Importance Incisional hernia is the most frequent surgical complication
after laparotomy. Up to 30% of all patients undergoing laparotomy
develop an incisional hernia.
Objective To compare laparoscopic vs open ventral incisional hernia repair
with regard to postoperative pain and nausea, operative results, perioperative
and postoperative complications, hospital admission, and recurrence
rate.
Design Multicenter randomized controlled trial between May 1999 and
December 2006 with a mean follow-up period of 35 months.
Setting All patients were operated on in a clinical setting at 1 of
the 2 participating university medical centers or at the other 8 teaching
hospitals.
Participants Two hundred six patients from 10 hospitals were randomized equally
to laparoscopic or open mesh repair. Patients with an incisional hernia
larger than 3 cm and smaller than 15 cm, either primary or recurrent,
were included. Patients were excluded if they had an open abdomen
treatment in their medical histories.
Intervention Laparoscopic or open ventral incisional hernia repair.
Main Outcome Measures The primary outcome of the trial was postoperative pain. Secondary
outcomes were use of analgesics, perioperative and postoperative complications,
operative time, postoperative nausea, length of hospital stay, recurrence,
morbidity, and mortality.
Results Median blood loss during the operation was significantly less
(10 mL vs 50 mL; P = .05) as well
as the number of patients receiving a wound drain (3% vs 45%; P < .001) in the laparoscopic group.
Operative time for the laparoscopic group was longer (100 minutes
vs 76 minutes; P = .001). Perioperative
complications were significantly higher after laparoscopy (9% vs 2%).
Visual analog scale scores for pain and nausea, completed before surgery
and 3 days and 1 and 4 weeks postoperatively, showed no significant
differences between the 2 groups. At a mean follow-up period of 35
months, a recurrence rate of 14% was reported in the open group and
18%, in the laparoscopic group (P = .30).
The size of the defect was found to be an independent predictor for
recurrence (P < .001).
Conclusions and Relevance During the operation, there was less blood loss and less need
for a wound drain in the laparoscopic group. However, operative time
was longer during laparoscopy. Perioperative complications were significantly
higher in the laparoscopic group. Visual analog scores for pain and
nausea did not differ between groups. The incidence of a recurrence
was similar in both groups. The size of the defect was found to be
an independent factor for recurrence of an incisional hernia.
Incisional hernia is the most frequent surgical complication
after laparotomy. Up to 30% of all patients undergoing laparotomy
develop an incisional hernia. This is associated with discomfort,
pain, respiratory restriction, and dissatisfactory cosmetic results.1-6 The associated morbidity often results in subsequent hernia repair.7,8 Although significant improvements
have been achieved in the field of incisional hernia concerning operative
technique and the use of prosthetic materials, recurrence rates remain
high at 32% to 63%.9 Risk factors
associated with recurrence, such as hernia size, unfortunately cannot
be influenced.10 The quest for more
effective and less invasive techniques continues.
The introduction of minimally invasive surgery in the early
1990s enabled the possibility of laparoscopic incisional hernia repair.11 Laparoscopy has proved to be a safe, effective,
efficient, and less painful technique for many types of surgery and
has become the current “gold standard” for cholecystectomy,
for example.12 Laparoscopic incisional
hernia repair is a widely used and accepted operative technique, assuming
general advances of laparoscopy are also valid for this group. Recent
studies have shown that in the short term laparoscopic repair is superior
to open repair in terms of less blood loss, fewer perioperative complications,
and shorter hospital stay.13,14 Long-term outcomes such
as recurrence rates are yet unknown. So far, level 1 randomized clinical
trials for benefits or disadvantages of laparoscopic incisional hernia
repair are scarce.15
The ongoing debate about the expected merits of laparoscopic
vs open incisional hernia repair prompted the need for a level 1 randomized
controlled trial. The aim of this study was to compare laparoscopic
vs open ventral incisional hernia repair with regard to postoperative
pain and nausea, operative time, blood loss, perioperative and postoperative
complications, length of hospital stay, and recurrence rates.
Approval was obtained from the Erasmus Medical Center ethical
committee and the local ethical committees of all 9 participating
centers prior to enrollment of patients in this study. Informed consent
was obtained for all patients. The consent form and consent process
were carefully evaluated by the Erasmus Medical Center ethical committee
and data monitoring committee on a continual basis. All participating
centers provided experienced and dedicated hernia surgeons.
