Observations on the Use of Seprafilm® on the Brachial Plexus in 249 Operations for Neurogenic Thoracic Outlet Syndrome

Purpose

Seprafilm® was initially used successfully as a membrane to reduce abdominal adhesions. Subsequently it was tried in a number of other areas to reduce postoperative scarring. Seprafilm® was employed in this study to see if it would reduce postoperative scarring after supraclavicular thoracic outlet decompression for neurogenic thoracic outlet syndrome (NTOS).

Material and methods

There were 249 operations for primary NTOS (185) and recurrent NTOS (64). Seprafilm® was applied to the nerve roots at the end of each procedure. Diagnosis was established by careful history and extensive physical exam consisting of several provocative maneuvers. Scalene muscle block confirmed the diagnosis.

Results

Success rates for primary operations, 1–2 years postoperation were 74% for scalenectomy without first rib resection and 70% for scalenectomy with first rib resection. For reoperations, success rate for scalenectomy and neurolysis after transaxillary rib resection was 78% whereas success rate for neurolysis after supraclavicular scalenectomy was 68%. Seprafilm® did not significantly improve overall results compared to our results 15 years ago, although in reoperations there was a trend toward improvement with Seprafilm®. Observations in 10 reoperations after use of Seprafilm® revealed that there were fewer adhesions between fat pad and nerve roots, making it much easier to find the nerve roots. Recurrence was because of scar formation around individual nerve roots.

Conclusion

Seprafilm® made reoperations easier by reducing scarring between scalene fat pad and brachial plexus. However, it did not prevent scar tissue forming around the individual nerve roots nor did it significantly lower the failure rate for primary operations. The trend supported the use of Seprafilm® in reoperations.     

Highly purified collagen coating enhances tissue adherence and integration properties of monofilament polypropylene meshes

Introduction and hypothesis

Complications related to tissue integration of polypropylene implants used in the treatment of pelvic organ prolapse are relatively prevalent. Collagen, a biocompatible, less immunogenic material with modulating properties on the inflammatory process, may improve polypropylene integration. The objective was to study biomechanical and histological effects of monofilament polypropylene mesh coated with purified collagen gel.

Methods

Forty rats were implanted with two fragments of polypropylene mesh in their abdominal walls (one on each side of the linea alba). One of the fragments had a collagen gel coating (group I) while the other one did not (group II). The animals were euthanized at 7, 14, 90, and 180 days after implantation and their abdominal walls were excised for analysis.

Results

The biomechanical study showed that mesh adherence to neighboring tissue increased significantly in group II (p?<?0.05). Acute (p?<?0.001) and chronic (p?=?0.004) inflammatory responses as well as granulation tissue formation (p?=?0.001) were less intense in group II at 7 and 14 days. Granulomatous inflammation and foreign body reaction was less significant at 7 days in group II (p?=?0.029 and p?<?0.001). The birefringence analysis showed higher mean brightness density in the late phase of implantation in group II meshes (p?=?0.000).

Conclusion

Polypropylene mesh coated with purified collagen gel increases adherence to tissue, promotes a less intense and lasting inflammatory response and triggers a greater organization and packing arrangement of collagen fibers in the late phase of implantation.     

Evaluating the porcine dermis graft InteXen® in three-compartment transvaginal pelvic organ prolapse repair

Introduction and hypothesis

The aim was to assess the efficacy of three-compartment pelvic organ prolapse (POP) vaginal repair using the InteXen® biocompatible porcine dermal graft as compared to traditional colporrhaphy with sacrospinous ligament suspension.

Methods

Preoperative, operative, postoperative and follow-up data were collected retrospectively. Objective recurrence was defined as POP quantification ≥ stage II and subjective recurrence as a symptomatic bulge.

Results

Each group consisted of 63 patients. Surgery time was longer using InteXen® (72?±?24.5 vs 55?±?23.5 min, p?=?0.0002). Length of hospital stay (4.6?±?1.6 vs 4.9?±?2.1 days, p?=?0.34) as well as duration of follow-up (37.1 vs 35.7 months, p?=?0.45) were equivalent between the two groups. No case of mesh erosion or infection was noted. The objective (17% vs 8%, p?=?0.12) and subjective recurrence rates (13% vs 5%, p?=?0.12) between the two groups were not statistically different.

