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151
11 Early Colorectal Cancer Management
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S.R. Brown et al. (eds.), Contemporary Coloproctology,
DOI 10.1007/978-0-85729-889-8_12, © Springer-Verlag London Limited 2012
12.1 The Safety of Laparoscopic Surgery
12.1.1 Introduction
The aim of this chapter is to review the spectrum of common laparoscopic colorec-
tal complications, to review the best data available concerning safety issues, and to
interrogate available analyses which compare open or “conventional” colorectal
surgery and take an overview of all these issues.
The evidence base available to review safety and complications in laparoscopic
colorectal surgery is now extremely large. There are 22 relevant meta-analyses
reviewing complications within laparoscopic colorectal surgery, of which one is
specifi c to the rectum.
There are several published large multicenter international randomized controlled
trials, including the CLASSICC trial. This is the largest trial yet to have reported on
both colon and rectal surgery. It has subsequently reported on 3-year outcomes, 5-year
outcomes, adhesions and hernia formation, sexual dysfunction, and on cost [ 1– 3 ] .
The European COLOR trial has reported on the near equivalence of colorectal
outcomes, and the COLOR II international trial will soon report on their fi ndings in
H. J. Gallagher, M.B.Ch.B., FRCS (*) • S. E. Noblett, M.B.Ch.B., FRCS
Department of Surgery ,
The Newcastle upon Tyne Hospitals NHS Foundation Trust ,
Freeman Road, High Heaton ,
Newcastle upon Tyne , NE7 7DN, UK
e-mail: hugh.gallagher@nuth.nhs.uk
Chapter 12
Colon Cancer: Advantages of the Laparoscopic
Approach and the Principles of Enhanced
Recovery
Hugh J. Gallagher and Sophie E. Noblett
154
H.J. Gallagher and S.E. Noblett
rectal surgery [ 4 ] . The US-based NCI COST Study Group trial has reported on both
early and 5-year outcomes [ 5 ] .
Also available are over 100 randomized control trials, of which subsequent meta-
analyses have regarded eight as of suffi ciently high quality to incorporate in their
own results.
The Cochrane database of systematic reviews has provided four reports on lap-
aroscopic colorectal surgery, both on long-term results and short-term results, lap-
aroscopic versus open total mesorectal excision, and laparoscopic versus
hand-assisted surgery. In short, therefore, there is no lack of good evidence in the
literature to analyze the safety of laparoscopic colorectal surgery.
In order to best understand the safety issues associated with laparoscopic sur-
gery, it is convenient to divide complications into several groupings in order to best
interpret the data.
1 . Generic Operative Complications
The most common grouping is generic complications which include standard
systemic complications such as cardiovascular, thrombotic, and respiratory
complications.
2 . Surgery-Specifi c Complications
These are complications specifi c to the surgery. These would include superfi -
cial surgical site infections (SSIs), deep surgical infections, anastomotic leak
rates, etc.
Also included in this grouping would be the rare procedural complications
specifi c to laparoscopic surgery including port site herniation, inadvertent
organ damage, great vessel injury, and injury to the superfi cial epigastric
arteries.
3 . Oncological Safety
The initial reports of outcomes after laparoscopic colorectal surgery were
marred by excessive disease recurrence, particularly locally and in port sites.
This in fact was one of the main drivers in the NCI COST trial analysis in the
USA.
In using this large pool of data to assess the safety of laparoscopic surgery, we
have to be aware of an inherent bias within some of the early international multi-
center randomized controlled trials. The reader must critically take into account the
role of the steep learning curve for laparoscopic colorectal surgery. Braga et al. a
decade ago, demonstrated that complications were signifi cantly higher in the fi rst
35 patients, performed by individual surgeons [
6 ] . Such an early learning curve bias
toward complications must be considered to have manifested itself in the early mul-
ticenter randomized control trials. For example, within the CLASSICC trial, each
participating individual had only to confi rm a prior experience of 20 laparoscopic
cases prior to recruiting patients into the trial. None of the trials attempted to bal-
ance or validate the surgeon’s laparoscopic versus open operative experience and
skills. Therefore, they must now be interpreted with caution, and the more recent
meta-analyses lend a more reliable data source.
155
12 Colon Cancer: Advantages of the Laparoscopic Approach
12.1.2 Overall Morbidity
The Cochrane analysis has reviewed over 20 trials, recruiting a total of 2,879
patients, and found that with all colorectal resections, the overall morbidity was
20.6% [
7 ] . Further review of this 20.6% complication rate revealed that the overall
morbidity within the laparoscopic group was 18.2% versus the open approach which
was 23% P < 0.02. Their overall conclusion was that global morbidity is lower for
laparoscopic versus open surgery within the available high-quality evidence.
