Long-term Clinical and Patient-Reported Outcomes After Transversus Abdominis Release With Permanent Synthetic Mesh: A Single Center Analysis of 1203 Patients.

OBJECTIVE: We aimed to report long-term clinical and patient-reported outcomes of transversus abdominis release (TAR) with permanent synthetic mesh performed in a high-volume abdominal wall reconstruction practice. SUMMARY BACKGROUND DATA: Despite increasing utilization of TAR in abdominal wall reconstruction, long-term clinical and patient-reported outcomes remain uncertain. METHODS: Prospectively collected registry data from the Cleveland Clinic Center for Abdominal Core Health were analyzed retrospectively. Patients undergoing elective, open VHR with TAR and permanent synthetic mesh implantation between August 2014 and March 2020 with 30-day clinical and ≥1 year clinical or patient-reported outcome follow-up were included. Outcomes included composite hernia recurrence, characterized by patient-reported bulges and recurrent hernias noted on physical exam or imaging, as well as hernia-specific quality of life and pain. RESULTS: A total of 1203 patients were included. Median age was 60 years [interquartile range (IQR): 52-67], median body mass index was 32 kg/m 2 (IQR: 28-36), median hernia width was 15 cm (IQR: 12-19), and 57% of hernias were recurrent. Fascial reapproximation was achieved in 92%. At a median follow-up of 2 years (IQR: 1-4), the overall composite hernia recurrence rate was 26%, with sensitivity analysis yielding best-case and worst-case estimates of 5% and 28%, respectively. Patients experienced improved hernia-specific quality of life and pain regardless of recurrence outcome; however, those who did not recur experienced more substantial improvement. CONCLUSIONS: TAR with permanent synthetic mesh remains a valuable, versatile technique; however, surgeon and patient expectations should be tempered regarding long-term durability. Despite a high rate of recurrence, patients experience measurable improvements in quality of life.

Mediumweight polypropylene mesh fractures after open retromuscular ventral hernia repair: incidence and associated risk factors.

PURPOSE: Mediumweight (MW) and heavyweight (HW) polypropylene have demonstrated similar clinical and patient-reported outcomes in the setting of open retromuscular ventral hernia repair (VHR). While MW mesh has an anecdotal risk of central mesh fracture, that phenomenon is not well-characterized. We sought to assess the incidence of and risk factors for MW polypropylene mesh fractures after VHR. METHODS: The ACHQC registry was queried for patients with CT-documented hernia recurrence after open retromuscular VHR with MW polypropylene mesh at our institution with 1-year follow-up between January 2014 and April 2022. Images were reviewed by five blinded surgeons at Cleveland Clinic to reach consensus that hernia recurrence mechanism was central mesh fracture. Patients without clinical recurrence or patient-reported bulge were used as a comparator group. RESULTS: Eighty patients were identified with radiographically documented recurrence; 28 had recurrence from mesh fractures and these were compared to 644 patients without recurrence. Incidence of MW fracture was 4.2%. Bridging of anterior fascia was more common in the group with the central mesh fracture (33.3% vs 3.3%, p < 0.001); the incidence of fracture was 30% (9/30) in patients requiring a bridged closure. Mesh fracture was associated with larger hernias (median width: 20 cm [16-26] vs 15 cm [12-18], p < 0.001,), length (25 cm [23-30] vs 23 cm [19-26], p = 0.004). CONCLUSION: MW polypropylene mechanical failures are surprisingly common, particularly in settings of bridged fascial closure and larger hernias. Use of HW polypropylene should be considered in this setting, and industry should be encouraged to create larger pieces of HW polypropylene mesh.

COVID-19 is Observed in Older Children During the Omicron Wave in New York City.

