Robotic hernia repair: the trainee "Drag" factor-a single-surgeon 9-year experience.

PURPOSE: The use of robotic assisted surgery is increasing but training residents in its use may be associated with increased operative time and cost. The objective of this study is to compare the operative time of robotic incisional/ventral hernia repair (RIVHR) and robotic inguinal hernia repair (RIHR) when performed with and without a resident or fellow trainee. METHODS: A review of prospectively collected data was performed on all patients who underwent RIVHR and RIHR by a single surgeon over a 9-year period (2014-2023). Study variables included presence of trainee (resident or fellow), procedure time, console time, and recurrent hernia. Primary outcomes include procedure time and console time. RESULTS: A total of 402 surgeries were included for analysis. Residents assisted in 190 (47%) of the procedures, while fellows assisted in 97 (24%), and 115 (29%) were performed without a trainee. Median (IQR) console times in RIVHR assisted by fellows was 102 (72-145) minutes, compared to 90 (71-129) minutes among surgeries assisted by residents and 65 (52-82) minutes among surgeries performed without a trainee (p < 0.0001), a similar trend was observed for RIHR. The duration of hernia repair assisted by trainees was significantly longer than surgeries performed without a trainee. CONCLUSION: Operative time for RIVHR and RIHR is significantly lower when performed without a trainee. However, RIHR assisted by residents showed a consistent decrease in operative time over the 9-year period.

Robotic-assisted, laparoscopic, and open incisional hernia repair: early outcomes from the Prospective Hernia Study.

PURPOSE: To provide a comparative analysis of short-term outcomes after open, laparoscopic, and robotic-assisted (RAS) ventral incisional hernia (VIH) repairs that include subject-reported pain medication usage and hernia-related quality of life (QOL). METHODS: Subjects were ≥ 18 years old and underwent elective open, laparoscopic or RAS VIH repair without myofascial release. Perioperative clinical outcomes through 30 days were analyzed as were prescription pain medication use and subject-reported responses to the HerQLes Abdominal QOL questionnaire. Observed differences in baseline characteristics were controlled using a weighted propensity score analysis to obviate potential selection bias (inverse probability of treatment weighting, IPTW). A p value < 0.05 was considered statistically significant. RESULTS: Three hundred and seventy-one subjects (RAS, n = 159; open, n = 130; laparoscopic, n = 82) were enrolled in the study across 17 medical institutions within the United States. Operative times were significantly different between the RAS and laparoscopic groups (126.2 vs 57.2, respectively; p < 0.001). Mean length of stay was comparable for RAS vs laparoscopic (1.4 ± 1.0 vs 1.4 ± 1.1, respectively; p = 0.623) and differed for the RAS vs open groups (1.4 ± 1.0 vs 2.0 ± 1.9, respectively; p < 0.001). Conversion rates differed between RAS and laparoscopic groups (0.6% vs 4.9%; p = 0.004). The number of subjects reporting the need to take prescription pain medication through the 2-4 weeks visit differed between RAS vs open (65.2% vs 79.8%; p < 0.001) and RAS vs laparoscopic (65.2% vs 78.75%; p < 0.001). For those taking prescription pain medication, the mean number of pills taken was comparable for RAS vs open (23.3 vs 20.4; p = 0.079) and RAS vs laparoscopic (23.3 vs 23.3; p = 0.786). Times to return to normal activities and to work, complication rates and HerQLes QOL scores were comparable for the RAS vs open and RAS vs laparoscopic groups. The reoperation rate within 30 days post-procedure was comparable for RAS vs laparoscopic (0.6% vs 0%; p = 0.296) and differed for RAS vs open (0.6% vs 3.1%; p = 0.038). CONCLUSIONS: Short-term outcomes indicate that open, laparoscopic, and robotic-assisted approaches are effective surgical approaches to VIH repair; however, each repair technique may demonstrate advantages in terms of clinical outcomes. Observed differences in the RAS vs laparoscopic comparison are longer operative time and lower conversion rate in the RAS group. Observed differences in the RAS vs open comparison are shorter LOS and lower reoperation rate through 30 days in the RAS group. The operative time in the RAS vs open comparison is similar. The number of subjects requiring the use of prescription pain medication favored the RAS group in both comparisons; however, among subjects reporting a need for pain medication, there was no difference in the number of prescription pain medication pills taken. While the study adds to the body of evidence evaluating the open, laparoscopic, and RAS approaches, future controlled studies are needed to better understand pain and QOL outcomes related to incisional hernia repair. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02715622.