Inclusion criteria were hernia diameter between 3 and 15 cm,
location at the ventral abdominal wall at least 5 cm from the costae
and inguinal area, indication for elective repair, age 18 years or
older, and written informed consent. Exclusion criteria included a
contraindication for pneumoperitoneum, an absolute contraindication
for general anesthesia, and a history of an open abdomen treatment.
Patients participating in other trials were also excluded.
After obtaining informed consent, patients were randomized by
computer-generated lists stratified by center and primary or recurrent
incisional hernia. Patients and medical staff were not blinded to
the allocated procedure.
Laparoscopic incisional hernia repair
Laparoscopic incisional hernia repair was performed through
3 to 5 abdominal trocars (one 10 mm and 2 to four 5 mm). Pneumoperitoneum
was achieved by Veress needle or open introduction of a blunt-tip
trocar for inflation with carbon dioxide to achieve intra-abdominal
pressure up to 15 mm Hg. A 0° or 30° laparoscope was used
to provide a view of the inner surface of the abdominal wall. The
additional 5-mm trocars were positioned at the opposite site of the
hernia. The hernia port size was measured. Extensive adhesiolysis
was performed if necessary using diathermy. The omentum and bowel
were detached from the abdominal wall to expose the hernial defect.
The hernia sac was not dissected. The mesh was introduced into the
abdominal cavity through the 10-mm trocar. The mesh was then placed
over the defect with at least 5-cm overlap at all sides. Fixation
of the mesh was achieved by 5-mm nonabsorbable tackers (Protack AutoSuture;
Tyco Healthcare). A concentric ring of tackers was placed in the peripheral
margin of the mesh. Transfascial sutures were often used for mesh
positioning and supplementary fixation. Hemostasis was achieved before
removal of the trocars. All 10-mm trocar fascial defects were closed.
Skin defects were closed with absorbable monofilament sutures.
Open incisional hernia repair
Incisions were made in the old scar depending on the localization
and size of the hernia. The subcutaneous layer and scar tissue were
dissected from the abdominal wall to identify and expose the hernia
sac. The hernia port size was measured. Dissection of the hernia sac
from beneath the rectus muscles was performed if possible. Opening
and resection of the hernia sac was avoided. Whenever possible, the
posterior rectus sheath or peritoneum was dissected from the rectus
muscles. After closing of the peritoneum or posterior rectus sheath,
a mesh was positioned preperitoneally or in the sublay position, respectively,
with at least 5-cm overlap at all sides. The mesh was fixated to the
rectus muscle at each corner and side with nonabsorbable (polypropylene)
sutures. The anterior rectus sheath was closed only if tension-free
repair was possible. The use of wound drainage was not protocolized
for the study. Subcutaneous drains with low-vacuum closed systems
were placed in case of large dissection areas. The skin was closed
with monofilament absorbable sutures or staples.
After the operation, patients were transported to the surgical
ward. Patients in whom extubation was not possible were admitted to
the intensive care unit for observation and ventilatory support. Postoperative
analgesia consisted of paracetamol and nonsteroidal anti-inflammatory
drugs or intravenous analgesics if necessary. Patients were discharged
from the hospital when they mobilized autonomously.
Primary and secondary outcomes
The primary outcome of the trial was postoperative pain. Secondary
outcomes were use of analgesics, perioperative and postoperative complications,
operative time, postoperative nausea, length of hospital stay, recurrence,
morbidity, and mortality.
Preoperatively, patients were asked to complete visual analog
scales for pain and nausea. Follow-up visual analog scales were completed
at 3 days, 1 week, and 4 weeks postoperatively. After discharge from
the hospital, patients were invited for follow-up visits at outpatient
clinics at 1 week, 6 weeks, 1 year, and 5 years.
All patient data were analyzed on an intention-to-treat basis.
Patients who did not undergo incisional hernia repair or withdrew
consent were excluded from analysis.
Since there were no data available in this field at the time,
prior power calculation could not be performed. It was thought that
relevant differences could be detected with 200 patients.
Time until recurrence was evaluated using Kaplan-Meier curves
and the log-rank test. Pain and nausea visual analog scale scores
were compared with repeated-measures analysis of variance. Other continuous
variables were compared using an independent-samples t test or Mann-Whitney test in cases of nonnormal distribution.
Statistical analysis was performed using SPSS (IBM SPSS). P ≤ .05 (2-tailed) was considered
significant.
