Surgery 173 (2023) 13671373

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Surgery
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Single-stapled anastomosis is associated with a lower anastomotic ®

| Chesktor
leak rate than double-stapled technique after minimally invasive total e
mesorectal excision for MRI-defined low rectal cancer
Caterina Foppa, MD, PhD*", Michele Carvello, MD*", Annalisa Maroli, PhD",
Matteo Sacchi, MD”, Marco Gramellini, MD*", Marco Montorsi, MD*",
Antonino Spinelli, MD, PhD*>"
2 Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
© IRCCS Humanitas Research Hospital, Division of Colon and Rectal Surgery, Rozzano, Milan, Italy

ARTICLE INFO ABSTRACT

Article history: Background: After total mesorectal excision, distal rectal transection and anastomosis are critical for
Accepted 11 February 2023 short-term, oncological, and functional outcomes, including anastomotic leak. A double-pursestring,
Available online 24 March 2023 single-stapled anastomosis avoids cross-stapling, overcoming the potential drawbacks of trans-
abdominal rectal transection and double-stapled anastomosis. This study aims to compare the anasto-
motic leak rate in double-stapled and single-stapled anastomoses after minimally invasive total
mesorectal excision for magnetic resonance imaging—defined low rectal cancer.
Methods: Adult patients (>18 years old) undergoing minimally invasive total mesorectal excision for
magnetic resonance imaging—defined low rectal cancer with a stapled low anastomosis (below 5 centi-
meters from the anal verge) between January 2010 and January 2022 ata single institution
were allocated to
2 groups according to the anastomosis: double-stapled (abdominal stapled transection and double-stapled
anastomosis) or single-stapled (transanal rectal transection and double-pursestring single-stapled anas-
tomosis). The exclusion criteria were nonrestorative procedures or any type of manual anastomosis. The
primary endpoint was the rate of 90-day clinical and radiologic anastomotic leak.
Results: In total, 185 single-stapled and 458 double-stapled were included. Clinical and tumor character-
istics were comparable between the groups. The 90-day anastomotic leak rate was significantly lower in the
single-stapled group (6.48% vs 15.28%; P =.002), with similar rates of grade and timing. Thirty- and 90-day
complication rates were higher in the double-stapled group (P =.0001; P =.02), with comparable Clavien-
Dindo grades.At multivariable analysis, double-stapled anastomosis (P=.01), active smoking (P=.03), and
the presence of comorbidities (P —.01) resulted as independent risk factors for an anastomotic leak.
Conclusion: Transanal transection and double-pursestring, single-stapled anastomosis were associated
with a lower anastomotic leak rate after minimally invasive total mesorectal excision for magnetic
resonance imaging—defined low rectal cancer.
© 2023 Elsevier Inc. All rights reserved.

Introduction improvement in surgical technique and perioperative care,” the AL

An anastomotic leak (AL) is a major complication after total
mesorectal excision (TME) that can result in higher morbidity and
mortality rates, long-term anorectal dysfunction, a decreased
quality of life, and worse oncological outcomes.'
rate after TME did not significantly decrease over time, ranging
from 10% to almost 30%° © depending on the site of the anasto-
mosis, risk factors, and AL definition.” ° The distal rectal transec-
tion and anastomosis steps are critical for short-term, oncological,
Despite the and functional outcomes, including anastomotic leak (AL).

* Reprint requests: Professor Antonino Spinelli, IRCCS Humanitas Research Hos-
pital, Division of Colon and Rectal Surgery, via Manzoni 56, 20089 Rozzano, Milan,
Ttaly.
E-mail address: antonino spinelli@hunimed.cu (A. Spinelli);
Twitter: @AntoninoSpin
Transection
Transection of the rectum after minimally invasive TME (MI-
TME) remains challenging because it is ideally performed at a right
angle to the long axis of the rectum with an adequate distal margin

