A bilayer patch device for inguinal hernia repair

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摘要

The description of the the bilayer patch device for 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: anesthesia, inguinal canal approach, dissection of inguinal canal, dissection of hernia sac, dissection of posterior space, the Prolene Hernia System, positioning the mesh, fixing the mesh.
Consequently, this operating technique is well standardized for the management of this condition.

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刊物

2001-03

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WeBSurg.com, Mar 2001;1(03).
URL: http://www.websurg.com/doi-ot02en189.htm

A bilayer patch device for inguinal hernia repair

1. Introduction

In inguinal hernia surgery, the quality of the outcome depends on a meticulous application of “herniology”.
In tension-free inguinal hernia repair in adults, the use of a non-absorbable polypropylene prosthesis is the gold standard.
The Prolene (polypropylene) Hernia System (PHS) is constructed as a three-in-one model (underlay, connector and overlay components). It can be used in all types of primary or recurrent inguinal hernias. Developed according to a new concept, this prosthesis covers and reinforces the anterior surface of the posterior wall of the inguinal region and the posterior surface of the myopectineal region. It also obstructs the canal of the myopectineal orifice via an anterior approach. Performed in an outpatient setting under local or regional anesthesia, this approach is new and appealing. Its fixation requires perfect anatomical knowledge of the inguinal region.

2. Anatomy

• Myopectineal orifice

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

• Structure of MPO

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)

• Superior pane

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.
1. Spermatic cord
2. Internal inguinal ring

• Medial portion

Its medial portion is known as the inguinal (or Hesselbach’s) triangle.
There, the TF forms the interfoveolar ligament which is the medial margin of the IIR.
1. Interfoveolar ligament
2. Inguinal triangle

• Inferior pane

Its inferior pane is traversed laterally by the femoral vessels and is protected medially by the lacunar ligament. Defects through this pane present as femoral hernias in various positions relative to the femoral vessels.
The TF condenses within the inferior pane to form the periosteum of the superior pubic ramus, where it is also known as the pectineal (or Cooper’s) ligament.
1. Femoral vessels
2. Lacunar ligament
3. Pectineal ligament

3. Indications

Indications
- all types of inguinal and femoral hernias;
- external, oblique inguinal hernias beyond Type I defects (Nyhus classification), including recurrent hernias;
- direct hernias, notably recurrent hernias;
- large hernial defects which often require the insertion of a very large plug;
- 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
- young patient;
- hematological disorders (borderline indication);
- cirrhosis (borderline indication);
- very large hernias;
- patient refusal;
- allergy to local anesthetics.

4. Operating room set-up

• Patient

Example of a patient operated on for a right-sided hernia:
- 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.
Compression must be avoided at the level of body support areas.
This position should be comfortable for the patient as well as for the surgical team.
The installation of the operating drapes should be wide, covering the lower limbs, the entire thorax, the upper abdomen, the upper limbs, while leaving the head perfectly free to enable the surgeon to see and talk with the patient.

• Team

1. The surgeon stands on the side of the hernia which he/she is to operate.
2. The first assistant stands opposite him/her.
The presence of a scrub nurse is optional.
If present, he/she stands near the instrument table on the side opposite the surgeon.
3. The anesthesiologist stands at the level of the patient’s head.

• Equipment

1. Anesthetic equipment
2. Operating table
3. Instrument table
4. Electrocautery device
The anesthetic equipment should enable cardio-vascular as well as oxymetric monitoring.
The surgical equipment should be kept to a minimum.