BACKGROUND: The Omicron variant of SARS-CoV-2 has a predilection for the upper airways, causing symptoms such as sore throat, hoarse voice, and stridor. OBJECTIVE: We describe a series of children with COVID-19-associated croup in an urban multicenter hospital system. METHODS: We conducted a cross-sectional study of children ≤18 years of age presenting to the emergency department during the COVID-19 pandemic. Data were extracted from an institutional data repository comprised of all patients who were tested for SARS-CoV-2. We included patients with a croup diagnosis by International Classification of Diseases, 10th revision code and a positive SARS-CoV-2 test within 3 days of presentation. We compared demographics, clinical characteristics, and outcomes for patients presenting during a pre-Omicron period (March 1, 2020-December 1, 2021) to the Omicron wave (December 2, 2021-February 15, 2022). RESULTS: We identified 67 children with croup, 10 (15%) pre-Omicron and 57 (85%) during the Omicron wave. The prevalence of croup among SARS-CoV-2-positive children increased by a factor of 5.8 (95% confidence interval 3.0-11.4) during the Omicron wave compared to prior. More patients were ≥6 years of age in the Omicron wave than prior (19% vs. 0%). The majority were not hospitalized (77%). More patients ≥6 years of age received epinephrine therapy for croup during the Omicron wave (73% vs. 35%). Most patients ≥6 years of age had no croup history (64%) and only 45% were vaccinated against SARS-CoV-2. CONCLUSION: Croup was prevalent during the Omicron wave, atypically affecting patients ≥6 years of age. COVID-19-associated croup should be added to the differential diagnosis of children with stridor, regardless of age. © 2022 Elsevier Inc.

The Efficacy of Liposomal Bupivacaine on Postoperative Pain Following Abdominal Wall Reconstruction: A Randomized, Double-blind, Placebo-controlled Trial.

OBJECTIVE: To study the efficacy of liposomal bupivacaine on postoperative opioid requirement and pain following abdominal wall reconstruction. SUMMARY BACKGROUND DATA: Despite the widespread use of liposomal bupivacaine in transversus abdominis plane block, there is inadequate evidence demonstrating its efficacy in open abdominal wall reconstruction. We hypothesized that liposomal bupivacaine plane block would result in decreased opioid requirements compared with placebo in the first 72 hours after surgery. METHODS: This was a single-center double-blind, placebo-controlled prospective study conducted between July 2018 and November 2019. Adult patients (at least 18 yrs of age) undergoing open, elective, ventral hernia repairs with mesh placed in the retromuscular position were enrolled. Patients were randomized to surgeon-performed transversus abdominis plane block with liposomal bupivacaine, simple bupivacaine, or normal saline (placebo). The main outcome was opioid requirements in the first 72 hours after surgery. Secondary outcomes included total inpatient opioid use, pain scores determined using a 100 mm visual analog scale, length of hospital stay, and patientreported quality of life. RESULTS: Of the 164 patients who were included in the analysis, 57 patients received liposomal bupivacaine, 55 patients received simple bupivacaine, and 52 received placebo. There were no differences in the total opioid used in the first 72 hours after surgery as measured by morphine milligram equivalents when liposomal bupivacaine was compared with simple bupivacaine and placebo (325 ± 225 vs 350 ± 284 vs 310 ± 272, respectively, P = 0.725). Similarly, there were no differences in total inpatient opioid use, pain scores, length of stay, and patient-reported quality of life. CONCLUSIONS: There are no apparent clinical benefits to using liposomal bupivacaine transversus abdominis plane block when compared with simple bupivacaine and placebo for open abdominal wall reconstruction.

Intralesional therapies for vascular malformations of the head and neck.

Vascular malformations of the head and neck represent a spectrum of complex vascular anomalies, requiring a multidisciplinary approach toward diagnosis and treatment. Several intralesional therapeutic agents have been devised and pioneered over the years, some of which are now primary and standard of care for the management of these lesions. In this article, the authors discuss the currently available intralesional therapeutic agents for the management of vascular malformations in the head and neck region.

Clinical and surgical outcomes of splenectomy for autoimmune hemolytic anemia.

