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Surg Endosc and Other Interventional Techniques

DOI 10.1007/s00464-015-4453-x

REVIEW

Laparoscopic versus open surgery for complicated appendicitis


in adults: a randomized controlled trial
Yoshiro Taguchi1 Shunichiro Komatsu1,2 Eiji Sakamoto1 Shinji Norimizu1

Yuji Shingu1 Hiroshi Hasegawa1

Received: 16 April 2015 / Accepted: 16 July 2015


Springer Science+Business Media New York 2015

Abstract between groups. No significant differences between groups


Background The aim of this study was to assess whether were found in hospital stay, duration of drainage, analgesic
laparoscopic appendectomy (LA) for complicated appen- use, or parameters for postoperative recovery except days
dicitis (CA) effectively reduces the incidence of postop- to walking.
erative complications and improves various measurements Conclusion These results suggested that LA for CA is
of postoperative recovery in adults compared with open safe and feasible, while the distinguishing benefit of LA
appendectomy (OA). was not validated in this clinical trial.
Methods This single-center, randomized controlled trial
was performed in the Nagoya Daini Red Cross Hospital. Keywords Complicated appendicitis  Laparoscopic
Patients diagnosed as having CA with peritonitis or abscess surgery  Open surgery  Complication  RCT
formation were eligible to participate and were randomly
assigned to an LA group or an OA group. The primary
study outcome was development of infectious complica- With the accumulated experience in laparoscopic surgery
tions, especially surgical site infection (SSI), within for digestive diseases, the laparoscopic approach has been
30 days of surgery. more frequently employed for complicated appendicitis
Results Between October 2008 and August 2014, 81 (CA) in adults and children. Recent studies, including
patients were enrolled and randomly assigned with a 1:1 retrospective analyses of large databases or meta-analyses,
allocation ratio (42, LA; 39, OA). All were eligible for showed that laparoscopic appendectomy (LA) is associated
study of the primary endpoint. Groups were well balanced with a reduction in wound infection rates and in-hospital
in terms of patient characteristics and preoperative levels of stays as well as less postoperative pain with quicker
C-reactive protein. SSI occurred in 14 LA group patients functional recovery [16]. On the other hand, postoperative
(33.3 %) and in 10 OA group patients (25.6 %) (OR 1.450, intraabdominal abscess (IAA) remains a major concern in
95 % CI 0.5533.800; p = 0.476). Overall, the rate of LA for perforated appendicitis. Indeed, the reported rate of
postoperative complications, including incisional or organ/ postoperative IAAs diverges widely in different studies
space SSI and stump leakage, did not differ significantly comparing LA versus open appendectomy (OA) for CA [1
3, 515].
These previous retrospective reports provide the initial
framework for higher-level studies on LA versus OA for
& Yoshiro Taguchi CA, and randomized controlled trials evaluating the
yoshirotaguchi@hotmail.com laparoscopic approach for CA are warranted [16]. We
1 designed this randomized controlled study to investigate
Department of Digestive Surgery, Nagoya Daini Red Cross
Hospital, 2-9, Myoken-cho, Showa-ku, Nagoya 466-8650, whether LA for CA effectively reduces the incidence of
Japan postoperative complications and improves various mea-
2
Department of Gastroenterological Surgery, Aichi Medical surements of postoperative recovery in adults compared
University, Nagakute, Aichi, Japan with OA.

