Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up.

BACKGROUND: Long-term resorbable mesh represents a promising technology for ventral and incisional hernia repair (VIHR). This study evaluates poly-4-hydroxybutyrate mesh (P4HB; Phasix Mesh) among comorbid patients with CDC class I wounds. STUDY DESIGN: This prospective, multi-institutional study evaluated P4HB VIHR in comorbid patients with CDC class I wounds. Primary outcomes included hernia recurrence and surgical site infection. Secondary outcomes included pain, device-related adverse events, quality of life, reoperation, procedure time, and length of stay. Evaluations were scheduled at 1, 3, 6, 12, 18, 24, 30, 36, and 60 months. A time-to-event analysis (Kaplan-Meier) was performed for primary outcomes; secondary outcomes were reported as descriptive statistics. RESULTS: A total of 121 patients (46 male, 75 female) 54.7 ± 12.0 years old with a BMI of 32.2 ± 4.5 kg/m 2 underwent VIHR with P4HB Mesh (mean ± SD). Fifty-four patients (44.6%) completed the 60-month follow-up. Primary outcomes (Kaplan-Meier estimates at 60 months) included recurrence (22.0 ± 4.5%; 95% CI 11.7% to 29.4%) and surgical site infection (10.1 ± 2.8%; 95% CI 3.3 to 14.0). Secondary outcomes included seroma requiring intervention (n = 9), procedure time (167.9 ± 82.5 minutes), length of stay (5.3 ± 5.3 days), reoperation (18 of 121, 14.9%), visual analogue scale-pain (change from baseline -3.16 ± 3.35 cm at 60 months; n = 52), and Carolinas Comfort Total Score (change from baseline -24.3 ± 21.4 at 60 months; n = 52). CONCLUSIONS: Five-year outcomes after VIHR with P4HB mesh were associated with infrequent complications and durable hernia repair outcomes. This study provides a framework for anticipated long-term hernia repair outcomes when using P4HB mesh.

The Influence of an Online Platform (Hernia U) in Surgical Education and Patient Management.

Introduction: Hernia U was created with the objective to expand the educational landscape of abdominal wall surgery. It is an online platform where surgeons can register with no cost and subscribe for different courses. The aim of this study is to evaluate the impact of the platform on patient management and surgical education. Methods: A questionnaire regarding the influence of Hernia U in surgical education and patient management was emailed to professionals who had previously participated in any course of the Hernia U. Variables were shown with absolute and relative frequencies. Pearson's χ2 and Fisher's exact test were performed to analyze relationships between variables as appropriate. Results: Nine hundred three participants responded to the questionnaire. Seven hundred fifty-two (83.3%) were men; 248 (27.4%) participants were older than 50 years old; 240 (26.6%) were between 41 and 50 years old. Two hundred seventy-four (30.4%) participants had been in practice for more than 20 years, 242 (26.8%) between 11 and 20 years, and 161(17.8%) between 5 and 10 years. When analyzing the impact of time spent on the platform, spending over an hour per week was significantly associated with self-reported change in practice patterns compared to spending less than an hour per week (p < 0.0003). More experienced surgeons (10 or more years of practice) were less likely to change their practice patterns when compared to less experienced surgeons. Conclusion: Hernia U has allowed surgeons to change their daily practice and to boost their education. Surgeons spending more than one hour weekly in the platform are more likely to adopt changes.

A prospective, multicenter trial of a long-term bioabsorbable mesh with Sepra technology in cohort of challenging laparoscopic ventral or incisional hernia repairs (ATLAS trial).

