prevent nerve injury. We aimed to (1) evaluate the feasibility of performing peripheral human nerve visualization utilizing nerves' own autofluorescence in an ex-vivo model; (2) compare the effect of three different nerve fiber fixation methods on the intensity of fluorescence, indicated as the intensity ratio; and (3) similarly compare three different excitation ranges. METHODS: Samples from various human peripheral nerves were selected postoperatively. Nerve fibers were divided into three groups: Group A nerve fibers were washed with a physiologic solution; Group B nerve fibers were fixated with formaldehyde for 6 h first, and then washed with a physiologic solution; Group C nerve fibers were fixated with formaldehyde for six hours, but not washed afterwards. An Olympus IX83 inverted microscope was used for close-up image evaluation. Nerve fibers were exposed to white-light wavelength spectrums for a specific time frame prior to visualization under three different filters-Filter 1-LF405-B-OMF Semrock; Filter 2-U-MGFP; Filter 3-U-MRFPHQ Olympus, with excitation ranges of 390-440, 460-480, and 535-555, respectively. The fluorescence intensity of all images was subsequently analyzed using Image-J Software, and results compared by analysis of variance (ANOVA). RESULTS: The intensity ratios observed with Filter 1 failed to distinguish the different nerve fiber groups (p = 0.39). Conversely, the intensity ratios seen under Filters 2 and 3 varied significantly between the three nerve-fiber groups (p = 0.021, p = 0.030, respectively). The overall intensity of measurements was greater with Filter 1 than Filter 3 (p < 0.05); however, all nerves were well visualized by all filters. CONCLUSION: The current results on ex vivo peripheral nerve fiber autofluorescence suggest that peripheral nerve fiber autofluorescence intensity does not greatly depend upon the excitation wavelength or fixation methods used in an ex vivo setting. Implications for future nerve-sparing surgery are discussed.


Subject(s)
Nerve Fibers , Peripheral Nerves , Humans , Spectrum Analysis
14.
Surg Endosc ; 35(12): 7042-7048, 2021 12.
Article in English | MEDLINE | ID: mdl-33475844

ABSTRACT

BACKGROUND: Common bile duct injuries (BDI) during laparoscopic cholecystectomy (LC) continue to be the source of morbidity and mortality. The reason for BDI is mostly related to the misidentification of the extrahepatic bile duct structures and the anatomic variability. Near-infrared fluorescent cholangiography (NIFC) has proven to enhance visualization of extrahepatic biliary structures during LCs. The purpose of this study was to describe the most important steps in the performance of NIFC. METHODS: In accordance to the most current surgical practice of LC at our institution, a consensus was achieved on the most relevant steps to be followed when utilizing NIFC. Dose of indocyanine green (ICG), time of administration, and identification of critical structures were previously determined based on prospective and randomized controlled studies performed at CCF. RESULTS: The ten steps identified as critical when performing NIFC during LC are preoperative administration of ICG, exposure of the hepatoduodenal ligament, initial anatomical evaluation, identification of the cystic duct and common bile duct junction, the cystic duct and its junction to the gallbladder, the CHD, the common bile duct, accessory ducts, cystic artery and, time-out and identification of Calot's triangle, and evaluation of the liver bed. CONCLUSIONS: Routine use of NIFC is a useful diagnostic tool to better visualize the extrahepatic biliary structures during LC. The implementation of specific standardized steps might provide the surgeon with a better algorithm to use this technology and consequently reduce the incidence of BDI.


Subject(s)
Cholangiography , Cholecystectomy, Laparoscopic , Cholecystectomy, Laparoscopic/adverse effects , Coloring Agents , Humans , Indocyanine Green , Prospective Studies
15.
Surg Endosc ; 35(7): 3989-3997, 2021 07.
Article in English | MEDLINE | ID: mdl-32661711

