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Inguinal Hernia Repair Using Self-adhering

Sutureless Mesh: Adhesix™: A 3-Year Follow-
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Article in The American surgeon · February 2016

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Inguinal Hernia Repair Using Self-adhering
Sutureless Mesh: Adhesix™: A 3-Year Follow-up
with Low Chronic Pain and Recurrence Rate
MALEK TABBARA, M.D., LAURENT GENSER, M.D., MANUELA BOSSI, M.D., MAXIME BARAT, M.D.,
CLAUDE POLLIAND, M.D., SERGIO CARANDINA, M.D., CHRISTOPHE BARRAT, M.D.

From the Department of Surgery, Jean Verdier Hospital, University Paris XIII, Bondy, France

To review our experience and outcomes after inguinal hernia repair using the lightweight self-
adhering sutureless mesh “Adhesix™” and demonstrate the safety and efficacy of this mesh. This
is a 3-year retrospective study that included 143 consecutive patients who underwent 149 inguinal
hernia repairs at our department of surgery. All hernias were repaired using a modified Lich-
tenstein technique. Preoperative, perioperative, and postoperative data were prospectively col-
lected. Incidence of chronic pain, postoperative complications, recurrence, and patient satisfaction
were assessed three years postoperatively by conducting a telephone survey. We had 143 patients
with a mean age of 58 years (17–84), who underwent 149 hernia repairs using the Adhesix™ mesh.
Ninety-two per cent (131 patients) were males. Only 10 patients (7%) had a postoperative pain for
more than three years. In our series, neither age nor gender was predictive of postoperative pain.
Only one patient had a hematoma lasting for more than one month and only four patients (2.8%)
had a recurrence of their hernia within three years of their initial surgery. Ninety per cent of the
patient expressed their satisfaction when surveyed three years after their surgery. In conclusion,
the use of the self-adhering sutureless mesh for inguinal hernia repair has been proving itself as
effective as the traditional mesh. Adhesix™ is associated with low chronic pain rate, recurrence
rate, and postoperative complications rate, and can be safely adopted as the sole technique for
inguinal hernia repair.

Iandprocedure
NGUINAL HERNIA REPAIR account for the most common
performed in general surgery worldwide,
around 700,000 operations are performed each
debilitating pain incidence ranging between 8 and 10 per
cent.4, 5 LT involves dissection of the inguinal canal to
isolate the hernial sac, the placement and the fixation
year, both in the United States and in Europe.1 The of a mesh over the defect of the inguinal floor. In this
gold standard for inguinal hernia treatment has been perspective, chronic pain is thought to be the result of
defined for decades as the tension-free Lichtenstein an inflammatory reaction triggered by the aforemen-
technique (LT).2, 3 This technique combines safety, tioned LT steps such as nerve severance, mesh fixation
effectiveness, and a low hernia recurrence rate.1–3 method, or to an inflammatory reaction of the mesh
Nevertheless, this technique can still be complicated itself.5, 6 In their study, Quyn et al.7 compared suture
by chronic pain with a reported incidence of all levels fixation to self-adhesive meshes and noted a chronic
pain reaching as high as 63 per cent with severe pain incidence of 21 and 7.9 per cent at six months and
18.8 and 6.3 per cent at one year (P < 0.05), re-
spectively. They concluded that inguinal hernia repair
We disclose no affiliation with any organization with a financial with a sutureless mesh may lead to less chronic pain
interest, direct or indirect, in the subject matter or materials dis- and less restriction of activities of daily living than
cussed in the manuscript (such as consultancies, employment, a conventional mesh fixation.
expert testimony, honoraria, lecturing fees, retainers, stock options,
or ownership) that may affect the conduct or reporting of the work Therefore, a modification or elimination of these
submitted. factors is needed to reduce the chronic pain rate and
Presented as a poster at the 36th Annual International Congress permit the patients to return to their normal daily ac-
of the European Hernia Society, May 28–31, 2014, Edinburgh, tivity with a better quality of life. The use of light-
United Kingdom. weight and self-adhering sutureless mesh could in fact
Address correspondence and reprint requests to Malek Tabbara,
M.D., Department of Digestive and Metabolic Surgery, Jean Ver- be able to allow repair of inguinal hernias without the
dier Hospital, Avenue du 14 Juillet, 93143, Bondy, France. E-mail: necessity of using suture to fix them and thus permit-
malektabbara@gmail.com. ting to avoid a possible cause of chronic pain.3,8 In this

