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.

Characterization of host response, resorption, and strength properties, and performance in the presence of bacteria for fully absorbable biomaterials for soft tissue repair.

PURPOSE: The objective was to evaluate the host response, resorption, and strength properties, and to assess the performance in the presence of bacteria for Phasix™ Mesh (Phasix™) and Gore® Bio-A® Tissue Reinforcement (Bio-A®) in preclinical models. METHODS: In a rat model, one mesh (2 × 2 cm) was implanted subcutaneously in n = 60 rats. Animals were euthanized after 2, 4, 8, 12, 16, or 24 weeks (n = 5/mesh/time point), and implant sites were assessed for host inflammatory response and overall fibrotic repair thickness. In a rabbit model, meshes (3.8 cm diameter) were bilaterally implanted in subcutaneous pockets in n = 20 rabbits (n = 10 rabbits/mesh) and inoculated with 108 CFU clinically isolated methicillin-resistant Staphylococcus aureus (MRSA). One mesh type was implanted per animal. Animals were euthanized after 7 days, and implants were assessed for abscess formation, bacterial colonization, and mechanical strength. RESULTS: In the rat study, Phasix™ and Bio-A® exhibited similar biocompatibility, although Bio-A® demonstrated a significantly greater inflammatory response at 4 weeks compared to Phasix™ (p < 0.01). Morphometric analysis demonstrated rapid resorption of Bio-A® implants with initially thicker repair sites at 2, 4, 8, and 12 weeks (p < 0.0001), which transitioned to significantly thinner sites compared to Phasix™ at 16 and 24 weeks (p < 0.0001). In the rabbit bacterial inoculation study, Phasix™ exhibited significantly lower abscess score (p < 0.001) and bacterial colonization (p < 0.01), with significantly greater mechanical strength than Bio-A® (p < 0.001). CONCLUSIONS: Host response, resorption, repair thickness, strength, and bacterial colonization suggest a more stable and favorable outcome for monofilament, macroporous devices such as Phasix™ relative to multifilament, microporous devices such as Bio-A® over time.

Design and implementation of the Americas Hernia Society Quality Collaborative (AHSQC): improving value in hernia care.

PURPOSE: Wide variation in care and costs exists regarding the management of abdominal wall hernias, with unproven benefit for many therapies. This work establishes a specialty society-based solution to improve the quality and value of care delivered to hernia patients during routine clinical management on a national scale. METHODS: The Americas Hernia Society Quality Task Force was charged by the Americas Hernia Society leadership to develop an initiative that utilizes the concepts of continuous quality improvement (CQI). A disease-based registry was created to collect information for CQI incorporating real-time outcome reporting, patient reported outcomes, stakeholder engagement, and collaborative learning methods to form a comprehensive quality improvement effort. RESULTS: The Americas Hernia Society Quality Collaborative (AHSQC) was formed with the mission to provide health care professionals real-time information for maximizing value in hernia care. The initial disease areas selected for CQI were incisional and parastomal hernias with ten priorities encompassing the spectrum of care. A prospective registry was created with real-time analytic feedback to surgeons. A data assurance process was implemented to ensure maximal data quality and completeness. Four collaborative meetings per year were established to meet the goals of the AHSQC. As of the fourth quarter 2014, the AHSQC includes nearly 2377 patients at 38 institutions with 82 participating surgeons. CONCLUSIONS: The AHSQC has been established as a quality improvement initiative utilizing concepts of CQI. This ongoing effort will continually refine its scope and goals based on stakeholder input to improve care delivered to hernia patients.

Biomechanical evaluation of fixation properties of fibrin glue for ventral incisional hernia repair.