5. 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. Atraumatic grasper
4. Scissors
5. Bilayer patch PHSTM
6. Gauze pads
7. Retractors
8. Auto-static retractor
9. Local anesthetic (lidocaine)

6. Major principles

• Defect

An inguinal hernia is a defect in the myopectineal region related to the alteration of parietal tissues. Such an alteration may be treated by reinforcing the wall of the inguinal canal. This reinforcement has become a standard.
1. Parietal defect

• Reinforcement

Reinforcement of the wall of the inguinal canal with the mesh can be:
- anterior (on the anterior surface of the posterior wall of the inguinal canal) (Lichtenstein et al., Am J Surg 1989;157:188-93);
- posterior (on the posterior surface of the myopectineal region) (Rives et al., Ann Chir 1968;22:159-71);
- inside the inguinal ring or the parietal defect (plug repair, Robbins and Rutkow, Surg Clin North Am 1993;73:501-12).
1. Anterior reinforcement
2. Posterior reinforcement
3. Internal reinforcement

• PHS

Both the anterior and posterior approaches in hernia repair have their advantages. Yet, only posterior reinforcement with a wide prosthesis can establish a lasting protection.

The Prolene Hernia System™ (PHS) with its three components (1. underlay, 2. connector and 3. overlay components) combines techniques of anterior and posterior wall reinforcement and obturation of the inguinal canal or hernia defect.
1. Underlay component
2. Connector
3. Overlay component

7. Anesthesia

• Local anesthesia

The procedure is performed under local anesthesia (512 out of 759 cases) or under locoregional or epidural anesthesia or rachianalgesia (244 out of 759 cases). It is performed by the surgeon and as such accompanies the surgical act.
In patients with a high anxiety level, a neuroleptanesthesia may be combined. General anesthesia may be necessary (3 out of 759 cases).
1. Local anesthesia administered by the surgeon

• Products

100 mL of a lidocaine solution containing 0.5% adrenaline is used. In general, 60 mL to 80 mL are enough to ensure the infiltration of all tissue layers.
1. Lidocaine 100 ml
2. 60 mL to 80 mL are sufficient

• Superficial tissue layer

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 tissue layer

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.
1. Cutaneous incision
2. 5 mL of lidocaine are injected.
3. Incision of the subcutaneous layer

• Inguinal canal

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. Genitofemoral nerve infiltrated near the deep inguinal ring

8. Inguinal canal approach

• Anesthesia

• Local anesthesia

Local anesthesia is performed to approach the inguinal canal and a specific portion of the skin is incised.
1. Local anesthesia performed by the surgeon

• Anesthetics

Several safe and effective anesthetic agents are currently available.
Our choice, however, is a 50:50 mixture of 1% lidocaine and 0.5% bupivacaine, with 1/200,000 epinephrine.
An average of 45 ml of this mixture is usually sufficient for a unilateral hernia repair.
1. 50:50 mixture of 1% lidocaine and 0.5% bupivacaine, with 1/200,000 epinephrine

• Skin incision

The 4 to 5 cm oblique cutaneous incision is performed alongside the inguinal canal and centered on the zone of tumefaction.
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, 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

9. Inguinal canal/dissection

• Anterior space

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.
This anterior space will house the onlay patch of the device.
1. Anterior space will eventually house the onlay patch of the device

• Dissection/spermatic cord

The cord 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. Cord separated from the floor of the inguinal canal

• Dissection/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. The anatomical cleavage between the two muscle layers is avascular and the dissection can be done rapidly and without causing trauma.

10. Hernia sac/dissection

• Identification/sac

The hernia sac is usually identified easily by having the patient cough. The sac will have to be freed from surrounding tissues.
1. The hernia sac is identified posterior to the cord on the medial part of the inguinal canal.

• Indirect hernias

Separation of the hernia sac from the spermatic cord is done once the fibers of the cremaster and covering fibers of the TF up to its neck have been longitudinally opened.
1. Longitudinal opening of the muscle fibers of the cremaster

• Direct hernias

The sac is discovered posterior to the cord, on the medial part of the inguinal canal.
The hernia sac is easily identified when the patient is made to cough. It is dissected up to its neck. Then the TF is dissected at its neck.
1. The hernia sac is identified posterior to the cord on the medial part of the inguinal canal.
2. TF dissected at its neck

• Associated hernias

Hernias may be associated. In cases of pantaloon hernias, vessels should ideally be divided to reapproximate the two sacs. This will facilitate dissection of the posterior space.
1. Associated hernias overlapping the epigastric vessels
2. Division of epigastric vessels to reapproximate the two sacs

