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.

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.

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.

Prospective, multicenter study of laparoscopic ventral hernioplasty. Preliminary results.

BACKGROUND: A standard technique for laparoscopic ventral hernioplasty (peritoneal onlay using an expanded polytetrafluoroethylene [ePTFE] patch for hernias >/=4 cm2) is being used in a prospective, multicenter, long-term study. METHODS: Demographic, operative, and postoperative data were collected and analyzed. Follow-up clinical evaluations were conducted 7-10 days, 4 weeks, 6 months, 1 year, and then annually after surgery in all patients. RESULTS: In the first 2 years of the study, 144 patients were enrolled; nine were lost to follow-up. The mean operating time was 120 min. The mean follow-up was 222 days (range 5-731). Postoperative complications were five infections, three cases of prolonged ileus, one bowel obstruction, 23 seromas (15 resolved without intervention), and six hernia recurrences. Hospital discharge occurred a mean of 2.3 days after surgery and return to normal activity a mean of 15 days postoperatively. CONCLUSIONS: Laparoscopic prosthetic ventral hernioplasty avoids the large wound required in open repairs, with attendant complications and recurrences, and appears safe, especially if an ePTFE mesh is used. Compared with conventional open ventral hernioplasty, the laparoscopic technique may also allow shorter hospitalization and a quicker return to normal activities after surgery.

Totally preperitoneal laparoscopic inguinal herniorrhaphy using balloon distention.

BACKGROUND: After having performed over 200 transabdominal preperitoneal (TAPP) laparoscopic hernia repairs with no recurrences and no neuropathies, we recently changed to a totally preperitoneal repair due to the development of a balloon trocar that easily 'creates' the preperitoneal space. METHODS: The totally preperitoneal operation is similar to our TAPP procedure in that it involves detailed delineation of Cooper's ligament, spermatic cord and transversus abdominis arch with fixation of mesh to Cooper's ligament and arch for an anatomic tension-free hernia repair. RESULTS: Our early experience consists of 60 hernia repairs in 50 patients (46 male, 4 female). There were 32 direct, 26 indirect and two femoral hernias. Eight hernias were recurrent. The operation takes approximately 1 h. There has been no morbidity. As with the TAPP procedure, minimal postoperative discomfort and return to regular activity within 2 to 3 days is the norm. CONCLUSIONS: We believe that the avoidance of the peritoneal incision and the attendant risks of intraabdominal adhesions associated with the TAPP procedure make the totally preperitoneal technique the preferred method of laparoscopic hernia repair.

Laparoscopic femoral hernia repair using a mesh dart.

We report 2 patients with femoral hernias (1 incarcerated) that were encountered during laparoscopic hernia repair for symptomatic direct inguinal hernias. The femoral hernias were readily repaired using the BARD dart that has been described previously for use during open femoral herniorrhaphy. We believe that this is the first report using the dart for laparoscopic femoral herniorrhaphy.

Preliminary evaluation of laparoscopic herniorrhaphy.

Since November 1990, 50 laparoscopic herniorrhaphies have been done in 47 patients (three patients with bilateral repairs), including 31 indirect and 19 direct inguinal hernias, three of which were recurrent. The 47 patients included 42 men and five women. Small indirect hernias were treated by plugging the hernia orifice with a tightly rolled polypropylene mesh plug. Large indirect, all direct, and combined hernias were treated by creating a peritoneal flap and stapling a polypropylene mesh screen preperitoneally over the defect. The mesh was stapled to Cooper's ligament, iliopubic tract, and transversus abdominous arch. Forty-five patients were discharged on the day of surgery and the other two within 24 h. The average return to full activity has been two days. The only intraoperative complication was an easily controlled trocar site bleeder. Postoperatively one minor trocar site infection occurred. One persistent and one recurrent hernia were among the group, both large indirect hernias done early in our experience (by the plug technique) before stapling instruments were available. The technique of laparoscopic herniorrhaphy is in its infancy and still evolving as our understanding of anatomy and technology improves. Even if long-term follow-up shows an acceptable recurrence rate and less patient disability, surgeons must weigh the wisdom of converting a procedure from local to general anesthesia and an inexpensive procedure into a more expensive procedure.

Laparoscopic posterior truncal vagotomy and anterior seromyotomy: a porcine model.

A training technique for posterior truncal vagotomy and an anterior seromyotomy in the anesthetized pig is described. The first of five procedures was performed open in a conventional method. All succeeding procedures were performed after the establishment of a pneumoperitoneum with CO2 insufflation and the placement of two 10 mm trocars and three 5-mm trocars. A 45 degree camera and monopolar electrocautery were used during the video laparoscopic procedure. After completion of the procedure, the pigs were opened to closely inspect the surgery performed. Though there are some minor anatomic differences between porcine and human anatomy, the pig is an excellent model for gaining technical experience in the performance of a posterior truncal vagotomy and anterior seromyotomy.

Use of technetium-labeled red blood cell scintigraphy in the detection and management of gastrointestinal hemorrhage.

The effectiveness of technetium 99m-labeled red blood cell scintigraphy in localizing hemorrhage, directing surgical intervention, and screening patients for arteriography was determined in 103 patients. The radionuclide scan result was compared to the bleeding site determined by arteriography, endoscopy, or surgery. Eighty-five patients had a bleeding site identified; 18 patients did not and were excluded. Thirty-one scans were performed in 29 patients for upper gastrointestinal hemorrhage. Five positive scans incorrectly localized an upper gastrointestinal bleeding site, although two scans localized the site, for a scan sensitivity of 8%. Fifty-nine scans were performed in 56 patients with lower gastrointestinal bleeding. Fifteen scans were positive, three incorrectly localizing the hemorrhage. Seventy-four percent of the patients with lower gastrointestinal hemorrhage documented by arteriography, endoscopy, or surgery had negative scans for bleeding. The radionuclide scan sensitivity for lower gastrointestinal bleeding was 23%. Surgery was required in 18 patients for bleeding, 11 of whom had negative scans for bleeding. In seven surgical patients with positive scans, in no instance did the scan direct the surgical intervention. Eighteen patients underwent scintigraphy and arteriography; nearly one half of the patients with negative scans for bleeding had positive localizing arteriograms, although almost one half of the patients with positive scans for bleeding had negative arteriograms. Scintigraphy failed to localize hemorrhage in 85% of the patients. Technetium 99m-labeled red blood cell scintigraphy did not direct surgical intervention, nor did it adequately screen patients for arteriography.

Factors affecting morbidity following hepatic trauma. A prospective analysis of 482 injuries.

During a 5-year period, 482 patients with liver injuries were studied prospectively: 65% resulted from penetrating and 35% from blunt injuries. The injuries were graded by the hepatic injury scale (grades I to VI); transfusion requirements and perihepatic abscesses correlated with increasing scores. Minor surgical techniques were needed in 338 patients and 144 patients required major techniques. Omental packing was used in 60% of the major injuries and yielded 7% mortality and 8% abscess rates. Gauze packs were used for management of 10% of major injuries and yielded 29% mortality and 30% abscess rates. The patients were randomized to no drain, closed suction, or sump drainage and respective perihepatic abscess rates were 6.7%, 3.5%, and 13% (p less than 0.03; suction compared to closed suction). Multivariate analysis demonstrated increasing abdominal trauma indices and transfusion requirements as well as sump drainage to be associated independently with perihepatic infection.