112
No. 2 INGUINAL HERINIA REPAIR USING ADHESIX™ ? Tabbara et al. 113

study, we present our experience of 149 inguinal hernia the conjoint tendon to expose the rectus muscle apo-
repairs using Adhesix™, the light weight, self-adhering neurosis, to make space to spread out the mesh. The
sutureless mesh. The primary outcome of our study hernia sac was dissected (and in some cases opened)
is to evaluate the recurrence rate and compare it with and reduced without any suturing to avoid tension.
the recurrence rates of conventional mesh repair de- Local hemostasis was obtained, and the cord was
scribed in the literature. The secondary outcomes were retracted vertically. The mesh was then trimmed to fit
to evaluate the rate of chronic pain and patients’ sat- in the inguinal floor. The flaps of the mesh were
isfaction three years postsurgery. opened and loosely closed around the spermatic cord
away from the muscle plane to avoid premature ad-
hesion. The mesh was oriented in the axis of the cord
Materials and Methods and carefully descended to its definitive position. The
The medical records of patients who underwent re- fixation to the muscle plane was achieved by applying
pair of inguinal hernia at Jean Verdier Hospital, Bondy, pressure on the mesh with dry forceps, starting in-
France, between September 2008 and June 2011 were feriorly and medially with an overlap of 2 cm on the
reviewed. Patients were identified using our electronic pubic bone, then progressing superiorly and laterally
medical record (MEDIWEB). Inclusion criteria were placing it under the external oblique aponeurosis with-
patients older than 18 years, who had Type I or II in- out any digital manipulation. No additional fixation was
direct and/or direct (European Hernia Society classi- used. The external oblique aponeurosis and the skin
fication)9 inguinal hernia and who were operated using were then closed with running absorbable sutures.
the self-adhering sutureless mesh technique described
in the surgical technique section.9 All patients’ data Follow-up
and information were collected prospectively and an-
The patients’ follow-up was performed by conducting
alyzed retrospectively. The following data were col-
a telephone survey after three years from the date of
lected: general patient demographics (gender, age),
surgery to identify patients’ complaints and quality of
type of anesthesia, side of the inguinal hernia, and
life such as chronic postoperative pain (>3 years), sero-
prior history of hernia at the same side.
mas (>1 month), hematoma (>1 month), postoperative
irritability symptoms (paresthesia, numbness), and sat-
Adhesix™: A Lightweight Self-adhering Mesh isfaction of the patients. The average follow-up time was
Adhesix is a mesh impregnated with a self-adhering 35.8 months and ranged between 14 and 51 months. All
gel. The mesh is made of nonabsorbable lightweight patients had completed a 1-year clinical follow-up.
polypropylene (32 g/m2). The self-adhering gel con-
sists of a polyvinylpyrrolidone and polyethylene gly- Statistical Analysis
col (solvent). The gel is absorbable, self-adhering, and
Continuous values are expressed as mean and standard
has no animal or human origin. Once in contact with
deviation. Continuous values were compared by Student’s
the tissue, the self-adhering gel coated on the poly-
t test and categorical data by univariate chi-squared and
propylene mesh is activated by the heat and moisture
Fisher’s exact tests. A P value of less than 0.05 was used to
and turns into a tacky gel that permits the mesh to stick
denote statistical significance. Statistical analysis was
on its both sides. The mesh can still be adjusted for
performed using IBM SPSS Statistics (Chicago, IL, USA).
a limited amount of time after its application.

