Tentacle-shaped mesh for fixation-free repair of umbilical hernias
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Mesh fixation and broad overlap represent an open issue in umbilical hernia repair. A proprietary-designed implant with tentacle straps at its boundary has been developed to ensure a suture-free repair and a broader coverage of the abdominal wall. The study describes the results of umbilical hernia procedures carried out with the tentacle-shaped implant and the related surgical technique.
A proprietary tentacle-shaped flat mesh having a central body with integrated radiating arms at its edge was used to repair large umbilical hernias in 62 patients. The implant was placed in preperitoneal sublay. The friction of the straps, crossing the abdominal wall thanks to a special needle passer, was intended to assure adequate grip to hold the implant in place assuring a fixation-free procedure and broad overlap of the hernia defect.
In a mean follow-up of 48 months (range 10–62 months), 4 seromas and 2 ischemia of the navel skin occurred. No infections, hematomas, chronic pain, mesh dislocation, or recurrence has been reported.
The tentacle strap system of the prosthesis effectively ensured an easier implant placement avoiding the need for suturing the mesh. The arms of the implant ensured a proper orientation and stabilization of the mesh in association with a broad defect overlap. The specifically developed surgical procedure showed a quick postoperative recovery, a very low complication rate, and no recurrences even in the long term.
KeywordsHernia Umbilical Hernia repair Tentacle mesh Fixation free Friction force Freexation
Umbilical hernia is a rather frequent pathology, having an incidence of 10–14% compared to all hernias. For decades, it was performed with direct suture technique with recurrences up to 54% [1, 2, 3]. In recent years, the use of synthetic implants has contributed to a drastic reduction in recurrences [4, 5, 6]. Nevertheless, prosthetic umbilical hernia repair is affected by frequent, specific postoperative complications consequent to mesh fixation and insufficient overlap of the mesh over the hernia opening, which can lead to tissue tearing, mesh migration, and recurrences . To eliminate these problems, a prosthetic device has been developed, composed of an oval flat mesh with incorporated tentacle straps at its boundary, that allows a simple, fast "fixation free" positioning of the implant, assuring broad coverage of the umbilical region. This implant is delivered by mean of a proprietary passer that allows simple, quick deployment of the device distant from the hernia edge. The mesh is held in place without fixation by the tentacle straps that are pulled out from the preperitoneal space to the subcutaneous space passing through the rectus muscles and fascia. The present report aims to demonstrate the effectiveness of the use of an adequately sized tentacle-shaped mesh in patients suffering from umbilical hernia defects larger than 2 cm in diameter.
Materials and methods
Patients demographics, treatment details, and results
Number of patients: 62
Primary umbilical hernia: 48 (16 incarcerated)
Gender: 24 male–38 female
Recurrent umbilical hernia: 14 (3 multi-recurrent– 5 incarcerated)
Mean age 41 years (25–63)
Mean hernia defect size: 3.5 cm ( 2–5 cm)
Mean BMI: 29.40 (24–36)
Mean mesh overlap: 6 cm (5–7 cm)
Wound infection: 0 (0%)
Time needed for mesh placement and strap positioning: mean 6 min (4–8 min)
Seroma: 4 (6%)a
Intraoperative complications: 0
Navel ischemia after omphaloplasty: 2 (3%)a
Hospital stay: 1 day (day surgery)
Recurrence: 0 (0%)
Mean follow-up length: 48 months (10–62 months)
Total complication rate: 15.4%
In the cohort of 62 patients who underwent umbilical hernia repair with the tentacle-shaped implant, broad coverage of the abdominal wall far beyond the hernia opening was achieved. We measured a mean overlap of ca. 6 cm (range 5–7 cm) assessed from the hernia border to the lateral edge of the implant. The mean time needed to properly deliver all tentacles and deploy the mesh was 6 min (range 4–8 min). No suture fixation of the implant was necessary. The procedures were carried out in day surgery and the patients could be discharged on the same day of the operation. In the postoperative period, we observed 4 (6%) seromas and 2 ischemia of the navel skin after reconstruction. These minor complications were resolved within 15 days with conservative therapy. There were no wound infections, hematoma, chronic pain, or nerve-entrapment symptoms (Table 1). US scans during follow-up showed that all tentacles laid in the correct position. The placement of the tentacles would have unveiled an eventual implant dislocation, but no mesh dislocation was documented. During follow-up, no patient was lost. Patients were questioned regarding pain, any limitations to abdominal-wall mobility and overall satisfaction. In particular, no discomfort due to strap placement in the subcutaneous fat was reported. For all 62 patients, the mean follow-up was 48 months (range 10–62 months). No mesh dislocation or recurrence was reported. No significant pain or discomfort was described by the patients, even in the long term.