BACKGROUND: This prospective, multicenter, single-arm, open-label study evaluated P4HB-ST mesh in laparoscopic ventral or incisional hernia repair (LVIHR) in patients with Class I (clean) wounds at high risk for Surgical Site Occurrence (SSO). METHODS: Primary endpoint was SSO requiring intervention <45 days. Secondary endpoints included: surgical procedure time, length of stay, SSO >45 days, hernia recurrence, device-related adverse events, reoperation, and Quality of Life at 1, 3, 6, 12, 18, and 24-months. RESULTS: 120 patients (52.5% male), mean age of 55.0 ± 14.9 years, and BMI of 33.2 ± 4.5 kg/m2 received P4HB-ST mesh. Patient-reported comorbid conditions included: obesity (86.7%), active smoker (45.0%), COPD (5.0%), diabetes (16.7%), immunosuppression (2.5%), coronary artery disease (7.5%), chronic corticosteroid use (2.5%), hypoalbuminemia (0.8%), advanced age (10.0%), and renal insufficiency (0.8%). Hernia types were primary ventral (44.2%), primary incisional (37.5%), recurrent ventral (5.8%), and recurrent incisional (12.5%). Patients underwent LVIHR in laparoscopic (55.8%) or robotic-assisted cases (44.2%), mean defect size 15.7 ± 28.3 cm2, mean procedure time 85.9 ± 43.0 min, and mean length of stay 1.0 ± 1.4 days. There were no SSOs requiring intervention beyond 45 days, n = 38 (31.7%) recurrences, n = 22 (18.3%) reoperations, and n = 2 (1.7%) device-related adverse events (excluding recurrence). CONCLUSION: P4HB-ST mesh demonstrated low rates of SSO and device-related complications, with improved quality of life scores, and reoperation rate comparable to other published studies. Recurrence rate was higher than expected at 31.7%. However, when analyzed by hernia defect size, recurrence was disproportionately high in defects ≥7.1 cm2 (43.3%) compared to defects <7.1 cm2 (18.6%). Thus, in LVIHR, P4HB-ST may be better suited for small defects. Caution is warranted when utilizing P4HB-ST in laparoscopic IPOM repair of larger defects until additional studies can further investigate outcomes.

Robotic-assisted onlay technique: new approach using anterior mesh positioning in ventral hernia repair-an easy way to spread robotic surgery.

There is still a lot of debate about what is the best technique for ventral hernia (VH) repair surgery. Robotic-assisted procedures are an excellent alternative to overcome the technical difficulties of regular laparoscopic surgery. The onlay technique is one of the most performed surgeries worldwide in open ventral hernia surgery, and the anatomy is easily recognized by all surgeons. Introducing the robotic onlay approach, using robotic-assisted surgery to perform ventral hernia repair with a technique is usual for most surgeons. This "new" approach may change the initial concept that minimally invasive abdominal wall surgery requires specific and tedious training and can help standardize ventral hernia repair by robotic surgery and facilitate training, allowing more surgeons to perform minimally invasive abdominal wall surgery. Finally, clinical studies are needed to measure the impact of Robotot implementation in MIS ventral hernia repair and long-term results.

Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up.

BACKGROUND: This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes. MATERIALS AND METHODS: P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing. RESULTS: A total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 ± 12.0 years and mean BMI of 32.2 ± 4.5 kg/m2 (±standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% ± 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% ± 0.03% of patients. CONCLUSIONS: Long-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing.

Society of Robotic Surgery review: recommendations regarding the risk of COVID-19 transmission during minimally invasive surgery.

OBJECTIVES: To determine the risk of COVID-19 transmission during minimally invasive surgical (MIS) procedures METHODS: Surgical society statements regarding the risk of COVID transmission during MIS procedures were reviewed. In addition, the available literature on COVID-19 and other viral transmission in CO2 pneumoperitoneum, as well as the presence of virus in the plume created by electrocautery during MIS was reviewed. The society recommendations were compared to the available literature on the topic to create our review and recommendations to mitigate COVID-19 transmission. RESULTS: The recommendations promulgated by various surgical societies evolved over time as more information became available on COVID-19 transmission. Review of the available literature on the presence of COVID-19 in CO2 pneumoperitoneum was inconclusive. There is no clear evidence of the presence of COVID-19 in plume created by electrocautery. Technologies to reduce CO2 pneumoperitoneum release into the operating room as well as filter viral particles are available and should reduce the exposure risk to operating room personnel. CONCLUSION: There is no clear evidence of COVID-19 virus in the CO2 used during MIS procedures or in the plume created by electrocautery. Until the presence or absence of COVID-19 viral particles has been clearly established, measures to mitigate CO2 and surgical cautery plume release into the operating room should be performed. Further study on the presence of COVID-19 in MIS pneumoperitoneum and cautery plume is needed.