Results
Surgical Technique
Demographics
A 5- to 8-cm inguinal skin incision was made at the
side of the hernia; the external oblique aponeurosis A total of 185 consecutive patients were operated in
was divided. The pubic bone was dissected, allowing our surgery department for inguinal hernia repair using
an easy access and dissection of the spermatic cord. Adhesix™ between September 2008 and June 2011.
The cremasteric muscle was resected when they in- Forty-two patients (23%) were lost to follow-up and
terfered with the dissection of the hernia sac and the 143 consecutive patients (77%) were included in the
three nerves (ilio-inguinal, ilio-hypogastric, and geni- study. Our series consist of 149 inguinal hernia repairs
tal branch of the genitofemoral nerve) were identified in these 143 patients, 51 per cent (73 patients) had right
and preserved. The inguinal ligament was dissected inguinal hernia repair, 45 per cent (64) had left in-
toward the pubis and up to the anterior superior iliac guinal hernia repair, and 4 per cent (6 patients) had
spine. A wide dissection of the inguinal floor was done bilateral inguinal hernia repair. Only three patients
medially between the external oblique aponeurosis and (2%) had repair of a recurrent inguinal hernia. The
114 THE AMERICAN SURGEON February 2016 Vol. 82

mean age was 57.8 years (17–84); most of the patients Satisfaction and Return to Normal Daily Activity
(91.6%; 131) were male while only 8.4 per cent (12) Seven patients reported the inability to return to their
were female. normal daily activity one month postsurgery. This was
mostly due to irritability symptoms (Table 1). When
Recurrence surveyed after three years, 129 patients (90%) an-
None of the recurrences occurred within the first swered that they were satisfied with their surgery while
three months of follow-up with clinical examination. 14 patients (10%) expressed their discontent; that was
Only four patients (2.8%) had a recurrence of their mostly due to their postoperative pain, paresthesia, and
inguinal hernia during the 3-year follow-up survey, irritation symptoms.
two of which were at the right side and the other two on
the left side. None of these patients were rehospitalized Discussion
in our institution or another hospital.
In any hernia repair, chronic pain and recurrence rate
consist of the two main outcomes that define the suc-
Postoperative Pain cess of this common surgery. In fact, chronic pain
Ten patients (7%) complained of postoperative pain represents the most common problem in any inguinal
lasting for more than three years. There were nine male hernia repair. Risk factors that influence chronic pain
and one female patients complaining of pain; however, have been described and include existing preoperative
a univariate analysis showed that gender difference pain; nerve injury during dissection; pre-existing pain;
was not statistically significant to predict postoperative severe pain during early postoperative period; and
pain (P 4 0.85). The age group of 50 years and older mesh-related factors such as mesh with small pores,
was found to have 50 per cent of the pain complaints weight of the mesh, and suture fixation of the mesh.6
with no significant difference with patients younger In our previous study evaluating 186 patients three
than 50 years (P 4 0.12). When asked to evaluate their months post their inguinal hernia repair using Adhe-
pain using the visual analog scale (VAS), only three six™, we showed that there were no intraoperative
patients described a pain more than 5 with a mean VAS complications, a low rate of postsurgical complications
of 4.9 (Fig. 1). Thirteen patients (9%) reported dis- (4.5%) and no recurrences. A VAS score of zero was
comfort or paresthesia at the site of surgery, eight reported by 93/184 (50.5%) patients at one week, 130/
(5.6%) were at the right side and five (3.5%) were at 171 (76.0%) patients at one month, and 119/132
the left side. Eight of them had also an associated pain (90.2%) patients at three months follow-up (P <
lasting for more than three years. 0.0001).8 This study comes to complete the latter and
to describe the chronic pain rate and recurrence rate
nearly three years postsurgery. The main aim of our
Postoperative Complication
hernia repair technique was to trim down the chronic
Only one patient had a hematoma on the left side that pain and the recurrence rate while obtaining a strong
lasted for more than one month. There was no seroma, and good-quality repair. This was achieved by elimi-
wound infection, or any other early postoperative com- nating the risk factors discussed above: a meticulous
plications reported in our patients’ series. dissection, identification and sparing of the nerves was

FIG. 1. Pain evaluation after 3 years.