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Methods hydrochloride 1 g every 12 h), which were continued in the


postoperative period until the inflammatory response aba-
Study design and participants ted as comprehensively determined by clinical and labo-
ratory findings such as fever, pain, bowel movement, oral
This single-center, open-label, randomized controlled trial intake, white blood cell count, and CRP.
was performed at the Nagoya Daini Red Cross Hospital. Laparoscopic appendectomy was performed using a
CA in this study was defined as acute appendicitis in two-handed, four-trocar technique. A 12-mm umbilical
which perforation or an intraabdominal abscess was pre- port was introduced by the open method, subsequently
sent. Patients older than 19 years of age who were diag- creating a pneumoperitoneum. A 5-mm flexible laparo-
nosed as having CA with peritonitis or abscess formation scope (Olympus, Tokyo, Japan) was used. In addition, two
by abdominal examination, laboratory data, or CT were trocars were used: 5-mm in the suprapubic position and
eligible for participation. Exclusion criteria were the 5-mm in the left lower abdomen. A 5-mm supplementary
presence of other diseases, such as colon cancer or trocar was placed, if required, in the right lower quadrant of
inflammatory bowel disease; the need for additional sur- the abdomen. The mesoappendix was dissected using an
gical treatments (e.g., addition of colon resection); inap- energy device, and the appendix was divided with an
propriateness of the laparoscopic approach due to previous endolinear stapler. To avoid contamination, the appendix
abdominal surgery or remarkable distension of the intes- was removed in an endoscopic bag through the umbilical
tine; instability of respiration or circulation due to systemic wound. The 12-mm port sites were closed with 2-0 Vicryl
infectious complications; and lack of understanding of the suture (Ethicon, Somerville, NJ), and skin apposition was
purpose of the study. Study patients were recruited and done with subcuticular sutures using 4-0 PDSII suture
underwent surgery in the surgical department of the (Ethicon, Somerville, NJ).
Nagoya Daini Red Cross Hospital. Patients were enrolled Open appendectomy was performed through a midline
between October 2008 and August 2014 and provided or pararectal incision. A wound retractor (Alexis wound
written informed consent before participating in the trial. protection system: Applied Medical, Rancho Santa Mar-
The study protocol was approved by the institutional garita, CA, USA) was placed in the wound upon entry into
review board of the Nagoya Daini Red Cross Hospital. An the peritoneal cavity and remained in place throughout the
English-language summary of the protocol was submitted procedure. The mesoappendix was ligated, and the
(registration ID UMIN000003711) to the Clinical Trials appendiceal stump was ligated and inverted into the cecum
Registry managed by the University Hospital Medical with a purse-string suture. The abdominal wall was closed
Information Networks in Japan, which can be accessed on a in layers with absorbable sutures (1-0 PDSII suture), and
commission-free basis on the Internet (http://www.umin. the skin was closed with single nonabsorbable sutures (3-0
ac.jp/ctr/index.htm). Monocryl suture; Ethicon, Somerville, NJ).
Both groups of patients underwent thorough peritoneal
lavage using several liters of warm saline until the drainage
Randomization
fluid became clear regardless of whether an abscess or
peritonitis was present. Closed suction drains were placed
Randomization was performed before the operation. Allo-
in the abscess cavity when encountered. While one of the
cation to groups (1:1 ratio) was made by weighted mini-
trocar wounds was used for drainage in LA, in OA the
mization at the time of enrollment using the following
drain was brought out through a stab wound separate from
criteria: age (\45 or ]45 years), sex (male or female),
the main abdominal incision.
body mass index (\22 or ]22), and C-reactive protein
Analgesics were given intramuscularly (pentazosine), as
(CRP) level (\15 or ]15 mg/dl). All factors were
a suppository (diclofenac sodium), or orally (loxoprofen)
weighted equally. Randomization was performed using a
as needed. Epidural analgesia was not used in any study
computer-based randomization program (FileMaker Pro),
patient. Patients in both groups were urged to walk from
which allowed complete concealment of the randomization
postoperative day 1, in accordance with the same program
sequence. Patients and investigators were not masked to
for recovery. Oral intake was reintroduced as soon as it
group assignment.
could be tolerated and when bowel function became ade-
quate without any signs of stump leakage or exacerbated
Surgery inflammation. Patients were to be discharged when both
oral intake and physical activity had recovered sufficiently.
All operations were performed by six senior surgeons with Postoperative complications were recorded both during
sufficient experience in laparoscopic surgery. All patients hospitalization and at follow-up. Follow-up in the outpa-
received preoperative intravenous antibiotics (cefozopran tient clinic continued for at least 30 days after surgery.