11. Posterior space/dissection

• Technique

This is the key step of the procedure. It must be performed meticulously, taking care not to cause tissue trauma, in order to avoid any risk of hematoma.
In all types of indirect and direct hernias, the posterior space is created using a gauze pad or a peanut swab.
A gauze pad allows to displace the tissues, and particularly the properitoneal fat, without causing trauma. It has proven to be the best dissection instrument for this space.
1. Gauze pad to do the dissection of the posterior space without trauma

• Indirect hernias

To actualize the posterior space, the peritoneum is freed from its attachments to the posterior wall by inserting a 4x4 soft gauze sponge through the internal ring.
1. Peritoneum freed from the posterior wall medially, externally, cephalad and caudally

• Direct hernias

The posterior space can be freed once the transversalis fascia has been opened around the hernial neck or above it with a horizontal incision in the inguinal triangle. This approach can also be used for indirect hernias. After dissection, the pectineal ligament should be perfectly visible.
1. Opening of the fascia transversalis around the hernial neck
2. Horizontal incision of the transversalis fascia through the inguinal triangle

• Associated hernias

In cases of associated large direct hernias and indirect hernias with a pantaloon presentation, the epigastric vessels can be divided and the two defects are converted into one. This will facilitate the repair.
1. Pantaloon hernia
2. The epigastric vessels can be divided and the two defects converted into one.

12. The PHS

• Reinforcement

Under local or regional anesthesia, the posterior and the anterior surface of the posterior inguinal wall are reinforced with a non-absorbable bilayer patch.
1. Reinforcement of the posterior wall of the inguinal canal

• Structure

• PHS

The Prolene Hernia System (PHS) is composed of two polypropylene leaves which are attached by a connector. It has three components which are to be positioned posterior, anterior and internal to the hernia defect.
[three-in-one model: underlay component (1), connector (2) and overlay component (3)].

• Underlay component (1)

Its underlay component (a mesh measuring 10 cm in diameter) amply covers the posterior surface of the inguinal canal.
Inferiorly: beyond the pectineal ligament
Superiorly: above the transversus arch
Medially: behind the rectus muscle
Laterally: beyond the internal ring
It alone covers and protects the entire myopectineal orifice (MPO) from within the abdominal cavity. It is placed deep to the deep epigastric vessels.

• Connector (2)

It is positioned within the defect. It is atraumatic and is not pointed.
1. Connector positioned within the defect

• Onlay component (3)

The oblong shaped onlay component is wide enough and long enough to cover the entire anterior surface of the canal’s posterior wall. It is fixed with a few sutures to the posterior wall.
1. Oblong onlay component
2. Mesh fixed with a few sutures to the posterior wall of the inguinal canal

• Function

1. Its underlay component (1) is designed to protect the canal’s posterior wall from behind, covering and protecting the entire MPO from within the abdominal cavity.
2. Its connector (2) remains in the defect.
3. Its onlay component (3) covers the full width of the posterior wall of the inguinal canal.

• Size

The mesh is in the form of a sterile kit available in 3 sizes.

13. Positioning the mesh

• Positioning

The prosthesis is folded. Its underlay component is inserted into the internal ring and spread out in the posterior space to be securely positioned. The connector is placed in the internal ring and the onlay component is spread out in the anterior space leaving a space for the cord.
1. Underlay component spread out in the posterior space
2. Connector placed in the internal ring
3. Onlay component spread out in the anterior space

• Mesh preparation

The underlay component of the PHS lies on a sterile field. Both ends (internal and external) of the onlay component are grasped by atraumatic graspers in order to respect the “no touch” principle.
Then the onlay and the underlay components are grasped and held in position with a grasper close to the connector in the center of the underlay graft. The mesh is handled firmly and precisely.

