Download One large Versus two meshes Fixation During laparoscopic

One large Versus two meshes Fixation During laparoscopic Transabdominal
preperitoneal bilateral inguinal hernioplasty : A Randomized Prospective Trial
Nader Shaaban MD, Maged Rihan MD, MRCS.
Department of General Surgery, Faculty of Medicine, Cairo University
Abstract
Background
Transabdominal preperitoneal hernioplasty (TAPP) is a feasible method for the treatment of
bilateral inguinal hernia. The objective of this study is to compare the clinical outcome and
cost of using one large versus using two meshes in simultaneous bilateral endoscopic TAPP
inguinal hernioplasty.
Patients and Methods
Between July 2007 and February 2009, a total of 60 male patients with bilateral inguinal
hernias were randomized to two equal groups and underwent bilateral TAPP: Group (A) have
one large mesh and Group (B) have two meshes fixation. The primary endpoints were
number of applied tacking staples, severity of pain, analgesic requirement, and incidence of
seroma. Secondary endpoints were length of hospital stay, number of days required to
resume normal outdoor activities and work, recurrence rate, and incidence of chronic pain.
Results
The 2 groups were comparable in age, and types of hernia. TAPP were successfully
performed in all patients. The group A consumed significantly less analgesics compared with
that of the group B (P =0.034). There was a significant difference in the postoperative pain
score at rest and on coughing from the day of operation to postoperative day 6 between the
groups. The incidence of seroma was slightly higher in group A (20 %) than in group B (10 %)
(P = 0.015). Length of hospital stay and time taken to resume normal activities and work were
comparable between the 2 groups. With a median follow-up of 1.2 years, no recurrent hernia
has been detected in either group, but the incidence of chronic pain in the group B (23 %)
was higher than that of the group A (13.6 %).
Conclusion
This randomized prospective clinical trial demonstrated a significant reduction of cost and
analgesic consumption by using one large mesh fixation during bilateral TAPP, but it was
associated with a minimal increased incidence of postoperative seroma.
Keywords: TAPP –Bilateral inguinal hernia- One mesh fixation.
Introduction
Following the laparoscopic revolution, laparoscopic hernia repair has become one of the
commoner laparoscopic operations. Several studies have demonstrated a definite advantage
over open repair with regard to reduced post-operative pain1, 2 and earlier return to work and
normal activities. Bilateral hernias are repaired without extra incisions and recovery for these
is very quick. 1, 3, 4
In the last years, this approach tends to become the gold standard procedure for the one day
surgery of groin hernias. Transabdominal preperitoneal hernioplasty (TAPP) is a feasible
method for the treatment of bilateral hernia. The laparoscopic exploration allows the intra
operative diagnosis of other associated hernias. The anatomic landmarks are easily
recognizable and the learning curve could be shortened. The postoperative recovery is rapid
and the patient can quicker return to his normal activity; in this way, the day surgery could be
considered.5
Inadequate mesh fixation has been reported to be a main cause for hernia recurrence after
laparoscopic repair.6–9 Endoscopic stapling has been the most commonly adopted technique
for prosthetic mesh fixation. Mechanical anchorage of the mesh not only reduces the risk of
mesh migration but also enhances the bursting strength of the repair. 10,11
With an increasing emphasis on the evaluation of functional recovery, acute pain has become
an important outcome parameter after hernia surgery. 12 Seroma is the commonest morbidity
following laparoscopic hernia repair, with a reported incidence ranging from 3.4% to 11.7%.
Its occurrence sometimes causes alarm to the patients as it mimics a postoperative
recurrence of hernia. 13–16
The present randomized prospective trial was designed to test the null hypothesis that the
early clinical outcomes including reduction of postoperative pain and cost of bilateral TAPP
using one mesh are better to those using two meshes. We present a description of our
technique by using one large mesh in repairing bilateral inguinal hernia, and also describe the
outcome and complications we have experienced.
