Meta-analysis of defunctioning stoma in low anterior resection with total mesorectal excision for rectal cancer: evidence based on thirteen studies
Gu and Wu World Journal of Surgical Oncology
Meta-analysis of defunctioning stoma in low anterior resection with total mesorectal excision for rectal cancer: evidence based on thirteen studies
Wen-long Gu 2
Sheng-wen Wu 0 1
0 Department of General Surgery, The Affiliated Jianhu Hospital of Nantong University, Jianhu People's Hospital , Jianhu 224700, Jiangsu Province , China
1 Department of General Surgery, The Affiliated Jianhu Hospital of Nantong University, Jianhu People's Hospital , Jianhu 224700, Jiangsu Province , China
2 Department of Medical Oncology, The Affiliated Jianhu Hospital of Nantong University, Jianhu People's Hospital , Jianhu 224700, Jiangsu Province , China
Background: Recent studies have shown that a protective stoma can reduce morbidity in low anterior resection for rectal cancer; however, the necessity of it is still controversially discussed. Methods: We performed this meta-analysis to provide a comprehensive evaluation of the role of defunctioning stoma in low anterior resection for rectal cancer on the rates of anastomotic leakage and reoperation related to leakage with or without defunctioning stoma by calculating the pooled risk ratio. Results: Studies and relevant literature published between 2004 and 2014 regarding the construction of a protective stoma after low anterior resection were searched though PubMed and EMBASE databases. Finally, a total of 13 studies including 8,002 patients were included in this meta-analysis. The results indicated that protective stomas significantly reduced the rate of postoperative anastomotic leakage and reoperation after low anterior rectal resection. The pooled risk ratios were 0.47 (95% CI: 0.33-0.68, P <0.0001) and 0.36 (95% CI: 028-0.46, P <0.00001), respectively. Conclusions: The findings from this present meta-analysis suggest that a defunctioning stoma could effectively reduce the clinical consequences of anastomotic leakage and reoperation, it is recommended in patients undergoing low rectal anterior resection for rectal cancer.
Defunctioning stoma; Low anterior resection; Meta-analysis; Rectal cancer
With better equipment and improved surgical techniques,
low anterior resection with a low colorectal or coloanal
anastomosis has become the technique of choice for rectal
cancer, allowing a safe performance of anastomosis at a
lower level in a way that the anal sphincter is saved .
Additionally, widespread propagation of standardized total
mesorectal excision has improved overall survival .
However, total mesorectal excision may be associated with
an increased risk of developing anastomotic leakage with
attendant morbidity and mortality in the postoperative
period . Leaks may be associated with decreased local
control and survival [4,5] and it is still one of the most
fatal complications that occur after low anterior resection
. Even experienced surgeons sometimes find it difficult
to predict which patient will have an anastomotic leak,
and know that leaks may occur even when the
anastomosis is technically sound and the risk factors for leakage
are absent. When leakage ensues, it may increase
morbidity, mortality, prolong the duration of hospital stay, and
affect the short- or long-term quality of life [7,8].
Therefore, the rate of anastomotic leakage has been considered
as one of the quality indicators of surgical performance.
Several retrospective or non-randomized prospective
studies have shown that the absence of a protective stoma
is a risk factor for leakage after low anterior resection ,
but others have disputed this . Some surgeons use a
protective stoma after low anterior resection to prevent
the occurrence of anastomotic leak because it is believed
that by diverting the fecal stream and keeping the
anastomosis free of material, leakage will be less likely. While
other surgeons reported that covering a protective stoma
had no influence on anastomotic leak and reoperation
rate, and the complications that can be caused by the
stoma itself should not be ignored [11-17]. Although a
defunctioning stoma is widely performed in low anterior
resection for rectal cancer, it is still not clear whether
protective stoma is useful for patients. Therefore, the role of
defunctioning stoma in rectal cancer surgery is
controversial. The primary aim of this meta-analysis was to evaluate
the validity for low anterior resection with and without
the creation of a defunctioning stoma.