No. 2 INGUINAL HERINIA REPAIR USING ADHESIX™ ? Tabbara et al. 115

TABLE 1. Patients Who Were Unable to Return to Normal chronic groin pain rate was found to be significantly
Daily Activity lower when glue was used. Hematoma, acute post-
Hernia operative pain, and return to normal activities were
Patient Side VAS Complaint also reduced when glue fixation was used. However,
1 Left 4 Burning sensation when no difference was found between the two groups in
jogging terms of hernia recurrence, postoperative seroma,
2 Left 5 Paresthesia on strenuous
physical activity numbness, and length of hospital stay. These results
3 Right 6 Paresthesia when walking were consistent with another meta-analysis by de
4 Left 5 Intermittent discomfort when Goede et al.14 who confirmed that glue fixation was
coughing a faster procedure, associated with lower pain, and had
5 Right 5 Unresolved pain after 1-year
postsurgery comparable hernia recurrence rates when compared
6 Right 6 Hypoesthesia with suture fixation.
7 Right 5 Unbearable pain causing All the aforementioned studies confirm our results
physical inactivity and authenticate the benefits of using a sutureless
technique for repair of inguinal hernia using the
modified LT.
achieved whenever feasible, a low-weight mesh was used Our study has its limitations mostly due to its ret-
and finally a sutureless fixation was done. While 9 per rospective nature. The effect of existing preoperative
cent (13 patients) reported discomfort or paresthesia at the pain was not assessed in our series. However, this does
site of surgery, only 7 per cent (10 patients) complained of not alter our conclusions, in fact, while preoperative
chronic pain rate with a mean VAS score of 4.9. pain was found to be an important predictive factor for
Our results are consistent with what has already been occurrence of postoperative chronic pain, it remains
published in the literature regarding the use of very hard to assess in this kind of retrospective study.
sutureless fixation technique for inguinal hernia repair. Dennis et al.15 noted in their study that a prospective
Chastan study10 was among the first to describe the use study with 3000 patients would be required to achieve
of sutureless self-gripping mesh reporting on 52 pa- 5 per cent significance and 80 per cent power and show
tients who underwent 70 hernia repairs using an open the effect of preoperative pain. Another limitation is
LT. He described a pain rate of 1.3 at discharge, 0.1 at the fact that this study is based on a telephone survey,
one month, and almost none at one year (one patient which could be difficult, imprecise, unfocused, and
reporting VAS of 1 on strenuous activity). There was sometimes boring for the patient. We tried to limit all
no recurrence after two years of follow-up in his series. these issues by conducting a short interview, using
Lionetti et al.11 in their study compared 72 patients clear and straightforward unambiguous questions.
where fibrin glue fixation was used versus 76 patients
who underwent classic Lichtenstein with suture fixa- Conclusion
tion. Patient who had sutureless repair of their hernia
were faster to return to work and daily life activities. The use of self-adhering sutureless mesh in inguinal
Six patients (7.8%) who had suture fixation suffered hernia repair has been proving itself as effective as the
from chronic pain, whereas no patient with glue fixa- traditional LT for Types I and II inguinal hernia (EHS
tion demonstrated this feature. They concluded that the classification). Our study shows low chronic pain rate,
use of light-weight mesh and fibrin glue gives signif- low recurrence rate, and low postoperative complica-
icantly better results in terms of postoperative pain and tions rate and high patients’ satisfaction rate. Adhe-
return to daily life. In their controlled blinded trial, six™ should be considered a safe and effective mesh to
Campanelli et al.12 randomized 159 patients to fibrin use in inguinal hernia repair.
sealant group and 160 patients to the suture fixation
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