INTRODUCTION: Use of adhesives for mesh fixation in hernia is increasing. There has been minimal study of mesh incorporation and interface strength with adhesive fixation for ventral hernia repair. The purpose of this study was to evaluate the fixation properties of fibrin glue as it compared to suture fixation of mesh in an onlay position. METHODS: Twenty-four mongrel pigs were divided into three study arms based on time points for biomechanical evaluation: 24 h (n = 8), 7 days (n = 8), and 14 days (n = 8). Initial procedures included placement of two 4 × 6 cm pieces of wide-pore polypropylene mesh in an onlay position. One was fixated with 4 ml of fibrin glue and the other with four interrupted 2-0 polypropylene sutures. The shear strength of fixation was evaluated using a uniaxial testing device along with histological evaluation. Maximum force was normalized by the width of the mesh. RESULTS: Mesh-tissue interface of glued and sutured specimens at 7 and 14 days did not fail in our testing configuration. Only at the 24-h time point the mesh detached from the tissue, and the sutured interface (10.4 N/cm) was significantly stronger than glued interface (4.9 N/cm, p = 0.004). Histopathologic and gross evaluations of the specimens revealed similar histologic features at all time points for both glued and sutured specimens. CONCLUSIONS: With mesh in the onlay position, fixation to the abdominal wall occurs quickly. Though sutures were stronger at 24 h, as early as 1 week, the strength of the fixation exceeded the tissue or the mesh strength in our testing configuration for both glue and suture groups. Fixation strength is independent of technique at the latter time points. There are potential clinical advantages to the exclusive use of fibrin glue for fixation including acute post-operative pain, chronic post-operative pain, and recurrence for ventral incisional hernia repair.

Primary prevascular and retropsoas hernias: incidence of rare abdominal wall hernias.

OBJECTIVE: To describe the incidence and treatment of prevascular and retropsoas hernias in a large-volume general surgery practice. BACKGROUND: Femoral hernias are considered uncommon with an incidence between 2 and 8 % of groin hernias. There are no large studies describing the subtypes of femoral hernias or retropsoas hernias, and therefore no reported incidence or standardized treatment recommendations for these hernias exist. METHODS: This study is a retrospective review of all patients undergoing total extraperitoneal (TEP) laparoscopic herniorrhaphy between August 1993 and December 2011. A single surgeon performed all the repairs. Demographics and patient outcomes were reported. RESULTS: 2,436 patients underwent 3,242 TEP repairs. The subtypes were: indirect 1,523 (46.9 %), direct 1,473 (45.4 %), femoral 156 (4.8 %), obturator 35 (1.1 %), prevascular 25 (0.77 %), Spigelian 20 (0.61 %), retropsoas 3 (0.09 %). Prevascular hernias accounted for 16 % of femoral hernias. Patients with prevascular hernias had a mean age of 70.3 years and were all male. 13 of the 25 patients (52 %) with prevascular hernias had other associated defects and four (16 %) of the patients had prevascular hernias as a recurrence from a prior hernia operation. There were three patients with retropsoas hernias that only would not have been seen from an anterior open approach. There are no intraoperative complications or known recurrences from this study group. CONCLUSIONS: Prevascular and retropsoas hernias are uncommon, but have a higher incidence than previously believed. Prevascular hernias tend to be associated with older age and other defects. The diagnosis and management of these hernias are readily achieved using the laparoscopic TEP approach.

A technique for placement of a bioabsorbable prosthesis with fibrin glue fixation for reinforcement of the crural closure during hiatal hernia repair.

INTRODUCTION: Level 1 data suggest that mesh reinforcement of the crural closure for hiatal hernia repair decreases the recurrence of hernia. The fear of erosion of the prosthetic into the esophagus has kept the use of mesh for hiatal hernia repair from becoming routine. A recent study found several cases of esophageal stenosis/erosion from the use of a biologic mesh. For these reasons, we evaluated a new resorptive prosthetic and new method of fixation of the prosthetic for crural reinforcement during hiatal hernia repair. METHODS: From February 2009 until December 2010, 70 patients underwent hiatal hernia repair using a synthetic bioabsorbable prosthetic made of polglycolide and teimethylene carbonate (Gore BioA Tissue Reinforcement™, Flagstaff, AZ). There were 48 patients with paraesophageal hiatal hernias and 22 with large sliding hiatal hernias. In this study, a square piece of mesh just the size to cover the crural closure only was utilized. Fibrin glue (Tisseel™) was applied over the suture closure of the crura, the mesh was then placed over the glue and held in place for several seconds, and then more fibrin glue was applied on top of the mesh. RESULTS: The new bioabsorbable polymer mesh was readily placed through a 10-mm trocar, had good handling characteristics laparoscopically, and no pre-operative preparation was required of the prosthetic. The material and the fibrin glue created a very substantial reinforcement of the crural closure, and the average time to place and fix the mesh was approximately 5 min. There were no short-term complications from the mesh, and no patient has had any significant post-operative sequelae. CONCLUSION: Crural closure reinforcement during hiatal hernia repair can be done readily with this new bioabsorbable polymer-based mesh. Fibrin glue fixation of this new prosthetic can be done quickly and it creates a strong, fixed barrier that may decrease the chance of erosion. Further studies will need to be done to evaluate long-term efficacy and complications associated with its use.