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Primary outcome the LA group and 39 in the OA group. No patient was


excluded after randomization, and no one was lost to follow-
The primary study outcome was development of an up. Finally, a total of 42 patients in the LA group, including
infectious complication, especially a surgical site infection one conversion to laparotomy and one laparoscopic drainage
(SSI), within 30 days of the operation. According to the followed by interval appendectomy, and 39 patients in the
American College of Surgeons National Surgical Quality OA group were analyzed on an intention-to-treat basis
Improvement Program (ACS-NSQIP) definitions, superfi- (Fig. 1). Among the 48 excluded patients, 14 patients
cial SSI includes infections involving only the skin or underwent LA, including one conversion case, and 34
subcutaneous tissue at the incision; deep SSI includes underwent OA. Ten of the 12 patients excluded due to severe
infections involving deep soft tissues (e.g., fascial and comorbidity had cardiocerebral diseases of American Soci-
muscle layers) at the incision; and organ-space SSI ety of Anesthesiologists (ASA) class 4 (nine patients),
includes infections involving any part of the anatomy that peritoneal dissemination of neoplasm (two patients), and/or
was opened or manipulated during an operation [17]. The previous major abdominal surgery (four patients). Of the
definition of stump leakage included any clinical or radi- remaining two, one was a recipient of renal transplantation
ologic evidence of a problem (such as discharge of with administration of steroid and immunosuppressant drugs
intestinal content through a drain), whether or not reoper- and the other was in the 34th week of pregnancy.
ation or any other intervention was required. Additional Patient and disease characteristics (age, sex, body mass
tests such as chest and abdominal computed tomography index, ASA classification, comorbidities, prior abdominal
were performed to assess leakage-related complications. surgery, preoperative CRP) were equally distributed between
the two groups (Table 1). SSI occurred in 14 LA group
Secondary outcomes patients (33.3 %) and in 10 OA group patients (25.6 %) (OR
1.450, 95 %CI 0.5533.800; p = 0.476). Overall, the rate of
Secondary endpoints include operating time, analgesic use postoperative infectious complications, including incisional
frequency, start of oral intake, recovery of bowel move- or organ/space SSI and stump leakage, did not differ signifi-
ment, restoration of physical activity, length of postoper- cantly between the study groups (Table 2). All of the inci-
ative hospital stay, and changes in the white blood cell sional SSIs in LA occurred in the umbilical wound used for the
count and CRP level after surgery. extraction of the specimen. The number of bowel obstructions
did not differ significantly between the two groups. No post-
Statistical analysis operative mortality was recorded in either group (Table 3).
The accuracy of the preoperative diagnosis of abscess or
Our sample size calculation was based on an assumed peritonitis was 93 % according to operative findings
wound infection rate of 40 % in appendectomy for CA (Table 3). No significant differences were found concerning
[18]. Given an intended reduction to 10 %, an a value of changes in the white blood cell count or CRP level between the
0.05 in the Chi-square test, and a power of 0.8, the sample two groups before and after surgery (Fig. 2).
size required was estimated to be 38 in each arm. The study In all patients in both groups, an infected wound was
was set to include the randomization of 100 patients. The opened to obtain optimal drainage followed by lavage with a
statistical analysis was performed using the Statistical water shower. The mean length of healing of the infected
Package for the Social Sciences (SPSS) version 22.0 wounds was comparable between groups (LA 27.2 days, OA
(SPSS, Chicago, IL, USA) for Windows. The Chi-square 28.0 days). Drains were placed intraoperatively in 90.5 % of
test or the Fishers exact test was used for comparison of LA and in 89.7 % of OA patients. In 14 patients (LA 7, OA 7)
categorical variables. Continuous variables were compared with stump leakage and/or intraabdominal abscess, duration
using a t test when normally distributed or otherwise using of drainage was prolonged over 14 days after surgery.
the MannWhitney U test. Wilcoxon signed-rank test was Operative time was significantly longer with LA than
used for nonparametric data when appropriate. In all tests, with OA, whereas intraoperative blood loss was signifi-
p \ 0.05 was regarded as significant. This trial is reported cantly less in LA than in OA. The appendiceal stump was
in accordance with the CONSORT statement. closed mainly by staples in LA, but by ligation or suture in
OA. Significant differences were found only in days to start
walking (OR 4.246, 95 % CI 1.16215.514; p = 0.029),
Results while the other measures for postoperative recovery (days
to oral intake of liquids, days to oral intake of solids, and
During the study period, 129 patients underwent appendec- times of analgesic use) did not differ significantly. Post-
tomy for CA out of a total of 676 appendectomies. Among operative hospital stay and duration of drainage in LA were
these, 81 patients were enrolled and randomized, with 42 in comparable with those in OA. There were no significant