Umbilical hernia is commonly perceived as a disease requiring low attention from the surgical community. Despite this, many patients who undergo surgical repair of umbilical protrusion suffer from adverse events that could be avoided by improving the operative strategy using appropriate prosthetic devices. Among the complications that affect umbilical hernia repair, recurrence represents a controversial subject in literature. Usually, small defects (< 2 cm) are repaired open, with direct suture of the gap, while larger defects can be treated open or laparoscopic with the deployment of an implant in onlay or sublay fashion. Some studies involving large cohorts of patients indicate a recurrence rate of 1–10% after prosthetic umbilical hernia repair [8, 9]. Nevertheless, other reports specify an incidence of recurrences between 11 and 18% [4, 10]. Independent of these incongruences, in prosthetic umbilical repair, several factors are involved in the pathogenesis of recurrence: defect size, BMI, smoking, pregnancy, and reduced mesh overlap. A broad mesh coverage in a small surrounding like the umbilical area represents one of the most important problems that seems to be rarely debated in literature. Actually, the prosthetic coverage of a repaired umbilical defect is seldom larger than a few cm. This seems to be a major issue that, especially in obese patients with large defects, can facilitate the reappraisal of the protrusion. Another significant challenge is represented by mesh fixation at the boundary of the umbilical area, which is often extremely difficult and can lead to postoperative complications like tissue tear, hematoma and/or mesh dislodgment . Furthermore, the position of the mesh used for reinforcing the abdominal wall also plays an important role. In the literature, it is well acknowledged that a deeper mesh placement helps in avoiding recurrences [12, 13]. For this reason, a preperitoneal sublay deployment of an implant seems to be more indicated to prevent recurrences. To overcome all these issues, a proprietary tentacle-shaped implant in different sizes has been developed for the surgical treatment of ventral and incisional hernia. The inherent friction force exerted by the tentacle straps crossing the abdominal-wall tissue has been already tested in an experimental trial on a porcine model to demonstrate the effectivity of the principle of mesh fixation through friction . The tentacle mesh used to repair umbilical hernias in the above-described patient cohort seems to possess suitable characteristics to adequately resolve the problems connected to the surgical treatment of this frequent protrusion. Thanks to a well-established surgical strategy, achieving a broad dissection between posterior rectus sheath and peritoneal sheath does not appear challenging if carried out with careful separation of these elements. Once the preperitoneal planes are dissected, the delivery of the tentacle mesh by means of the proprietary passer is quick and easy; it allows the tentacles to pass from the posterior rectus sheath towards the subcutaneous layer crossing the abdominal wall. Piercing the abdominal wall with the passer, from the subcutaneous layer until the posterior rectus sheath, is quite easy. Actually, despite being carried out blind, the forefinger dome interposed between the posterior rectus sheath and the detached peritoneum consents a safe introduction and guidance of the passer needle through the preperitoneal interstitium as far as the wound opening. This maneuver also allows deployment of the mesh edges distal from the hernia border. Despite the distance from the hernia defect, there is no need for fixating the borders of the implant, the mesh is simply held in place by the friction exerted by the straps passing the abdominal wall structure laterally from the defect. The 3 mm-large passer needle tunneled across the tissue forces the 2 cm large strap to roll along its axis. Therefore, the friction exerted by its rolled contour into the small tunnel allows stable positioning of the arm within the tissues. This principle of physics has already been proven in the literature and is a suitable way to assure a fixation-free but firm positioning of polypropylene strips used for the treatment of female genital prolapse [15, 16, 17, 18, 19]. This kind of fixation-free implant stabilization is carried out under complete operator visualization, unlike point-to-point sutures carried out in a deep, narrow, and dark space. Delivery of the tentacle straps with the needle passer eliminates point fixation, thus simplifying the hernia repair procedure that can be performed in a shorter time. The limited mean time of 6 min needed for mesh placement and strap positioning seems to further confirm that the surgical repair can be carried out safely and quickly. The stabilizing feature of the tentacle strap system leads us to define its fixation-free effect as “freexation”. The surgical approach with the tentacle-shaped implant also revealed sharply reduced postoperative complications: the use of the tentacle mesh showed a reasonable postoperative complication rate of 9.7%. In the described patient sample, adverse events were represented only by 4 seromas, and 2 navel ischemia. The latter is a typical occurrence when, in large defects, the umbilical skin is tightly adherent to the hernia sack and after dissection remains with limited vascular support even if adequately resected before omphaloplasty. Thanks to the use of the tentacle-shaped mesh, among the patient sample, a mean mesh overlap from the hernia border ranging from 5 to 7 cm was assessed, which in this kind of procedure can be well defined as a broad overlap. It is the wide overlap assured by the tentacle mesh that is presumed to be the reason for the lack of recurrences in the examined patient cohort. In addition, postoperatively, all patients reported low pain that within 1 week sensibly diminished. Postoperative low pain seems to be linked to the non-fixation of the mesh to the myotendineal (and highly sensitive) surrounding of the umbilical region. In postoperative check-ups, easy localization of the straps with ultrasound scan was helpful, in particular in terms of recurrence prediction during patient follow-up which, to date, has not happened.
Umbilical hernia repair with the described tentacle-shaped implant appears to yield improved results compared with conventional pure tissue or conventional prosthetic repair procedures. Aside from a quick, safe placement technique and the reduced rate of adverse events, usually reported in meshes that need fixation, a more significant benefit is determined by the very broad coverage assured by the implant shape and the related surgical technique. We deem it was the main reason why no recurrences were reported in the patients of the cohort. Overall, the advantages of using this proprietary designed implant are clearly demonstrated and result in fixation-free mesh placement, simplified procedure, broader coverage of the abdominal wall, shortening of operative time, and reduced intra- and early postoperative complications.
This research did not receive any specific grant.
AG conceived the study. AG and GR designed the study. CGL, GL, and EE collected data from the registry. AA and PGC verified the analytical methods. CPG supervised the findings of this work. All authors discussed the results and contributed to the final manuscript.
This study was not funded.
Compliance with ethical standards
Conflict of interest
The corresponding author is the developer of the implant and related surgical technique. All other authors have no conflict of interest.
Approval from institutional ethics committee was obtained for this study.
Human and animal rights
The study including human participants has been performed in accordance with the ethical standards of the Declaration of Helsinki and its later amendments.
Informed consent was obtained from all patients prior to all surgical procedures.
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