INTRODUCTION: We investigated short and long-term remission rates after splenectomy in patients with primary and secondary autoimmune hemolytic anemia (AIHA). METHODS: All adults who underwent splenectomy for primary or secondary AIHA at a single center (2004-2018) were retrospectively reviewed. Short-term response was determined at 30-day postoperatively and long-term at one year. Complete response was defined as hemoglobin > 10 g/dL without hemolysis, transfusions, or need for additional medical therapy for > 6 months. RESULTS: Short-term complete response was attained in 22 of 36 patients (61%), partial response in 3 (8%), no response in 11 (31%). The response rate at 1 year was complete in 14/36 (39%), partial in 14 (39%), and 8 non-response (22%). At last available follow-up (median 33.1 months (IQR 19-59), 16/37 patients had experienced a complete response (43%), 14 partial response (38%), 7 non-response (19%). 80% of partial responders with primary AIHA required maintenance therapy compared to 100% with secondary AIHA. CONCLUSION: Splenectomy is associated with short- and long-term improvement in anemia and hemolysis in the majority of patients with AIHA. Immunosuppressants remain important supplemental therapy.

Registry-Based Trainee Assessments: Leveraging a Quality Collaborative for Surgical Education.

INTRODUCTION: We present our experience developing and embedding a registry-based module for resident feedback. METHODS: At our institution, entering operative data into the institutional quality collaborative registry is standard practice. In February 2019, a surgical education module was embedded into the registry to capture procedure-specific resident operative assessments. Faculty engagement with the sugical education module was assessed during its first year in existence (February 2019-February 2020). RESULTS: In total, 1074 of 1269 (85%) operative assessments were completed by 27 faculty via the surgical education registry module. Median faculty engagement rate with the module following resident-assisted procedures was 91% [IQR 76%-100%]. Residents received a median of 7 operative assessments [IQR 2-19] over the study period. CONCLUSION: By embedding a surgical education module into an existing surgical quality collaborative registry, procedure-specific operative assessments can be routinely captured.

Registry-Based Randomized Controlled Trials: A New Paradigm for Surgical Research.

BACKGROUND: Randomized controlled trials (RCTs) are the gold standard to establish evidence for surgical practice but can be hindered by high costs, complexity, and time requirements. Recently, observational registries have been leveraged as platforms for clinical trials to address these limitations, though few registry-based surgical RCTs have been conducted. Here, we present our group's approach to surgical registry-based RCTs and early results. MATERIALS AND METHODS: To facilitate these trials, we focused on registry integration into surgeons' workflows, routine collection of patient-reported outcomes at clinic visits, and pragmatic trial design featuring broad inclusion criteria and standard of care follow-up. These features maximize generalizability and facilitate follow-up by minimizing visits and tests outside of normal practice. RESULTS: Since 2017, our group has completed enrollment in 4 registry-based RCTs with another 5 trials ongoing. Of these, 4 trials have been multicenter. Over 1000 patients have been enrolled in these studies, with follow-up rates of 90% or greater. Most of these trials are on track to complete enrollment in approximately 2 y from their start date. Beyond salary support, resource utilization is low. None of our trials has been terminated due to lack of resources or futility. CONCLUSIONS: Registry-based RCTs allow for efficient conduct of pragmatic surgical trials. Thoughtful study design, registry integration into surgeons' routines, and a team culture embracing research are paramount. We believe registry-based trials are the future of affordable, high-level, prospective surgical research.

The Diagnostic Utility of Splenectomy in Idiopathic Splenomegaly.

