4DDOME® inguinal hernia repair

The description of the 4DDOME® inguinal hernia repair covers all aspects of the surgical procedure used for the management of inguinal hernia. Operating room set up, position of patient and equipment, instruments used are thoroughly described. The technical key steps of the surgical procedure are presented in a step by step way: local anesthesia, dissection of indirect inguinal hernia, repair: 4DDOME® technique, 4DDOME® placement, anterior mesh placement, end of procedure, other types of hernias. Consequently, this operating technique is well standardized for the management of this condition.

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4DDOME®   inguinal   hernia   repair

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Abstract
The description of the 4DDOME® inguinal hernia repair covers all aspects of the surgical procedure used for the management of inguinal hernia.
Operating room set up, position of patient and equipment, instruments used are thoroughly described. The technical key steps of the surgical procedure are presented in a step by step way: local anesthesia, dissection of indirect inguinal hernia, repair: 4DDOME® technique, 4DDOME® placement, anterior mesh placement, end of procedure, other types of hernias.
Consequently, this operating technique is well standardized for the management of this condition.
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2006-03
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WeBSurg.com, Mar 2006;6(03).
URL: http://www.websurg.com/doi-ot02en328.htm

4DDOME®   inguinal   hernia   repair

1. Introduction
Presently, the goals of modern hernia surgery are not only prevention of future herniation from areas of the inguinal floor beyond the region of the original hernia (<1%), but are also to repair hernias with less postoperative pain and a shorter recovery period (Schumpelick, 2000). To corroborate this, medicolegal complaints mainly refer to residual pain after anterior inguinal hernia repair. Residual pain is partly related to the dissection technique, to the excess of prosthetic material but also to fixation techniques which are responsible for chronic painful discomfort in 1 to 17% of patients (Vrijland et al., 2002).

The use of 4DDOME®, a semi-absorbable obturator implant for the treatment of inguinal hernias may be the alternative modality as it is sufficiently resistant to intra-abdominal pressure and has low residual volume after absorption. 4DDOME® is made of 10% non-absorbable light polypropylene and 90% absorbable PLLA (Poly-L-Lactide Acid). There is less than 0.08 g of polypropylene left after PLLA absorption.
Its atraumatic, semi-rigid shape has been shown to resist the abdominal pressures without any distortion/deformation for at least 2 months. It can be used in all types of primary or recurrent inguinal hernias.

Developed according to a new concept its objective is not only to reconstruct the hernia orifice using an anterior approach, but also to strengthen the posterior wall of the inguinal region/the transversalis fascia where it is weak. Doing so, it contributes to correcting alterations of the transversalis fascia, thought to be responsible for the natural integrity of the deep inguinal ring (Melis et al., 2000). This type of inguinal hernia repair may be performed in an outpatient setting, using local or regional anesthesia. A good knowledge of the anatomy of the inguinal region is required to perform this procedure.
2. Technical principles
Principle of 4DDOME® repair:
4DDOME® is a composite prosthesis that obturates the parietal defect. It has to be resistant to the abdominal pressure without adding significant foreign body material. For rigidity purposes, a new composite poly-L-lactic acid (cPLLA) dome-shaped mesh was developed. It combines 90% absorbable poly-L-lactic acid with 10% non-absorbable and light polypropylene. The addition of cPLLA to light polypropylene mesh seems to reduce the problems of shrinkage and foreign body inflammatory reaction.
4DDOME® is combined with an anterior mesh similar to the one used in Lichtenstein open tension-free hernioplasty. The 4DDOME® repair technique combines a spherical dome, which is used to push back the hernia sac, and a precut, slit onlay patch to cover the deep layer of the inguinal canal.