Between May 1999 and December 2006, 206 patients were randomly
assigned to undergo either laparoscopic (n = 99) or open
(n = 107) incisional hernia repair. The 2 groups were similar
in age, sex ratio, mean body mass index, American Society of Anesthesiologists
score, hernia size, and preoperative comorbidity (Table 1). Twelve patients withdrew consent
or underwent no incisional hernia repair after randomization. In total,
194 patients were included for analysis (Figure 1).
Operative data for both groups are shown in Table 2. The mean operative time in
the laparoscopic group was significantly longer than in the open group
(76 minutes vs 100 minutes; P = .001).
In the laparoscopic group, 8 of the 94 patients (8.5%) required conversion
to open repair because of technical reasons. The estimated blood loss
was significantly higher in the open group compared with the laparoscopic
group (median, 50 mL vs 10 mL; P = .05).
None of the patients required blood transfusion. Closed suction drains
were placed subcutaneously in 45 patients in the open group and in
the abdominal cavity in 3 patients in the laparoscopic group (P < .001).
The overall perioperative complication rate for laparoscopic
repair (10%) was significantly higher than open repair (2%) (P = .049). The operative complications
included enterotomy, serosal bowel injury, and bladder perforation.
Postoperative complications occurred more often in the laparoscopic
group; however, the difference in postoperative complications was
not significant (35% vs 26%; P = .13).
Important postoperative complications in both groups were hematomas,
wound infections, airway infections, and urinary tract infections
(Table 3). The median duration
of hospital stay was similar in the laparoscopic and open groups (3
days [interquartile range (IQR), 2-4 days] and 3 days [IQR, 2-5 days]
days, respectively; P = .50). Preoperative
measured hernia size was equal in both groups (median, 5 cm [IQR,
4-10 cm] in the open group vs 5 cm [IQR, 4-8 cm] in the laparoscopic
group; P = .44).
Postoperative pain and nausea
There were no significant differences in preoperative and postoperative
pain scores (Figure 2). During
4 weeks of follow-up, pain scores were similar. At the 4-week follow-up,
23 patients (25%) in the laparoscopic group and 24 patients (24%)
in the open group reported persisting pain, requiring prolonged analgesia
use (P = .54). Visual analog scale
scores for nausea were also comparable for both groups.
At a mean (SD) follow-up of 35 (33.3) months after index surgery,
146 of 194 patients (75%) completed follow-up (Figure 3). Patients were examined at
the outpatient clinic for the presence of incisional hernia in standing
and decubitus positions. In case of doubt, ultrasonography or computed
tomography scan was performed. Cumulative recurrence rates were 18%
(n = 17)in the laparoscopic group vs 14% (n = 14)
in the open group (P = .30) (Table 4). Recurrence rates in the different
hospitals ranged from 0% to 33%. There were no significant differences
between centers regarding recurrence rates.
The underlying study is not the first evaluation of the value
of laparoscopic incisional hernia repair. Earlier trials were either
not randomized, enrolled small numbers of patients, or included varied
study populations. To our knowledge, this multicenter study is the
largest randomized controlled trial comparing laparoscopic and open
incisional hernia repair.
In our study, laparoscopic incisional hernia repair was not
associated with less postoperative pain and nausea compared with open
incisional hernia repair. The operative time was significantly longer
for laparoscopic repair. Also, perioperative complications were significantly
higher in the laparoscopic group. During a median follow-up period
of 14 months, recurrence rates were comparable. Hernia size was, as
previously reported, positively correlated with recurrence rates (P = .01).10
The basic techniques of laparoscopic incisional hernia repair
have not been subject to major changes since their introduction in
the early 1990s.11 Prospective studies
on operative and long-term results have led to improvement of techniques
and implant materials. For example, after Halm et al16 reported high rates of adhesions and bowel
resection associated with intraperitoneal use of polypropylene mesh,
use of this technique became obsolete. Meanwhile, significant improvements
have been achieved in research and development of less adhesive prosthetic
materials.
For open incisional hernia repair, sufficient evidence exists
to support the superiority of mesh repair over suture repair in terms
of recurrences.9,17 Polypropylene
is the most widely used material for open mesh repair and is most
often placed in the sublay (retromuscular) position.18 A recent Cochrane review, however, yielded
insufficient evidence as to which type of mesh or which mesh position
(onlay or sublay) should be used.19 In the underlying trial, the use of mesh was mandatory for all
incisional hernia repairs, frequently using polypropylene material
in the sublay or intraperitoneal position.
Shorter operative time for laparoscopic incisional hernia repair
was reported by a number of recently published studies,13,14,20,21 while other studies show no differences or longer operative times
in the laparoscopic group.22,23 In small incisional hernia,
introduction of trocars and positioning of instruments can be time-consuming.