This conclusion is supported by the available meta-analyses. Reza in 2006 and
Solomon in 2004 reviewed the short-term outcome data in well-constructed ran-
domized control trials and drew largely comparable conclusions [ 8, 9 ] . Laparoscopic
surgery was demonstrated to have a low morbidity rate (24.05% versus 30.80%,
95% confi dence = 0.77 (0.63–0.95); P = 0.014, n = 4,111 random affects model).
Interestingly, Solomon in 2007 performed a similar meta-analysis of nonran-
domized comparisonal trials and achieved near-identical results [ 10 ] .
Both these large meta-analyses and the subsequent Cochrane systematic review
of evidence support the assertion that laparoscopic surgery is safer than open sur-
gery in terms of global morbidity.
12.1.3 Generic Complications
12.1.3.1 Pain
Meta-analysis of pain data is conclusive. Postoperative pain is considerably less
than open surgery on the fi rst postoperative day. The largest of the studies reviewing
this was published by Leung in 2004 [ 11 ] . This compared 203 laparoscopic with
200 conventional operations, demonstrating a mean pain score of 46 laparoscopic
versus 54 in the conventional surgery group. This gave a mean difference of −8 with
a confi dence of −12.59 to −3.41. While this pain trending continued in the second
and third day, it failed to reach the same level of 95% confi dence.
12.1.3.2 Respiratory Safety
The evidence for respiratory safety is less well established. A feature when attempt-
ing to analyze the degree of respiratory complications is the number of studies that
choose to analyze respiratory physiology as their primary end point rather than true
pulmonary complication rates. Braga in 2002 reported on 72 patients randomized
between open and laparoscopic surgery [ 6 ] . No differences in respiratory outcomes
were demonstrated between the groups. Milsom in 2001 performed an RCT involving
110 patients which demonstrated an average time to return to 80% of forced expira-
tory volume was 2.5 days in the laparoscopic group versus 3.5 days, P < 0.05 [ 12 ] .
However, this did not translate into a signifi cant improvement in respiratory
156
H.J. Gallagher and S.E. Noblett
complications. Schwenk in 1999 performed a prospective randomized controlled
trial to look at respiratory function, p02 saturations, and pneumonia rates between
laparoscopic and open surgery. This study established there was a 0% versus 6%
pneumonia rate, favoring the laparoscopic group [
13 ] .
The available meta-analyses clearly demonstrate that laparoscopic surgery is
associated with improved respiratory physiology, but there appear to be no sub-
stantive differences in respiratory outcomes. The overall safety of laparoscopic and
conventional open surgery is similar for the respiratory domain, with an overall
risk of 2%.
12.1.3.3 Cardiovascular Morbidity
Again, review of the available meta-analysis data shows no convincing difference in
cardiovascular morbidity between laparoscopic and conventional approaches to col-
orectal surgery [
7 ] . In a total of 1,706 patients reviewed, in the Cochrane analysis,
there were only 11 cardiovascular complications in the laparoscopic group with a
similarly small 14 patients affected in the conventional group. This gives an overall
cardiovascular complication rate of 1.5%.
12.1.3.4 Thrombotic Morbidity
There was initial concern that the decreased venous return consequent upon the
prolonged pneumoperitoneum required for laparoscopic colorectal surgery may
predispose to an increased thrombotic morbidity. This has not, however, mani-
fested itself in any increase in either DVT or pulmonary embolism risk. Interpreting
the available data is very diffi cult due to the heterogeneity of the usage of both
mechanical and pharmacological antithrombosis measures. It is clear however
that within the world literature, the risk of thrombosis would appear to be as low
as 0.5%.
Another mechanism which has been postulated to counterbalance the decreased
venous return is the lack of venous engorgement within the deep veins of the leg
due to the steep head-down position utilized by laparoscopic colorectal
anesthetists.
Overall, there are minimal reported safety issues for laparoscopic colorectal sur-
gery within this domain.
12.1.3.5 Urinary Tract Infection
Again, urinary tract infections appear to be equivalent between both laparoscopic
and colorectal groups, with an overall rate of only 1.5% across the world literature
and meta-analyses.
157
12 Colon Cancer: Advantages of the Laparoscopic Approach
12.1.3.6 Summary
On reviewing generic complications, the only primary safety advantage to laparo-
scopic surgery would be in the management of postoperative pain. There appear
to be no signifi cant differences in either cardiovascular, respiratory, thrombotic
complications, or urinary tract infections, with the rates of all these complications,
as reported in analyzable randomized controlled trials, being reassuringly low.
