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56
A. A. Samara
and studies with data from multiple RCTS; studies with data from a single RCT are evaluated
with the second highest level of evidence (Level
B) [16] (Fig.5.1).
The quality of surgical research has increased
in recent decades, but traditionally the scientic
surgical community does not favour the conduct
Table 5.1 Health-related quality of life denitions
Authors Denition
Hays RD
etal. [8]
Torrance
GW [9]
Ebrahim
S [10]
Gold MR
etal. [11]
Abbreviations: HR-QoL Health-related Quality of Life,
QALYs Quality-adjusted life years
HR-QoL is how well a person functions
in life and his or her perceived wellbeing
in physical, mental, and social domains
of health
HR-QoL is an all-inclusive concept
incorporating all factors that impact upon
an individual’s life. Health-related quality
of life includes only those factors that are
part of an individual’s health
HR-QoL are those aspects of selfperceived well-being that are related to or
affected by the presence of disease or
treatment
HR-QoL can refer to the values assigned
to different health states. These values
used to calculate the QALY are on a scale
where zero is equal to dead and one is
equal to full health
of RCTs [17, 18] since many of the “gold standard” operating techniques were established
prior to the introduction of RCTs in 1950s.
Furthermore, and as the benet for the patients
remains clear it may be considered unethical to
treat a patient group with a novel or placebo
treatment [17]. Other factors associated with a
lower preference for RCTs include issues with
blinding techniques, effects of surgeon factor,
variable learning curves of each intervention and
special circumstances as emergency surgeries
[17, 19]. Despite these obstacles, growing interest in RCTs is apparent over the last two decades
as surgeons receive further education and training related to appropriate health research
methodologies.
In the present chapter, we aim to present the
main results of Randomised Controlled Trials
evaluating Quality of Life as an outcome in surgical patients. Due to the heterogeneity of this
subject, including RCTs in patients of all surgical aspects (cardiac, gastrointestinal and gynecological surgery) and the per se variations of
different systems regarding operative techniques
and morbidity, a system-based approach was
followed.
Fig. 5.1 Level of
evidence pyramid.
Adapted from
SpingerLink
5 Quality ofLife asEndpoint inSurgical Randomised Controlled Trials
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57
Cardiac Surgery
Cardiovascular diseases remain one of the leading causes of morbidity and mortality worldwide with a high impact on patients’ HR-QoL
[20]. Over the last decades cardiac surgery has
made vast progress in reducing mortality and
major postoperative complications. In this context, a key indicator of surgical outcome with
growing popularity is the impact on functional
status of patients, as well as the ability and time
patients can resume or improve their day-to-day
lives [21].
Improvements in surgical techniques and
enhanced understanding of the pathophysiology
of mitral valve (MV) dysfunction have led to
improved outcomes. Current guidelines recommend early intervention for asymptomatic
patients with severe degenerative mitral regurgitation (MR) [22]. In this context, a recent systematic review with HR-QoL as an outcome reports
acceptable postinterventional HR-QoL comparable to the matched general population, and identied patient-specic and surgical-specic factors
associated with poorer long-term HR-QoL [22].
Table5.2 displays ve recent RCTs [23–27, 40]
comparing different techniques and approaches
with HR-QoL as an outcome. Minimally invasive
procedures (chordal-sparing replacement) or
approaches (minithoracotomy) and transcatheter
technologies have demonstrated satisfactory
results regarding HR-QoL, compared with the
conventional standard techniques. The follow-up
period generally ranged between 12 and 36
months. It is also noteworthy that variant tools
and scores were used to determine HR-QoL, with
Short-Form 36 (SF-36) the most commonly used.
Many RCTs have been conducted to compare
coronary artery bypass graft surgery (CABG)
and percutaneous coronary intervention (PCI)
regarding mortality and myocardial infarction
rates; however, there is limited up-to-date evidence from RCTs about changes in QoL following treatment for acute coronary syndrome
(ACS) patients. A recently published meta-analysis concluded that the mean QoL of patients
diagnosed with ACS was higher after receiving
treatment compared to baseline, with patients in
the CABG group having slightly higher QoL
gains compared to those in the PCI group [41].