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Fig. 1 Trial profile

Table 1 Clinical characteristics of study patients differences in unintentional reoperation or interventional


Laparoscopic Open radiology (IVR) after surgery between the two groups
(Table 3). Moreover, no significant difference in medical
Number 42 39 costs as assessed by total hospital charges, including the
Age (median, range, years) 46 (2185) 49 (2081) costs for single-use staplers and other laparoscopic devices,
Sex ratio (M:F) 28:14 25:14 was found between the two groups (LA 874,929.5
Body mass index (kg/m2) 22.54 3.49 21.56 3.12 275,686.04 vs. OA 867,905.9 307,102.03 yen,
Preoperative CRP (mg/dL) 15.23 7.16 14.30 8.13 p = 0.914).
ASA classification
I (normal healthy patient) 27 24
II (mild systemic disease) 10 12
Discussion
III (severe systemic disease) 5 3
Comorbidities
Perforated appendicitis is associated with increased mor-
Diabetes mellitus 4 2
bidity rates. The surgical management of CA generally
Previous abdominal surgery 2 2
requires a larger abdominal incision and longer operating
Values are mean SD time, with increased surgical stress to patients, compared

Table 2 Postoperative
Laparoscopic (n = 42) Open (n = 39) Odds (95 % CI) p
complications
SSI any 14 (33.3 %) 10 (25.6 %) 1.450 (0.5533.800) 0.476
Incisional 8 (19.0 %) 3 (7.7 %) 2.824 (0.69111.533) 0.197
Organ space 8 (19.0 %) 7 (17.9 %) 1.076 (0.3503.308) 1.000
Leakage 4 (9.5 %) 5 (12.8 %) 0.716 (0.1782.885) 0.732
Bowel obstruction 2 (4.8 %) 0 1.050 (0.9811.123) 0.494
SSI surgical site infection

