Laparo- Endoscopic Single site Surgery vs Conventional Laparoscopic Removal of the Gall Bladder

The laparoscopic cholecystectomy led to a surgical revolution in the early 90s.
The minimal invasive technique resulted in less pain, less hospitalization and
better cosmetic result. After a fast implementation, the technique is now
standardized, with 3 to 4 trochars and use of the *critical view of
safety* [1,2].
Since the publications of Kalloo and Rao in 2004 about NOTES; operating through
natural orifices a second revolution seemed to present itself. Technical
restrictions and closer scrutiny in comparison with 20 years ago no
breakthrough of NOTES was seen. There is renewed interest for refinement of
minimally invasive technique. Operating through a single incision through the
umbilicus is one example. The umbilicus is not a "natural orifice", but a scar
and naturally lends itself to cosmetic and practical reasons as well access to
the abdomen [3-6].
Applying a single approach to transumbilical laparoscopy is not new, but has
rather little followers [7-9]. Recently, a number of ports have come available
that make use of this technique (Single Incision Laparoscopic Surgery-port
(SILS) or Laparo-Endoscopic Single Site Surgery (LESS) [8, 10-16].
In 2007, our clinic performed the first hybrid NOTES transvaginal
cholecystectomy with good results. On April 21, 2009 the first laparoscopic
cholecystectomy was performed using the SILS * port and we have since performed
fiftheen procedures.
All procedures were successfully completed without conversion or additional
incisions. In all cases, the Critical View of Safety was achieved. The average
was operating time was 43 (31-51) minutes. Blood loss was in all cases close to
zero.
All patients felt well after surgery and gave an average VAS pain score of 4.5
(2-6) by use of paracetamol and diclofenac the morning after surgery. The pain
was in all cases at the site of the incision. Day after surgery all patients
were discharged in good condition. There were no readmissions. A check two
weeks postoperative revealed one patient with a small wound abscess. After
incision this ionfection completely healed. In addition, one patient developed
a hypertrophic scar is. Nevertheless, all patients were satisfied with the
cosmetic result. All were pain free after the fifth postoperative day.
This new approach seems a step towards less invasive surgery and seems
promising. However, there remain a number of questions that must be answered
before this technique can be used by default. The technique can not directly be
used by anyone, because it requires some training through the small space which
needs to be worked. Also, the ammount of pain experienced postoperatively might
be greater. Because the LESS technique uses the umbilicus there is
theoretically a higher risk of infection of the umbilicus if not properly
disinfected. In addition, the incision is about an inch longer than the usual
incision just below the umbilicus. It is therefore possible that an umbilical
rupture occurs faster. In this randomized study, we further explore these
potential drawbacks.

Main objective research
Investigate whether a significant difference exists in pain (VAS score) between
the conventional laparoscopic approach and the approach for a gallbladder
removal LESS

Secondary goals
a. Explore the possibility of a significant difference in abdominal and
umbilical rupture between the different approaches
b. Investigate whether a significant difference in wound infection between the
different approaches.
c. Investigate whether a difference in patient satisfaction as to the final
outcome between the different approaches.
d. Investigate whether there is a difference in overall complications between
the different approaches
e. Investigate whether there is a difference in operative time
f. Investigate whether there is a difference in treatment costs

In our clinic on an annual basis approximately 300 gall bladders are removed.
Such removals are always up first approached laparoscopically. Only with
anatomical problems or serious complications these are sometimes converted to
an open procedure.
The time between operation an being put on the waiting list is currently 3
months. After patients are seen by the surgeon for symptomatic gallstones a
standard blood test and a standard ultrasound is performed. At this moment,
the patient is informed of the possibility for participation in this
investigation and the patient gets additional information to take home. After
two weeks the patient is called back by the attending surgeon and in case of a
positive response, patients are invited for an informative conversation, and
remaining questions can be asked. If the patient wants to participate, an
Informed Consent (IC) will be signed.
Once these patients are included, patients were randomized using the envelope
method. The patient knows a few months before the operation which approach it
will get. The waiting time is the same for both interventions and participation
in this study will not delay care
The operations themselves are performed as described under the heading
"different approaches".
Postoperatively we will use the regular police checks. Patients are seen by the
principal investigator and the attending surgeon. During these visits, the
patient weighed and the medication inventory. All data is recorded on the CRF.
The follow-up visits can be found in the attached survey plan. During the 1 and
6 monthly checks will the incisions be investigated and judged whether or not
infection. In addition, patients are prompted complaints. During the 6 monthly
check is in addition to all the patients were asked how satisfied they are with
the outcome on a scale of 1 to 10 and is investigated with an ultrasound or
abdominal wall fractures.

PreOK Na operatie 1 Week TC 1
Maand 3 Maand
Length X X X
Weight X X X
History X
Echo abdomen X X
Laboratory X
Complaints X X X X
VAS score X X
X X X

The conventional technique

Patients undergo surgery under general anesthesia and positioned in the supine
position. The operator is left of the patient. The other set-up is as usual in
a laparoscopic cholecystectomy.
After local anesthesia 4 incisions are made, allowing the same number of gates
surgery. A 10mm 30 ° laparoscope (EndoEYE, Olympus, Pennsylvania United States)
without accompanying trochard inserted next three 5mm instruments. Through the
gate, the gallbladder midaxillaire stretched around the liver.
Then as usual the triangle of Callot and open structures in the triangle
dissected to 'Critical View of Safety "is obtained, as described by Strasberg
[2]. For clipping of cystic duct and artery cystica their usual 10mm clips
used. Then the gallbladder in the normal way diathermisch leverbed dissected.
Once the gallbladder was completely dissected by this incision below the navel
removed. The fascia and skin are closed Monocryl and PDS respectively.

The technique LESS

Patients undergo surgery under general anesthesia and positioned in the "French
position" with the operator between the legs. The other set-up is as usual in a
laparoscopic cholecystectomy with four incisions.
After local anesthesia with the umbilical geëverteerd Kocherklem one on either
side. The umbilicus is a small longitudinal incision of approximately 2 cm. The
TriPort * (shown below) simply inserted through the abdominal wall.
Insufflation is via an adherent to the TriPort * tube with a tap. A 10mm
extension 30 ° laparoscope (EndoEYE, Olympus, Pennsylvania United States)
without accompanying trochard introduced next two 5mm instruments. This gives
sufficient room for individual instruments side by side to move. In a Kirschner
wire midclaviculairlijn the ninth rib stabbed in the abdomen. It is using an
old-fashioned Enderpen, at the end has an eye, a curved hook. The fundus of the
gallbladder can truly be hung on the hook as a coat on the coat. Provided these
are only the serosa was derived does not usually gallekkage. It become fixated
the gallbladder after the Kirschner wire was erected and externally fixed with
a Kocher.

2 Additional visits for the patient, one of 15-20 minutes before the operation
for more detailed information and an extra time after surgery (three months) of
15 minutes and at that time an ultrasound of the abdominal wall (control
breukjes)