Nyhus-Wantz Lectureship: EHS/AHS Joint Hernia Congress-2012.

When given the honor to deliver the Nyhus-Wantz Lecture at the 5th Annual AHS/EHS International Hernia Congress, the word that came to mind immediately was collegiality. The dictionary tells us collegiality is the cooperative interaction among colleagues. I believe that both Doctors Nyhus and Wantz epitomized this cooperation. Both surgeons were critical in the exchange of ideas between Europe and The Americas regarding herniology that were critical to our past and laid the foundation for our future. In addition, both Doctors Nyhus and Wantz and their work have been extremely important in my development as a hernia surgeon. During the lecture, I will try to touch on these concepts to honor those that have made us what we are today.

Ventralex mesh in umbilical/epigastric hernia repairs: clinical outcomes and complications.

BACKGROUND: Umbilical and epigastric hernias have historically been repaired without mesh resulting in recurrence rates in some series of up to 40%. Recent data suggests mesh repair of these hernias may decrease recurrent hernia rates. Ideal placement of the mesh is behind the defect, which is difficult to do without a large incision in these hernias unless done laparoscopically. The Ventralex hernia patch is a composite PTFE/polypropylene patch allowing intraperitoneal placement behind the hernia defect through a small incision, and without the cost of laparoscopy. To date, only one study exists evaluating this new prosthesis. METHODS: This study is a retrospective chart review of all umbilical and epigastric hernias repaired with the Ventralex hernia patch by a single surgeon. Patient characteristics and operative and post-operative data were collected. Hernia recurrence is the primary outcome. Secondary outcomes include complication rates. RESULTS: Eighty-eight patients from 2003-2006 were evaluated. The population included patients aged 25-86 (mean 52) with nineteen females (22%). The average BMI was 32 (range 18-68). Eighteen patients were smokers, five patients were diabetic, and two patients were chronic steroid users. The size of patches used were small (72%), medium (27%), and unknown (1%). Average operating room time was 52 min (range 19-194). The different types of hernias repaired were umbilical (68%), epigastric (30%), and incisional (2%). Follow-up visits ranged from 8 days to 3.1 years in all but five patients (6%). No hernia recurrences were found in follow-up. Complications included two patients (2.2%) with mesh infection requiring removal of the patch, one patient with post-operative urinary retention, and seroma formation in another patient. CONCLUSIONS: The composite PTFE/polypropylene hernia patch is effective in preventing hernia recurrence in umbilical, epigastric, and small ventral hernia repairs and can be accomplished with a low rate of complications.

Laparoscopic ventral hernia repair (LVHR) in morbidly obese patients.

OBJECTIVE: The aim of this study was to evaluate our experience with LVHR in morbidly obese patients (BMI >40) and to compare their outcomes to those of patients with lower BMI. METHODS: Data on adult (>18 years old) patients who underwent LVHR with mesh over the last 13 years performed by four experienced surgeons were collected retrospectively and from a previously collected database. Of the 1,071 patients, 901 had completed LVHR and were available for follow-up. One hundred and thirty-four patients (group A) met BMI criteria for morbid obesity (>or=40, mean 46), 767 patients had BMI < 40, mean 30 (group B). The follow-up time ranged from 1 to 91 months. The Wilcoxon rank sum test was used for nonparametric data analysis. Outcomes were stratified on the follow up time and analyzed using Cochran-Mantel-Haenszel methodology. RESULTS: The groups did not differ in terms of ASA score, previous surgery and conversion rate (p=0.22, 0.32 and 0.23). Morbidly obese patients were younger (48.3 vs. 54; p<0.01) and were more often female (p=0.02), but this did not correlate with outcome. Group A also had longer operative time (154 vs. 119 min, p<0.01) and hospital stay (3.6 vs. 2.4 days, p=0.03). Mesh size was significantly larger in group A (449 vs. 349 cm(2), p=002). During mean follow-up time of 19 months hernia recurrence was 8.3% in group A and 2.9% in group B (p=0.003), with an odds ratio of 4.3 (95% CI 1.9-9.9). However, there was no significant difference in the rate of complications (19.7 vs. 15.3%; p=0.46). CONCLUSIONS: LVHR in the morbidly obese population is both safe and feasible, although there is a higher, but still acceptable recurrence rate. Despite the increased risk for recurrence, LVHR in morbidly obese patients minimizes the potential wound and mesh complications that frequently occur for open mesh repair in this group of patients.