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Table 3 Clinical outcomes


Laparoscopic (n = 42) Open (n = 39) Odds (95 % CI) p

Operative time (min) 84.6 34.57 63.5 20.76 1.066 (1.0281.106) 0.001
Blood loss (g) 25.1 64.02 71.5 117.77 0.976 (0.9590.993) 0.005
Days to resumption of liquids 1.1 0.37 1.4 1.18 0.432 (0.1131.652) 0.220
Days to resumption of solids 4.1 2.80 4.6 4.80 0.920 (0.7201.176) 0.507
Days to walking 1.5 0.67 1.3 0.51 4.246 (1.16215.514) 0.029
Duration of drainage (days) 8.9 10.54 8.4 7.99 0.990 (0.8301.182) 0.914
Duration of intravenous antibiotics (days) 5.5 4.28 4.4 3.03 0.923 (0.8111.050) 0.221
Length of postoperative stay (days) 11.4 8.57 11.9 6.65 1.023 (0.8201.278) 0.838
Analgesic use (times) 8.0 8.08 6.5 7.82 1.050 (0.9291.188) 0.434
Pentazosine 0.8 1.39 0.5 1.07 1.144 (0.5992.185) 0.684
NSAID 7.2 7.57 6.0 7.82 1.051 (0.9281.190) 0.470
Appendiceal stump \0.001
Linear stapler 39 2
Ligation 2 37
None 1 0
Postoperative diagnosis 0.582
Peritonitis 22 16
Abscess 17 20
Uncomplicated appendicitis 3 3
Postoperative interventional radiology 4 5 0.716 (0.1782.885) 0.732
Unintentional reoperation 1 0 1.024 (0.9771.074) 1.000
Mortality 0 0
Values are mean SD
NSAID nonsteroidal anti-inflammatory drug

with surgery for uncomplicated appendicitis. The effec- previous retrospective studies. An explanation for the rel-
tiveness of the laparoscopic approach for CA has been atively higher (but not significant) rate of incisional SSI in
extensively studied [115]. However, the role of laparo- LA than in OA may be that the incidence of wound
scopy in CA is still undefined due to lack of high-level infection was effectively suppressed in the OA group to a
evidence (e.g., randomized controlled trials). The present level lower (7.7 %) than we expected compared with data
randomized controlled trial addressed the issue as to in previous reports [3, 18]. The wound protection system
whether LA for CA effectively reduces the incidence of applied in all cases in OA may have contributed to the
postoperative complications and improves various mea- inhibition of incisional SSI in that group [19, 20]. On the
sures of postoperative recovery in adults in comparison other hand, no protective device against contaminated fluid
with OA, following a recently published study [16] in or irrigation with saline could be applied to the small trocar
which safety of LA for OA was assessed. No significant wounds in LA, except for an endoscopic bag to extract the
between-group differences were found in the parameters resected specimen.
for surgical outcomes and postoperative recovery studied Distinguishing features of the laparoscopic approach
except for operative time, appendiceal stump closure, days over the conventional open approach include earlier
to walking, and blood loss. resumption of oral intake, quicker return to activity, and
Suppression of wound infection and reduction in the reduced pain, resulting in a shorter hospital stay [2, 18, 21].
hospital stay have been emphasized as major benefits of An interesting aspect of the present findings is that such
LA for CA [2, 4, 18]. Surprisingly, the rate of incisional measures of postoperative recovery in LA were compara-
SSI or length of hospital stay was not reduced in the LA ble to those in OA, and advantages of the laparoscopic
group in the present study. Disadvantages of OA may have approach related to postoperative pain, physical activity, or
been overestimated because of potential bias concerning bowel function were not observed. Early postoperative
disease severity, antibiotics, analgesics, or surgeons in benefits of the procedure may become negligible when

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Fig. 2 Changes in the white blood cell (WBC) count and C-reactive protein (CRP) level before and after surgery. Values are shown as
mean SD. LA laparoscopic appendectomy, OA open appendectomy