htps://doi.org/10.1016/j.surg.2023.02.018
0039-6060/© 2023 Elsevier Inc. Al rights reserved.
1368 C Foppa et al. / Surgery 173 (2023) 13671373
for safe tumor clearance. The apparent impossibility of creating a
right-angled stapler that can be inserted through a port conspires
with the narrowness of the pelvis to make a perfect anastomosis
from above extremely difficult'~"" Straight or limited angulation
instruments for minimally invasive surgery (MIS) often produce
oblique staple lines with anorectal stumps, which may be subop-
timal for anal function. Multiple firings are usually necessary to
complete transection.'” Furthermore, traditional abdominal tran-
section often involves inadequate assessment for perfect posi-
tioning of the staple line.”” Transanal TME (TaTME) and transanal
transection and single-stapled (TTSS) technique, described more
recently,*'° provide a precise rectotomy under visual control,
avoid multiple stapler-firings, and potentially reduce the risk of
distal margin involvement with cancer.
Anastomosis
Ideally, the perfect anastomosis should avoid multiple, crossing
staple lines and the so-called dog-ears, occurring during a double-
stapled (DS) anastomosis, which have been identified as structural
weak points often associated with tissue ischemia and therefore at
risk for AL'® The US Food and Drug Administration has recently
warned about the increased leak risk when staple lines are crossed.”
The double-pursestring single-stapled (SS) anastomosis has
been identified as a potential benefit of TaTME and—more recen-
tly—of TTSS, reducing the risk for AL by avoiding structural weak
points."“1>1¥ A recent study from our group reported a lower AL
rate when the single-stapling technique for rectal cancer (RC) is
performed.' Nevertheless, the superiority of SS anastomosis over
DS in MI-TME remains unproven on a large scale.
This study aimed to compare AL rates in colorectal DS and SS
anastomoses after MI-TME for magnetic resonance imaging (MRI)-
defined low RC.
Methods
Data of patients undergoing MI-TME for MRI-defined low RC
(low rectal cancer [LOREC]) between January 1, 2010 and January
31, 2022 were collected from a prospectively maintained institu-
tional database. A dedicated data manager collected data with an
additional overview by 2 surgeons. Before proceeding with data
analysis, another surgeon performed a database cleaning. The MRIs
were reviewed by a surgeon frained to assess low rectal cancer
according to the LOREC criteria. An experienced radiologist
rechecked all images.
Eligibility criteria
The study population included all consecutive adult patients
(>18 years old) undergoing an MI-TME for MRI-defined low RC with
a stapled anastomosis performed below 5 centimeters of the anal
verge. Patients were allocated to 2 groups according to the tech-
niques of transection and anastomosis:
1) DS: transabdominal MI linear stapled rectal transection and DS
anastomosis
2) SS: transanal rectal transection with electrocautery and double-
pursestring SS anastomosis
The exclusion criteria were nonrestorative procedures, any type
of manual anastomosis, and interventions converted to open sur-
gery. To minimize the intergroup heterogeneity, all patients un-
dergoing a “total neoadjuvant” regimen were excluded from the
analysis.
Endpoints
The primary study endpoint was the 90-day rate of AL classified
according to the International Study Group of Rectal Cancer defi-
nitions and severity grading system.” Both clinical and radiologic
ALs were included. Anastomotic leaks occurring within 30 days
from surgery were defined as “early.” Complications were reported
according to the Clavien-Dindo'® classification. The highest-
ranking complication was recorded for each patient. Preoperative