Materials and Methods
Inclusion criteria were age at least 18 years, male sex, medical fitness for general anesthesia,
and suitability for TAPP. Between July 2007 and February 2009, 60 patients presented with
bilateral inguinal hernia were included in this study. Patients who underwent concomitant
operative procedures were excluded. Informed consent was obtained prior to randomization.
Patients were randomized to 2 arms of treatment, one mesh group (A) and two meshes group
(B), by sealed envelopes containing random number in the operation theater. A prospective
collection of data using standardized data entry sheet was performed.
Surgical Technique
Patients were operated in a supine Trendelenburg's position under general anesthesia.
Preoperative antibiotic, ampicillin 1 g with sulpactam 500 mg, was given intravenously on
induction of general anesthesia. A 3-port technique was used, with urinary catheterization. A
transverse 10-mm infraumbilical incision was made for the camera port. Carbon dioxide was
insufflated to a pressure of 14 mm Hg. Another 10-mm trocar port was then inserted to the
right side of the umbilicus in the midclavicular line under endoscopic guidance. The third 5mm trocar port was placed at of the umbilicus in the midclavicular line. The pre-peritoneal
space is then entered by incising the peritoneum transversely from the region of the medial
umbilical ligament laterally and anterior to the hernial defect. Peritoneal flaps are then
developed. Direct sacs and small indirect sacs are fully reduced. Larger indirect sacs are
dissected and having freed from the cord structures, circumcised, and the distal part of a
large sac is left insitu. The anatomy is then defined and the posterior flap fully developed, the
dissection going at least 5cms posterior to the internal ring. In group B, the dissection is
carried to the symphysis pubis medially in both sides. In group A, the dissection is carried
medially anterior to the inferior epegastric vessels and the median umbilical ligament to reach
the other side without incising the overlying peritoneum. In group B a 15 x 10 cm prolene
mesh is then fashioned and inserted in eash side to cover the posterior wall of the inguinal
canal, deep inguinal ring and femoral ring on each side. The medial border of the mesh is
adjacent to the symphysis pubis and the posterior part is placed well behind the internal ring.
When the mesh is satisfactorily placed, it is stapled in place, staples being applied to the
pubic bone and Cooper’s ligament. Further staples are placed into the muscle layers
anteriorly but none into or below the ileo-pubic tract or posterior to this. In group A a 30 x 10
cm prolene mesh is then fashioned and inserted, staples were not applied medially nor to the
pubic bone, as the supporting effect of the inferior epigastric vessels and the median umbilical
ligaments were replacing the role of the medial stapling fixation. The peritoneum is then
reconstituted by suturing with vicryl 3/0 and the operation completed by closing the external
oblique at the port sites and skin closure. Hernia types were determined intraoperatively
according to the Nyhus classification.17
Postoperative Management
After assessment of the patients, they were discharged on the second day of surgery.
Postoperative analgesic regimen, including oral diclofenac sodium SR 100 mg daily and
paracetamol 500 mg, 3 times daily upon patients’ request, were standardized. All patients had
follow-up at the outpatient clinic 1 week after discharge. During follow-up, all complications
and clinical recurrence were recorded. Subsequent follow-ups were scheduled at 3, 6, and 12
months and yearly thereafter.
Outcome Assessment
The primary endpoints were number of applied tacking staples, severity of postoperative pain,
analgesic requirement, and incidence of seroma. Severity of pain was assessed by a linear
analogue pain score on a scale from 0 to 10 daily after operation. All patients were taught to
fill in a pain score chart to document their daily pain score at rest and on coughing at home.
The visual analogue pain scale is a simple-to-use instrument consisting of a 10-cm line placed
horizontally on the paper with "No pain" and "The worst pain you could possibly imagine"
placed at the left and right ends, respectively.
Patients were instructed to mark the spot on the line correlating to the level of all pain being
experienced at the time of the medical visit. The level of pain is calculated by measuring (in
millimeters), the distance from the left end of the scale to the mark. The validity, sensitivity,
and reliability of the visual pain analogue scale have been confirmed. 18-20
Total amount of analgesic consumption was based on the total number of analgesic tablets
consumed by the patient during the postoperative period. A seroma was defined as the
clinical presence of a palpable fluid collection over the groin in the absence of bruising during
follow-up.