ABSTRACT

BACKGROUND: Feeding jejunostomy is an alternative route of enteral nutrition in patients undergoing major gastrointestinal operations when a feeding gastrostomy is not suitable. METHODS: A single institution review of patients who underwent open or laparoscopic jejunostomy tube (JT) placement between 2009 and 2019 was performed. Data collected included demographics, preoperative serum albumin, surgery indication, concomitancy of procedure, size of JT tube and time to its removal. JT complications were analyzed in the early postoperative period (< 30 days) and in a long-term follow-up (> 30 days). The Chi-square test was used to compare rates of complications according to tube size. RESULTS: Seventy-three patients underwent JT placement, and gastroesophageal cancer (n = 48, 65.7%) was the most common indication. The JT was most frequently placed concomitantly (n = 56, 76.7%) to the primary operation and through a laparoscopic approach (n = 66, 90.4%). A total of 14 patients (19.1%) had early complications and 15 had late complications (20.5%). The reasons for early complications were clogged JT (n = 8, 10.9%), JT dislodgement (n = 3, 4.1%), leakage (n = 2, 2.7%), small bowel obstruction adjacent to the site of the jejunostomy tube (n = 2, 2.7%), JT site infection (n = 1, 1.3%), and intraperitoneal JT displacement (n = 1, 1.3%). The reasons for late complications were clogged JT (n = 6, 8.2%), JT dislodgement (n = 6, 8.2%), JT site infection (n = 3, 4.1%), and JT leakage (n = 1, 1.3%). There was no procedure-related mortality in this series. However, 12 patients (16.4%) died due to their baseline disease. The mean time to tube removal was 83.4 ± 93.6 days. The most frequently used JT size was 14 French (n = 39, 53.4%) but in nine patients the tube size was not reported. No statistical significance (p = 0.75) was found when comparing the two most commonly used sizes to rates of complications. CONCLUSION: The rate of JT complications in our study is comparable to other published reports in literature. As an alternative route for nutritional status optimization, the procedure appears to be safe despite the number of complications.


Subject(s)
Jejunostomy , Stomach Neoplasms , Enteral Nutrition/adverse effects , Humans , Intubation, Gastrointestinal , Jejunostomy/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Retrospective Studies
16.
Surg Endosc ; 35(12): 7027-7033, 2021 12.
Article in English | MEDLINE | ID: mdl-33433676

ABSTRACT

INTRODUCTION: Sleeve gastrectomy (SG) is the commonest bariatric procedure worldwide. Yet there is significant variation in practice concerning its various aspects. This paper report results from the first modified Delphi consensus-building exercise on SG. METHODS: We established a committee of 54 globally recognized opinion makers in this field. The committee agreed to vote on several statements concerning SG. An agreement or disagreement amongst ≥ 70.0% experts was construed as a consensus. RESULTS: The committee achieved a consensus of agreement (n = 71) or disagreement (n = 7) for 78 out of 97 proposed statements after two rounds of voting. The committee agreed with 96.3% consensus that the characterization of SG as a purely restrictive procedure was inaccurate and there was 88.7% consensus that SG was not a suitable standalone, primary, surgical weight loss option for patients with Barrett's esophagus (BE) without dysplasia. There was an overwhelming consensus of 92.5% that the sleeve should be fashioned over an orogastric tube of 36-40 Fr and a 90.7% consensus that surgeons should stay at least 1 cm away from the angle of His. Remarkably, the committee agreed with 81.1% consensus that SG patients should undergo a screening endoscopy every 5 years after surgery to screen for BE. CONCLUSION: A multinational team of experts achieved consensus on several aspects of SG. The findings of this exercise should help improve the outcomes of SG, the commonest bariatric procedure worldwide, and guide future research on this topic.


Subject(s)
Gastric Bypass , Obesity, Morbid , Consensus , Delphi Technique , Gastrectomy , Humans , Obesity, Morbid/surgery , Retrospective Studies , Treatment Outcome , Weight Loss
17.
Surg Endosc ; 34(8): 3606-3613, 2020 08.
Article in English | MEDLINE | ID: mdl-31559579

ABSTRACT

BACKGROUND: Osteoarthritis (OA) affects 56,000,000 Americans, 30% with obesity. Their risk of developing OA is 5 times higher. With each extra kilogram above ideal weight, the risk of OA increases to 13%. The study aim is to describe changes in OA treatment after undergoing bariatric surgery (BS). METHODS: After IRB approval, we conducted a retrospective analysis of all severely obese patients and OA that underwent laparoscopic adjustable gastric banding, laparoscopic sleeve gastrectomy (LSG), and laparoscopic Roux-en-Y gastric bypass from 2004 to 2018. Changes of OA severity were assessed based on the requirement of invasive intervention (INI) at 12 and 24 months after BS. INI was defined as the need for surgical drainage; articular injection; and surgical interventions such as meniscectomy, total hip replacement, and total knee replacement. RESULTS: A total of 11.52% (N = 486) had OA diagnosed prior to BS, the most common location being unilateral hip 31.1% (N = 151). A total of 35.2% (N = 159) of patients required pain management (PM) for OA at 12 months. Of these, 90% (N = 144) required only INI and 5.6% (N = 9) required PM only. Baseline and postoperative BMI were associated to need for INI. At 12 months, the 66.7% (N = 301) who did not require INI had a baseline BMI of 44.70 ± 8.22 and total weight loss percent (TWL%) of 14.29 ± 13 (P = 0.05; 95% CI 0.96-1.00). LSG patients were the majority compared to other procedures (44.5%; N = 134). On the other hand, 64.3% (N = 175) did not require INI at 24 months and had a baseline BMI of 17.82±17.4 and TWL% of 2.43 ± 6 (P = 0.003; 95% CI 1.04-1.25). The risk to require INI was reduced by 69.9% at 12 months and 80% at 24 months. Need for pain medications at 12 months was reduced by 96.9%. CONCLUSION: According to this study data, bariatric surgery reduces the need for INI in patients with OA. The effect seems to be related to the amount of weight loss. Additional studies conducted on a larger scale are necessary to validate findings.