Conclusions

InteXen® was well tolerated but had similar efficacy to traditional colporrhaphy and sacrospinous ligament suspension.     

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

Background

The shrinkage of mesh has been cited as a possible explanation for hernia recurrence. Expanded polytetrafluoroethylene (ePTFE) is unique in that it can be visualized on computed tomography (CT). Some animal studies have shown a greater than 40% rate of contraction of ePTFE; however, very few human studies have been performed.

Study design

A total of 815 laparoscopic incisional/ventral hernia (LIVH) repairs were performed by a single surgical group. DualMesh Plus (ePTFE) (WL Gore &; Associates, Newark, DE) was placed in the majority of these patients using both transfascial sutures and tack fixation. Fifty-eight patients had postoperative CTs of the abdomen and pelvis with ePTFE and known transverse diameter of the implanted mesh. The prosthesis was measured on the CT using the AquariusNet software program (TeraRecon, San Mateo, CA), which outlines the mesh and calculates the total length. Data were collected regarding the original mesh size, known linear dimension of mesh, seroma formation, and time interval since mesh implantation in months.

Results

The mean shrinkage rate was 6.7%. The duration of implantation ranged from 6?weeks to 78?months, with a median of 15?months. Seroma was seen in 8.6% (5) of patients. No relationship was identified between the percentage of shrinkage and the original mesh size (P?=?0.78), duration of time implanted (P?=?0.57), or seroma formation (P?=?0.074). In 27.5% (16) of patients, no shrinkage of mesh was identified. Of the patients who did experience mesh shrinkage, the range of shrinkage was 2.6?C25%.

Conclusions

Our results are markedly different from animal studies and show that ePTFE has minimal shrinkage after LIVH repair. The use of transfascial sutures in addition to tack fixation may have an implication on the mesh contraction rates.     

Laparoscopic intraperitoneal mesh fixation with fibrin sealant (Tisseel<Superscript>®</Superscript>) vs. titanium tacks: a randomised controlled experimental study in pigs

Background

The main reason for hospital stay after laparoscopic ventral hernia repair (LVHR) is probably pain, which also causes a lengthening of the patient’s time to assume normal daily activities and work. It is likely that titanium tacks may be the main contributing factor to early (and maybe chronic) pain after LVHR. Therefore, non-invasive and patient-friendly mesh fixation methods must be considered. The present study was designed to investigate the technical applicability, safety and effect of Tisseel^® for intraperitoneal mesh fixation.

Methods

Nine 40-kg Danish Landrace female pigs had two pieces of MotifMESH^® and two pieces of Proceed^® mesh fixed in the intraperitoneal position by a laparoscopic technique. The two pieces of the same mesh were fixed with fibrin glue (Tisseel) and titanium tacks, respectively. All pigs were euthanised on the 30th postoperative day and the mesh–tissue samples were tested for strength of ingrowth (peel test), adhesion formation, mesh shrinkage and examined for histological alterations.

Results

No meshes were displaced from their initial position at autopsy, but we observed two cases of mesh folding that could have resulted in hernia recurrence in real patients. There were no significant differences in the strength of ingrowth between different mesh types or fixation methods, measured as peel work per area of mesh (J/m²) and peak force per width of mesh (N_max/cm). The Proceed mesh shrank by 11% compared to 4% for the MotifMESH mesh (p =  0.002). There was no difference in the grade of adhesions (%) between fixation methods (p = 0.794) or different mesh types (p = 0.296). In the same fashion, there was no difference in the strength of adhesions (grades 0–4) between the two fixation methods or different mesh types (p>0.5, χ² test). There was no significant difference in the formation of fibrosis or inflammation between the different meshes or fixation methods. All samples showed significant foreign-body reaction with giant cells.

Conclusion

Our results suggest that the laparoscopic fixation of an intraperitoneal mesh with Tisseel is safe and technically feasible in a pig model. There is still no evidence that fibrin-sealing alone is appropriate for intraperitoneal mesh fixation in hernia repair, but the technique might become an alternative or supplement to mechanical mesh fixation. Until then, further experimental research in animal hernia models with larger meshes is needed, especially with a focus on mesh folding and displacement.