tumor staging was performed according to the European Society for
Medical Oncology and National Comprehensive Cancer Network
guidelines.””! Indications to neoadjuvant chemo-radiotherapy (50
Gy + capecitabine) were locally advanced (stage II: T3/4NOMO or
stage Ill: any T N+MO0) RCs evaluated with contrast MRI. Rectal
cancer was defined as “low” if located—entirely or partially—below
the origin of the levator ani muscle on the pelvic bone (as described
by the Pelican Cancer Foundation in the LOREC program).””
Mesorectal fascia threatening and extramural vascular invasion
were always assessed. A disease restaging was performed about 8
weeks from the end of the treatment, and surgery was scheduled
between 10 and 12 weeks. This policy did not change over the study
period. The American Joint Commission on Cancer (seventh edi-
tion) staging scheme for rectal carcinoma was used for the patho-
logical staging of the tumor.”*
Clinical and oncologic follow-up was performed according to an
institutional protocol. Further exams were prescribed at each in-
terval if needed.
Statistical analysis
The categorical and dichotomous variables are reported as fre-
quencies and percentages; continuous variables were tested for
normal distribution using the Shapiro-Wilks test (with P < .05
indicating non-normal distribution) and are represented as mean +
SD if normally distributed or as median and IQR if skewed. The
categorical and dichotomous variables were analyzed using Pear-
son’s 2 statistic with Fisher exact test. The continuous variables
were analyzed using an unpaired t test or Mann-Whitney test,
depending on the distribution.
A multivariable logistic regression analysis was performed to
ascertain the effect of significant (P < .05) variables from the uni-
variable analysis on the risk of developing AL. The odds ratio (OR)
and relative 95% Cls are reported for each variable.
All tests were 2-sided. Statistical analysis was performed using
IBM SPSS Statistics version 25.0 (IBM SPSS, Inc, Armonk, NY).
Results
Patients’ characteristics
Of 1,283 TMEs for RC performed in the study period, 643 pa-
tients met the inclusion criteria (185 SS and 458 DS). The baseline
patients’ characteristics—including sex, age, body mass index,
smoking, American Society of Anesthesiologists class, comorbid-
ities, and previous abdominal surgery—were comparable (Table I).
Comorbidities and the Charlson comorbidity index classes are
detailed in Supplementary Table S1.
Tumor characteristics and operative outcomes
The median distance of the tumor from the anal verge, the
proportion of patients undergoing neoadjuvant treatment, and the
preoperative stage were comparable among the groups (Table I1).
 . Foppa et al./ Surgery 173 (2023) 13671373 1369
Table 1
Baseline and clinical characteristics, n (%), mean + SD, median (IQR)
Characteristic S5 DS P value
Number of patients 185 458
Sex, females. 62 (33%) 191 (42%) 066
Age.y 6277:1236 6467+1186 069
BMI, kg/m® 2480£352 2505426 475
Smoking 301
Active smokers 32(17%) 85(19%)
Ex-smokers 27 (15%) 88 (19%)
Nonsmokers 126 (68%) 285 (62%)
ASA classification 068
ASAT 65 (35%) 119 (26%)
ASATI 99 (53%) 286 (62%)
ASATIE 18 (10%) 50 (11%)
ASA IV 3(2%) 3(1%)
Clinically relevant comorbidities 114 (62%) 312 (68%) 18
ca 4(2-13) 5(2-10) 470
Previous abdominal surgeries 74 (40%) 208 (45%) 210
Continuous normally distributed variables were analyzed with an unpaired 2-sided
test; continuous non-normally distributed variables were analyzed with an unpaired
2-sided Mann-Whitney test. Categorical and dichotomous variables were analyzed
with a % test and Fisher exact test.
ASA, American Society of Anesthesiologists; BMI, body mass index; CCI, Charlson co-
morbidity index; DS, double-stapled; S5, single-stapled.