Subject(s)
Bariatric Surgery , Obesity, Morbid , Osteoarthritis , Humans , Obesity, Morbid/complications , Obesity, Morbid/epidemiology , Obesity, Morbid/surgery , Osteoarthritis/complications , Osteoarthritis/epidemiology , Osteoarthritis/surgery , Retrospective Studies , Weight Loss/physiology
18.
Surg Endosc ; 34(7): 3197-3203, 2020 07.
Article in English | MEDLINE | ID: mdl-31492989

ABSTRACT

BACKGROUND: Arterial hypertension (HTN) is one of the most important risk factors for the development and progression of chronic kidney disease (CKD). Rapid weight loss after bariatric interventions has a positive impact on blood pressure levels of hypertensive patients. The aim of our study is to assess the prevalence of HTN in patients with CKD after bariatric surgery (BS). METHODS: We retrospectively reviewed severely obese patients who underwent BS from 2010 to 2017. We used guidelines of the American College of Cardiology to define HTN. Only patients meeting ACC criteria and the calculation of estimated glomerular filtration rate (eGFR) using CKD epidemiology collaboration study equation preoperatively and at 12-month follow-up were included in the analysis. RESULTS: From a total of 2900 patients, 29.13% (845) met the required criteria and had variables for the calculation of eGFR recorded preoperatively. 36.92% (312) had preoperative HTN and s classified as CKD stage ≥ 2. We observed a predominantly female population 63.83% (203) with mean age of 54.10 ± 11.58. Patients preoperatively classified in CKD 2, 3a, and 3b exhibited the greatest prevalence reduction of HTN at 12-month follow-up (68.59%, n = 214 vs. 36.59%, n = 114; 16.67%, n = 52 vs. 6.41%, n = 20; 7.69%, n = 24 vs. 1.28%, n = 4; p < 0.0001). A marked improvement in CKD was also observed along with improvement in HTN. The greatest benefit corresponded to patients classified preoperatively in CKD 2, 3a and 3b. A total of n = 70 (62.5%) patients with HTN were classified as CKD 2 preoperatively compared to n = 55 (49.11%) at 12-month follow-up (p = 0.0436). Similarly, n = 22 (19.64%) patients with HTN were classified preoperatively as CKD 3a compared to n = 7 (6.25%) and n = 12 (10.71%) patients as CKD 3b compared to n = 4 (3.57%) during the same time period (p = 0.0028, p = 0.0379, respectively). CONCLUSIONS: Rapid weight loss after BS significantly reduces prevalence of HTN in all stages of CKD at 12-month follow-up. Additionally, there was a positive impact on classification of CKD at 12-month follow-up.


Subject(s)
Bariatric Surgery/adverse effects , Hypertension/epidemiology , Obesity, Morbid/physiopathology , Postoperative Complications/epidemiology , Renal Insufficiency, Chronic/physiopathology , Adult , Aged , Blood Pressure/physiology , Female , Glomerular Filtration Rate/physiology , Humans , Hypertension/etiology , Male , Middle Aged , Obesity, Morbid/complications , Obesity, Morbid/surgery , Postoperative Complications/etiology , Postoperative Period , Prevalence , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/surgery , Retrospective Studies , Risk Factors , Weight Loss/physiology
19.
Surg Endosc ; 34(2): 675-685, 2020 02.
Article in English | MEDLINE | ID: mdl-31062156