META Score: An International Consensus Scoring System on Mesh-Tissue Adhesions.

BACKGROUND: Currently, the lack of consensus on postoperative mesh-tissue adhesion scoring leads to incomparable scientific results. The aim of this study was to develop an adhesion score recognized by experts in the field of hernia surgery. METHODS: Authors of three or more previously published articles on both mesh-tissue adhesion scores and postoperative adhesions were marked as experts. They were queried on seven items using a modified Delphi method. The items concerned the utility of adhesion scoring models, the appropriateness of macroscopic and microscopic variables, the range and use of composite scores or subscores, adhesion-related complications and follow-up length. This study comprised two questionnaire-based rounds and one consensus meeting. RESULTS: The first round was completed by 23 experts (82%), the second round by 18 experts (64%). Of those 18 experts, ten were able to participate in the final consensus meeting and all approved the final proposal. From a total of 158 items, consensus was reached on 90 items. The amount of mesh surface covered with adhesions, tenacity and thickness of adhesions and organ involvement was concluded to be a minimal set of variables to be communicated separately in each future study on mesh adhesions. CONCLUSION: The MEsh Tissue Adhesion scoring system is the first consensus-based scoring system with a wide backing of renowned experts and can be used to assess mesh-related adhesions. By including this minimal set of variables in future research interstudy comparability and objectivity can be increased and eventually linked to clinically relevant outcomes.

Prospective, multicenter, pairwise analysis of robotic-assisted inguinal hernia repair with open and laparoscopic inguinal hernia repair: early results from the Prospective Hernia Study.

PURPOSE: To evaluate and compare peri-operative outcomes through 30 days, including pain and quality of life (QOL) through 3 months across three cohorts of inguinal hernia repair (IHR) patients (robotic-assisted, laparoscopic, and open IHR). METHODS: The Prospective Hernia Study is an ongoing, multicenter, comparative, open-label analysis of clinical and patient-reported outcomes from robotic-assisted surgery (RAS) versus open and RAS versus laparoscopic IHR procedures. Patient responses to the Carolinas Comfort Scale (CCS) questionnaire provided QOL outcomes. RESULTS: 504 enrolled patients underwent unilateral or bilateral IHR (RAS, n = 159; open, n = 190; laparoscopic, n = 155) at 17 medical institutions from May 2016 through December 2018. Propensity score matching provided a balanced comparison: RAS versus open (n = 112 each) and RAS versus laparoscopic (n = 80 each). Overall, operative times were significantly different between the RAS and laparoscopic cases (83 vs. 65 min; p < 0.001). Fewer RAS patients required prescription pain medication than either open (49.5% vs. 80.0%; p < 0.001) or laparoscopic patients (45.3% vs. 65.4%; p = 0.013). Median number of prescription pain pills taken differed for RAS vs. open (0.5 vs. 15.5; p = 0.001) and were comparable for RAS vs laparoscopic (7.0 vs. 6.0; p = 0.482) among patients taking prescribed pain medication. Time to return to normal activities differed for RAS vs. open (3 vs. 4 days; p = 0.005) and were comparable for RAS vs. laparoscopic (4 vs. 4 days; p = 0.657). Median CCS scores through 3 months were comparable for the three approaches. Postoperative complication rates for the three groups also were comparable. One laparoscopic case was converted to open. CONCLUSION: This study demonstrates that IHR can be performed effectively with the robotic-assisted, laparoscopic, or open approaches. There was no difference in the median number of prescription pain medication pills taken between the RAS and laparoscopic groups. A difference was observed in the overall number of patients reporting the need to take prescription pain medication. Comparable operative times were observed for RAS unilateral IHR patients compared to open unilateral IHR patients; however, operative times for RAS overall and bilateral subjects were longer than for open patients. Operative times were longer overall for RAS patients compared to laparoscopic patients; however, there was no difference in conversion and complication rate in the RAS vs. laparoscopic groups or the complication rate in the RAS vs. open group. Time to return to normal activities for RAS IHR patients was comparable to that of laparoscopically repaired patients and significantly sooner compared to open IHR patients.