INTRODUCTION: With increasing frequency, patients with idiopathic splenomegaly are referred to surgeons for splenectomy. We evaluated the diagnostic utility of splenectomy and feasibility of a minimally invasive approach in the face of idiopathic splenomegaly. METHODS: We retrospectively reviewed 68 patients who underwent splenectomy for idiopathic splenomegaly. The primary endpoint was the rate of definitive diagnosis based on final surgical pathology of the removed spleen. RESULTS: Preoperative workup included a bone marrow biopsy and peripheral blood smear in 93% and 100% of patients, respectively, with none having lymphadenopathy warranting biopsy. Splenectomy provided a definitive diagnosis for 44 (64.7%) patients. Of these, 34 (50%) patients had an underlying malignancy, of which more than half were splenic marginal zone lymphoma. There were 33 (48.5%) laparoscopic, 23 (33.8%) open, 10 (14.7%) laparoscopic converted to open, and two (2.9%) laparoscopic hand-assist cases. Conversion to open was due to splenic size [median craniocaudal length 21.8 cm (cm)] in eight and staple line bleeding at the splenic hilum in two patients. Overall, the laparoscopic approach was completed in patients with a smaller splenic size compared to open (median craniocaudal length 15.2 vs. 26.0 cm, p < 0.0001). The open group had one (1.5%) intra-operative mortality due to uncontrollable hemorrhage. Thirty-day complication rates were similar for laparoscopic and open approaches (p = 0.10). CONCLUSION: Splenectomy is an effective diagnostic modality in determining a pathologic cause for splenomegaly in this patient population. Laparoscopic splenectomy can be performed safely in appropriate cases with craniocaudal splenic size having the largest influence on surgical approach.

Laparoscopic splenectomy for immune thrombocytopenia (ITP): long-term outcomes of a modern cohort.

BACKGROUND: The advent of newer second-line medical therapies (SLMT) for immune thrombocytopenia (ITP) has contributed to decreased rates of splenectomy, following a trend to avoid or delay surgery. We aimed to characterize the long-term outcomes of laparoscopic splenectomy (LS) for ITP at our institution, examining differences in LS efficiency when performed before or after SLMTs. METHODS: Adults with primary ITP who underwent LS between 2002 and 2016 were identified. Retrospective review of electronic medical records was supplemented with telephone interviews. Treatment response was defined according to current guidelines as complete responders (CR), responders (R), and non-responders (NR). Kaplan-Meier estimates assessed relapse-free rates, and predictors of long-term response were investigated using logistic regression. RESULTS: 109 patients met inclusion criteria, from which 42% were treated with an SLMT before referral to LS. LS was completed in all cases, with no conversions or intraoperative complications. The perioperative morbidity was 7.3%, including 3 deep vein and 2 portal vein thrombosis, one reoperation for bleeding, and no mortalities. Splenectomy was initially effective in 99 patients (CR + R = 90.8%), and 10 patients were NR. At a median 62-month follow-up, 25 patients relapsed, resulting in a 68% CR + R rate. Proportion of CR + R was similar in patients who previously received SLMT and those who did not (61 vs. 76.7%, p = 0.08). CR + R patients were younger (45 vs. 53, p = 0.03), had higher preoperative platelet counts (36 vs. 19, p = 0.01), and experienced a higher increment in platelet counts during hospital stay (117 vs. 38, p < 0.001) as well as 30-days postoperatively (329 vs. 124, p < 0.001). Only a robust response in platelet count at 30-days postoperatively was independently associated with long-term response (OR 1.005, p = 0.006). CONCLUSION: LS was curative in 68% of patients, with no statistically significant difference when performed before or after SLMTs. Outcomes remain challenging to predict preoperatively, with only a robust increase in platelet counts on short term being associated with long-term response.

Development of a Disease-based Hernia Program and the Impact on Cost for a Hospital System.

OBJECTIVE: The aim of this study was to assess the impact of developing a hernia program on mesh utilization. BACKGROUND: With the ongoing changes in healthcare, the value of all interventions will see increased scrutiny. Hernia mesh can be one of the most costly components of hernia repairs. A disease-based institutional hernia program that defines roles for mesh utilization and measures outcomes has the potential to add significant value to hospital systems. METHODS: In August 2014, a disease-based hernia program was initiated across a hospital system. In collaboration with hospital administration, surgical operations, and all surgeons involved in the care of hernia patients, general guidelines for mesh utilization based on CDC wound class were created. All hernia repairs performed between January 2013 and November 2015 were reviewed. RESULTS: Approximately, 13,937 hernias were repaired during the study period. Biologic mesh was used in 0.4% of clean, 7.1% of clean-contaminated, 38.5% of contaminated, and 58.8% of dirty cases. After initiation of the hernia program there was a reduction in biologic mesh utilization across the system (clean: 66% reduction; clean-contaminated: 63% reduction; contaminated: 55% reduction; dirty: 47% reduction). Surgeons who participated in the hernia program used significantly less biologic mesh in clean (P < 0.01), clean-contaminated (P = 0.01) and contaminated (P < 0.01) hernia repairs. CONCLUSIONS: The development of a system-wide hernia program based on collaboration with the hospital administration, operating room purchasing and clinicians resulted in a significant reduction in costly mesh utilization. This collaborative effort from all stakeholders involved in the care of a specific disease process could provide a reproducible model to improve the value equation through cost reduction strategies in today's healthcare environment.