Intracorporeal versus extracorporeal anastomosis for minimally invasive right colectomy: A multi-center propensity score-matched comparison of outcomes.

BACKGROUND: The primary objective of this study was to retrospectively compare short-term outcomes of intracorporeal versus extracorporeal anastomosis for minimally invasive laparoscopic and robotic-assisted right colectomies for benign and malignant disease. Recent studies suggest potential short-term outcomes advantages for the intracorporeal anastomosis technique. METHODS: This is a multicenter retrospective propensity score-matched comparison of intracorporeal and extracorporeal anastomosis techniques for laparoscopic and robotic-assisted right colectomy between January 11, 2010, and July 21, 2016. RESULTS: After propensity score-matching, there were a total of 1029 minimal invasive surgery cases for analysis-379 right colectomies (335 robotic-assisted and 44 laparoscopic) done with an intracorporeal anastomosis and 650 right colectomies (253 robotic-assisted and 397 laparoscopic) done with an extracorporeal anastomosis. There were no significant differences in any preoperative patient characteristics between groups. The minimally invasive intracorporeal anastomosis group had significantly longer operative times (p<0.0001), lower conversion to open rate (p = 0.01), shorter hospital length of stay (p = 0.02) and lower complication rate from after discharge to 30-days (p = 0.04) than the extracorporeal anastomosis group. CONCLUSIONS: This comparison shows several clinical outcomes advantages for the intracorporeal anastomosis technique in minimally invasive right colectomy. These data may guide future refinements in minimally invasive training techniques and help surgeons choose among different minimally invasive options.

Robotic radical prostatectomy with concomitant repair of inguinal hernia: is it safe?

Robotic radical prostatectomy (RARP) is well established as a safe and effective treatment for prostate cancer. According to published studies, patients undergoing RARP are at increased risk of being diagnosed with an inguinal hernia after RARP and are four times more likely to have an inguinal hernia repair (IHR) following RARP. Several studies have demonstrated the effectiveness and safety of IHR during RARP. Overall, it has been observed that IHR adds on average, 12-15 min in total surgical time and there were no significant differences between RARP with or without IHR with respect to postoperative complications. This study analyzes a large series of patients undergoing RARP (1100) and compares them to a group that underwent RARP with IHR (39). Between December 2008 and January 2015, 1139 patients underwent RARP at Florida Hospital in Celebration, FL. Of the total patients, 39 underwent concomitant IHR. All procedures were performed by the same surgeons (urologist and general surgeon), using the same techniques of RARP and TAPP inguinal hernia repair. After 30 days, the differences were evaluated between groups regarding surgical time, EBL and postoperative complications. The average age of patients undergoing the procedure was 61.65 years. The mean procedure time was approximately 120 min (min), with an additional period of 68 min for IHR (mean = 188; p = 0.0001). There was a significant difference in BMI between the groups, 28.3 kg/m2 for patients undergoing RARP and 26.8 kg/m2 for those who underwent RARP and IHR (p = 0.028). The EBL averaged 110.87 mL, with no significant difference between groups (p = 0371). There was no significant association between clinical stage of the patient and the type of procedure performed (p = 12:35). There was no significant difference in the presence of comorbidities and the operation preformed. There were 61 events recorded postoperatively, 57 (5.2%) among patients who underwent only RARP and 4 (10.26%) among those who had both. Taken together, the small amounts of complications in both groups prevent statistical significance. This study compared two groups of patients undergoing RARP: those with IHR and those without. Our study demonstrated an increase in surgical time; however, there was no increase in postoperative complications. From the data presented, we suggest that the performance of both procedures concomitantly is feasible and safe.

Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up.

