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.

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.

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.

Repair of umbilical and epigastric hernias.

Umbilical and epigastric hernias are primary midline defects that are present in up to 50% of the population. In the United States, only about 1% of the population carries this specific diagnosis, and only about 11% of these are repaired. Repair is aimed at symptoms relief or prevention, and the patient's goals and expectations should be explicitly identified and aligned with the health care team. This article details some relevant and interesting anatomic issues, reviews existing data, and highlights some common and important surgical techniques. Emphasis is placed on a patient-centered approach to the repair of umbilical and epigastric hernias.

NOTES(®) stapled cystgastrostomy: a novel approach for surgical management of pancreatic pseudocysts.

BACKGROUND: Traditional approach for surgical management of mature pancreatic pseudocysts is by internal surgical drainage. Endoscopic drainage procedures have also been described. We describe Natural Orifice Translumenal Endoscopic Surgery (NOTES(®)) stapled cystgastrostomy as a less invasive surgical procedure. STUDY DESIGN: Case series. METHODS: NOTES(®) cystgastrostomy was performed in six patients with mature pseudocysts from June 2007 to July 2009 under institutional review board (IRB) protocol. The size of the pseudocysts varied from 8 to 23 cm, and all of the pseudocysts were considered complex pseudocysts. The operative team included two general surgeons and a gastroenterologist. The procedure included endoscopic ultrasound (EUS)-guided puncture of the stomach just below the gastroesophageal (GE) junction to gain access to the pseudocyst, guidewire placement, and then dilatation with a balloon to 18-20 mm. Endoscopic necrosectomy and debridement were performed when possible, followed by transoral surgical anastomosis under endoscopic visualization with the SurgAssist™ SLC 55 (Power Medical Interventions, Langhorne, PA) 4.8-mm stapler. Anastomotic length varied from 5.5 to 8 cm. In one patient, diagnostic laparoscopy was performed after the procedure due to inadvertent pneumoperitoneum; no leak or perforation was identified. RESULTS: Length of stay varied between 2 and 14 days. All patients had routine esophagogastroduodenoscopy (EGD) at 1 and 6 weeks postoperatively to evaluate patency; computed tomography (CT) scan was done at 2-3 months to demonstrate resolution of the pseudocyst. All patients had significant decrease in pseudocyst size with patent anastomosis on postoperative EGD, although one patient required endoscopic anastomotic dilatation due to continued symptoms 6 weeks after the operation. Her pseudocyst completely resolved 4 months postoperatively. An additional patient required subsequent distal pancreatectomy due to recurrent symptoms of chronic pancreatitis. CONCLUSION: NOTES(®) cystgastrostomy is comparable to previously described surgical approaches, yet is as minimally invasive as endoscopic drainage procedures previously described for management of pseudocysts. It is less invasive than laparoscopic or open cystgastrostomy, yet provides definitive treatment.

Gastrotomy closure with the lock-it system and the Padlock-G clip: a survival study in a porcine model.

BACKGROUND AND STUDY AIMS: The success of natural orifice surgery depends on secure closure of the transmural gut opening, so a rapid, secure, and easy-to-place closure method is desirable. Our aim was to determine whether a gastrotomy can be closed safely and effectively from within the stomach in a survival model by using a novel, endoscopically placed device: the Padlock-G system. PATIENTS AND METHODS: This was a pilot study of 4 survival animals in an animal laboratory setting. Gastrotomies were made in the stomachs of laboratory swine, and the abdomen was explored by using a standard gastroscope. Gastrotomies were then closed by using the Padlock-G system. Survival for 2 or 6 weeks was the primary outcome measurement. Secondary outcomes included ease of use, visual assessment of closure integrity immediately and at necropsy, presence of adhesions, evidence of infection, and histologic appearance at the closure sites. RESULTS: All animals thrived, ate normally, and gained weight. None developed fever, tachycardia, or signs of peritoneal irritation. Closure-site inspection at necropsy revealed excellent healing, with epithelial growth over the Padlock-G. There were no ulcers, serosal surfaces were tightly closed, and no defects could be seen. There were no signs of peritoneal inflammation, intra-abdominal adhesions, or gastric spillage. Histologic evaluation showed organizing granulation tissue with fibrosis, vascular proliferation, and mild chronic inflammatory infiltrate (i.e., scar). CONCLUSIONS: The Padlock-G is easy to place, provides a durable closure, and allows survival animals to thrive without adverse sequellae. This device provides a suitable closure system for transgastric NOTES.