Table Il Risk factors associated with AL

Tumor characteristics, n (%), median (IQR)
Characteristic s5 Ds P value At univariable analysis, DS anastomosis (OR 2.39; 95% Cl:
Number of patients 185 458 1.28—-4.44; P < 0.001), active smoking (P = .008), comorbidities (OR
Distance from the anal verge, cm 5 (3-6) 5 (4-6) 983 2.33; 95% Cl: 1.31-4.13; P = .002), and increased operative time
Neoadjuvant therapy 140(76%) 335(73%) 508 (mean deviation 10.74; 95% ClI 0.47—1.43) resulted as significant
Radiological tumoral stage 882 risk factors for AL. The multivariable logistic regression analysis
Stage | 33(18%) 90(20%) confirmed DS anastomosis (OR 2.27; 95% CI 1.21-4.26; P = .011),
Stage I 14 (8%) 33 (7%)
Stage Il 128 (69%) 305 (67%) active smoking (OR 1.87; 95% CI 1.06—3.29; P =.030), comorbidities
Stage IV 10 (5%) 30 (6%) (OR 2.12; 95% CI 1.18—3.81; P =.011), and increased operative time
Continuous normally distributed variables were analyzed with an unpaired 2- (OR 1.002; 95% CI 1.00—1.005) as independent risk factors for AL
sided ¢ test; continuous non-normally distributed variables were analyzed (Table VI).
with an unpaired 2-sided Mann-Whitney test. Categorical and dichotomous
variables were analyzed with an %2 analysis and Fisher exact test.
DS, double-stapled; S, single-stapled. Discussion

This study compared AL rates between 2 different anastomoses

Operative time, intraoperative complications, intraoperative
blood transfusions, and estimated blood loss were comparable. The
rate of patients undergoing an ileostomy did not differ (Table Ii1).
Postoperative outcomes
The 90-day rate of AL was significantly lower in the SS group
(6.48% vs 15.28%; P =.002), with a similar distribution in grade (A,
B, C) and timing (early versus late).
A higher rate of 30-day and 90-day complications occurred in
the DS group (33.84% vs 18.37%; P =.0001 and 8.07% vs 3.24%, P =
1024, respectively), with a comparable distribution in the Clavien-
Dindo scale. Complications are reported in
Supplementary Table 52, No differences in the rate of postoperative
transfusions were reported. Length of stay was shorter in the SS
group (P =.0001) (Table V).
Pathology data
Tumor stage was comparable in the 2 groups. No positive distal
margins were reported in any group, and the rate of radial margin
positivity did not differ (Table V).
(DS versus SS) after MI-TME for MRI-defined low RC. Our results
showed a significantly higher AL rate in the DS group, which was
also identified as an independent risk factor for AL at multivariable
logistic regression analysis.
Rectal cancer surgery has gone through a progressive technical
evolution, starting from the adoption of TME as standard treatment,
the introduction of stapled anastomosis, the MI approach, and
transanal techniques. Consequently, the rate of sphincter-
preserving surgery with low anastomosis has significantly risen,
leading to increased anastomotic-related issues.”"
Knight-Griffen in 1980%° (DS) and Moran in 1994°° (open triple
stapling [TS]) offered successful solutions to the steps of rectal
transection and anastomosis. Their DS and TS techniques rapidly
became the most widely adopted over the traditional handsewn
detail in
anastomosis for open and MI colorectal anastomosis. These tech-
niques have the advantage of being quicker and easier to perform
by eliminating the need for a distal rectal pursestring.
Although the initial iteration of the DS anastomosis in the open
surgery era seemed to offer equivalent outcomes to the traditional
SS anastomosis with distal pursestring,’’ the advent of MIS
changed the game, increasing the challenges in the steps of tran-
section and anastomosis. Accordingly, the safety profile may have
changed.
The distal transection in the narrow pelvis—performed by a
linear stapler through a right iliac fossa or suprapubic port—is even
1370 C Foppa et al. / Surgery 173 (2023) 13671373
Table 111
Operative data, n (%), mean SD
Data S5 DS P value
Number of patients 185 458
Operative time, min 283407397 2812948782 782
Intraoperative complications 2(1%) 5(1%) 999
Intraoperative blood transfusion 1 (0,5%) 1(02%) 493
EBL, mL 0(0-20) 0(0-45) 116
Tleostomy construction 178 (96%) 442 (96%) 818
Continuous normally distributed variables were analyzed with an unpaired 2-sided ¢
test; continuous non-normally distributed variables were analyzed with an unpaired 2-
sided Mann-Whitney test. Categorical and dichotomous variables were analyzed with an
% analysis and Fisher exact test.
Ds, double-stapled; EBL, estimated blood loss; SS, single-stapled.