Two bibliographic databases (PubMed and Embase) were
searched for all relevant literature, including articles
referenced in the publications. The medical subject headings
(MeSH) and keywords searched for individually and in
combination were as follows: stoma, defunctioning
stoma, protective stoma, low anterior resection,
rectal cancer, and anastomotic leakage. The search ended
in January 31st 2014, and no lower date limit was used.
Bibliographies cited in an identified article were also
searched manually to retrieve other suitable studies. We
also screened the references of the relevant studies to
check for potentially relevant articles.
Inclusion and exclusion criteria
Criteria for eligibility of a study included in this
metaanalysis were i) studies that compared low anterior
resection with or without a protective stoma; ii) recent
clinical trials from 2004 to 2014. When a study reporting
the same patient cohort was included in several
publications, only the most recent or complete study was
selected. Exclusion criteria included i) case reports, letters,
and reviews without original data; ii) non-English papers;
iii) animal or laboratory studies; or iv) articles that were
not full-text and non-comparative studies. To avoid the
influence of redundant studies, we checked all of the
authors and organizations, and evaluated the accrual
period and community of patients enrolled for each study.
Extracted data were crosschecked between the two
authors to rule out any discrepancy. The following data
was independently extracted for each included study:
first authors surname, publication year, sample size,
and the number of patients that developed an
anastomotic leak and needed a reoperation related to leakage
after low anterior resection with or without protective
stoma. Disagreements were discussed by the authors and
resolved by consensus.
Statistical analysis was carried out using the Review
Manager 5.2. A pooled risk ratio (RR) with 95%
confidence intervals (CIs) was used to assess outcomes of the
studies. I2 statistics was used to evaluate the
betweenstudy heterogeneity analysis in this meta-analysis .
The random effects model was used when an obvious
heterogeneity was observed among the included studies
(I2 > 50%). The fixed effects model was used when there
was no significant heterogeneity between the included
studies (I2 50%). Publication bias was estimated using
a funnel plot with an Eggers linear regression test;
funnel plot asymmetry on the natural logarithm scale of the
RR was measured by a linear regression approach.
This study complies with current laws of china.
In total, 13 studies were included in the meta-analysis
[19-31], all of which were published between 2004 and
2014. There were four randomized controlled trials
[20,26,27,31] and nine non-randomized studies with a
total population of 8,002 patients, of whom 3,562 had a
protective stoma and 4,440 did not. The sample size of
the trials ranged from 34 to 1,958. All studies reported
the number of patients who developed an anastomotic
leak and required a reoperation after low anterior
resection or ultralow anterior resection. Table 1 lists the
main characteristics of the 13 studies included in this
There was obvious between-study heterogeneity among
the 13 included studies (I2 = 61%), thus the random
effects model was used to calculate the pooled RRs with
corresponding 95% CIs. The present meta-analysis
demonstrated that the absence of a protective stoma was
associated with a higher incidence of anastomotic leak
and reoperation, with pooled RRs of 0.47 (95% CI: 0.33
0.68, P <0.0001, Figure 1) and 0.36 (95% CI: 0280.46,
P <0.00001, Figure 2), respectively. This revealed that a
statistically significant advantage was conferred by a
protective stoma in patients undergoing low anterior
Funnel plot and Eggers test were used to evaluate
the publication bias of the included studies. The shape
of the funnel plot for the meta-analysis of studies on
Table 1 Main characteristics of the 13 included studies
Chude et al. 
Eriksen et al. 
Gong et al. 
Karahasanogl et al. 
Lefebure et al. 
Matthiessen et al. 
Matthiessenet al. 
Nurkin et al. 
Seo et al. 
Shiomi et al. 
Ulrich et al. 
LAR, Low anterior resection; uLAR, Ultralow anterior resection; NA, Not applicable.
postoperative anastomotic leakage demonstrated obvious
asymmetry (Figure 3).
With the development of rectal cancer and the
improvement of medical instruments, together with higher
requirements by patients for the quality of post-surgical life,
ultralow anterior rectal resection has become the major
low sphincter preserving procedure. However, this
procedure can also increase the risk of anastomotic leakage .