Loop-anchor purse-string closure of gastrotomy in NOTES(R) procedures: survival studies in a porcine model.

INTRODUCTION: Transgastric NOTES(®) procedures remain without a simple method to close the gastrotomy. In four survival swine studies, we have tested a novel gastric closure device: the loop-anchor purse-string (LAPS) closure system. METHODS: In four anesthetized pigs, an endoscopic gastrotomy was performed. Four loop anchors were arrayed in a 2-cm square pattern around the gastrotomy. The endoscope was passed into the abdominal cavity, and the gastrotomy was cinched closed. RESULTS: Procedure times ranged from 50-180 minutes. Three pigs survived 14 days. One animal was sacrificed early due to signs of sepsis. Another animal developed fevers and was treated with antibiotics. At necropsy, there were no abscesses, including in the septic animal. Histologic examination revealed evidence of healing in all animals. DISCUSSION: The LAPS system holds promise with early success in an animal model. Future human studies are needed to determine viability as a human visceral closure device.

Gastric transmural pressure measurements in vivo: implications for natural orifice transluminal endoscopic surgery (NOTES).

BACKGROUND: The success of natural orifice surgery depends on a reliable, secure closure of the opening in the gut. Forces that might be exerted on the gastric wall to disrupt closure have not been measured in humans or animals. OBJECTIVE: To determine how transmural gastric pressure gradients vary under different experimental conditions. DESIGN: In vivo porcine model. SETTING: Animal laboratory. PATIENTS: Eleven laboratory pigs. INTERVENTIONS: Pressure transducers were placed in the abdomen and stomachs of the test animals. Simultaneous pressure measurements were obtained to determine the stresses applied to the gastric wall during various maneuvers. MAIN OUTCOME MEASUREMENTS: Continuous intra-abdominal and intragastric pressures in vivo. Transgastric pressure gradients (DeltaP) were computed in real time by subtracting gastric pressure from abdominal pressure. RESULTS: In all cases, the measured gastric pressures were nearly identical to those measured in the abdominal cavity because the stomach is entirely contained within the abdomen. The transmural gastric pressure gradients were near zero during a variety of experimental conditions. LIMITATION: Anesthetized animal model, not engaged in usual activities. Relatively low pressures generated during a cough sequence and a Valsalva maneuver compared with reported values in the literature. CONCLUSION: Estimates of gastric pressures that must be tolerated by gastric closure devices after natural orifice transluminal endoscopic surgery procedures have been greatly overestimated. Absolute gastric pressure is counteracted by external (intra-abdominal) pressure such that the net transmural gastric pressure gradient remains near zero under a variety of conditions.

Single-port laparoscopic cholecystectomy: initial experience.

BACKGROUND: As surgeons embrace the concept of increasingly less invasive surgery, techniques using only a single small incision have begun to gain traction. Several commercially available products have emerged recently. The TriPort system and the SILS Port are single-port devices that allow the surgeon to perform laparoscopic surgery through a 2- to 3-cm periumbilical incision. This study aimed to ascertain whether these devices allow safe and reliable access for laparoscopic cholecystectomy. METHODS: From March 2008 to June 2009, single-port laparoscopic cholecystectomy was attempted for 22 patients with an average age of 40 years (range, 23-73 years). The data collected prospectively after institutional review board approval included demographics, operative time, complications, and reasons for conversion to standard four-port laparoscopic surgery. RESULTS: The operation was completed successfully for 21 of the 22 patients (15 women and 7 men) using five different techniques. The mean body mass index (BMI) of the patients was 32.7 kg/cm(2) (range, 22.3-46.1 kg/cm(2)). Three of the patients had previously undergone laparoscopic Roux-en-Y gastric bypass. The mean operative time was 80.8 min (range, 51-156 min). One patient experienced a Richter's hernia postoperatively, which required a reoperation and subsequent bowel resection. One patient required conversion to a standard four-port laparoscopic cholecystectomy because the articulating instrument could not reach the gallbladder from the umbilicus. CONCLUSION: The results from the current series show single-port laparoscopic cholecystectomy to be a promising technique. A variety of patient demographics appear suited to this approach. The operative time in this series compares favorably with that for the standard four-port operation. The feasibility of single-port laparoscopic cholecystectomy is now established. However, routine application of this novel technique requires an evaluation of its safety and cost effectiveness in larger studies. In addition, its superiority over standard laparoscopic cholecystectomy in terms of postoperative pain, cosmesis, and overall patient satisfaction requires further study. Refinements in instrumentation will enable wider use of this novel minimally invasive approach.