In the open technique, the hernia is often already reduced within
this time. In the laparoscopic technique, the positioning and fixation
of the mesh to the ventral abdominal wall can be time-consuming. A
major factor that might have affected the operative time in the laparoscopic
group was the extensive adhesiolysis in the midline of the abdominal
wall. Adhesiolysis was necessary for positioning the mesh but also
for observing any other small hernia or “Swiss-cheese”
defects. A combination of these factors could possibly explain the
significantly longer operative time in the laparoscopic group. One
hundred minutes to perform a laparoscopic ventral incisional hernia
repair, however, is reasonable and conforms to data from previous
studies.13,14
Several small randomized studies reported no differences in
postoperative pain after laparoscopic and open incisional hernia repair.13,14,20 One trial
reported reduced use of analgesics after laparoscopic repair.21 Postoperative pain after incisional hernia
repair often originates not from the hernia itself, but from the surrounding
tissues. Mesh fixation materials, eg, tackers or transfascial sutures,
are believed to be responsible for postoperative pain.24 The advantages of laparoscopy regarding
surgical wounds and wound pain could possibly be offset by mesh fixation
materials such as tackers and transfascial sutures.
Several studies have shown a shorter length of hospital stay
after laparoscopic incisional hernia repair (1.5 vs 3 days).13,14,20-22 After laparoscopic surgery, patients are expected to mobilize and
recover faster. This, however, could not be confirmed by our data
since length of hospital stay was comparable for both groups.
Previous studies have not shown significant differences in recurrence
rates for laparoscopic and open incisional hernia repair.13,14,20-22 Contrary to previous studies that reported recurrence rates up
to 20% with mesh repair, there are some studies showing exceptionally
low recurrence rates varying between 0% and 5%.9,13,14 In this
study, recurrence rates were found to be similar for both groups at
an overall rate of 17% (14% vs 18%; P = .30).
These relatively high recurrence rates, compared with recent studies,
could possibly be explained by obligatory clinical examination of
all patients included in our study. Likewise, patients who did not
report any complaints or symptoms of possible recurrence by questionnaire
were also invited to the outpatient clinics. Another explanation could
possibly be the smaller numbers of included patients in previously
conducted studies, resulting in exceptionally low recurrence rates
due to chance.
Based on this large randomized clinical trial, laparoscopic
incisional hernia repair is an effective technique with recurrence
rates comparable with open repair. Perioperative complications, however,
were significantly higher after laparoscopic repair. Common advantages
of laparoscopic surgery, such as reduced amount of blood loss and
less wound drainage, also applied for this study. Despite the statistical
difference in blood loss between the 2 techniques, the clinical significance
is negligible. Short-term benefits of laparoscopic incisional repair
described in previous studies, eg, perioperative complications, operative
time, and length of hospital stay, could not be confirmed. Long-term
results and data on cost-effectiveness are necessary to make a more
complete comparison between the 2 operative techniques.
Correspondence: Hasan H. Eker, MD,
Erasmus Medical Center, Department of Surgery, s Gravendijkwal 230,
Room z-835, 3015 CE Rotterdam, the Netherlands (h.eker@erasmusmc.nl).
Accepted for Publication: April 16,
2012.
Author Contributions:Study concept and design: Hansson, Pierik, Bonjer, Jeekel,
and Lange. Acquisition of data: Eker, Hansson,
Buunen, Janssen, and Lange. Analysis and interpretation
of data: Eker, Hansson, Buunen, Hop, Bonjer, Jeekel, and Lange. Drafting of the manuscript: Eker, Hansson, Bonjer,
Jeekel, and Lange. Critical revision of the manuscript
for important intellectual content: Eker, Hansson, Buunen,
Janssen, Pierik, Hop, Bonjer, Jeekel, and Lange. Statistical analysis: Eker, Hansson, Buunen, Hop, and Lange. Administrative, technical, and material support: Eker, Buunen, and Janssen. Study supervision: Hansson, Buunen, Pierik, Bonjer, Jeekel, and Lange.
Conflict of Interest Disclosures: None
reported.
Additional Contributions: Anneke van
Duuren provided data management. Dirk M. Boland, MD, PhD, Erwin van
der Harst, MD, PhD, Jack J. Jakimovicz, MD, PhD, George P. van der
Schelling, MD, PhD, Laurents P. S. Stassen, MD, PhD, and Dingeman
J. Swank, MD, PhD, are gratefully acknowledged for their participation
and support.
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