Table IV anastomosis, directly controlling the level of the distal rectal

Postoperative outcomes, n (%), median (IQR) transection and allowing to perform an SS anastomosis.’®
Outcomes s5 Ds P value Recently, our group described the transanal transection and
single-stapled anastomosis (TTSS)'*'” strategy, which offers rectal
Number of patients 185 458 transection under precise visual control and a double-pursestring
Length of stay, d 5(226) 6(2-150) <.0001
30-day postoperative complications 34 (18%) 136(30%) 003 SS anastomosis to all patients requiring a total proctectomy,
Clavien-Dindo I 5(3%) 23(5%) 574 independently of the approach chosen by the surgeon for rectal
Clavien-Dindo Ii 16 (8%) 56 (12%) dissection whether based on preference, availability, anatomy,
Clavien-Dindo lla 5(3%) 14 (3%) expertise, or indications. The technical steps of TTSS are detailed
Clavien-Dindo Ilib 7(3%) 42 (9%)
Clavien-Dindo IV 101%) 101%) in Figure 1.
90-day postoperative complications 6 (3%) 37(8%) 024 Although TaTME and TTSS share the concept of a transanal
Clavien-Dindo I 3(2%) 6(1%) 185 transection and a double-pursestring SS anastomosis, there are 3
Clavien-Dindo It - 9(2%) key technical differences between the techniques, which have been
Clavien-Dindo lila 1(05%) 12(3%) previously described.®
Clavien-Dindo Ilib 2(0.5%) 10 (2%)
Clavien-Dindo IV - - However, despite the encouraging premises of SS anastomosis,
Postoperative transfusions 1005%) 11(2%) 194 no definitive conclusion about its superiority regarding the AL rate
90-day AL 12(7%) 70 (15%) 002 in MIS can be drawn from the current literature. Although a recent
AL grade 465 single-institution report comparing transanal with laparoscopic
A 3(2%) 17 (4%)
B 5(3%) 18 (4%) TME showed a lower AL rate in TaTME,*” another multicentric real-
C 4(2%) 35(7%) world analysis by the TaTME International Registry (using the much
AL timing 603 more stringent definition of the International Study Group of Rectal
Early (within 30 d) 9(5%) 57(12%) Cancer) did not show a lower anastomotic failure rate after TaTME
Late (from 30 d to 90 d) 3 (2%) 13 (3%) compared to after laparoscopic or robotic TME."" A recently pub-
Continuous normally distributed variables were analyzed with an unpaired 2-sided lished meta-analysis based on nonrandomized studies reported a
£ test; continuous non-normally distributed variables were analyzed with an un- significantly lower AL rate after TaTME over laparoscopic TME,'®
paired 2-sided Mann-Whitney test. Categorical and dichotomous variables were
analyzed with an 72 analysis and Fisher exact test. whereas a network meta-analysis including 30 randomized
AL anastomotic leak; DS, double-stapled; S5, single-stapled. controlled trials of 5586 patients operated for RC with open,
laparoscopic, robotic, or transanal TME approach did not report any
difference in terms of AL rates among these approaches.”’ Other
more challenging from above, still precluding a perpendicular di- studies comparing TaTME and open/laparoscopic/robotic TME did
vision of the lower rectum: crossing staple lines by repeated firings not report any difference in AL rates among the procedures.””** A
or incorrect staple height in relation to tissue thickness increase the study”’ compared a prospective cohort of TaTME patients with a
risk of AL, especially when 3 or more linear staple firings are retrospective cohort of patients operated by laparoscopy, poten-
needed.'”®> Furthermore, intersecting lateral staple lines tially biasing the results. However, most of these studies focused on
(dogears) obtained after a DS anastomosis are also considered weak the quality of TME dissection—if performed by open, laparoscopic,
structural spots, possibly prone to leak.'®*” Other pitfalls of a DS robotic, or transanal approach—rather than the steps of transection
anastomosis are an oval-shaped morphology**—resulting in an and anastomosis. Additionally, AL definition, grade, and timing
increased risk of anastomotic stricture—and an uncontrolled distal were inconsistent among papers.
transection margin.'*'? Our group recently published a comparative analysis on AL rates
The limitations of MI DS anastomosis were recognized by many between conventional laparoscopic DS, TaTME, and TTSS cases
authors, who described possible alternatives.’”* *” However, performed for mid-low RC by 1 surgeon at 1 institution. In this
none of these alternatives to DS have been widely adopted because study, both SS techniques (TaTME and TTSS) resulted in a signifi-
of difficult reproducibility, complexity, and the need for dedicated cantly lower AL rate (6% and 2%, respectively) when compared to DS
stapling devices. (17.3%; P =.002)."°
Recently, the Food and Drug Administration, in the recom- In this monocentric study conducted in a tertiary center, the SS
mendation “Surgical Staplers and Staples for Internal Use,” recog- technique resulted in a significantly lower rate of AL when
nized the increased risk of AL rates when staple lines are crossed, compared to DS (6.48% vs 15.20%, respectively). Additionally, DS
recommending, when possible, to avoid cross-stapling.'” anastomosis was an independent risk factor for AL at multivariable
Transanal TME introduced a different approach to overcome logistic regression analysis. These results contribute to assessing
the limitations of the abdominal approaches with a DS the possible superiority of SS on DS with regard to AL.
 . Foppa et al. / Surgery 173 (2023) 13671373 1371
Table V
Pathological data, n (%), mean + SD
Data S5 DS P value
Number of patients 185 458
Tumoral stage (T) 123
0 31017%) 54(12%)
I 36(16%) 66(14%)
° 46(25%) 99(22%)
bs) 73(39%) 213 (46%)
T4 5(3%) 26 (6%)
Nodes stage (N) 759
No 127 (69%) 312 (68%)
N1 45(24%) 106 (23%)
N2 13(7%) 40 (9%)
Metastasis stage (M) 594
Mo 175(95%) 412 (93%)
M1 10 (5%) 30 (7%)
Positive circumferential margin (tumor deposits) 4(2%) 6(13%) 484
Pathological stage, according to AJCC eighth edition 299
Stage 0 27(15%) 60(13%)
Stage | 4927%) 111(25%)
Stage lla 13(7%) 48 (10%)
Stage Il 28(15%) 47(10%)
Stage llla 26 (14%) 64 (14%)
Stage lllb 2(02%) 52(11%)
Stage llic 10 (5%) 30 (7%)
Stage IV 10 (5%) 46 (10%)
Continuous normally distributed variables were analyzed with an unpaired 2-sided ¢ test;
continuous non-normally distributed variables were analyzed with an unpaired 2-sided Mann-
Whitney test. Categorical and dichotomous variables were analyzed with an %? analysis and
Fisher exact test.
D5, double-stapled; EBL estimated blood loss; S5, single-stapled.