More specically, results from RCTs comparing
HR-QoL of patients after revascularization of
coronary arteries with CABG and PCI suggest
that both methods are associated with a postinterventional increase in HR-QoL, however
CABG offers a slightly better outcome compared with the percutaneous technique
(Table 5.2) [28–35]. Moreover, RCTs [36–39]
were used to evaluate the standard CABG technique with off-pump coronary artery bypass
(OPCAB) in terms of HR-QoL. The OPCAB
technique offers no signicant advantages over
traditional CABG in terms of HR-QoL [42];
however, a cost-effectiveness RCT suggested
that OPCAB surgery offers similar results with
CABG over a 6-month period at signicantly
less cost [38]. The follow-up period ranged
between 6 and 72 months, with a 12-month
period being the most common. Similarly with
RCTs regarding mitral valve repair, different
tools and scores were used to determine HR-QoL,
with SF-36 and Seattle Angina Questionnaire
(SAQ) being the most commonly used.
58
TMVr provided substantial benets in
terms of symptoms, functional status, and
quality of life
Better quality-adjusted survival at 10 years
when mitral-valve replacement is
compared to repair for severe ischemic MR
A statistically signicant amelioration was
evidenced within all the SF-36 domains
irrespective of the approach
There was no signicant difference
between the two study groups with respect
to any measure of quality of life or
functional status at 12 months. SF-12 score
improved over baseline in physical health
of 16.6% in the repair group and 18.4% in
the replacement group
There was a statistically signicant
difference only regarding amelioration in
physical status in 30-days. The results were
equal regarding mental status in 30-days
and both mental and physical status in
12-months
Both CABG and DES-PCI were associated
with substantial and sustained quality-of-
life benets over 5 years of follow-up.
CABG resulted in greater angina relief,
A. A. Samara
although the absolute treatment benet was
small.
CABG provides slightly better
intermediate term health status and quality
of life than DES-PCI—mainly between 6
months and 2 years after initial treatment
Number
of
patients QoL instrument Follow up Conclusion regarding QoL
months
614 KCCQ and SF-36 score 24
transcatheter mitral
valve repair (TMVr)
24
months
longitudinal SF-6D
251 QALYs calculated from
vs. standard medical
care
mitral-valve repair or
replacement
3 years
on
average
months
scores
class
80 SF-36 and functional
minithoracotomy vs.
251 SF-12 score 12
median sternotomy
mitral-valve repair vs.
chordal-sparing
replacement
months
279 SF-36 score 12
percutaneous repair vs.
conventional surgery
60
months
SF-36 score
1800 SAQ Questionnaire and
PCI using drug-eluting
stents vs. CABG
surgery
months
1880 SAQ Questionnaire 24
PCI using drug-eluting
stents vs. CABG
surgery
Table 5.2 RCTs in cardiac surgery
symptomatic patients with
HF
2019 Mitral-valve repair in
Author Year Operation Comparison
Arnold etal.
[23]
ischemic mitral
2018 Mitral-valve repair for
Ferket etal.
[24]
regurgitation
2014 Mitral-valve repair for
Nasso etal.
Barlow disease
2014 Mitral-valve repair for
[25]
Acker etal.
ischemic mitral
regurgitation
[26]
replacement
2011 Mitral-valve repair or
Feldman
etal. [27]
patients with 3-vessel or left
main coronary artery
disease
2017 Coronary arteries surgery in
Abdallah
etal. [28]
patients with diabetes
mellitus and multivessel
coronary artery disease
2013 Coronary arteries surgery in
Abdallah
etal. [29]
5 Quality ofLife asEndpoint inSurgical Randomised Controlled Trials
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There is a signicant difference in
health-related quality of life 12-months.
The GABG group had better physical
function compared with the percutaneous
group
The mental health status remained similar
There was greater relief from angina after
CABG than after PCI at 6 and 12 months,
although the extent of the benet was small
The quality of life was better in both
CABG and PCI groups compared to MT
after 1 year of follow-up. Patients in the
CABG group presented the greater and
progressive improvement of QoL
in both groups
High-risk patients with medically
refractory ischemia randomised to PCI
versus CABG surgery have equivalent
6-month HRQL
Over 12 months of follow-up, health status
was improved to a greater extent for
CABG patients than for PCI patients,
primarily due to the adverse inuence of
restenosis after PCI
There is no g difference in health-related
quality of life 1 year after CABG or PCI,
however, more favourable outcomes found
in degree of perceived energy in the CABG
group
59
(continued)
Number
of
patients QoL instrument Follow up Conclusion regarding QoL
12
months
months
SF-36 score, EQ-5D
1800 SAQ questionnaire,
PCI using drug-eluting
stents vs. CABG
surgery
542 SF-36 score 12
Medical therapy (MT)
vs. PCI vs. CABG
surgery
PCI vs. CABG surgery 543 SF-36 score 12
months
PCI vs. CABG surgery 389 SF-36 score 6
months
PCI vs. CABG surgery 475 SAQ Questionnaire 12
months
12
months
Prole and a set of 12
other questions
PCI vs. CABG surgery 154 Nottingham Health
coronary syndromes
without ST-segment
patients with 3-vessel or left
main coronary artery
disease
patients with stable
coronary artery disease
2011 Coronary arteries surgery in
Author Year Operation Comparison
Cohen etal.