BACKGROUND: Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that poly-4-hydroxybutyrate (P4HB) resorbable mesh supports strength restoration of the abdominal wall. This study evaluated outcomes of high-risk subjects undergoing VIHR with P4HB mesh. METHODS: This was a prospective, multi-institutional study of subjects undergoing retrorectus or onlay VIHR. Inclusion criteria were CDC Class I, defect 10-350 cm2, ≤ 3 prior repairs, and ≥ 1 high-risk criteria (obesity (BMI: 30-40 kg/m2), active smoker, COPD, diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, hypoalbuminemia, advanced age, and renal insufficiency). Physical exam and/or quality of life surveys were performed at regular intervals through 18 months (to date) with longer-term, 36-month follow-up ongoing. RESULTS: One hundred and twenty-one subjects (46M, 75F) with an age of 54.7 ± 12.0 years and BMI of 32.2 ± 4.5 kg/m2 (mean ± SD), underwent VIHR. Comorbidities included the following: obesity (n = 95, 78.5%), hypertension (n = 72, 59.5%), cardiovascular disease (n = 42, 34.7%), diabetes (n = 40, 33.1%), COPD (n = 34, 28.1%), malignancy (n = 30, 24.8%), active smoker (n = 28, 23.1%), immunosuppression (n = 10, 8.3%), chronic corticosteroid use (n = 6, 5.0%), advanced age (n = 6, 5.0%), hypoalbuminemia (n = 3, 2.5%), and renal insufficiency (n = 1, 0.8%). Hernia types included the following: primary ventral (n = 17, 14%), primary incisional (n = 54, 45%), recurrent ventral (n = 15, 12%), and recurrent incisional hernia (n = 35, 29%). Defect and mesh size were 115.7 ± 80.6 and 580.9 ± 216.1 cm2 (mean ± SD), respectively. Repair types included the following: retrorectus (n = 43, 36%), retrorectus with additional myofascial release (n = 45, 37%), onlay (n = 24, 20%), and onlay with additional myofascial release (n = 8, 7%). 95 (79%) subjects completed 18-month follow-up to date. Postoperative wound infection, seroma requiring intervention, and hernia recurrence occurred in 11 (9%), 7 (6%), and 11 (9%) subjects, respectively. CONCLUSIONS: High-risk VIHR with P4HB mesh demonstrated positive outcomes and low incidence of hernia recurrence at 18 months. Longer-term 36-month follow-up is ongoing.

Four-arm single docking full robotic surgery for low rectal cancer: technique standardization.

The authors present the four-arm single docking full robotic surgery to treat low rectal cancer. The eight main operative steps are: 1- patient positioning; 2- trocars set-up and robot docking; 3- sigmoid colon, left colon and splenic flexure mobilization (lateral-to-medial approach); 4-Inferior mesenteric artery and vein ligation (medial-to-lateral approach); 5- total mesorectum excision and preservation of hypogastric and pelvic autonomic nerves (sacral dissection, lateral dissection, pelvic dissection); 6- division of the rectum using an endo roticulator stapler for the laparoscopic performance of a double-stapled coloanal anastomosis (type I tumor); 7- intersphincteric resection, extraction of the specimen through the anus and lateral-to-end hand sewn coloanal anastomosis (type II tumor); 8- cylindric abdominoperineal resection, with transabdominal section of the levator muscles (type IV tumor). The techniques employed were safe and have presented low rates of complication and no mortality.

Four-arm single docking full robotic surgery for low rectal cancer: techniques and post-operative outcomes / Cirurgia totalmente robótica para o tratamento do câncer do reto distal: técnicas e resultados do pós-operatório imediato