• Underlay graft

• Reinforcement

The underlay patch reinforces the posterior wall of the inguinal canal on its posterior surface. Its positioning needs to be perfect. This is facilitated by the fold memory of the mesh.
1. Reinforcement of the posterior wall of the inguinal canal

• Introduction

Using the insertion maneuver, with a finger in the direct defect or through the IIR, pulsations of the iliac artery can be felt laterally.
The folded mesh is slid down the medial side of the finger into the preperitoneal space. The onlay graft is pulled outwards while keeping a finger in the connector to maintain the underlay graft as it spreads into position in the posterior space.
1. Muscular wall
2. Transversalis fascia
3. Peritoneum

• Deployment

Once the mesh has been unfolded, it is maintained in position by exerting pressure on the connector.
The technical goal of deployment is to spread out the underlay graft circumferentially using a finger or a grasper, its outer edges at a maximum distance from the connector.

• Positioning and control

The underlay graft should be placed posteriorly to the myopectineal region and epigastric vessels. It will be pushed against the anterior muscular wall by the patient’s intra-abdominal pressure.
Proper positioning of the underlay graft is checked by having the patient cough or by performing the Valsalva maneuver.
1. Underlay patch placed posteriorly to the epigastric vessels

• Onlay patch

• Reinforcement

The onlay patch reinforces the posterior wall of the inguinal canal on its anterior surface. The connector remains in the internal ring or the hernial defect to ensure that the patch is perfectly centered over the weakened area.
1. Reinforcement of the posterior wall of the inguinal canal

• Medially

The medial part of the onlay graft is flattened against the transversus arch and the end of its medial leaf is positioned 2 cm over the pubic tubercle.
The mesh is then incised laterally to permit passage of the spermatic cord.
1. Medial part of the onlay graft flattened against the transversus arch
2. Medial leaf positioned 2 cm over the pubic tubercle
3. Mesh incised laterally to allow passage of the spermatic cord

• Laterally

The slit lateral leaf of the onlay graft should be placed in the anterior space beneath the EOA. The flaps are approximated above and below the spermatic cord.
For most indirect hernias, the lateral incision of the mesh is extended until it reaches the connector, whereas for most direct hernias, this incision remains external.
1. The spermatic cord passes through the slit in the onlay graft.

14. Fixing the mesh

• Fixation

Fixation of the PHS is indispensable as it ensures immobility of the entire three-piece device. It is carried out on the onlay graft.
1. Fixation is carried out on the onlay graft.

• Fixing external flaps

The two external flaps are sutured together. They must be overlapped to prevent recurrences through the slit in the graft. As a rule, 3 sutures are used for indirect hernias and 4 sutures for direct hernias.
1. The two external flaps are sutured together.

• Fixing the mesh

After checking for correct positioning of the underlay graft, interrupted sutures are placed on the onlay graft over the pubic tubercle, in the middle of the transversus arch and the inguinal ligament. Sutures can be placed elsewhere if needed.
1. Fixation over the pubic tubercle, in the middle of the transversus arch and the inguinal ligament

15. End of the procedure

After final testing of the repair, the spermatic cord and nerves are laid on the onlay graft and the leaves of the EOA are approximated.
The subcutaneous tissues are apposed, and the skin is closed with an absorbable subcuticular suture and a topical adhesive.
1. The spermatic cord and nerves are laid on the onlay graft.
2. The leaves of the EOA are approximated.

16. Postop period

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.

17. Results

- reported recurrence rate: less than 1% (no recurrence in 759 patients who underwent surgery with a mean follow-up of 12 months);
- risk of local hematoma or seroma: less than 1% (6 out of 759 patients);
- risk of local infection: less than 1% (6 out of 759 patients);
- one patient in 759 (1.3 per 1000) presented with a deep infection which necessitated the extraction of the mesh via a local approach (Shouldice);
- a few patients presented with testalgia which progressively disappeared over 3 to 8 weeks;
- there was no report of testicular atrophy.

18. Conclusions

By examining the first postoperative results, the PHS is a simple therapeutic modality, easily reproducible with a minimum of training. It permits lasting repair of inguinal hernias avoiding all risks of recurrent interstitial or even femoral hernias.
Performed under local or regional anesthesia in outpatient surgery, the PHS repair makes it possible for the patient to rapidly resume normal physical activity, including strenuous labor with minimal postoperative discomfort.
The risk of therapeutic failure should be low if technical principles are respected.

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