Secondary outcome measures included operative time, length of hospital stay, number of
days required to resume normal outdoor activities and work, recurrence rate, and incidence of
chronic groin pain. Operative time was defined as the time from the skin incision to the
placement of the last suture. Length of hospital stay was referred to the total number of nights
spent in hospital after operation. Chronic groin pain was assessed by a standardized
questionnaire at 1 year after operation.21
Results
Between July 2007 and February 2009, a total of 60 male patients with bilateral inguinal
hernias were randomized to two equal groups and underwent bilateral TAPP: Group (A) have
one large mesh and Group (B) have two meshes fixation. The 2 groups were comparable in
sex, age, body weight, and types of hernia (Table 1).
TABLE 1. Patients Characteristics
Charecteristic
Age yr [mean (range)]
Body weight kg
Types of hernia*[no. (%)]
II
IIIA
IIIB
IIIC
IVA
IVB
*Nyhus classification17
Group A (n=30)
49 (40.6 – 56.3)
60 (53.5 – 66.5)
Group B (n=30)
51 (40.0 – 61.0)
62 (58.0 – 70.0)
11(18.3)
38(63.3)
8(13.3)
0(0)
2(3.3)
1(1.7)
6(10)
41(68.3)
7(11.7)
1(1.7)
4(6.7)
1(1.7)
P
0.627
0.153
0.491
All TAPP were successfully performed, and there were no conversions to open repair. The
median operative time was 105 minutes (range, 75–130 minutes) and 95 minutes (range, 70–
120 minutes) in A and B groups, respectively. There were no intraoperative complications or
hospital mortality.
In the first week the total number of analgesic tablets consumed by the group A (4.5 tablets;
range, 2–10 tablets) was significantly less than that of the group B (7 tablets; range, 4–14
tablets) (P = 0.034).
Comparison of daily pain scores at rest and on coughing from the day of operation to
postoperative day 6 between the 2 groups, showed that the mean values of the pain score is
lower in group A than in group B, especially on coughing (Figs. 1 and 2).
10
Mean pain score at rest
8
6
Group B
Group A
4
2
0
Day 0
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
FIGURE 1. Chart showing the mean values of daily postoperative pain score at rest in both groups.
Mean pain score on coughing
10
8
6
Group B
Group A
4
2
0
Day 0
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
FIGURE 2. Chart showing the mean values of daily postoperative pain score on coughing in both
groups.
The median length of hospital stay was 1 day (range, 1–1 day) in group A and 1 day (range,
1–2 days) in group B (P = 0.428).
Postoperatively there were no major complications, and none of the patients had wound
infection. Group A had a higher incidence of postoperative seroma (20%) than the Group B
(10%) (P = 0.015). They resolved spontaneously without the need for surgical intervention.
The time taken to resume normal outdoor activities was comparable between the group A (3
days; range, 2–4 days) and group B (3 days, range, 2–5 days) (P = 0.681).
The number of tacking staples used in the fixation of the two meshes in group B ranged from
10 to 12 tacking staples, and ranged from 6 to 8 tacking staples only in the fixation of the
large mesh in group A. The total cost for the use of two meshes was???????, which was
greater than that for the use of one mesh.
Follow-up ranged from 8 to 27 months. With a median follow-up of 1.2 years, none of the
patients was found to have recurrence. A total of 48 patients had follow-up exceeding 1 year.
Of these, the incidence of chronic pain was (23%) (n = 6 of 26) in group B, which was higher
than that of group A (13.6%) (n = 3 of 22).
Discussion
For the unilateral inguinal hernia, during the TAPP procedure, the use of large meshes
(100x150 mm) are recommended to reduce the recurrence rate. 22 For the bilateral hernia two
meshes, 22, 23 or a single large mesh could be used like in Stoppa procedure. 24
A previous report documented that the actual tendency is to use two separate meshes
technique covering the bilateral defects which is technically easier and associated with good
short and long term results. 25
However, we realized in our study that the lower cost, less need for postoperative pain killers,
and decrease of the acute and chronic pain reported by the patients of the one mesh group;
all these factors are much more significant even if this technique needs more dissection, more
operative time and has more liability for postoperative seroma formation which was self
limited and did not require any intervention.