     

A comparison of Progrip® and Adhesix® self-adhering hernia meshes in an onlay model in the rat

Background

Atraumatic fixation is a key element of modern hernia repair. Two different concepts of self-adhering meshes were directly compared in this study. Adhesix^® (AH) is coated with polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP), whereas Parietene Progrip^® (PP) relies on the mechanical principle of micro grips made of polylactic acid (PLA). These meshes are the main competitors in the field.

Methods

AH and PP were tested in Sprague–Dawley rats at 14 and 90 days. Four groups were operated (n = 8 animals per group). Two meshes were implanted per animal in an operation model of onlay hernia repair. Dislocation, tissue integration and foreign-body reaction were evaluated.

Results

AH dislocated significantly more frequently (every second mesh) at both time points of observation than PP. Tissue integration was good with PP and could not be reliably assessed in AH due to frequent dislocation. Histologic examination revealed only a mild foreign body reaction in all groups.

Conclusions

In our hands, PP (mechanical grip fixation) was superior to hydrogel fixation with PEG and PVP in AH in an onlay model. The reason for dislocation of AH requires further clarification as well as the impact of long-term degradation of the PLA grips.     

Dried human amniotic membrane as an antiadherent layer for intraperitoneal placing of polypropylene mesh in rats

Background

Intraabdominal peritoneal onlay polypropylene (PP) mesh repair of incisional hernia has the potential risk of adhesions, bowel obstructions, and intestinal fistulae. Fresh or cryopreserved human amniotic membrane (HAM) has been tested as an antiadherent layer in animals, with excellent outcomes. However, it has disadvantages: it is difficult to handle, and it is expensive to store. Another processing method is available: drying in a laminar flow hood and gamma irradiation. Because this method impairs the membrane’s cell viability, it may affect its antiadherent properties. However, such properties may also result from the collagen matrix and its basement membrane, which remain after drying. The aim of the present study was to asses dried irradiated HAM in adhesion prophylaxis in rats.

Methods

Twenty-four female rats were randomized into two groups. In the first group (control group), PP meshes were placed in the intraabdominal space, and in the second group (treatment group), PP meshes coated with HAM were used. Animals were killed on day 30 after surgery. Adhesions and parietal prosthetic incorporation were assessed macroscopically and expressed as the average percentage of the covered area. The portion of the abdominal wall was then resected for histological testing.

Results

The treatment group had a significantly higher percentage of adhesions and parietal incorporation compared with the control group (p = 0.003). Histological testing showed a higher inflammatory response in the treatment group, with an intense foreign body reaction.

Conclusions

Dried irradiated HAM does not prevent adhesion formation in intraabdominal peritoneal onlay PP mesh repair in rats. Any use of this biomaterial in adhesion prophylaxis must be undertaken respecting graft cell viability as much as possible.     

Lower exposure rates of partially absorbable mesh compared to nonabsorbable mesh for cystocele treatment: 3-year follow-up of a prospective randomized trial

Introduction and hypothesis

In surgery for pelvic organ prolapse (POP) the use of alloplastic meshes has become common. Among possible complications, mesh exposure is the most frequent problem. It is hypothesized that exposure rates are correlated to mesh weight and the amount of foreign material. Therefore, we conducted a prospective open-label randomized multicenter trial comparing a conventional polypropylene mesh (PP) with a partially absorbable polypropylene mesh (PA) for cystocele treatment.

Methods

A total of 200 patients with POP > stage I were randomized either to a conventional or a partially absorbable mesh. Exposure rates were observed after 3, 12, and 36 months and correlated to mesh material, patient characteristics, intraoperative data, and treatment centers. Furthermore, management of mesh exposure, satisfaction with surgery, and postoperative pain were evaluated.

Results

At all follow-up intervals mesh exposure rate was smaller in the group of the partially absorbable mesh (3 months PP 11.3 % vs PA 3.2 %, p?=?0.0492; 12 months 6.6 % vs 6.3 %; 36 months 7.5 % vs 3.4 %). Over the course of time, mesh exposure was observed in 27 patients, with surgical intervention necessary in 11 patients. The rate of recurrent POP was higher (p?>?0.05) in patients with the partially absorbable mesh. The majority of patients were fully satisfied with the operation (52.8 %) and had no pelvic floor pain (67.5 %).

Conclusion

In this prospective, randomized trial with a long-term follow-up there was a low exposure rate in both treatment groups with a trend toward fewer exposures in the group of the partially absorbable mesh.     