Mesenchymal stem versus stromal cells: International Society for Cell & Gene Therapy (ISCT®) Mesenchymal Stromal Cell committee position statement on nomenclature.

The International Society for Cell & Gene Therapy (ISCT®) Mesenchymal Stromal Cell (ISCT MSC) committee offers a position statement to clarify the nomenclature of mesenchymal stromal cells (MSCs). The ISCT MSC committee continues to support the use of the acronym "MSCs" but recommends this be (i) supplemented by tissue-source origin of the cells, which would highlight tissue-specific properties; (ii) intended as MSCs unless rigorous evidence for stemness exists that can be supported by both in vitro and in vivo data; and (iii) associated with robust matrix of functional assays to demonstrate MSC properties, which are not generically defined but informed by the intended therapeutic mode of actions.

Update of Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS)): Part B.

In 2014 the International Endohernia Society (IEHS) published the first international "Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias". Guidelines reflect the currently best available evidence in diagnostics and therapy and give recommendations to help surgeons to standardize their techniques and to improve their results. However, science is a dynamic field which is continuously developing. Therefore, guidelines require regular updates to keep pace with the evolving literature. METHODS: For the development of the original guidelines all relevant literature published up to year 2012 was analyzed using the ranking of the Oxford Centre for Evidence-Based-Medicine. For the present update all of the previous authors were asked to evaluate the literature published during the recent years from 2012 to 2017 and revise their statements and recommendations given in the initial guidelines accordingly. In two Consensus Conferences (October 2017 Beijing, March 2018 Cologne) the updates were presented, discussed, and confirmed. To avoid redundancy, only new statements or recommendations are included in this paper. Therefore, for full understanding both of the guidelines, the original and the current, must be read. In addition, the new developments in repair of abdominal wall hernias like surgical techniques within the abdominal wall, release operations (transversus muscle release, component separation), Botox application, and robot-assisted repair methods were included. RESULTS: Due to an increase of the number of patients and further development of surgical techniques, repair of primary and secondary abdominal wall hernias attracts increasing interests of many surgeons. Whereas up to three decades ago hernia-related publications did not exceed 20 per year, currently this number is about 10-fold higher. Recent years are characterized by the advent of new techniques-minimal invasive techniques using robotics and laparoscopy, totally extraperitoneal repairs, novel myofascial release techniques for optimal closure of large defects, and Botox for relaxing the abdominal wall. Furthermore, a concomitant rectus diastasis was recognized as a significant risk factor for recurrence. Despite still insufficient evidence with respect to these new techniques it seemed to us necessary to include them in the update to stimulate surgeons to do research in these fields. CONCLUSION: Guidelines are recommendations based on best available evidence intended to help the surgeon to improve the quality of his daily work. However, science is a continuously evolving process, and as such guidelines should be updated about every 3 years. For a comprehensive reference, however, it is suggested to read both the initially guidelines published in 2014 together with the update. Moreover, the presented update includes also techniques which were not known 3 years before.

Open ventral hernia repair with a composite ventral patch - final results of a multicenter prospective study.

BACKGROUND: This study assessed clinical outcomes, including safety and recurrence, from the two-year follow-up of patients who underwent open ventral primary hernia repair with the use of the Parietex™ Composite Ventral Patch (PCO-VP). METHODS: A prospective single-arm, multicenter study of 126 patients undergoing open ventral hernia repair for umbilical and epigastric hernias with the PCO-VP was performed. RESULTS: One hundred twenty-six subjects (110 with umbilical hernia and 16 with epigastric hernia) with a mean hernia diameter of 1.8 cm (0.4-4.0) were treated with PCO-VP. One hundred subjects completed the two-year study. Cumulative hernia recurrence was 3.0% (3/101; 95%CI: 0.0-6.3%) within 24 months. Median Numeric Rating Scale pain scores improved from 2 [0-10] at baseline to 0 [0-3] at 1 month (P < 0.001) and remained low at 24 months 0 [0-6] (P < 0.001). 99% (102/103) of the patients were satisfied with their repair at 24 months postoperative. CONCLUSIONS: The use of PCO-VP to repair primary umbilical and epigastric defects yielded a low recurrence rate, low postoperative and chronic pain, and high satisfaction ratings, confirming that PCO-VP is effective for small ventral hernia repair in the two-year term after implantation. TRIAL REGISTRATION: The study was registered publically at clinicaltrials.gov ( NCT01848184 registered May 7, 2013).