Some concern has arisen regarding the potential complications of prosthetic stapling, such as
sensory nerve entrapment. To address this issue, in addition to that of cost containment,
performance of laparoscopic hernia repair without fixation of the mesh has been advocated.
Recent reports26–28 demonstrated comparable early recurrence rates with and without
prosthetic mesh stapling, but long-term results remain to be proven. Besides, recurrence of
hernia after laparoscopic repair has been attributed to an inadequate mesh fixation. 29–31
Phillips et al9 suggested secure stapling of the mesh to reduce recurrence rate following
laparoscopic hernioplasty.
In our trial we nullify the adverse effects which may occur due to using more staples by using
only one large mesh which required less number of staples than in two meshes, especially in
the medline because of the anchoring and the supporting actions of the median umbilical
ligament and both the right and the left inferior epigastric vessels.
Chronic pain after inguinal hernia repair has been classified broadly as either somatic or
neuropathic in origin. Somatic pain may arise from tissue injury, tissue ischemia, or the
placement of staples or nonabsorbable sutures on the pubic bone.9 Meralgia paresthetica is a
rare but serious potential complication of prosthetic mesh stapling. 32-34 Tetik et al7 conducted
a multicenter study recruiting 1514 laparoscopic repairs of inguinal hernia and reported 2
neurologic complications that required repeat laparoscopy and staple removal.
In the present trial, the use of one large mesh for bilateral inguinal hernias conferred a
significant reduction of analgesic requirement compared with that of the two meshes group.
This finding may be explained by using a less number of tacking staples in group A. This
finding was consistent with a previous report12 documenting reduced acute and chronic pain
by avoiding prosthetic stapling and encouraging biologic fixation which avoids somatic and
neurologic injury associated with the use of staples.
In laparoscopic inguinal hernia repair, a potential tissue space left behind the dissected area
that was created by the hernia mass naturally occurs. Occurrence of fluid collection in this
pouch puts the surgeon in a dilemma about whether it is a complication or a natural process
of the healing. 35–37
Seroma is the commonest morbidity following laparoscopic hernia repair, with a reported
incidence ranging from 3.4% to 11.7%. Its occurrence sometimes causes alarm to the
patients as it mimics a postoperative recurrence of hernia. 13–16
The prevalence of postoperative seroma was higher in group A than in group B. Our findings
could be explained by the fact that more dissection is needed, especially in the midline, and
the larger size of the meshes in group A stimulated a more intense reaction in the tissues that
increase exudation and hence seroma formation.
Lowham et al6 conducted a multicenter study to evaluate the mechanisms leading to hernia
recurrence after laparoscopic and traditional preperitoneal herniorrhaphy. Mesh lifting by
hematoma and inadequate inferior mesh fixation represented the most common causes of
recurrence for surgeons experienced in traditional or laparoscopic preperitoneal hernia repair.
In another retrospective review of 7661 patients with 10,053 laparoscopic hernia repairs by
Felix et al,8 inadequate lateral and medial fixation of the mesh were the chief mechanisms
causing recurrence. As stapling of the mesh is contraindicated below the iliopubic tract,
median umbilical ligament and inferior epigastric vessels serve as a complementary tool for
prosthetic mesh fixation at the medial side of each defect and its ability to affix the mesh
without injuring the underlying structure. This may help to reduce the incidence of chronic
pain in the long run.
The main advantage of using one mesh in group A in this study was its cost, which was
nearly half the cost of two meshes repair in group B. In addition to the reduction of analgesic
medications, acute and chronic pain compared to group B.
Conclusion
This randomized prospective trial demonstrated a significant reduction of analgesic
requirement and cost by using one large mesh fixation during bilateral TAPP, but it was
associated with an increased incidence of postoperative seroma.
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