Surgical resident performance on a virtual reality simulator correlates with operating room performance.

BACKGROUND: To define the ability of a virtual reality (VR) simulator to reflect clinical skill in surgical residents, we compared clinical laparoscopic performance and contemporary lab performance during curricular VR skills training. METHODS: Nine postgraduate year (PGY) 1 and 2 surgical residents were assessed during laparoscopic cholecystectomies and appendectomies using a web-based interactive database (OpRate)over a 6-mo period. Operative performance data were collected at the conclusion of procedures (mean responses of attending surgeons in nine areas pertaining to resident preparedness and technical skill). During this period, all residents undertook iterative laparoscopic training using a new VR trainer (SEP: SimSurgery AS, Oslo, Norway; METI, Sarasota FL). OpRate performance over 4-wk blocks and closest VR performance data (mean time, path length, and errors for three iterations of six basic skills tasks) were tested for correlation by linear (Pearson) correlation method. RESULTS: Residents performed 1 to 6 operative cases each (median = 3) during time blocks used for comparisons (median separation operative and SEP performance data 18 d). Significant correlation of operative and VR scores was found for time to task completion in 5 of 6 VR tasks. Results were most significant for a gallbladder dissection task (P = 0.0066, correlation coefficient = -0.6671). No significant correlation of path length or error data and operative performance was observed for any VR task. CONCLUSIONS: These data indicate that time to task completion on a VR training device correlates with resident performance in the clinical operating room. Serial evaluations will determine if concurrent performance improvement over time can be demonstrated.

Loop-anchor purse-string versus endoscopic clips for gastric closure: a natural orifice transluminal endoscopic surgery comparison study using burst pressures.

BACKGROUND: The success of natural orifice surgery depends on a reliable, secure closure of the opening in the gut. Few tests of the integrity of these closures have been published. OBJECTIVE: To determine whether a gastrotomy can be closed safely and effectively from within the stomach by using looped T-anchors-a novel, endoscopically placed device. DESIGN: Head-to-head comparison trial of 2 closure methods in 9 explanted porcine stomachs. SETTING: Animal laboratory. INTERVENTION: Paired gastrotomies were made in porcine explants. One was closed by using endoscopic clips, and the other was closed by using modified T-anchors in a purse-string fashion. MAIN OUTCOME MEASUREMENTS: Gastric transmural pressure gradients at bursting of these closures were measured while the explanted stomachs were inflated with a high-pressure insufflator. RESULTS: The mean burst pressure of the looped T-anchors was 27.3 mm Hg, whereas that of the clip closures was 14 mm Hg. By using 10 mm Hg as a threshold for a "secure" closure, 7 of 9 clip closures failed to meet the threshold value, whereas all 9 of the T-anchor closures met or exceeded the threshold value (P = .0023, 2-tailed Fisher exact test). LIMITATION: Nonsurvival study. CONCLUSION: Looped T-anchors provide a secure gastric closure for natural orifice surgery and are superior to endoscopic clips for this purpose.

The role of diagnostic laparoscopy for acute abdominal conditions: an evidence-based review.

Diagnostic laparoscopy is minimally invasive surgery for the diagnosis of intraabdominal diseases. This study aim was a critical examination of the available literature on the role of laparoscopy for the diagnosis and treatment of acute intraabdominal conditions. A systematic literature search of English-language articles on MEDLINE, the Cochrane database of evidence-based reviews, and the Database of Abstracts of Reviews of Effects was performed for the period 1995-2006. The level of evidence in the identified articles was graded. This review examines the role of diagnostic laparoscopy for acute nonspecific abdominal pain, trauma, and the acute abdomen experienced by the critically ill patient. The indications, contraindications, risks, benefits, diagnostic accuracy of the procedure, and associated morbidity are discussed. The limitations of the available literature are highlighted, and evidence-based recommendations for the use of diagnostic laparoscopy to determine acute intraabdominal conditions are provided.