Is It Time to Reconsider Postoperative Epidural Analgesia in Patients Undergoing Elective Ventral Hernia Repair?: An AHSQC Analysis.

OBJECTIVE: We aimed to evaluate the association of epidural analgesia (EA) with hospital length of stay (LOS), wound morbidity, postoperative complications, and patient-reported outcomes in patients undergoing ventral hernia repair (VHR). BACKGROUND: EA has been shown to reduce LOS in certain surgical populations. The LOS benefit in VHR is unclear. METHODS: Patients having VHR performed in the Americas Hernia Society Quality Collaborative (AHSQC) were separated into 2 comparable groups matched on several confounding factors using a propensity score algorithm: one group received postoperative EA, and the other did not. The groups were then evaluated for hospital LOS, 30-day wound morbidity, other complications, and 30-day patient-reported outcomes using pain and hernia-specific quality-of-life instruments. RESULTS: A 1:1 match was achieved and the final analysis included 763 patients receiving EA and 763 not receiving EA. The EA group had an increased LOS (5.49 vs 4.90 days; P < 0.05). The rate of wound events was similar between the groups. There was an increased risk of having any postoperative complication associated with having EA (26% vs 21%; P < 0.05). Pain intensity-scaled scores were significantly higher (worse) in the EA group versus the non-EA group (47.6 vs 44.0; P = 0.04). CONCLUSIONS: The LOS benefit of EA noted for other operations may not apply to patients undergoing VHR. Further study is necessary to determine the beneficial role of invasive pain management procedures in this group of patients with an extremely common disease state.

Open retromuscular keyhole compared with Sugarbaker mesh for parastomal hernia repair: Early results of a randomized clinical trial.

BACKGROUND: Open parastomal hernia repair can be performed using retromuscular synthetic mesh in a keyhole or Sugarbaker configuration. Relative morbidity and durability are unknown. Here, we present perioperative outcomes of a randomized controlled trial comparing these techniques, including 30-day patient-reported outcomes, reoperations, and wound complications in ≤90 days. METHODS: This single-center randomized clinical trial compared open parastomal hernia repair with retromuscular medium-weight polypropylene mesh in the keyhole and Sugarbaker configuration for permanent stomas between April 2019 and April 2022. Adult patients with parastomal hernias requiring open repair with sufficient bowel length for either technique were included. Patient-reported outcomes were collected at 30 days; 90-day outcomes included initial hospital length of stay, readmission, wound morbidity, reoperation, and mesh- or stoma-related complications. RESULTS: A total of 150 patients were randomized (75 keyhole and 75 Sugarbaker). There were no differences in length of stay, readmission, reoperation, recurrence, or wound complications. Twenty-four patients (16%) required procedural intervention for wound morbidity. Ten patients (6.7%) required abdominal reoperation in ≤90 days, 7 (4.7%) for wound morbidity, including 3 partial mesh excisions (1 keyhole compared with 2 Sugarbaker; P = 1). Four mesh-related stoma complications requiring reoperations occurred, including stoma necrosis (n = 1), bowel obstruction (n = 1), parastomal recurrence (n = 1), and mucocutaneous separation (n = 1), all in the Sugarbaker arm (P = .12). Patient-reported outcomes were similar between groups at 30 days. CONCLUSION: Open parastomal hernia repair with retromuscular mesh in the keyhole and Sugarbaker configurations had similar perioperative outcomes. Patients will be followed to determine long-term relative durability, which is critical to understanding each approach's risk-benefit ratio.