Intraperitoneal modification of the Rives-Stoppa repair for large incisional hernias.

INTRODUCTION: Recurrence rates for open repair of ventral/incisonal hernias historically range from 6% for the classic Rives-Stoppa repair to 35-45% for some of the techniques more commonly used in the United States. We report a modification to the classic Rives-Stoppa repair that allows intraperitoneal placement of the prosthetic, secured with a running suture. The abdominal muscles are closed over the mesh to protect it from any superficial wound problems that might develop and to restore normal architecture of the abdominal wall. METHOD: A chart review was undertaken on all patients undergoing open ventral incisional hernia repair by a single surgeon from 2000 to 2006. All hernias were repaired with the intraperitoneal modification mimicking the principles of the Rives-Stoppa repair. Patient characteristics and operative and postoperative data were collected. Primary outcome was recurrence of hernia. Secondary outcomes were complications and rate of mesh infection. RESULTS: One hundred and fifteen patients were evaluated. Thirty-four patients had repair of recurrent ventral hernias. The average patient was obese, female, and 59 years old. Twenty-five patients used tobacco, eleven were diabetic, and seven used chronic corticosteroids. Meshes utilized included ePTFE, coated polyester, coated polypropylene, and biologic mesh. Average size of mesh was 465.4 cm2. There were four recurrences (3.4%), three of which were due to mesh infection requiring mesh removal. Recurrence rate not secondary to mesh removal was 0.9%. Complications occurred in 26% with seroma formation being the most frequent (16%). CONCLUSION: The intraperitoneal modification to the original Rives-Stoppa repair leads to a very low recurrence rate for large ventral hernia repairs with minimal complications and low rate of mesh infection.

Laparoscopic parastomal hernia repair using a nonslit mesh technique.

BACKGROUND: The management of parastomal hernia is associated with high morbidity and recurrence rates (20-70%). This study investigated a novel laparoscopic approach and evaluated its outcomes. METHODS: A consecutive multi-institutional series of patients undergoing parastomal hernia repair between 2001 and 2005 were analyzed retrospectively. Laparoscopy was used with modification of the open Sugarbaker technique. A nonslit expanded polytetrafluoroethylene (ePTFE) mesh was placed to provide 5-cm overlay coverage of the stoma and defect. Transfascial sutures secured the mesh, allowing the stoma to exit from the lateral edge. Five advanced laparoscopic surgeons performed all the procedures. The primary outcome measure was hernia recurrence. RESULTS: A total of 25 patients with a mean age of 60 years and a body mass index of 29 kg/m2 underwent surgery. Six of these patients had undergone previous mesh stoma revisions. The mean size of the hernia defect was 64 cm2, and the mean size of the mesh was 365 cm2. There were no conversions to open surgery. The overall postoperative morbidity was 23%, and the mean hospital length of stay was 3.3 days. One patient died of pulmonary complications; one patient had a trocar-site infection; and one patient had a mesh infection requiring mesh removal. During a median follow-up period of 19 months (range, 2-38 months), 4% (1/25) of the patients experienced recurrence. CONCLUSION: On the basis of this large case series, the laparoscopic nonslit mesh technique for the repair of parastomal hernias seems to be a promising approach for the reduction of hernia recurrence in experienced hands.

Minimal adhesions to ePTFE mesh after laparoscopic ventral incisional hernia repair: reoperative findings in 65 cases.

BACKGROUND AND OBJECTIVES: Laparoscopic ventral incisional hernia repair involves intraabdominal placement of a synthetic mesh, and the possibility of formation of severe visceral adhesions to the prosthesis is a principal concern. Little clinical information based on reoperative findings is available about adhesions to biomaterials placed intraabdominally. We conducted a multi-institutional study of adhesions to implanted expanded polytetrafluoroethylene (ePTFE) mesh at reoperation in patients who had previously undergone laparoscopic incisional hernia repair done with the same mesh implantation technique. METHODS: Nine surgeons retrospectively assessed the severity of adhesions to ePTFE mesh at reoperation in 65 patients. For each case, adhesions were assigned a score of 0 to 3, with 0 indicating no adhesions and 3 severe adhesions. RESULTS: The mean time from mesh implantation to reoperation was 420 days (range, 2-1 739 days). No adhesions were observed in 15 cases. Forty-four cases received an adhesion score of 1, and 6 cases a score of 2; no scores of 3 were assigned. Thus, 59 patients (91 %) had either no or filmy, avascular adhesions. No enterotomies occurred during adhesiolysis. CONCLUSIONS: In this large series of reoperations after laparoscopic incisional hernia repair, no or minimal formation of adhesions to implanted ePTFE mesh was observed in 91 % of cases, and no severe cohesive adhesions were found. Comparative analyses of newer materials based on clinical reoperative findings are warranted to assess the safety of intraabdominally placed meshes.