Pancreatic pseudocystgastrostomy with a peroral, flexible stapler: human natural orifice transluminal endoscopic surgery anastomoses in 2 patients (with videos).

BACKGROUND: Complex, symptomatic pancreatic pseudocysts often must be surgically drained. Natural orifice surgery is an emerging field in which surgical procedures are performed by using an endoluminal approach through an existing body orifice. PATIENTS AND SETTING: Two patients at our institution, an academic, tertiary care center. DESIGN: Two patients who underwent a standard, stapled, surgical cystgastrostomy for drainage of a complex, infected pseudocyst by using a flexible stapling device are described. These procedures were performed under endoscopic observation and guidance, all transorally, without the need for laparotomy or laparoscopy. RESULTS: Both patients had a technically successful outcome, and both did well after surgery, with only mild chest pain and throat discomfort in one, and no adverse sequelae at all in the other patient. Both patients had complete resolution of their complex, debris-filled pseudocysts at 6 weeks when examined by endoscopy and at 3 months when examined by CT. CONCLUSIONS: An entirely endoscopic, peroral, stapled pseudocystgastrostomy is feasible and can lead to an excellent outcome. For properly selected patients, this may be an alternative to more traditional types of surgical cystgastrostomy.

Prosthetic material in inguinal hernia repair: how do I choose?

With numerous prosthetic options and a changing landscape of prosthetic development, a systematic approach to choosing a prosthetic is more sensible than trying to memorize all the details of each prosthetic. The surgeon should hone a single technique for the vast majority of inguinal hernia repairs to maximize proficiency. This limits the number of prosthetics to those suitable for that technique. Narrowing the choice further should be based on the likelihood that a given prosthetic will achieve the preoperative goals of the hernia repair. For alternative clinical scenarios, the surgeon should know one to two additional techniques, which may require a different prosthetic. The surgeon should use existing experimental and clinical data to estimate long-term benefits of any new prosthetic.

A new web-based operative skills assessment tool effectively tracks progression in surgical resident performance.

PURPOSE: The study aim was to demonstrate that a new database tool for assessment of surgical resident operative skills discerns predictable progression in those skills over successive residency years for specific index case types. METHODS: A Web-based interactive database (OpRate) was used to assess selected aspects of resident operative performance as determined by supervising attending surgeons in a medium-sized residency (5-6 residents per postgraduate year [PGY]). This assessment consisted of (1) 3 questions pertaining to patient information, technical, and disease-specific preparedness; (2) 4 laparoscopic technical skills questions pertaining to tissue handling, dexterity, planning, and ability to function independently; and (3) similar open technical skills questions, with the addition of 2 questions defining knot tying ability. Two years of assessment data were examined for cholecystectomy (CH), appendectomy (AP), colon resection (CR), ventral hernia repair (VH), and inguinal hernia repair (IH). Mean scores for total, technical, and preparedness responses, as well as each response area were compared for successive training years for each case type. Mean performance data between postgraduate years were compared by ANOVA, and interitem reliability was assessed by Cronbach's alpha determinations. RESULTS: OpRate data for 579 cases (142 CH, 67 AP, 73 CR, 202 IH, and 95 VH) were examined. Significant incremental increases in open and laparoscopic technical skills scores by training year were observed for all case types (ANOVA, p < 0.0001). Individual technical skills as well as technical and disease-specific preparedness response areas also demonstrated significant improvement by successive training year. Cronbach's alpha determinations were 0.80-0.94 for the preparedness test items and the skills performance scores for all assessed procedures. CONCLUSIONS: Our early results show that the OpRate assessment tool is effective in identifying expected changes in operative performance across successive training years, with a satisfactory level of internal consistency for the test items. As such, the use of this database tool may offer the opportunity to (1) define performance benchmarks for specific levels of training and (2) identify areas where focused training may be required for specific residents.

Laparoscopic repair of blunt traumatic anterior abdominal wall hernia.

Traumatic abdominal wall hernia is a relatively uncommon finding secondary to blunt trauma. We report a unique case of laparoscopic diagnosis and immediate repair of a traumatic anterior abdominal wall hernia after blunt abdominal trauma.