Principle of anterior mesh repair:
The repair of abdominal wall hernias using a non-absorbable prosthetic mesh is one of the most commonly performed general surgical procedures. The aim of using a mesh is to achieve a physiological reinforcement of the abdominal wall through the induction of fibrosis (Schumpelick, 2000). It results in a tension-free repair of the defect.
3. Anatomy
• Myopectineal orifice
The present case is the one of a male patient.
The myopectineal orifice (MPO) is an oval-shaped planar aperture in each side of the lower anterior wall at its junction with the pelvis.
The endoabdominal fascia, known in the pelvis as the endopelvic fascia, and in the groin as the transversalis fascia (TF) is the precursor of many anatomic structures within or near the MPO.
1. MPO
2. Pelvis
• Anterior view/inguinal canal
The myopectineal orifice (MPO) is divided into inferior and superior panes by the inguinal ligament anteriorly and by the iliopubic tract posteriorly.
1. Periosteum of the superior public ramus (pectineal ligament) (inferior boundary)
2. Internal oblique muscle (superior boundary)
3. Transversus abdominis muscle (superior boundary)
4. Rectus muscle (medial boundary)
5. Iliopsoas muscle (lateral boundary)
6. Transversalis fascia
7. Inguinal ligament
8. Iliopubic tract (posteriorly)
• Posterior view/inguinal canal
Its superior pane is traversed by the spermatic cord (SC), which passes through the internal inguinal ring (IIR).
The TF, through which the deep epigastric vessels pass, forms the anterior and posterior crura of the IIR within the superior pane.
The posterior wall of the inguinal canal is strengthened by the interfoveolar ligament (Hesselbach's ligament).
1. Spermatic cord
2. Internal inguinal ring
3. Interfoveolar ligament and epigastric vessels
4. Inguinal triangle
4. Indications/contraindications
Indications
- external, oblique inguinal hernias beyond Type I defects (Nyhus classification), including recurrent hernias;
- direct hernias, notably recurrent hernias;
- contraindication to general anesthesia;
- large hernial defects that may require the insertion of a larger size 4DDOME®;
- the operation can be performed under local anesthesia: therefore there are few contraindications linked to patients who are elderly or in poor general physical condition.