patients are exposed to the profound effects of continued for percutaneous cannulation, wherein laparoscopic
infection and inflammation elicited by contamination due appendectomy is also hampered by the severe disease state.
to the perforated disease itself. Patients in both groups were Laparoscopic drainage can optionally be used in such a
urged to walk as early as possible after surgery in accor- situation, which may contribute to avoiding conversion to
dance with the same postoperative program for recovery of laparotomy. One patient in the LA group successfully
physical activity. This could account for the smaller underwent laparoscopic drainage and interval appendec-
advantage of LA related to physical activity than we tomy. The laparoscopic approach may have the potential
expected. benefit of lessening a surgeons hesitation about not
It is plausible that LA for perforated appendicitis should removing the inflamed appendix at the same time.
result in a decreased incidence of IAA because the The decision of whether to use ligation or a stapling
abdominal cavity can be better visualized and a more device for appendiceal stump closure in perforated
thorough washout can be performed. However, a higher appendicitis remains controversial [3133]. In the majority
incidence of IAA formation following the use of laparo- of our LA group cases, an endolinear stapler was used for
scopy has been reported [5, 11, 15], which possibly has appendiceal stump closure because we thought that the
hampered LA being adopted as a standard procedure for stapler has the advantages of relatively easy handling and
CA. Our findings showed that the rates of organ/space SSI, of avoiding ligation of fragile and necrotic tissue in CA,
with or without stump leakage, were similar between the presumably resulting in a reduction in the incidence of
study groups, with a comparable incidence of reoperation leakage. However, ligation or suture of the stump was
and IVR. These results are consistent with recent retro- possible and successfully done in most of the OAs with
spective studies [1, 3, 7, 8, 10, 14], and, therefore, LA for similar disease severity. Interestingly, the rates of stump
CA is considered safe and feasible with improvements in leakage were comparable between the LA and OA groups
techniques and devices. Nonetheless, the roles of extensive in this study. Regarding cost, no significant difference in
irrigation and routine drainage to reduce risks of IAA that total hospital charges, including the laparoscopic devices,
were employed in this study remain debatable [2226]. was found between groups in this study.
An alternative treatment for CA is nonsurgical, includ- This study was performed in a single center with a rel-
ing intravenous antibiotics and selective percutaneous atively small sample size and has several limitations. Data
drainage, followed by interval appendectomy [2730]. on cosmesis or the incidence of incisional hernia were not
There are refractory cases without any safe access routes recorded in this study, which might have disclosed some

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beneficial effects of the laparoscopic approach [34, 35]. 8. Galli R, Banz V, Fenner H, Metzger J (2013) Laparoscopic
The possibility cannot be excluded that the administration approach in perforated appendicitis: increased incidence of sur-
gical site infection? Surg Endosc 27:29282933
of analgesics does not always truly reflect actual pain 9. Katsuno G, Nagakari K, Yoshikawa S, Sugiyama K, Fukunaga M
levels, as this may follow department policies or standards (2009) Laparoscopic appendectomy for complicated appendicitis:
rather than real demand. The use of a visual analogue scale a comparison with open appendectomy. World J Surg 33:208214
may be more appropriate to assess postoperative pain. It is 10. Khiria LS, Ardhnari R, Mohan N, Kumar P, Nambiar R (2011)
Laparoscopic appendicectomy for complicated appendicitis: is it
conceivable that the benefits of LA would become more safe and justified?: a retrospective analysis. Surg Laparosc
evident in more complicated cases [4] or that there would Endosc Percutan Tech 21:142145
be some differences between small and large infected 11. Lim SG, Ahn EJ, Kim SY, Chung IY, Park JM, Park SH, Choi
incisions in the severity of illness, such as inflammatory KW (2011) A clinical comparison of laparoscopic versus open
appendectomy for complicated appendicitis. J Korean Soc
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cise analysis of patients with comorbidities or postopera- Outcomes after laparoscopic treatment of complicated versus
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trial. J Laparoendosc Adv Surg Tech A 19:721725
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In conclusion, the present findings suggested that LA for factors for post-operative intra-abdominal abscess. Surg Endosc
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16. Thomson JE, Kruger D, Jann-Kruger C, Kiss A, Omoshoro-Jones
Disclosures Yoshiro Taguchi, Shunichiro Komatsu, Eiji Sakamoto, JA, Luvhengo T, Brand M (2015) Laparoscopic versus open
Shinji Norimizu, Yuji Shingu, and Hiroshi Hasegawa have no conflict surgery for complicated appendicitis: a randomized controlled
of interest. trial to prove safety. Surg Endosc 29:20272032
17. Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG
(1992) CDC definitions of nosocomial surgical site infections,
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