Polyester (Parietex) mesh for total extraperitoneal laparoscopic inguinal hernia repair: initial experience in the United States.

Polypropylene mesh is the most commonly used mesh for open and laparoscopic hernia repair in the United States. A variety of newly developed polyester mesh products have recently become available. This is the first U.S. multiinstitutional study evaluating the initial experience of polyester mesh use for total extraperitoneal (TEP) laparoscopic inguinal hernia repair. Between January 2000 and June 2001, 337 patients underwent 495 TEP laparoscopic inguinal hernia repairs using polyester mesh. There were 309 men and 28 women in the study, whose average age was 45 years (range, 17-80 years). The average operative time for all cases was 54.3 min (range, 18-157 min). There were no conversions to open repair and no mortality. Complications included 12 seromas/hematomas (six aspirated), chronic pain in three patients, urinary retention in two patients, and one incidence each of the following: epididimitis, prostatitis, hydrocele, and port-site cellulitis. Additionally, one patient had carbon dioxide (CO2) in the Foley bag at the end of the surgery, but a normal cystogram showed no identified bladder injury. There has been one recurrence (0.2%), occurring 4 months after surgery, which was repaired using a transabdominal laparoscopic approach. The mean follow-up period was 11 months (range, 2-22 months). There have been no documented infections of the mesh, and no mesh has been removed. This study documents a favorable initial experience with polyester mesh for TEP laparoscopic inguinal hernia repair. There were no complications related to the mesh. There may be technical and long-term advantages with the use of polyester mesh for laparoscopic inguinal hernia repair. Longer follow-up evaluation and additional studies are warranted to evaluate these potential advantages.

Laparoscopic ventral and incisional hernia repair in 407 patients.

BACKGROUND: Recurrence rates after primary repair of ventral and incisional hernias range from 25% to 52%. Recurrence after open surgery is less likely if mesh is used, but the wide fascial dissection and required flap creation increase complication rates. Laparoscopic techniques offer an alternative. STUDY DESIGN: To assess the safety and efficacy of laparoscopic ventral and incisional herniorrhaphy, we reviewed the records of all our patients who underwent such a procedure from November 1993 to August 1999. A laparoscopic approach was attempted in all patients considered to require a mesh repair. Patient demographic characteristics, operative details, and outcomes were recorded. RESULTS: Of 415 patients scheduled to undergo laparoscopic ventral or incisional herniorrhaphy, conversion to an open procedure was necessary in 8. All the remaining 407 patients (205 men and 202 women; mean age 53.2 years; range 13 to 88 years) were included in the study. Mean fascial defect size was 100.1 cm2 (range 1 to 480 cm2). In 97% of patients, expanded polytetrafluoroethylene mesh was used. Mean operating time was 97 minutes (range 11 to 270 minutes). Mean estimated blood loss was 35 mL (range 10 to 150 mL). Average hospital stay was 1.8 days (range 0 to 17 days). There were 53 complications (13.0%), including cellulitis of a trocar site, infection requiring mesh removal, prolonged suture pain, persistent seroma, intestinal injury, hematoma or postoperative bleeding, prolonged ileus, urinary retention, respiratory distress, fever, intraabdominal abscess, and trocar site herniation. There were no deaths. During a mean followup time of 23 months (range 1 to 60 months), there were 14 hernia recurrences (3.4%), 6 in patients in whom only a stapling device (no sutures) had been used to secure the mesh to the abdominal wall. CONCLUSIONS: Laparoscopic repair was completed in 98.1% of patients in whom it was attempted. The complication rate was acceptable. A short hospital stay and minimal blood loss were documented. The recurrence rate was 3.4%. Laparoscopic ventral and incisional hernia repair appear to be safe and effective.