Contraindications
- hematological disorders (borderline indication);
- cirrhosis (borderline indication);
- very large hernias;
- patient refusal;
- local infection;
- strangulated hernias? (save for early diagnosed hernias)
5. Operating room set-up
• Patient
This position should be comfortable for the patient as well as for the surgical team.
- the patient is positioned supine;
- both legs straight and maintained along the axis of the body;
- both arms maintained at right angles in arm holders.
Operative field:
The sterile preparation and draping of the operative field should be wide, covering the lower limbs, the entire thorax, the upper abdomen, the upper limbs, at the same time leaving the patient’s head free and accessible for conversation with the surgeon.
The example we are using is that of a patient operated on for a right-sided inguinal hernia.
• Team
The surgeon stands on the side of the hernia, which he/she is to operate.
The assistant stands opposite him/her.
The presence of a scrub nurse is not required. When present, he/she stands near the instrument table on the side of the operating table opposite the surgeon.
1. Surgeon (right-sided hernia)
2. Assistant
• Equipment
1. Anesthetic equipment
2. Operating table
3. Instrument table
4. Electrocautery device
The anesthetic equipment should enable cardio-vascular as well as oxygen saturation monitoring.
The surgical equipment should be kept to a minimum.
6. Instruments
• Instruments
The procedure is most often performed under local anesthesia. It requires a fairly simple, standard set of instruments, which are:
1. Syringe
2. Bladed surgical knife
3. Graspers
4. Bipolar scissors
5. 4DDOME®
6. Slit mesh, “Lichtenstein”-type
7. Gauze pads
8. Retractors
9. Auto-static retractor
10. Local anesthetic (lidocaine + ropivacaine): it allows 5 to 6 hours anesthesia and 36 to 48 hours analgesia. In our institution, ropivacaine is preferred due to longer duration of action, avoiding addition of adrenalin 0.5 as usually proposed with lidocaine. Ropivacaine is preferred to marcaine (less toxic for the heart).
• The kit
The 4DDOME® device is composed of two prostheses:
- one semi-absorbable dome;
- one semi-absorbable onlay patch.
7. Local anesthesia
• Local anesthetics
Depending on the surgeon's habits, different anesthetics are being used.
- either 100 mL lidocaine solution containing 5% adrenaline;
- or 40 mL ropivacaine combined with 30 mL lidocaine and 30 mL physiological saline totalling 100 mL of anesthetic solution.
Generally, 60 mL to 80 mL are enough to ensure the infiltration of all tissue layers. Lidocaine has a more rapid onset and Ropivacaine has a more long-lasting effect.
• Superficial tissues
The procedure is performed under local anesthesia or under locoregional or epidural anesthesia or spinal anesthesia. It is performed by the surgeon.
In patients with a high anxiety level, a sedative may be combined. General anesthesia may be necessary.
Anesthesia begins by infiltration of the subcutaneous tissues along the path of the incision, going 1 to 2 cm beyond its edges.
1. Anesthesia along the path of the incision
• Deeper tissues
After the cutaneous incision, a pocket is created in the subcutaneous layer at the upper end of the incision up to the external oblique aponeurosis.
5 mL of lidocaine are then injected, just below the aponeurosis, without injecting into the cord itself.
Anesthesia is established while pursuing the incision of the subcutaneous layer.
After incision of the external oblique aponeurosis, the genital branch of the genitofemoral nerve is infiltrated, on the lower edge of the cord, near the deep inguinal ring.
During dissection, the hernial sac is infiltrated, notably at its neck.
1. Cutaneous incision
2. 5 mL of anesthetic solution are injected.
3. Incision of the subcutaneous layer
4. Genitofemoral nerve infiltrated near the deep inguinal ring
8. Dissection/indirect inguinal hernia
• Skin incision
As a reminder, the present case is the one of a male patient presenting with right indirect inguinal hernia.
The 4 to 5 cm oblique cutaneous incision is performed alongside the inguinal canal and centered on the zone of swelling.
1. 4 to 5 cm oblique cutaneous incision
• Opening of inguinal canal
An incision of the subcutaneous layer and of the external oblique muscle is performed until the external ring, in order to sufficiently open the inguinal canal and visualize the spermatic cord. The incision of these deep layers is oblique, following the direction of the inguinal canal.
1. Incision of the subcutaneous layer and of the external oblique muscle
• Dissections
• Inguinal canal
The anterior space is created by dissecting beneath the medial and lateral flaps of the external oblique aponeurosis (EOA), then the inferior part of the inguinal ligament, to free its shelving edge down to the pubic tubercle.
1. Anterior space with posterior wall of inguinal canal
• Spermatic cord
The spermatic cord surrounded by cremaster fibers is separated from the floor of the inguinal canal and the pubic bone for a distance of about 2 cm beyond the pubic tubercle.
1. Spermatic cord
2. Floor of the inguinal canal
• Anterior space
The lower leaf of the EOA is freed from the spermatic cord.
The upper leaf of the EOA is then freed from the underlying internal oblique muscle and aponeurosis for a distance of 3 cm above the inguinal floor.
The anatomical cleavage between these two layers is avascular and the dissection can be done rapidly and non-traumatically.
1. External oblique aponeurosis
2. Conjoined tendon
• Hernia sac
The hernia sac is usually identified easily by having the patient cough. The sac will have to be freed from surrounding tissues.
Separation of the hernia sac from the spermatic cord is done once the fibers of the cremaster and covering fibers of the transversalis fascia up to its neck have been longitudinally opened.
1. The hernia sac is identified posterior to the cord on the medial part of the inguinal canal.
2. Longitudinal opening of the muscle fibers of the cremaster
9. Repair: 4DDOME® technique
• Structure of 4DDOME®
4DDOME® is a bilayer, dome-shaped, composite mesh. It is made of:
- one external layer (made of PLLA, fully absorbable in a few months’ time by hydrolysis);
- one internal layer (made of 10% light polypropylene and 90% absorbable PLLA);
- a small piece of mesh inside the dome (an internal tip) that can be used to pick it up, manipulate, and place it.
The dimensional stability of the Dome combined with the physiological absorption of the PLLA ensure that the hernia sac is kept in place and that the transversalis fascia is strengthened thanks to the PLLA generating cellular fibrosis. After absorption, the low residual volume (10%) gives way to a patch of light polypropylene (less than 0.08 g).
1. External layer (PLLA)
2. Internal layer
3. Small piece of mesh inside dome
• The kit
The implant is available in a sterile kit, in three different sizes (24 mm, 30 mm, and 38 mm). The reference size is the medium one whose external diameter is 3 cm. The total weight of the mesh is 256 grams/m2; as 90% of the mesh is absorbable, there is less than 0.08g remaining (weight of dome after absorption of the PLLA component).
1. Small size (24 mm)
2. Medium size (30 mm)
3. Large size (38 mm)
10. 4DDOME® placement
4DDOME® preparation:
The kit is opened. The small piece of mesh inside the 4DDOME® implant is grasped with an atraumatic forceps.

Introduction into internal inguinal ring:
4DDOME® is pushed along the medial edge of the spermatic cord in order to maintain the hernia sac deep into the preperitoneal space.