Novel technique of overlaying a poly-l-lactic acid nanosheet for adhesion prophylaxis and fixation of intraperitoneal onlay polypropylene mesh in a rabbit model

Background

One problem with polypropylene mesh (PPM) used to repair abdominal wall hernias is dense adhesions to the visceral surface. The authors developed the biocompatible poly-l-lactic acid (PLLA) nanosheet (thickness?Methods The PLLA nanosheet was fabricated by the spin-coating method and peeling technique with polyvinyl alcohol (PVA) as a supporting film. Two 1.5-cm-square pieces of mesh were implanted on each peritoneal side of the midline incision. The mesh was fixed to the peritoneum with a suture and then overlaid with a 4-cm-square piece of Seprafilm or nanosheet. To examine the fixative property, mesh was overlaid with Seprafilm or nanosheet without a fixed suture. After 4?weeks, mesh adhesion, inflammatory reaction, fixation, and dislocation of mesh were evaluated.

Results

Nanosheet-overlaid meshes were flexible and fit over the peritoneum. Adhesion was observed in 10% of the nanosheet-overlaid meshes and in 50% of the Seprafilm-overlaid meshes. The adhesion tenacity grade was significantly lower with the nanosheet-overlaid meshes (0.1?±?0.1) than with the Seprafilm-overlaid meshes (1.0?±?0.4) (p?=?0.029), and the percentage of the adhesion area also was lower with the nanosheet-overlaid meshes (1.0?±?1.0% vs 8.5?±?3.2%; p?=?0.037). The mean inflammatory cell counts were lower with the nanosheet-overlaid meshes (p?=?0.0023). Regarding the fixative property, 37.5% of the nanosheet-overlaid meshes were fixated on the peritoneum, but no Seprafilm-overlaid mesh was fixated.

Conclusion

Overlaying of a PLLA nanosheet was effective for adhesion prophylaxis of intraperitoneal mesh. It also may have a possible beneficial effect on fixation of mesh.     

Early and late postoperative inflammatory and collagen deposition responses in three different meshes: an experimental study in rats

Purpose

Although meshes reduce abdominal hernia recurrence, they increase the risk of inflammatory complications. This study aimed to compare the early and late postoperative inflammation and collagen deposition responses induced by three meshes.

Methods

Rats were allocated into three groups. In group I, a polypropylene (PP) mesh was implanted in the abdominal wall. In groups II and III, PP + polyglactin (PP + PG) and PP + titanium (PP + TI) meshes were employed, respectively. On the seventh (7th) postoperative day, collagen deposition and inflammation were evaluated, and immunohistochemistry was performed on abdominal wall biopsies. These data were compared with those obtained on the fortieth (40th) postoperative day in a previous study.

Results

The early inflammatory responses were the same in all groups. With time, it decreased in group I (p = 0.047) and increased in group II (p = 0.003). Group I exhibited early elevated VEGF (p < 0.001), COX2 (p < 0.001), and collagen (p = 0.023) levels, and group II exhibited the most severe inflammatory tissue response. On the 40th postoperative day, the VEGF (p < 0.001) and collagen (p < 0.005) were reduced as compared with the 7th postoperative day in all groups.

Conclusions

Belatedly, the inflammatory reaction decreased in PP mesh group and increased in PP + PG mesh group. The PP mesh induced early great elevations in VEGF, COX2 and collagen levels, whereas the PP + PG mesh caused severe tissue inflammation with small elevation in these levels. PP + TI mesh induced inflammatory response levels between the others. In conclusion, the inflammatory response depends on the mesh density and also the mesh material with clinical implications.     

Clinical features and surgical outcomes of primary cauda equina tumours

Background

To identify clinical features, radiological findings and surgical outcomes of primary cauda equina tumours.

Methods

A consecutive series of 64 operations in 60 patients with primary cauda equina tumours from April 1999 to May 2009 at one institution comprised the study. The cases were divided into tumours of neural sheath origin (TNS, n?=?48) and tumours of non-neural sheath origin (TNNS, n?=?22). We analysed pain intensity, neurological abnormalities, MRI findings, surgical extent and functional outcome.