Update of Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS))-Part A.

In 2014, the International Endohernia Society (IEHS) published the first international "Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias." Guidelines reflect the currently best available evidence in diagnostics and therapy and give recommendations to help surgeons to standardize their techniques and to improve their results. However, science is a dynamic field which is continuously developing. Therefore, guidelines require regular updates to keep pace with the evolving literature. METHODS: For the development of the original guidelines, all relevant literature published up to year 2012 was analyzed using the ranking of the Oxford Centre for Evidence-Based Medicine. For the present update, all of the previous authors were asked to evaluate the literature published during the recent years from 2012 to 2017 and revise their statements and recommendations given in the initial guidelines accordingly. In two Consensus Conferences (October 2017 Beijing, March 2018 Cologne), the updates were presented, discussed, and confirmed. To avoid redundancy, only new statements or recommendations are included in this paper. Therefore, for full understanding both of the guidelines, the original and the current, must be read. In addition, the new developments in repair of abdominal wall hernias like surgical techniques within the abdominal wall, release operations (transversus muscle release, component separation), Botox application, and robot-assisted repair methods were included. RESULTS: Due to an increase of the number of patients and further development of surgical techniques, repair of primary and secondary abdominal wall hernias attracts increasing interests of many surgeons. Whereas up to three decades ago hernia-related publications did not exceed 20 per year, currently this number is about 10-fold higher. Recent years are characterized by the advent of new techniques-minimal invasive techniques using robotics and laparoscopy, totally extraperitoneal repairs, novel myofascial release techniques for optimal closure of large defects, and Botox for relaxing the abdominal wall. Furthermore, a concomitant rectus diastasis was recognized as a significant risk factor for recurrence. Despite insufficient evidence with respect to these new techniques, it seemed to us necessary to include them in the update to stimulate surgeons to do research in these fields. CONCLUSION: Guidelines are recommendations based on best available evidence intended to help the surgeon to improve the quality of his daily work. However, science is a continuously evolving process, and as such guidelines should be updated about every 3 years. For a comprehensive reference, however, it is suggested to read both the initial guidelines published in 2014 together with the update. Moreover, the presented update includes also techniques which were not known 3 years before.

Proper mesh overlap is a key determinant in hernia recurrence following laparoscopic ventral and incisional hernia repair.

BACKGROUND: Ventral hernia can be repaired through either an open or laparoscopic approach. A major problem following hernia repair is recurrence, and the technique used for hernia repair influences the rate of hernia recurrence. Data from individual studies show that the area of mesh overlap used during hernia repair correlates with hernia recurrence, but no meta-analyses have previously been published. The aim of this review was to perform a meta-analysis to determine if the area of mesh overlap correlates with the rate of hernia recurrence after ventral and incisional hernia repair. METHODS: Studies from 1990 to 2013 that used a mesh in open or laparoscopic procedures, and that reported both the area of mesh overlap beyond the fascial defect and the recurrence rate, were assessed for inclusion in the final analysis. A pooled estimation of combined overall risk was calculated according to a random effect model. RESULTS: A total of 95 articles, with 111 study populations, met all criteria and were included in the final analysis. For open procedures, results showed no correlation between the pooled estimation of risk for recurrence of ventral hernia and area of mesh overlap used for hernia repair (<3 cm, incidence rate 0.065; 3-5 cm, incidence rate 0.070; >5 cm, incidence rate 0.060). In laparoscopic procedures, the pooled estimation of risk for recurrence of hernia decreased with increasing area of mesh overlap (<3 cm, incidence rate 0.086; 3-5 cm, incidence rate 0.046; >5 cm, incidence rate 0.014). CONCLUSION: Risk of hernia recurrence decreases with increasing area of mesh overlap in laparoscopic, but not open, procedures for ventral hernia repair.