ABSTRACT

BACKGROUND: Incisionless fluorescent cholangiography (IFC) has recently been proven feasible, safe, and efficacious as an intraoperative procedure to help identify extrahepatic bile ducts during laparoscopic cholecystectomies (LC). We conducted a pilot survey of 51 surgeons attending an international conference who perform endoscopic cholecystectomies to identify their typical LC practices, and perceptions of IFC. METHODS: An international panel of ten IFC experts, all with > 500 prior IFC procedures and related research publications, convened during the 4th International Congress of Fluorescence-Guided Surgery in Boca Raton, Florida in February 2017. The panel was charged with developing questions about LC practices and experience with IFC, and perceptions regarding its advantages, barriers to use, and indications. These questions then were asked to other congress attendees during one of the didactic sessions using an online polling application. Attendees, who ranged from zero to considerable experience performing IFC, accessed the survey via their portable devices. RESULTS: Of the 51 survey participants, 51% were from North America; 77% identified themselves as general/minimally invasive surgeons, and roughly 60% performed under 50 cholecystectomies/year. Only 12% performed routine intraoperative cholangiography (IOC), while 72.3% routinely performed critical safety reviews. Thirty-five percent estimated that their institution's laparoscopic-to-open surgery conversion rate was > 1% during LC. Roughly 95% of respondents felt that surgeons should have access to a noninvasive method for evaluating extrahepatic biliary structures; 84% felt that the most advantageous characteristic of IFC is the lack of any biliary-tree incision; and 93.3% felt that IFC would have considerable educational value in surgical training programs; and 78% felt that any surgeon who performs LC could benefit. CONCLUSIONS: Surgeons who participated in our survey overwhelmingly recommended the routine use of IFC during laparoscopic cholecystectomy as a complimentary imaging technique. Prospective randomized clinical trials remain necessary to determine whether IFC reduces the incidence of bile duct injuries and other LC complications.


Subject(s)
Bile Duct Diseases/diagnosis , Bile Ducts, Extrahepatic/diagnostic imaging , Cholangiography/methods , Cholecystectomy, Laparoscopic/methods , Perception , Bile Duct Diseases/surgery , Congresses as Topic , Female , Humans , Male , Pilot Projects , Prospective Studies , Surveys and Questionnaires
20.
Ann Surg ; 270(3): 511-518, 2019 09.
Article in English | MEDLINE | ID: mdl-31290766

ABSTRACT

INTRODUCTION: According to the Chronic Kidney Disease Prognosis Consortium (CKD-PC), 1 in 4 patients age ≥ 65 in North America has some form of chronic kidney disease (CKD), while 3 in 100 will progress to kidney failure. The aim of this study was to evaluate whether bariatric surgery alters the progression of CKD to kidney failure in patients who are severely obese. METHODS: We conducted a retrospective review of all patients who underwent bariatric surgery at our institution over the last 16 years. Kidney function and injury were assessed using the average estimated glomerular filtration rate and urinary albumin-to-creatinine ratio (uACR) over 3 months preoperatively and postoperative at 12-month follow-up. The risk of progression from CKD to kidney failure was assessed using the Chronic Kidney Disease Prognosis Consortium (CKD-PC) equation. RESULTS: Out of 2924 patients reviewed over this period of time, 69 (2.4%) had the recorded data necessary to assess kidney injury and the risk of disease progression to kidney failure. Patients within moderate and severe stages of CKD-related albuminuria improved the most at 12-month follow-up (by 48% and 79%; P = 0.0001 and P = 0.025, respectively). This translated to a relative risk reduction for progression to kidney failure in CKD ≥ stage 3 patients of 70% at 2 years and 60% at 5 years (both P = 0.001). CONCLUSIONS: Bariatric surgery seems to improve kidney injury, especially among patients with the most severe stages of CKD. Marked 2- and 5-year risk reduction in the progression from CKD to kidney failure was observed.


Subject(s)
Bariatric Surgery/methods , Kidney Failure, Chronic/prevention & control , Obesity, Morbid/epidemiology , Obesity, Morbid/surgery , Renal Insufficiency, Chronic/epidemiology , Adult , Age Factors , Aged , Bariatric Surgery/statistics & numerical data , Body Mass Index , Comorbidity , Databases, Factual , Disease Progression , Female , Florida , Humans , Kidney Failure, Chronic/epidemiology , Kidney Function Tests , Linear Models , Male , Middle Aged , Obesity, Morbid/diagnosis , Prognosis , Reference Values , Renal Insufficiency, Chronic/diagnosis , Retrospective Studies , Risk Assessment , Sex Factors , Treatment Outcome
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