Acute Appendicitis Clinical Trial
Official title:
Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Transumbilical Single Incision Laparoscopic Appendicectomy
Laparoscopic appendicectomy is widely practiced in Hong Kong nowadays with shorter hospital
stay and less wound complications. Most of the time, three small wounds of less than 10mm
will be adequate enough for the completion of the surgery with minimal pain.
Recently, the concept of Natural Orifice Transluminal Endoscopic Surgery (N.O.T.E.S) led to
the attention of single incision laparoscopic surgery (SILS) again in the surgical
community. SILS is not a new idea. The first SILS for cholecystectomy was reported in 1997
by Navarra et al. However, the close proximity of the instruments, limitation in
triangulation during dissection and suboptimal exposure of the surgical field has made this
approach unpopular in last decade. Because the concept of N.O.T.E.S and the newly designed
access port, surgeons are now focused again on SILS. The Chinese University of Hong Kong has
recently release their preliminary results on the use of SILS on appendicectomy with
satisfactory results in terms of less post-operative pain and less prominent scar. However,
it was a case series with limited number of patients. In order to test the advantages of
SILS on the management of patients with acute appendicitis, a double blinded randomized
clinical trial is conducted.
Double Blinded Randomized controlled study of Conventional Laparoscopic Appendectomy Vs
Transumbilical Single Incision Laparoscopic Appendicectomy
Introduction:
Laparoscopic appendicectomy is widely practiced in HA hospital nowadays with shorter
hospital stay and less wound complications. Most of the time, three small wounds of less
than 10mm will be adequate enough for the completion of the surgery with minimal pain.
Recently, the concept of Natural Orifice Transluminal Endoscopic Surgery (N.O.T.E.S) led to
the attention of single incision laparoscopic surgery (SILS) again in the surgical
community[1,2,3] is not a new idea. The first SILS for cholecystectomy was reported in 1997
by Navarra et al. However, the close proximity of the instruments, limitation in
triangulation during dissection and suboptimal exposure of the surgical field has made this
approach unpopular in last decade. Because the concept of N.O.T.E.S and the newly designed
access port, surgeons are now focused again on SILS. The Chinese University of Hong Kong has
recently release their preliminary results on the use of SILS on appendicectomy with
satisfactory results in terms of lesser post-operative pain and less prominent scar.
However, it was a cases series with limited number of patients. In order to test the
advantages of SILS on the management of patients with acute appendicitis, a double blinded
randomized clinical trial is conducted.
Statistical Analysis:
The primary outcome that the trial to evaluate is operative time, post-operative pain and
wound infection rate. The working alternative hypothesis is that there will be significant
differences in umbilical wound infection rate between Conventional Laparoscopic Appendectomy
and Transumbilical Single Incision Laparoscopic Appendicectomy.
At least 80 patients (40 cases in each group) is needed to demonstrate a 25% difference in
umbilical wound infection rate at a statistical significance level of P> 0.05 and power of
80%. All analyses and comparisons between the two groups were performed on an
intention-to-treat basis.
The Student t-test, Mann-Whitney U test, the Chi-square test and Fisher exact test where
appropriate were used to compare the result between groups. All calculations were performed
by the software SPSS for Window version 15.0 (SPSS, Inc, USA). P <0.05 was considered as
statistical significant.
Detailed Description:
This study seeks to examine the ability of single incision laparoscopic appendicectomy to
reduce the post-operative pain and increase cosmetic outcome at the expense of longer
operation time and at higher cost. Patients will be randomized preoperatively by a computer
generated random allocation to either receive conventional laparoscopic appendicectomy or to
have transumbilical single incision laparoscopic appendicectomy.
Control group:
Patients will undergo conventional laparoscopic appendicectomy. A 10-mm subumbilical port
will be inserted by open method. Two 5-mm working ports will be inserted under laparoscopic
view at patient's left lower quadrant and suprapubic area. Umbilical fascia will be closed
by PDS-1 J-shape needle.
Local anaesthetic agent , Marcain 0.5% should be infiltrated into the fascial layers as well
as the skin layers with dosage up to 20ml. All skin wound will be approximated with 3-0
nylon interrupted stitches and covered with non-transparent dressings.
Compare group:
Patients will undergo transumbilical single incision laparoscopic appendicectomy. A single
incision is made on umbilicus within the margin of umbilical skin ring. Peritoneal cavity is
entered by open method and the fascia layer can be extended up to 2.5cm in length. A single
incision laparoscopic device (Olympus) will be inserted. Conventional laparoscopic
instruments will be used. Umbilical fascia will be closed by PDS-1 J-shape needle. Marcain
0.5% should be infiltrated into the fascial layers as well as the skin layers with dosage up
to 20ml. The umbilicus is reconstructed by interrupted 3-0 nylon by tacking the skin onto
the fascia layers.
Three non-transparent dressings will be placed as if conventional laparoscopic
appendicectomy has been done.
Randomization:
Randomization is performed before consent for surgery. Patients are randomly assigned by
means of sealed envelopes containing computer-generated random numbers into the following
groups:
1. Control group (conventional laparoscopic appendicectomy)
2. Compare group (single port laparoscopic appendicectomy)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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