Immunogenicity of virosomal adjuvanted trivalent influenza vaccination in allogeneic stem cell transplant recipients.

BACKGROUND: Influenza vaccination is generally recommended to hematopoietic stem cell transplant (HSCT) recipients. However, the seasonal subunit vaccination response is frequently suboptimal, and alternate more efficient vaccination systems must be examined. We compared the immunogenicity of an adjuvanted virosomal influenza and subunit vaccine in HSCT recipients. METHODS: The immunogenicity after a single dose (0.5 mL) of adjuvanted trivalent virosomal vaccination was evaluated in a study cohort of 21 HSCT recipients and compared to a control cohort of 30 HSCT recipients who received a single dose (0.5 mL) of non-adjuvanted seasonal trivalent subunit vaccination over 4 seasons from 2010 to 2014. Whole blood interferon-gamma (IFN-γ) release assays were tested, both before and 30 days after vaccination, in response to influenza pandemic (pdm) H1N1, H3N2, and B antigens. HLA-A*02 dextramers, to gauge for the absolute number of antigen-specific CD8(+) T-cells, and pdm 2009 hemagglutinin inhibition (HI) assays, to test for neutralizing antibodies, were used as immunological readouts. RESULTS: The pdm HI titers were poor in both cohorts with only 23% (5/21) after virosomal vaccination and 13.3% (4/30) in the seasonal vaccine cohort having protective titers (≥40). The delta change of IFN-γ production in response to influenza pdm H1N1 (P = 0.005) and influenza B antigens (P = 0.01) were significantly elevated in blood from individuals who received the virosomal as compared to the seasonal vaccine. The IFN-γ response to pdm H1N1 was stronger (P < 0.001), as compared to seasonal vaccination, in patients vaccinated >6 month post HSCT. We detected a significant increase in the frequency of matrix 1 (GILGFVTL) dextramer-specific CD8(+) T-cells after the virosomal vaccine (P = 0.01). No differences were seen in the hemagglutinin-specific CD8(+) T-cells between the 2 cohorts. CONCLUSION: Vaccination using a virosomal delivery system is beneficial in eliciting robust cellular immune responses to pdm H1N1 influenza in SCT recipients.

SCT for severe autoimmune diseases: consensus guidelines of the European Society for Blood and Marrow Transplantation for immune monitoring and biobanking.

Over the past 15 years, SCT has emerged as a promising treatment option for patients with severe autoimmune diseases (ADs). Mechanistic studies recently provided the proof-of-concept that restoration of immunological tolerance can be achieved by haematopoietic SCT in chronic autoimmunity through eradication of the pathologic, immunologic memory and profound reconfiguration of the immune system, that is, immune 'resetting'. Nevertheless, a number of areas remain unresolved and warrant further investigation to refine our understanding of the underlying mechanisms of action and to optimize clinical SCT protocols. Due to the low number of patients transplanted in each centre, it is essential to adequately collect and analyse biological samples in a larger cohort of patients under standardized conditions. The European society for blood and marrow transplantation Autoimmune Diseases and Immunobiology Working Parties have, therefore, undertaken a joint initiative to develop and implement guidelines for 'good laboratory practice' in relation to procurement, processing, storage and analysis of biological specimens for immune reconstitution studies in AD patients before, during and after SCT. The aim of this document is to provide practical recommendations for biobanking of samples and laboratory immune monitoring in patients with ADs undergoing SCT, both for routine supportive care purposes and investigational studies.

Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS)-part 1.