Results

The TNS group showed more leg pain (76 % vs. 44 %, p?=?0.019) with higher intensity (6.1?±?1.5 vs. 4.6?±?1.9, p?=?0.04). Motor weakness and bladder dysfunction were more common in the TNNS group (p?=?0.028 and p?=?0.00 in each). Flow voids of MRI were more frequently observed in TNNS (50 % vs. 4 %, p?=?0.01). The TNS group achieved total removal in all operations compared with total removal in 77 % in the TNNS group (p?=?0.001). The TNNS group showed higher recurrence rates (18 % vs. 0 %, p?=?0.009). The TNS group showed higher improvement of JOA scores postoperatively (p?=?0.049). Surgical complications were observed less frequently in the TNS group (19 % vs. 78 %, p?=?0.000).

Conclusions

TNS differs from TNNS by causing more frequent leg pain, higher pain intensity and more frequent flow voids. TNS has better surgical outcomes than TNNS in terms of higher rates of total removal, fewer surgical complications, better functional outcomes and less recurrence.     

Comparison of polypropylene mesh and porcine-derived,cross-linked urinary bladder matrix materials implanted in the rabbit vagina and abdomen

Introduction and hypotheses

Our aim was to compare histological and biomechanical effects of polypropylene (PP) mesh and porcine-derived, cross-linked urinary bladder matrix (cUBM) graft materials using a rabbit vaginal and abdominal model.

Methods

Forty rabbits were implanted with PP mesh (n?=?20) or cUBM (n?=?20) in the vagina and abdomen. Two grafts (PP or cUBM) of the same type were placed into each site, so each rabbit had four grafts. Grafts were harvested 12 weeks later and processed for histologic analysis and biomechanical testing.

Results

There were high rates of two types of grafts missing in the vagina. Vaginal PP was associated with erosion reaction (67 %), whereas abdominal PP and cUBM showed no sign of erosion. All patches adhered to rectus abdominis or vaginal mucosa and shrank to varying degrees, especially for PP grafts. Compared with vaginal PP, vaginal cUBM induced milder chronic inflammation response, had lower scores (P?=?0.000) for inflammation response, and showed higher scores for neovascularization (P?=?0.000) and fibroblastic proliferation (P?=?0.002). In the abdomen, both histopathological parameters were insignificantly different (P?>?0.05) between cUBM and PP. The mechanical properties of UBM did not deteriorate following implantation, whereas the ultimate tensile strength and elastic modulus of vaginal PP increased. PP had higher scores for tensile and break strength than did cUBM (P?<?0.05).

Conclusions

The cUBM has good biocompatibility, high ability to integrate with the vagina, and maintains mechanical properties in vivo. It may be a promising material for pelvic floor reconstruction.     

The efficacy and safety of chitosan dextran gel in a burr hole neurosurgical sheep model

Background

Achieving and maintaining haemostasis is of paramount importance in neurosurgery. Chitosan has been shown in both animal and human models to be significantly effective in haemostasis as well as in reducing adhesion formation.

Objectives

To evaluate the haemostatic potential and to study histopathological changes caused by novel chitosan dextran gel in a neurosurgical sheep model.

Method

Ten sheep underwent neurosurgical burr hole procedure. Bleeding control was tested at the level of bone, dura and brain separately with both chitosan gel and Gelfoam paste on separate burr holes. Baseline bleeding was measured at the time of injury using the Boezaart scale, and then every 2 min after the application of each agent until complete haemostasis or 10 min, whichever was earlier. Safety was assessed through MRI scans and histopathological analysis.

Results

Mixed modeling showed no statistical difference in time to haemostasis between chitosan gel and Gelfoam paste (means of log-normalized areas under the curve were 1.3688 and 1.3196 respectively) for each burr hole (p?=?0.7768). Logistic regression modeling showed that Chitosan significantly decreased the incidence of bleeding beyond the first time point measured after application of the treatment when compared to Gelfoam (OR?=?2.7, p?=?0.04). Average edema volume (cm³) on post-operative MRI was 0.97 for Gelfoam and 1.11 for (p?=?0.49) while average histology scores were 2.5 for Gelfoam versus 3.3 for chitosan (p?=?0.32).

Conclusion

Chitosan dextran gel is an effective haemostatic agent to control bleeding in brain tissue. It is safe and nontoxic to neural tissue.     

The effect of a chitosan coating on the adhesive potential and tensile strength of polypropylene meshes

Purpose

The polypropylene mesh used for the repair of abdominal wall hernia can cause intraabdominal adhesions. In this study, the effect of chitosan coating of the polypropylene meshes on the adhesion and tensile strength of the meshes was investigated.