BACKGROUND: laparoscopic rectal surgery has not yet achieved a high penetration rate because of its steep learning curve and its relatively high conversion rate. Robotic rectal resection represents the main indication of the use of the robotic platform in colorectal surgery. The aim of this study was to present an early experience with robotic surgery to treat mid and low rectal cancer focusing on the technique and early postoperative outcomes. METHODS: from December 2012 to October 2013, a total of 16 patients with colorectal diseases were operated on using a four-arm single docking full robotic procedure (daVinci Si Surgical System). The treatment of six consecutive patients who underwent robotic rectal cancer surgery for mid or low rectal adenocarcinoma was prospectively analyzed regarding technique standardization, pathological findings and postoperative outcomes. RESULTS: there were no conversions and one intraoperative complication. The mean operative time was 245 min (180-360 min). The mean console time was 170 min (110-240 min). All patients underwent a standardized totally robotic rectal dissection. There were no mortality or urinary dysfunction and one complication (postoperative ileo-16%). The median length of hospital stay was 6 (4-11 days). The median number of lymph nodes harvested was 22 (7-38), and distal and circumferential resection margins were negative in all specimen. R0 resection was achieved in all cases and complete total mesorectal excision in five specimen and nearly complete in one. CONCLUSION: standardized robotic rectal surgery is a promising alternative to treat patients with mid or low rectal cancer and is expected to overcome the low penetration rate of laparoscopic surgery in this field. This technique was successfully performed in six patients with excellent immediate postoperative and pathological results. Additional studies in a large series of patients are necessary to confirm those advantages. (AU)

INTRODUÇÃO: a utilização da cirurgia videolaparoscópica para o tratamento do câncer do reto ainda não apresentou uma alta penetração devido a longa curva de aprendizado e a uma taxa de conversão relativamente alta. A ressecção retal robótica é a principal indicação para o uso da plataforma robótica na cirurgia colorretal. O objetivo desse estudo é apresentar as técnicas e os resultados pós-operatórios imediatos com o uso da cirurgia robótica para o tratamento do câncer do reto distal. PACIENTES E MÉTODOS: no período de dezembro de 2012 a outubro de 2013 foram operados 16 pacientes com patologias colorretais utilizando o robô daVinci SI Surgical System. O tratamento de 6 consecutivos pacientes portadores de câncer do reto do terço médio e do terço inferior foram prospectivamente avaliados quanto a sistematização técnica, achados patológicos e evolução pós-operatória. RESULTADOS: não houve conversão e ocorreu uma complicação intraoperatória. A duração média das operações foi de 245 minutos (180-360 minutos) e o tempo médio do uso do console foi de 170 minutos (110-240 minutos). Ocorreu uma complicação pós-operatória (Íleo) e não houveram nenhuma disfunção urinária ou mortalidade. A duração média da internação hospitalar foi de 6 dias (4-11 dias). O número médio de linfonodos examinados foi de 22 (7-38) e todas as peças tinham margens distal e circunferencial negativas. Ressecção RO foi observada em todos os casos e o grau de excisão total do mesorreto foi completo em 5 peças e quase completo em uma. CONCLUSÃO: cirurgia robótica sistematizada esta tendo uma crescente aceitação e é uma ótima alternativa para o tratamento dos pacientes com câncer do reto distal. Esta tecnologia foi utilizada em 6 pacientes com excelentes resultados não só na recuperação pós-operatória imediata como também nos achados da avaliação patológica. Grandes series randomizadas são importantes para confirmar as possíveis vantagens dessa nova tecnologia. (AU)

Lap colectomy and robotics for colon cancer.

Robotic approaches have seen significant growth in the last 5 years. Taking advantage of three-dimensional visualization, improved articulation, and multiple operating arms provides theoretical and real advantages in colorectal cancer surgery. This article reviews the potential advantages and disadvantages, current outcomes, and future directions for robotic approaches to colon cancer surgery.

Totally robotic left colectomy.

Laparoscopic colectomy has been a challenge for surgeons due to steep learning curves, limited dexterity of instruments and non-depth perception with visualization. Robotics for left colectomy has been described in the past years using mostly single docking or hybrid techniques. With the advantages of the robotic technology including the use of 3D visualization, increase dexterity with 360-degree motion of the instruments, surgeons may see an increase in the adoption of minimally invasive surgery for colectomies. Surgeons know that multi-quadrant dissection can be difficult at best with the current platforms available due to the approach of the angles with the robotic arms and collisions. The use of a single docking technique can be challenging especially for the dissection of the splenic flexure especially in obese patients. We describe a double docking technique for the approach of the left colectomy that may help surgeons in the approach of multi-quadrant colorectal surgery.