Table VI
Univariable and multivariable logistic regression analyses on the risk factors for 90-day AL
Univariable analysis Multivariable analysis
Variable OR/MD 95%Cl Pvalue OR 95%CI P value
Anastomosis type (versus S5) 239 12810444 002 227 12110426 011
Sex (versus female) 063 03810103 072 - - -
Age.y 261 01510539 064 - - -
BMI kg/m® 0008 -093t0091 986 - - -
Smoking (versus nonsmokers) - - 008 - - 068
Ex-smokers - - 115 05710227 069
Active smoking - - 187 10610329 030
ASA grade (versus ASA ) - - 168 - - -
Clinically relevant comorbidities 233 13110413 002 212 118t0381 011
Previous abdominal surgeries 092 057t0146 412 - - -
Neoadjuvant therapy 075 04710113 137 - - -
Distance from the anal verge, cm 025 02610076 0337 - - -
Operative time, min 1074 241104461 0029 101 10010102 048
Tleostomy construction 082 04710143 0294 - - -
Operating surgeon - - 0863
Surgeon 1 - -
Surgeon 2 - -
Surgeon 3 - -
Surgeon 4 - -
Surgeon 5 - -
Surgeon 6 - -
Surgeon 7 - -
Surgeon 8 - -
Pathological stage (versus stage 0) - - 0265 - - -
‘The statistical analysis was performed using a multivariable binary logistic regression model. The model was statis-
tically significant (2[6] = 29.47: P <.0001) and explained 9% (Nagelkerke's R?) of the variance of 90-day AL, correctly
classifying 87% of cases. The Hosmer-Lemeshow test indicated a good model fitness (;°[8] = 10.77; P = 215).
ASA, American Society of Anesthesiologists; BMI, body mass index: MD, mean deviation; S5, single-stapled.