[30]
2007 Coronary arteries surgery in
Favarato
etal. [31]
elevation
2005 Revascularization in acute
Szygula-
Jurkiewicz
etal. [32]
for high-risk patients with
medically refractory
ischemia
arteries surgery
2003 Coronary arteries surgery
Rumsfeld
etal. [33]
2002 Revascularization coronary
Borkon etal.
[34]
arteries surgery
1999 Revascularization coronary
Wahrborg
etal. [35]
60
Long-term health outcomes with off-pump
coronary artery bypass are similar to those
with coronary artery bypass grafting with
cardiopulmonary bypass when both
operations are performed by experienced
surgeons
There was no statistically signicant
difference between the two groups
OPCAB surgery offered similar health
benets to CABG over a 6-month period,
but at signicantly less cost
In low-risk patients undergoing CABG
surgery, avoiding the use of
72–96
months
months
months
60
months
cardiopulmonary bypass had no effect on
5-year cognitive or cardiac outcomes
A. A. Samara
Number
of
patients QoL instrument Follow up Conclusion regarding QoL
EuroQoL
299 SF-36, CROQ, SAQ,
OPCAB vs. CABG
surgery
arteries surgery
2009 Revascularization coronary
202 CCS, SF-36 12
OPCAB vs. CABG
surgery
arteries surgery
2008 Revascularization coronary
tests, SF-36, EuroQoL
168 WHOQOL 6
OPCAB vs. CABG
2006 Revascularization coronary
281 10 neuropsychological
surgery
OPCAB vs. CABG
surgery
arteries surgery
arteries surgery in low risk
patients
2007 Revascularization coronary
Table 5.2 (continued)
Author Year Operation Comparison
Angelini
etal. [36]
Nogueira
etal. [37]
Al Ruzzeh
etal. [38]
van Dijk
etal. [39]
Abbreviations: HF Heart failure, KCCQ Kansas City Cardiomyopathy Questionnaire, SF-36 Short-Form 36, QALYs quality-adjusted life years, PCI percutaneous coronary
Revascularization Outcome Questionnaire, OPCAB off-pump coronary artery bypass, CCS Canadian Cardiovascular Score, WHOQOL World Health Organization
intervention, CABG coronary artery bypass graft, SAQ Seattle Angina Questionnaire, EQ-5D European Quality of Life–5 Dimensions instrument, CROQ Coronary
Quality-of-Life
5 Quality ofLife asEndpoint inSurgical Randomised Controlled Trials
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61
Gastrointestinal Surgery
Many RCTs have been conducted in recent
decades to compare operative results in terms of
overall survival, disease-free survival, recurrence
rates in gastrointestinal cancer surgery, and mortality and morbidity in operations for benign conditions (such as diverticulosis). However, data on
the impact of these operations related to patients’
postoperative QoL are still scarce. The impact of
functional decits following colorectal operations on QoL has been repeatedly conrmed;
based on these results different methods and
techniques have been tested [42]. Bariatric and
metabolic surgery was developed to improve the
impaired QoL in morbidly obese patients, which
is the primary reason why patients seek medical
advice [43].
Following the introduction of laparoscopic
surgery in the early 1990s, the feasibility and
safety of a laparoscopic approach in colorectal
surgery were determined by the results of several
RCTs [44]. In addition, a few RCTs [45–52]
were conducted to determine if the operative
approach had an impact on patients’ HR-QoL
(Table5.3). In 2010 Bartels etal. [59] systematically reviewed all available data from RCTs that
compared open and laparoscopic colectomy in
terms of QoL, and concluded that there was no
clinically relevant difference. There was however
great heterogeneity between the data, including
both patients with colorectal cancer and benign
diseases (diverticulosis and inammatory bowel
disease). Furthermore, a variety of tools and
scores were used to determine QoL, making it
difcult to conduct a pool data analysis. SF-36
and EORT-C30 were the most commonly used
tools comparing QoL after open and laparoscopic
colectomy.