Positioning and fixation:
Correct position of 4DDOME® is checked by either having the patient cough or by performing a Valsalva’s maneuver.
Its positioning and fixation to the muscular wall is maintained by 3 absorbable, or non-absorbable monofilament sutures.
11. Anterior mesh placement
• Principles
As in open tension-free Lichtenstein hernioplasty, the mesh is used to strengthen the inguinal floor.
The mesh is placed between the transversalis fascia and the external oblique aponeurosis. It extends beyond Hesselbach’s triangle (inguinal triangle) to ensure enough connection between mesh and tissue.
Adequate fixation of the mesh edges to resistant neighboring tissues is critical in prevention of recurrences.
Such fixation may be limited as the 4DDOME® protects the anterior mesh from significant pressure, therefore preventing displacement in the immediate postoperative period (for one month).
• The mesh
1. Precut mesh in woven polypropylene
74% PLLA (Poly-L-Lactide Acid) combined with 26% polypropylene contributes to increase mesh rigidity and facilitate mesh placement.
The precut mesh can also be in unwoven polypropylene.
• Lichtenstein hernioplasty
As in open tension-free Lichtenstein hernioplasty, the mesh must be fixed in the anterior space just underneath the external oblique aponeurosis, anterior to the transversalis fascia, and posterior to the spermatic cord. The slit lateral component is passed medially to laterally around the spermatic cord in order to have the cord positioned between the two tails of the mesh. Several anchor and fixation points are required around the prosthesis.
• 4DDOME® technique
The mesh placement technique is similar to the one previously described, although it is not necessary to use too many fixation points. 4DDOME® is a barrier against intra-abdominal pressure. One stitch may be applied on the pubic spine, 2 or 3 stitches on the inguinal ligament, 1 or 2 stitches on the conjoined tendon and 1 or 2 stitches to reapproximate the lateral tails of the prosthesis. This contributes to shorten the operative time and limits the risk of pain induced by fixation.
12. End of procedure
One last check is performed, the spermatic cord and the nerves are repositioned on the onlay component and hemostasis is ensured. The aponeurotic layers of the external oblique muscle are then closed using absorbable sutures.

Subcutaneous tissues and skin are re-approximated using either absorbable sutures or glue.
13. Other types of hernias
• Direct hernias
The sac is found posterior to the cord, on the medial part of the inguinal canal. It is dissected up to its neck. When necessary, the transversalis fascia is dissected at its neck. This contributes to retract the sac caudally into the preperitoneal space.
The 4DDOME® is then introduced into the preperitoneal space and fixed to the transversalis fascia using 6 to 8 stitches of absorbable or non-absorbable suture material.
• Associated hernias
In cases of pantaloon hernias (hernias overlapping either side of the epigastric vessels), the vessels should ideally be divided to reapproximate the two sacs. This facilitates placement of the 4DDOME® into the posterior space.
In cases of distant hernias, it is sometimes preferable to use two 4DDOME® implants.
14. Postoperative management
Immediate postoperative management:
The patient may get up almost immediately after the intervention.
Postoperative pain is minimal, requiring only moderate oral intake of analgesics or NSAIDs for a period of 1-4 days.
Returning to work after hernia surgery largely depends on the patients' motivation and to their preoperative educational preparation. In general, patients return to work after tension-free hernioplasty from POD 2 to 14, depending on their occupation.
Hospital discharge is possible on the same day.

Follow-up:
4DDOME® repair allows an ideal healing of the abdominal wall. A progressive flattening of the 4DDOME® is observed between the second and the sixth postoperative month. The PLLA component of the 4DDOME® is absorbed and allows a complete restoration of the parietal wall with a limited amount of prosthetic material. Composite light polypropylene and poly-L-lactic acid (cPLLA) mesh is associated with less inflammatory reaction compared to pure polypropylene meshes whilst maintaining its capacity to induce fibrosis rich in type 2 collagen.
1. Control ultrasound evaluation performed respectively one month and 6 months postoperatively showed that disappearance of the 4DDOME® structure and PLLA absorption is complete for most patients 6 months after the intervention.
15. Discussion
Non-absorbable mesh materials achieve a long-lasting mechanical reinforcement of the abdominal wall (Goldstein, 1999; Bringman et al., 2003). Monofilament polypropylene is currently considered to be the ideal prosthetic mesh material and has received global acceptance (Folscher et al., 2000; Usher and Gannon, 1959). Nevertheless, the extent of periprosthetic foreign-body reaction, related to the amount of non-absorbable prosthetic material used (Klosterhalfen et al., 2002; Klosterhalfen et al., 1998), has led to the emergence of ‘light-weight’ polypropylene meshes (Klinge et al., 1999).

The use of composites meshes aims to limit inflammatory reactions, especially with PLLA and facilitate placement of light prostheses. 4DDOME® is a composite mesh that is fully designed to meet these criteria. Its objective is to reduce abdominal pressure on the posterior surface of the anterior mesh and maintain the reduction of the hernia sac. As a result, it is not usually necessary to resect the sac.
16. Conclusions
The 4DDOME® implant is a simple treatment option, easily reproducible with minimum training and may help to reduce the risk of long-term pain.

The procedure may be performed under local (80% of our patients) or regional anesthesia, with minimal early postoperative discomfort.

The low mesh residual volume after PLLA absorption and the low local inflammatory reaction combined with a deposit of type I and/or type III collagen fibers designates the 4DDOME® implant as an ideal product to be used in all patients presenting with medium-size inguinal hernia, young and slim patients included.

The risk of recurrence is seemingly low when the technical operative protocols are followed.
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