Incidence of asymptomatic SARS-CoV-2 infection in children undergoing elective otolaryngologic surgery throughout the COVID-19 pandemic.

Objective: Children infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are less clinically affected than adults, with most cases presenting as asymptomatic or mildly symptomatic. However, true rates of asymptomatic SARS-CoV-2 infection in children remain unclear. We sought to examine rates of SARS-CoV-2 in asymptomatic children and the role of children in transmission. Methods: We performed a retrospective review of patients between 6 months and 17 years of age who underwent elective or semi-elective otolaryngologic surgery with physicians affiliated with Weill Cornell Medicine between May 15, 2020 and March 31, 2022. Patients were included if they received molecular assay testing for SARS-CoV-2 without SARS-CoV-2 symptoms within 5 days of scheduled surgery. SARS-CoV-2 infection status, exposure, clinical symptoms, demographic data, and insurance status were recorded. Results: 1047 patients met inclusion criteria. Thirteen positive cases (1.24%) were identified in the study population. Six cases occurred between December 2021 and February 2022 following the classification of the omicron variant as a variant of concern in November 2021. Five of the 13 cases occurred in children under 2 years of age. Seven patients were male, and five were female. Residences spanned all five boroughs of New York City and the surrounding metropolitan area. Conclusion: Throughout the pandemic, children have had a low rate of asymptomatic disease and likely pose a low risk of transmission of SARS-CoV-2 to the general population. Our results suggest that testing of asymptomatic children is a low-yield practice that is unlikely to influence rates of SARS-CoV-2 in the general population. Level of Evidence: 3.

Open Retromuscular Lateral Abdominal Wall Hernia Repair: Algorithmic Approach and Long-Term Outcomes at a Single Center.

BACKGROUND: Lateral abdominal wall hernias are relatively rare and present unique challenges to repair. Our group has developed an algorithm for repair based on several anatomic characteristics identified on preoperative imaging. Herein, we report our algorithm and outcomes of a large series of open retromuscular lateral abdominal wall hernia repairs. STUDY DESIGN: Open retromuscular lateral abdominal wall hernia repairs performed at our institution from August 2014 through April 2021 were identified in the Abdominal Core Health Quality Collaborative. Hernia characteristics, etiology, operative techniques, postoperative outcomes, and long-term patient-reported outcomes were extracted from the Abdominal Core Health Quality Collaborative database, chart review, and telephone follow-up. RESULTS: Of 464 patients who underwent hernia repair, 121 with isolated lateral abdominal wall hernias (L1-4) and mean follow-up of 34 ± 24 months had a clinical recurrence rate of 0.9% (n = 1) and bulge rate of 37% (n = 42). The median Hernia-Related Quality of Life Survey and PROMIS pain intensity scores improved 37 and 9 points, respectively. Another 343 patients with lateral (L1-4) and midline (M1-5) abdominal wall hernias and mean follow-up of 29 ± 21 months had a clinical recurrence rate of 6% (n = 20) and bulge rate of 35% (n = 117). The median Hernia-Related Quality of Life Survey and PROMIS pain intensity scores improved by 43 and 16 points, respectively. CONCLUSION: We present an algorithm for open retromuscular lateral abdominal wall hernia repair with relatively low anatomic recurrence rates and substantial improvement in patient-reported quality of life and pain. Notably, postoperative bulging is commonly reported by patients, likely due to underlying denervation injuries from the original incision.

Transfascial Fixation vs No Fixation for Open Retromuscular Ventral Hernia Repairs: A Randomized Clinical Trial.