Method

After coating polypropylene meshes with 2?% chitosan, 5?×?3 cm patches were prepared. Under general anesthesia, sterile laparotomy was performed in 96 Wistar albino female rats that were equally allocated to 6 groups. In the first group, only laparotomy was performed. In the second group, chitosan was applied to the peritoneal cavity, and the laparotomy was closed. In the third group, polypropylene (prolene) patches were used to close the abdomen; in the fourth group, polypropylene polyglecaprone 25 (ultrapro) mesh patches were used to close the abdomen. In the fifth and sixth groups, chitosan-coated versions of the meshes used in the third and fourth groups, respectively, were applied. All skin incisions were closed in all groups. On the 7th and 21st?days, eight randomly selected rats from each group were killed. The abdomen was opened, and the adhesions were evaluated using the diamond score. The tensile strength of the meshes was measured by an Instron 4301 device. The histopathological evaluation of the inflammatory response was performed according to the Ehrlich and Hunt classification.

Results

The adhesion score was comparable among mesh groups but higher when mesh groups were compared with the control and chitosan groups (p<0.001). The tensile strength of meshes did not differ among mesh groups. Histopathologically, meshes with or without chitosan were similar in terms of inflammatory findings.

Conclusions

The chitosan coating did not affect the adhesion potential, the tensile strength, or the inflammatory response of the polypropylene meshes.     

Changes in prolapse surgery trends relative to FDA notifications regarding vaginal mesh

Introduction and hypothesis

In 2008 and 2011, the US Food and Drug Administration (FDA) released notifications regarding vaginal mesh. In describing prolapse surgery trends over time, we predicted vaginal mesh use would decrease and native tissue repairs would increase.

Methods

Operative reports were reviewed for all prolapse repairs performed from 2008 to 2011 at our large regional hospital system. The number of each type of prolapse repair was determined per quarter year and expressed as a percentage of all repairs. Surgical trends were examined focusing on changes with respect to the release of two FDA notifications. We used linear regression to analyze surgical trends and chi-square for demographic comparisons.

Results

One thousand two hundred and eleven women underwent 1,385 prolapse procedures. Mean age was 64?±?12, and 70 % had stage III prolapse. Vaginal mesh procedures declined over time (p?=?0.001), comprising 27 % of repairs in early 2008, 15 % at the first FDA notification, 5 % by the second FDA notification, and 2 % at the end of 2011. The percentage of native tissue anterior/posterior repairs (p?<?0.001) and apical suspensions (p?=?0.007) increased, whereas colpocleisis remained constant (p?=?0.475). Despite an overall decrease in open sacral colpopexies (p?<?0.001), an initial increase was seen around the first FDA notification. We adopted laparoscopic/robotic techniques around this time, and the percentage of minimally invasive sacral colpopexies steadily increased thereafter (p?<?0.001). All sacral colpopexies combined as a group declined over time (p?=?0.011).

Conclusions

Surgical treatment of prolapse continues to evolve. Over a 4-year period encompassing two FDA notifications regarding vaginal mesh and the introduction of laparoscopic/robotic techniques, we performed fewer vaginal mesh procedures and more native tissue repairs and minimally invasive sacral colpopexies.     

Comparison between trans-obturator trans-vaginal mesh and traditional anterior colporrhaphy in the treatment of anterior vaginal wall prolapse: results of a French RCT

Introduction and hypothesis

To compare the efficacy of a collagen-coated polypropylene mesh and anterior colporrhaphy in the treatment of stage 2 or more anterior vaginal wall prolapse.

Methods

Prospective, randomized, multicenter study conducted between April 2005 and December 2009. The principal endpoint was the recurrence rate of stage 2 or more anterior vaginal wall prolapse 12 months after surgery. Secondary endpoints consisted of functional results and mesh-related morbidity.