The occurrence of adverse intraoperative events was
identified as an important risk factor, as previously been
indicated by Matthiessen et al. . Moreover, a long
operation time and major perioperative bleeding are
inter-correlated factors previously discussed in other
studies as both single  and combined  risk
factors. Preoperative radiotherapy appeared to be a
predisposing factor for leakage in earlier studies of consecutive
cases . In addition to the already known risk factors,
such as male gender and low anastomoses, other risk
factors, such as type of anastomosis and intra-abdominal
drainage, have also been identified. Jestin et al. 
observed that adverse intraoperative events, a long
duration of surgery, and major bleeding, all of which are
indicators of complicated surgery, increase the risk of
leakage. When these occur, the events have been
associated with both reduced disease-free survival and overall
Defunctioning stoma in low anterior resection has
been considered to decrease the leakage rate and its fatal
consequences. However, the value of a protective stoma
has been the subject of controversy for many years. In
previous publications, overall leakage and reoperation
rates have been shown to be similar in patients with or
without a protective stoma . In addition, ostomy
construction and closure is associated with
considerable morbidity and increased costs . Potential
disadvantages of a protective stoma include the need for
Figure 1 Forest plot for a comparison of the study outcomes of low anterior resection with or without stoma vs. anastomotic leakage.
Risk ratios are shown with 95% CIs.
Figure 2 Forest plot of the study outcomes of low anterior resection with or without stoma vs. reoperation rate. Risk ratios are shown
with 95% CIs.
re-operation, longer hospital stay, and ostomy-related
complications, such as dehydration, which could prove
fatal. Therefore, the benefits of a protective stoma in
decreasing the rate of anastomotic leakage have to be
balanced against the morbidity of its construction and
closure . Nevertheless, the benefits conferred by a
protective stoma have not been unequivocally
demonstrated. To further evaluate this argument, we performed
the present meta-analysis. The straightforward conclusion
from the 13 included studies was that a protective stoma
after a low anterior resection significantly reduces the rate
of anastomotic leakage and the number of reoperations
related to leakage.
However, we still should regard these outcomes with
caution and evaluate them critically for the following
reasons. Firstly, funnel plots were performed to evaluate
publication bias. The shape of the funnel plot for the
meta-analysis of studies on postoperative anastomotic
leakage demonstrated obvious asymmetry in their
results. We interpreted this asymmetry as different case
selection, such as elective or emergency low anterior
resection for rectal cancer. Due to the limitations in terms
of medical ethics, not all of the trials were randomized
controlled trials and the sample size in some studies was
rather low, rendering the overall methodological quality
and reporting of the included studies rather poor.
Secondly, considerable selection bias existed in some of the
included studies. Surgeons relied on their personal
experience to predict the patients who were at high risk of
an anastomotic leakage, which may have been
inaccurate, leading to a selection bias of those who underwent
stoma formation. Thirdly, the original purpose of the
defunctioning stoma was to minimize the rate of
anastomotic leakage, but morbidity and mortality can occur at
the time of stoma closure. Furthermore, patients who
received a protective stoma require readmission for the
stoma closure .
In conclusion, despite the inherent limitations of
metaanalysis on stoma literature, this meta-analysis,
representing a quantified synthesis of all published studies of
protective stoma, has shown that a defunctioning stoma
significantly reduces the rate of anastomotic leakage and
Figure 3 Funnel plot for the publication bias.
reoperation in patients that receive low anterior
resection for rectal cancer. Morbidity associated with protective
stoma and complications of stoma closure are negligible
compared to the reoperations required for anastomotic
leakage in the absence of protective stoma. Therefore, a
defunctioning stoma can be useful for patients undergoing
rectal surgery, and is recommended during a low anterior
resection for rectal cancer.
The authors declare that they have no competing interests.
WLG carried out data analysis and wrote the manuscript; SWW and WLG
identified and acquired reports of trials, abstracted the data and assessed the
risk of bias; SWW conducted the statistical analyses and contacted authors of
included studies to obtain additional information; SWW drafted the
manuscript; Both authors read and approved the final manuscript.
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