Importance: Transfascial (TF) mesh fixation in open retromuscular ventral hernia repair (RVHR) has been advocated to reduce hernia recurrence. However, TF sutures may cause increased pain, and, to date, the purported advantages have never been objectively measured. Objective: To determine whether abandonment of TF mesh fixation would result in a noninferior hernia recurrence rate at 1 year compared with TF mesh fixation in open RVHR. Design, Setting, and Participants: In this prospective, registry-based, double-blinded, noninferiority, parallel-group, randomized clinical trial, a total of 325 patients with a ventral hernia defect width of 20 cm or less with fascial closure were enrolled at a single center from November 29, 2019, to September 24, 2021. Follow-up was completed December 18, 2022. Interventions: Eligible patients were randomized to mesh fixation with percutaneous TF sutures or no mesh fixation with sham incisions. Main Outcome and Measures: The primary outcome was to determine whether no TF suture fixation was noninferior to TF suture fixation for open RVHR with regard to recurrence at 1 year. A 10% noninferior margin was set. The secondary outcomes were postoperative pain and quality of life. Results: A total of 325 adults (185 women [56.9%]; median age, 59 [IQR, 50-67] years) with similar baseline characteristics were randomized; 269 patients (82.8%) were followed up at 1 year. Median hernia width was similar in the TF fixation and no fixation groups (15.0 [IQR, 12.0-17.0] cm for both). Hernia recurrence rates at 1 year were similar between the groups (TF fixation, 12 of 162 [7.4%]; no fixation, 15 of 163 [9.2%]; P = .70). Recurrence-adjusted risk difference was found to be -0.02 (95% CI, -0.07 to 0.04). There were no differences in immediate postoperative pain or quality of life. Conclusions and Relevance: The absence of TF suture fixation was noninferior to TF suture fixation for open RVHR with synthetic mesh. Transfascial fixation for open RVRH can be safely abandoned in this population. Trial Registration: ClinicalTrials.gov Identifier: NCT03938688.

Tympanostomy tubes in the age of quarantine.

OBJECTIVES: After state-mandated COVID-19 quarantine measures were lifted in 2020, pediatric otolaryngologists noticed that many children who were previously scheduled for tympanostomy tube (TT) placement for indications of acute otitis media (AOM) or chronic middle ear effusions (OME) no longer required surgery. This study aims to describe the effect of home-quarantine on pediatric patients with recurrent AOM and OME to increase our understanding of these conditions. METHODS: This was a retrospective review of pediatric patients that were originally scheduled for TT for recurrent AOM and/or OME, but had their procedure cancelled due to COVID-19. The chi-square test was used to compare the proportion of patients who no longer met indications for surgery stratified by original indication. Data was also collected for TT volume in the months before and after the start of the pandemic. RESULTS: Of 59 patients originally scheduled for TT, 31.0% of the 42 patients who returned for follow-up still met indications for a procedure after a period of home-quarantine. Of these, 76.9% had persistent OME, 61.5% had recurrent AOM, and 69.2% had persistent conductive hearing loss. After elective surgery resumed, there was a substantial decrease in the number of TT procedures performed compared to pre-pandemic data. CONCLUSION: After a period of quarantine, many patients previously scheduled for TT experienced resolution of their AOM or OME. Despite a nationwide recovery in outpatient surgical volume across otolaryngology practices, TT volumes remain low one year after the start of the pandemic, suggesting that continued COVID-19 precautionary measures are contributing to this lingering effect.

Effect of Intraoperative Urinary Catheter Use on Postoperative Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial.