Results

One hundred and forty-seven patients were included, randomized and analyzed: 72 in the anterior colporrhaphy group and 75 in the mesh group. The anatomical success rate was significantly higher in the mesh group (89 %) than in the colporrhaphy group (64 %) (p?=?0.0006). Anatomical and functional recurrence was also less frequent in the mesh group (31.3 % vs 52.2 %, p?=?0.007). Two patients (2.8 %) were reoperated on in the colporrhaphy group for anterior vaginal wall prolapse recurrence. No significant difference was noted regarding minor complications. An erosion rate of 9.5 % was noted. De novo dyspareunia occurred in 1/14 patients in the colporrhaphy group and in 3/13 patients in the mesh group. An analysis of the quality of life questionnaires showed an overall improvement in both groups, with no statistical difference between them. Satisfaction rates were high in both groups (92 % in the colporrhaphy group and 96 % in the mesh group).

Conclusion

Trans-obturator Ugytex® mesh used to treat anterior vaginal wall prolapse gives better 1-year anatomical results than traditional anterior colporrhaphy, but with small a increase in morbidity in the mesh group.     

A rat hysteropexy model for evaluating adhesion formation and comparison of two different structured meshes

Introduction and hypothesis

Peritonization of mesh during sacrohysteropexy is generally advocated to prevent adhesions to the viscera; however, randomized clinical trials are lacking, and peritonization may not be completely possible in a laparoscopic hysteropexy procedure. Our main objective was to describe a basic experimental rat sacrohysteropexy model. We hypothesized that even when peritoneal closure was omitted, using composite mesh would result in less adhesions to the viscera.

Methods

Twenty in-bred female virgin Wistar Hannover rats were used in this study. Standardized hysteropexy procedure and adhesion model is described step by step with two different mesh materials: polypropylene and a composite polyester. Mesh was anchored between the posterior cervix and anterior longitudinal ligament of the lumbar vertebrae. Macroscopic adhesion scores and histopathological tissue reaction was investigated.

Results

Macroscopically, the surface area involved in adhesions was similar between groups. However, adhesions in the polypropylene group were more dense, required sharp dissection for lysis, and yielded higher total macroscopic adhesion scores (p < 0.001). Histologically, a more pronounced host inflammatory response was encountered in the polyester group (p < 0.001).

Conclusions

We describe a rat hysteropexy model and a previously established uterine adhesion model. Adhesion scores in the composite mesh group were lower, and bowel involvement was not seen. Our findings are promising, and further research investigating antiadhesive composite mesh use for hysterosacropexy would be appropriate, especially when peritoneal closure is omitted.

     

PerFix? plug versus 4DDOME? implants for inguinal hernia repair: prospective multicentric randomised controlled trial

Introduction

Anterior mesh placement is the standard of care for hernia repair. The use of partially absorbable meshes may limit post-operative pain without altering the durability of the repair. We designed a prospective randomised study, which aims to compare the PerFix? plug to the 4DDOME^?, a partially absorbable mesh.

Materials and methods

Inguinal hernia patients were prospectively and randomly included in the study. Hernia repair was performed using either the PerFix? plug (Davol) or the 4DDOME^? implant (Cousin Biotech). Operative evaluation included type and duration of anaesthesia, characteristics of the incision, post-operative hospital stay and pain evaluated through a visual analogue scale (VAS) at day 1, day 8, month 1, month 6, and year 1. Return to personal or professional activity was evaluated. Quality of life was measured by a SF36 questionnaire at 1, 6, and 12?months’ follow-up.

Results

Ninety-five patients were prospectively enrolled and randomised to one type of prosthetic repair. The two groups of patients did not differ in terms of clinical characteristics, type of hernia, and intra-operative course. When comparing PerFix? plug to 4DDOME^? groups, the post-operative course was similar: pain (VAS 3.42 (SD 1.83) vs. 3.82 (SD 2.0), p?=?0.69); in-hospital stay (2.12 (SD 1.36) vs. 2.25 (SD 1.62), p?=?0.67); and return to personal (9.39?days (SD 8.15) vs. 9.48?days (SD 11.68), p?=?0.96) and professional activity (25.71?days (SD 17.47) vs. 22.82?days (SD 18.10), p?=?0.62). Post-operative pain and discomfort assessed by the SF36 questionnaire at day 8, months 1, 6, and 12 were similar, but significantly lower after 4DDOME^? repair at 3?months for “pain” (p?=?0.021) and at 6?months for “health” criteria (p?=?0.028).