12.1.4 Surgery-Specifi c Complications
Surgical morbidity can be defi ned as that specifi cally related to surgery; complica-
tions would include surgical site infections, intra-abdominal abscesses, anastomotic
failure, postoperative bleeding, postoperative ileus, deep wound dehiscence, and
reoperation for complications. A large analysis reviewed 16 trials with 1,688 par-
ticipants and established that the surgical morbidity was generally higher overall
than general morbidity overall at 12.7% [ 14 ] . There is considerable variation
between laparoscopic and open surgery, with laparoscopic surgery only having a
surgical morbidity of 1.7% versus 9.7%.
12.1.4.1 Anastomotic Safety
In the earlier meta-analyses, there appeared to be evidence of increased anastomotic
leak rates for laparoscopic versus the conventional approach. This extended across
both colon and rectal cancers. The pooled relative risks for colon cancer was 1.27%
with a 95% confi dence of 0.70–2.31 across four studies. Only two studies were
analyzable for rectal cancer, giving a pooled relative risk of rectal cancer of 1.25%
with 95% confi dence of 0.63–2.46. This may well have refl ected early learning
curve issues as more contemporary systematic reviews such as that by Krukowski
and Vale in 2008 have revealed that this safety concern has disappeared [ 15 ] .
Table 12.1 summarizes the higher volume trials analyzable for laparoscopic ver-
sus open anastomotic insuffi ciency. These larger trials, involving over 100 partici-
pants in each arm, have shown a trend towards lower leak rates in the laparoscopic
arm, but have failed to show a statistically signifi cant difference. The actual leak
Table 12.1 Leak rates in high-quality series of >100 cases
Study Laparoscopic leaks (%) Open leaks (%)
Braga et al. [
6 ] 8/136 (5.8%)
11/133 (8.3%)
Lacy et al. [
16 ] 0/111 (0%) 2/108 (1.8%)
Leung et al. [
11 ] 1/203 (0.5%) 4/200 (2%)
El-Gazzaz et al. [
17 ] 39/1516 (2.6%) 68/3258 (2.1%)
Total 48/1965 (2.4%) 85/3699 (2.2%)
158
H.J. Gallagher and S.E. Noblett
rates within these trials vary widely between 0% and 6% for the laparoscopic
approach versus 1% and 8% for conventional open surgery.
On grouping all these trials together, we have a laparoscopic leak rate in the ran-
domized trials featuring over 100 participants of 1.9% for laparoscopic versus a leak
rate of 3.2% for the conventional group. These excellent rates may refl ect the well-
recognized randomized control trial selection bias toward high-quality treatment.
Some individual large series failed to reach these standards. Rosin in 2007 reviewed
350 laparoscopic cases, giving a leak rate of 6.9% [
18 ] . Staudacher in 2005 reviewed
599 laparoscopic cases with a leak rate of 7.3% [ 19 ] . Leroy in 2004 presented 102
TMEs, where the leak rate was 17% [ 20 ] .
These fi gures show that anastomotic leak remains a signifi cant safety risk for
both laparoscopic and open colorectal resectional surgery. However, despite early
worrying fi gures, there is no substantive difference in anastomotic leak rates between
laparoscopic surgery and open surgery.
12.1.4.2 Wound Infections and Surgical Site Infections
It can be stated quite didactically that wound infections and surgical site infections
are signifi cantly lower in the laparoscopic surgery group. This has been specifi cally
looked at in the Cochrane systematic review which reveals an overall laparoscopic
wound infection/SSI rate of 4.6% versus an open rate of 8.7%, achieving a P value
of 0.002% [ 7 ] .
Poon in 2009 published a prospective trial involving 1,011 patients with SSIs as
a dedicated outcome measure [ 21 ] . The wound SSI rate was 2.7% in the laparo-
scopic group versus 5.7% in the open group. This series also reviewed the deep
surgical site infection rate and revealed no difference at 1.7% in both groups. This
may be as expected as deep surgical infections are a direct refl ection of anastomotic
leak rates. A meta-analysis of 1,793 patients analyzable for infection revealed 41
out of 895 (4.6%) laparoscopic cases developing a surgical site infection versus 77
of 892 (8.6%) conventionally operated patients. This yielded a P value of 0.02.
The evidence is conclusive that laparoscopic surgery has a dramatic effect in
reducing surgical site infections.
12.1.4.3 Sexual Dysfunction
Sexual dysfunction has widely been believed to be worse with laparoscopic surgery
as compared to open surgery. Jayne in 2003 revealed that 7 out of 15 laparoscopic
versus 1 out of 22 conventional surgeries developed sexual dysfunction [ 22 ] .
In 2005, the same author reviewed the CLASSICC data and revealed that laparo-
scopic rectal resection did not adversely affect bladder function [ 23 ] . There was a
trend within the trial toward worse male sexual function and erectile function (over-
all function: difference −11.18 (95% confi dence interval (c.i.) −22.99 to 0.63),
P = 0.063; erectile function: difference −5.84 (95% c.i. −10.94 to −0.74), P = 0.068).