Guidelines are increasingly determining the decision process in day-to-day clinical work. Guidelines describe the current best possible standard in diagnostics and therapy. They should be developed by an international panel of experts, whereby alongside individual experience, above all, the results of comparative studies are decisive. According to the results of high-ranking scientific studies published in peer-reviewed journals, statements and recommendations are formulated, and these are graded strictly according to the criteria of evidence-based medicine. Guidelines can therefore be valuable in helping particularly the young surgeon in his or her day-to-day work to find the best decision for the patient when confronted with a wide and confusing range of options. However, even experienced surgeons benefit because by virtue of a heavy workload and commitment, they often find it difficult to keep up with the ever-increasing published literature. All guidelines require regular updating, usually every 3 years, in line with progress in the field. The current Guidelines focus on technique and perioperative management of laparoscopic ventral hernia repair and constitute the first comprehensive guidelines on this topic. In this issue of Surgical Endoscopy, the first part of the Guidelines is published including sections on basics, indication for surgery, perioperative management, and key points of technique. The next part (Part 2) of the Guidelines will address complications and comparisons between open and laparoscopic techniques. Part 3 will cover mesh technology, hernia prophylaxis, technique-related issues, new technologic developments, lumbar and other unusual hernias, and training/education.

Components separation technique utilizing an intraperitoneal biologic and an onlay lightweight polypropylene mesh: "a sandwich technique".

PURPOSE: Reconstruction of large, complex abdominal wall hernias is an ongoing challenge. Primary closure of such hernias is often not possible. The components separation technique (CST) is a practical option, however, recurrence rates remain unacceptably high. In an attempt to reduce recurrences, we added a biologic underlay mesh and a lightweight polypropylene onlay mesh to the traditional CST. METHODS: Patients with a large hernia defect with or without multiple recurrences were selected to undergo a CST augmented with an acellular porcine dermal collagen mesh underlay. Following midline abdominal closure, a lightweight, large-pore polypropylene onlay mesh was fixed to the abdominal fascia. The skin and subcutaneous layers were closed over two sump drains and two closed suction drains. RESULTS: Fifty-one patients underwent a mesh-reinforced CST from May 2006 to June 2010. The study population averaged 57.9 ± 1.5 years of age with 24 males and 27 females, BMI of 34.3 ± 0.9 kg/m(2), ASA score of 2.62 ± 0.08, 29 % were smokers, 29 % were diabetic, and 69 % had at least one previous abdominal wall hernia repair. Operative time averaged 196.5 ± 7.2 min with a blood loss of 318 ± 24 mL, and average hernia defect size of 301 ± 31 cm(2). Length of follow-up averaged 20.6 ± 2.1 months; surgical site occurrences were identified in 39 %, most commonly from skin necrosis. Hernia recurrence rate was 3.9 %. CONCLUSIONS: Repair of large, complex abdominal wall hernias by CST augmented with a biologic underlay mesh and a lightweight polypropylene onlay mesh results in lower recurrence rates compared to historical reports of CST alone.

Does expanded polytetrafluoroethylene mesh really shrink after laparoscopic ventral hernia repair?

BACKGROUND: The shrinkage of mesh has been cited as a possible explanation for hernia recurrence. Expanded polytetrafluoroethylene (ePTFE) is unique in that it can be visualized on computed tomography (CT). Some animal studies have shown a greater than 40% rate of contraction of ePTFE; however, very few human studies have been performed. STUDY DESIGN: A total of 815 laparoscopic incisional/ventral hernia (LIVH) repairs were performed by a single surgical group. DualMesh Plus (ePTFE) (WL Gore & Associates, Newark, DE) was placed in the majority of these patients using both transfascial sutures and tack fixation. Fifty-eight patients had postoperative CTs of the abdomen and pelvis with ePTFE and known transverse diameter of the implanted mesh. The prosthesis was measured on the CT using the AquariusNet software program (TeraRecon, San Mateo, CA), which outlines the mesh and calculates the total length. Data were collected regarding the original mesh size, known linear dimension of mesh, seroma formation, and time interval since mesh implantation in months. RESULTS: The mean shrinkage rate was 6.7%. The duration of implantation ranged from 6 weeks to 78 months, with a median of 15 months. Seroma was seen in 8.6% (5) of patients. No relationship was identified between the percentage of shrinkage and the original mesh size (P = 0.78), duration of time implanted (P = 0.57), or seroma formation (P = 0.074). In 27.5% (16) of patients, no shrinkage of mesh was identified. Of the patients who did experience mesh shrinkage, the range of shrinkage was 2.6-25%. CONCLUSIONS: Our results are markedly different from animal studies and show that ePTFE has minimal shrinkage after LIVH repair. The use of transfascial sutures in addition to tack fixation may have an implication on the mesh contraction rates.