Conclusion

This clinical study demonstrated similar short-term results. The 4DDOME^? was associated with less pain and discomfort after 3 and 6?months. The combination of the dome shape and the double component mesh including an absorbable part meet the conflicting demands of early strength with a long-term low-weight material to minimise shrinkage and fibrosis. This design represents a potential advance in anterior tension-free hernia repair with mesh.     

Polypropylene meshes coated with a polysaccharide based bioadhesive for intra-abdominal mesh fixation in a rabbit model

Background

In this study, we evaluate a new bioadhesive for intra-abdominal onlay mesh fixation of a polypropylene–polyvinylchloride graft.

Methods

Three pieces of a commercially available polypropylene/polyvinylfluoride mesh, each 3 × 3 cm in size, and three pieces of the same mesh coated with a polysaccharide bioadhesive were fixated to the surface of the anterior abdominal wall of 30 New Zealand white rabbits. The fixation was performed either by using four transabdominal Prolene^® 4/0 sutures, four spiral tacks (Protack 5 mm Tyco), or cyanoacrylate glue (Glubran^® GEM, Viareggio, Italy). Each mesh position and the according kind of fixation were randomized before implantation. The animals were sacrificed 12 weeks postoperatively. After determining the extent of intra-abdominal adhesions, the meshes were excised en bloc with the anterior abdominal wall for tensile strength measurements and histological analysis.

Results

All meshes coated with the bioadhesive adhered to the intact peritoneum without extra fixation. Irrespective of the fixation technique coated meshes led to more and stronger adhesions. Mesh shrinkage by scarring was increased in coated meshes fixed with glue and low in uncoated meshes fixed with tacks. Testing the tensile strength, coated meshes fixed with transfascial sutures achieved the best results (16.14 ± 6.1 N), whereas coated meshes fixed with glue showed the lowest strength (10.39 ± 4.81 N). The foreign body reaction was considerably more distinctive using coated mesh. The mesh ingrowth was not influenced by this reaction.

Conclusions

All meshes coated with the new bioadhesive were self-adhesive in that way; they stayed in position when attached to the peritoneum. Although this may facilitate intra-operative mesh fixation, the bioadhesive displayed several disadvantages, such as stronger adhesions and an increased shrinkage of the implant. The tensile strength was not influenced by the use of the bioadhesive. At present, we see no major advantage for polysaccharide bioadhesive applied in this study.     

A comparison of outcomes between open and laparoscopic surgical repair of recurrent inguinal hernias

Background

Inguinal hernia recurrence after surgical repair is a major concern. The authors report their experience with open and laparoscopic repair of recurrent inguinal hernias.

Methods

After institutional review board approval, a retrospective review was performed with the charts of 197 patients who had undergone surgical repair of recurrent inguinal hernias from January 2000 through August 2009, and the data for 172 patients who met the inclusion criteria were analyzed. Surgical variables and clinical outcomes were compared using Student??s t test, the Mann?CWhitney U test, chi-square, and Fisher??s exact test as appropriate.

Results

The review showed that 172 patients had undergone either open mesh repair (n?=?61) or laparoscopic mesh repair (n?=?111) for recurrent inguinal hernias. Postoperative complications were experienced by 8 patients in the open group and 17 patients in laparoscopic group (p?=?0.70). Five patients (8.2%) in the open group and four patients (3.6%) in the laparoscopic group had re-recurrent inguinal hernias (p?=?0.28). Four patients in the open group (9.5%) and no patients in the laparoscopic group had recurrence during long-term follow-up evaluation (p?=?0.046). In the laparoscopic group, 76 patients (68.5%) underwent total extraperitoneal (TEP) repair, and 35 patients (31.5%) had transabdominal preperitoneal (TAPP) repair. Postoperative complications were experienced by 13 patients in the TEP group and 4 patients in the TAPP group (p?=?0.44). Two patients (2.6%) in the TEP group and two patients (5.7%) in the TAPP group had re-recurrent inguinal hernias (p?=?0.59).

Conclusions

This retrospective review showed no statistical difference in the re-recurrence rate between the two techniques during short-term follow-up evaluation. However, the laparoscopic technique had a significantly lower re-recurrence rate than the open technique during long-term follow-up evaluation. Both procedures were comparable in terms of intra- and postoperative complications. Among laparoscopic techniques, TEP and TAPP repair are acceptable methods for the repair of recurrent inguinal hernia. A multicenter prospective randomized control trial is needed to confirm the findings of this study.