It is estimated that nearly 35% of patients who
undergo total mesorectal excision (TME) for rectal cancer will ultimately develop the renowned
low anterior resection syndrome (LARS) characterized by severe anorectal dysfunction [60]. This
postoperative condition has a signicant impact
on patients’ QoL.Different rectal reconstructive
techniques have been introduced and tested on
their results regarding postoperative bowel function and HR-QoL, with J-pouch being the most
widely applied [61]. A recently published pooled
analysis of RCTs comparing J-pouch and a sideto- end anastomosis suggests that both techniques
are comparable in terms of bowel functional outcomes, QoL, and surgical outcomes [62].
Table 5.2 presents some of the most important
RCTs [53–58] comparing J-pouch with a straight
or side-to-end anastomosis. As study results were
controversial in many cases, J-pouch is associated with an improved quality of life compared
with straight anastomosis, but the results are similar when comparing J-pouch and side-to-end
anastomosis [63].
62
QοL benets were found
in laparoscopic group
compared with standard
open colectomy
resection was associated
with a better quality of
8 weeks Only minimal short-term
life in the rst 12 months
after surgery compared
with open surgery
for colon cancer
improved quality of life
during the rst
postoperative month
patterns and no
differences in any of the
functioning scales or
symptoms between the
two groups
differences were seen
between patients
undergoing laparoscopic
or open surgery in
HRQL scores for the
QLQ C30 or CR38 at
A. A. Samara
each assessment point
was associated with an
improved quality of life
QoL
Number of
patients QoL instrument Follow up Conclusion regarding QoL
449 QLI, SDS, Global
open
391 SF-36 48 months Laparoscopic colorectal
Laparoscopic vs.
open
cancer
285 EORTC-C30, EQ-5D 12 weeks Laparoscopic resection
open
EORTC-C30 and C38 36 months There were similar
794 (696 for
QoL)
Laparoscopic vs.
open
cancer
62 EORTC-C30 and C38 12 months No signicance
Laparoscopic vs.
open
cancer
104 SF-36 6 weeks Laparoscopic approach
Laparoscopic vs.
open
symptomatic
diverticulitis
2009 Sigmoid resection for
Table 5.3 RCTs in gastrointestinal surgery
Author Year Operation Comparison
Weeks etal. [44] 2002 Colectomy for cancer Laparoscopic vs.
Braga etal. [45] 2005 Colorectal resection for
Janson etal. [46] 2007 Colectomy for cancer Laparoscopic vs.
Jayne etal. [47] 2007 Colorectal resection for
King etal. [48] 2008 Colorectal resection for
Klarenbeek etal.
[49]
5 Quality ofLife asEndpoint inSurgical Randomised Controlled Trials
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QoL was similar between
the two groups
the two groups
gain in quality of life
maintained at 2 months
postoperatively for those
who received
laparoscopic relative to
open colonic resection
difference regarding
HR-QoL
difference regarding
HR-QoL
a better HRQL
n improved QoL in the
early months after
surgery compared with
patients who receive a
straight coloanal
63
(continued)
anastomosis
Number of
patients QoL instrument Follow up Conclusion regarding QoL
55 SF-36, GIQLI 6.7 years
Laparoscopic vs.
median
60 SF-36 and GIQLI 12 weeks QoL was similar between
open
Laparoscopic vs.
open
2 months There was a short-term
Symptoms Distress
Scale
592 Global QoL, QLI,
open
74 EORTC-C30 6 months There was no signicant
J-pouch vs. straight
88 FIQL 12 months There was no signicant
coloanal
anastomosis
J-pouch vs.
coloplasty pouch
12 months Patients with J pouch had
QLQ-CR38 and
GIQLI
64 EORTC QLQ-C30,
J-pouch vs. straight
50 FISI, FIQL 12 months Patients with J pouch had
coloanal
anastomosis
J-pouch vs. straight
coloanal
anastomosis
Chron disease
ileal pouch anal
anastomosis for
ulcerative colitis and
familial adenomatous
polyposis
2004 Proctocolectomy with
Author Year Operation Comparison
Eshuis etal. [50] 2010 Ileocolic resection for
Maartense etal.