159
12 Colon Cancer: Advantages of the Laparoscopic Approach
However, the higher rate of TME in the laparoscopic rectal group was acknowledged
to be a potential bias within the review. This difference of sexual function failed to
reach statistical signifi cance.
More recent results appear to refl ect a greater competence with laparoscopic
techniques; Lumley has published in 2008 that in 94% of patients, sexual function
is preserved [
24 ] . Gerone in 2008 reviewed potency and found this to be 57.8% and
orgasm and ejaculation to be 37.8% in a group of patients undergoing laparoscopic
TME, comparing favorably with similar open TME studies [ 25 ] .
It is hoped that rates of sexual dysfunction can further be reduced by improved
surgical training in laparoscopic pelvic surgery. Currently, the safety risk is low but
defi nite with male patients. There are no reported differences for females.
12.1.4.4 Ureteric Injuries
This is among the most dreaded of surgical complications, but there is surprisingly
little literature published on this. Aalbers in 2006 reported a 2.5% ureteric injury
rate [ 26 ] . Regedas in 1998 revealed a risk of only 0.8%, and Motson in his early
laparoscopic colorectal series in 1998 published an abstract revealing 2 out of 140
laparoscopic cases sustained a ureteric injury [ 27 ] . For laparoscopic surgery, a rate
of ureteric injury varying between 0.8% and 2.5% can be expected.
12.1.4.5 Compartment Syndromes
Compartment syndromes have certainly been reported following laparoscopic col-
orectal surgery; the time taken to perform the colonic procedures has been greater
than 290 min in these cases. Overall, compartment syndromes are reassuringly rare
in occurrence. There are anecdotal reports of intraocular compartment syndromes
within the United Kingdom, requiring both drug therapy and surgical intervention.
An excellent overview of this subject was published by Shorthouse in 2002 [ 28 ] . To
ameliorate the risk, the author has a 2-h moratorium in the head-down position at
which time the Trendelenburg position is reversed and 10 min of reperfusion time
given to the legs.
12.1.4.6 Incisional Hernias
The data available for analysis on incisional hernias is small, and indeed, the inter-
pretation of the data is diffi cult. There may be little clinical comparison between a
small port site hernia and a large midline incisional hernia, but the literature does
not discriminate between these events. From the data available and analyzable from
within the meta-analyses, the rate of herniation is 18/227 (8%) within laparoscopic
colorectal surgery versus 27/247 (11%) for open surgery, but this fails to reach sta-
tistical signifi cance [ 7 ] . Interestingly within these same groups, a higher proportion
160
H.J. Gallagher and S.E. Noblett
of the laparoscopic hernias were operated upon as opposed to the open hernias: 9/18
(50%) laparoscopic cases versus 7/18 (39%). This may refl ect an inherent willing-
ness to repair the smaller laparoscopic defect or may refl ect that laparoscopic defects
were more symptomatic.
The CLASSICC trial reported its results for incisional hernia in 2010 [
3 ] . Thirty-
six patients developed IH: 12 (9.2%) after open versus 24 (8.6%) after laparoscopic
surgery which was nonsignifi cant. Interestingly, further interrogation of the data
revealed that conversion from laparoscopic to open surgery (24.5% of patients) con-
siderably increased the risk of incisional herniation: 8.6%, 7.4%, and 11% for open,
completed laparoscopic, and converted operations, respectively.
Incisional or port site herniation remains a considerable longer term safety
issue for the laparoscopic colorectal patient. While the risk is broadly equivalent
between the groups at around 9%, the laparoscopic cohort has a higher chance of
reoperation.
12.1.4.7 Adhesions
Adhesions causing small bowel obstruction are a longer term complication, and data
are scant. In 2010, CLASSICC reported its results: 7/280 (2.5%) laparoscopic cases
versus 4/131 (3.1%) open cases required surgical intervention for adhesions.
Interestingly, conversion also increased the risk markedly to 6% in this subgroup [
3 ] .
12.1.4.8 Hemorrhage and Blood Loss
Two studies, Ramos et al. in 1995 and Franklin et al. in 1996, showed a signifi cantly
greater loss with the open approach:150–160 mL versus 370–450 mL. However, the
larger multicenter RCTs suggest no signifi cant difference between the laparoscopic
and open approaches [ 29, 30 ] .
12.1.4.9 Summary
Surgery-specifi c complications confer the greatest safety risks to the laparoscopic
colorectal patient. Laparoscopic surgery causes considerably less surgical site infec-
tions than open surgery, but there is equivalence in the other major complications.
12.1.5 Oncological Safety
The early phase of laparoscopic colorectal malignancy surgery was made con-
troversial by poor oncological outcomes, particularly port site and local recur-
rence. Through improved laparoscopic techniques, these risks have been reduced
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