Importance: Urinary catheters are commonly placed during laparoscopic inguinal hernia repair as a presumed protection against postoperative urinary retention (PUR), one of the most common complications following this operation. Data from randomized clinical trials evaluating the effect of catheters on PUR are lacking. Objective: To investigate the effect of intraoperative catheters on PUR after laparoscopic inguinal hernia repair. Design, Setting, and Participants: This 2-arm registry-based single-blinded randomized clinical trial was conducted at 6 academic and community hospitals in the US from March 2019 to March 2021 with a 30-day follow-up period following surgery. All patients who presented with inguinal hernias were assessed for eligibility, 534 in total. Inclusion criteria were adult patients undergoing laparoscopic, elective, unilateral, or bilateral inguinal hernia repair. Exclusion criteria were inability to tolerate general anesthesia and failure to understand and sign the written consent form. A total of 43 patients were excluded prior to intervention. Interventions: Patients in the treatment arm had placement of a urinary catheter after induction of general anesthesia and removal at the end of procedure. Those in the control arm had no urinary catheter placement. Main Outcomes and Measures: PUR rate. Results: Of the 491 patients enrolled, 241 were randomized to catheter placement, and 250 were randomized to no catheter placement. The median (IQR) age was 61 (51-68) years, and 465 participants (94.7%) were male. Overall, 44 patients (9.1%) developed PUR. There was no difference in the rate of PUR between the catheter and no-catheter groups (23 patients [9.6%] vs 21 patients [8.5%], respectively; P = .79). There were no intraoperative bladder injuries. In the catheter group, there was 1 incident of postoperative urethral trauma in a patient who presented to the emergency department with PUR leading to a suprapubic catheter placement. Conclusions and Relevance: Intraoperative urinary catheters did not reduce the risk of PUR after laparoscopic inguinal hernia repair. While their use did not appear to be associated with a high rate of iatrogenic complications, there may be a low rate of catastrophic complications. In patients who voided urine preoperatively, catheter placement did not appear to confer any advantage and thus their use may be reconsidered. Trial Registration: ClinicalTrials.gov Identifier: NCT03835351.

First human surgery with a novel single-port robotic system: cholecystectomy using the da Vinci Single-Site platform.

BACKGROUND: Interest in single-incision laparoscopic techniques continues to grow. A learning curve certainly exists, and although the techniques have improved, technical considerations including external clashes, poor visualization of critical structures, and surgeon fatigue remain. Applications of robotics to these newer techniques are evolving. The da Vinci Single-Site robotic surgery platform is a new semi-rigid robotic operative system designed to work with the Intuitive Surgical da Vinci Si operative system. The authors present the first human experience with this new device used to perform single-incision laparoscopic cholecystectomy. This study aimed to present the first human experience performing cholecystectomy with a novel robotic single-port platform. METHODS: After Cleveland Clinic Institutional Review Board approval, patients with symptomatic biliary disease fitting standard criteria for cholecystectomy were enrolled in the study. A total of 13 consecutive single-port, robotic cholecystectomy operations were performed. Patient demographics and operative results were evaluated. RESULTS: All 13 operations were completed successfully with the Single-Site platform. A critical view of safety as determined by the operative surgeon was obtained in all cases. One patient required placement of an additional extra-umbilical trocar for appropriate visualization secondary to gallbladder necrosis, and this incision also was used for eventual drain placement. For two patients, an intraoperative choloangiogram was performed. The mean operative time was 107 ± 54 min, and the mean docking time was 15 ± 9 min. Discharge for 11 patients was within 24 h. No significant complications occurred. CONCLUSION: Cholecystectomy using the da Vinci Single-Site system is feasible. Availability of this new semi-rigid, robotic surgery platform may increase access to the potential advantages of single-site surgery. Additional advantages of single-site surgery may be elucidated with further studies.

A Review of Quantitative Instruments for Understanding Breastfeeding Dynamics.

Breastfeeding, as a unique behavior of the postpartum period and an ideal source of nourishment, is profoundly impacted by the physiology and behavior of both mothers and infants. For more than three-quarters of a century, there has been an ongoing advancement of instruments that permit insight into the complex process of latching during breastfeeding, which includes coordinating sucking, swallowing, and breathing. Despite the available methodologies for understanding latching dynamics, there continues to be a large void in the understanding of infant latching and feeding. The causes for many breastfeeding difficulties remain unclear, and until a clearer understanding of the mechanics involved is achieved, the struggle will continue in the attempts to aid infants and mothers who struggle to breastfeed. In this review, the history of development for the most prominent tools employed to analyze breastfeeding dynamics is presented. Additionally, the importance of the most advanced instruments and systems used to understand latching dynamics is highlighted and how medical practitioners utilize them is reported. Finally, a controversial argument amongst pediatric otolaryngolo gists concerning breastfeeding difficulties is reviewed and the urgent need for quantification of latching dynamics in conjunction with milk removal rate through prospective controlled studies is discussed.