[51]
2018 Colectomy for cancer Laparoscopic vs.
McCombie etal.
[52]
for rectal cancer
Fürst etal. [53] 2002 Low anterior resection
resection for rectal cancer
Ho etal. [54] 2002 Ultralow anterior
for rectal cancer
Sailer etal. [55] 2002 Low anterior resection
resection for rectal cancer
Park etal. [56] 2005 Ultralow anterior
64
similar functional
outcomes and QoL
during the rst year after
stoma closure
had comparable results
A. A. Samara
on QoL
12 months Both techniques produce
Overactive Bladder-
Female Sexual
Function Index and
74 SF-36, FISI, SHIM,
Number of
patients QoL instrument Follow up Conclusion regarding QoL
J-pouch vs. a
side-to-end
anastomosis
12 months Both techniques produce
Validated Form
and SF-36
107 EORTC-QLQ-CR38
J-pouch vs. a
side-to-end
anastomosis
(continued)
Author Year Operation Comparison
Table 5.3
Laparoscopic hand-
assisted low anterior
resection for rectal cancer
2017
Okkabaz etal.
[57]
2012 Low anterior resection
Doeksen etal.
for rectal cancer after
neo-adjuvant
radiotherapy
[58]
SF-36 Short-Form 36, EORTC European Organization for Research and Treatment of Cancer, SDS Symptom Distress Scale, GIQLI GastroIntestinal Quality of Life Index, QLI
QoL Index, FIQL Fecal Incontinence Quality of Life Scale, GIQLI Gastro-intestinal Quality of Life Index, FISI fecal incontinence severity index, SHIM Sexual Health Inventory
for Men
5 Quality ofLife asEndpoint inSurgical Randomised Controlled Trials
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65
Gynecological Surgery
Surgery plays a pivotal role in the survival of
patients with gynecological cancers, as well as a
key role in the management of symptoms for
benign conditions. Gynecological surgical
patients can be particularly vulnerable to distress,
facing additional preoperative anxiety considering issues such as female self-image, altered sexual function, and loss of fertility [64]. Moreover,
patients with gynecological pathology face signicant deterioration in HR-QoL regardless of
the existence of a malignant disease. In some
cases, patients with a benign condition suffer
from a greater scale of pain and experience
greater QoL deterioration compared to patients
with malignant disease [65].
Endometriosis is a benign condition causing
chronic pain and dysmenorrhea in young women,
with a major impact on their daily lives. HR-QoL
in women with endometriosis is a growing concern increasingly voiced by both health professionals and patients themselves [66]. Several
RCTs have been conducted with QoL as an endpoint comparing different medical treatments,
however only a few RCTs comparing surgical
management of endometriosis have been published to date [67–71]. These trials compare different operative techniques (robotic vs.
laparoscopic), surgery or placebo treatment and a
conservative or radical surgery (Table5.4). The
results of the above studies indicate that surgical
management of endometriosis has a positive
impact on patients’ QoL, regardless of the operative technique or approach followed. Nevertheless,
considering the small number of patients included
in the RCTs and the heterogeneity in scales used
to evaluate QoL in endometriosis, these results
must be interpreted with caution.
Treatment of gynecological cancers affect all
dimensions of a patient’s life and affect the
HR-QoL of females. To the best of our knowledge, only two large RCTs have been conducted
in patients who underwent surgery for gynecological cancer, comparing open and minimally
invasive hysterectomy in terms of HR-QoL for
cervical and endometrial cancer, respectively
[72, 73]. Publication of the LACC (Laparoscopic
Approach to Cervical Cancer) trial in 2018 led to
drastic changes in recommendations for operative treatment of cervical cancer patients, proving
that recurrence rates are higher and disease-free
survival is lower for minimally invasive radical
hysterectomy than for open surgery, while postoperative QoL is similar between the treatment
groups [72]. Furthermore, endometrial cancer
patients who had a hysterectomy performed with
a minimal invasive technique had enhanced QoL
improvement from baseline during the early and
later phases of recovery and a favorable adverse
event prole that open surgery [73]. Considering
the scarcity of data on QoL in gynecological cancer patients undergoing surgery and the
importance of QoL in these patients, further
RCTs comparing HR-QoL must be conducted in
this study population to provide solid evidence.
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