Overall, the 30-day and 90-day complications rate was higher in The present study has some limitations. First, the temporal gap
the DS group, contributing to the longer hospital stay. Other vari- between the 2 techniques, which reflects the progressive reduction
ables associated with AL at logistic regression analysis (comorbid- of DS in favor of the emerging SS, as shown in Supplementary
es, smoking habit, operative time) are well-recognized risk Figure S1. Consequently, the surgeons’ learning curve in both
factors for AL** groups should be considered. Additionally, although all the
 ® & ¥ n
1372 C. Foppa et al. / Surgery 173 (2023) 13671373

Figure 1. (A) A full perimesorectal dissection down to the level of the anorectal muscle tube beyond the tumor is completed from above by the preferred abdominal technique
(open or minimally invasive); (B) after placing a Lone-Star retractor and a cylindrical trunk anoscope in the anal canal, a transanal pursestring is performed below the tumor; (C)
after closing the distal specimen margin by tightening of the pursestring, a full-thickness circumferential rectotomy is performed by electrocautery. The pneumoperitoneum and the
transillumination from the laparoscopic camera greatly facilitate and help to control rectal transection; (D) a circular stapler anvil is secured in the proximal transected colon, A
tubular drain is then positioned on the anvil's tip; (E) the colon is reinserted into the pelvis, and a pursestring is placed at the distal rectal cuff; (F) the drain is grasped and pulled
down transanally before tightening the rectal pursestring around the anvil; (G) the stapler is connected to the anvil; (H) the single-stapled anastomosis is performed. Reprinted with
‘permission from Spinelli et al. Transanal Transection and Single-Stapled Anastomosis (TTSS): A comparison of anastomotic leak rates with the double-stapled technique and with
transanal total mesorectal excision (TaTME) for rectal cancer. Eur J Surg Oncol. 2021 Dec;47(12):3123-3129. Copyright 2021 Elsevier.

surgeons were already experienced in low rectal cancer surgery, an
interoperative variability in experience and skills in minimally
invasive surgery and in performing the anastomosis should be
considered. However, anastomotic leaks are homogeneously
distributed in the period, reflecting that this event is not strictly
related to the surgeons’ experience (Supplementary Figure S2).
Moreover, the first operating surgeon did not affect the rate of AL in
the univariable analysis (Table VI). To note, all DS cases in this study
were performed by MIS. Results might be different for open DS
since the anastomosis is performed differently, using a thor-
acoabdominal stapler. Additionally, as perioperative protocols
changed and were implemented over time, length of stay and other
perioperative variables might be influenced, particularly in the first
years of the study period.
The single-institution design might be a limitation but also a
strength as the results give a “real-world” analysis of MI-TME from a
tertiary center.
This study also has other strengths worth mentioning. The strict
inclusion criteria allow for a homogeneous population of patients
operated for low RC. In fact, the major confounders in the literature
analyzing AL after MI-TME are represented by the definition of RC
and AL. Hence, to homogenize the study population and reduce a
selection bias at most, we used MRI-defined criteria to assess low
RC, and we used the strict AL classification by the International
Study Group of Rectal Cancer, which includes asymptomatic leaks
(grade A). Additionally, cases performed by surgeons at different
points of the learning curve were included.
The current study includes some cases of our previous work'”
comparing AL between TTSS, TaTME, and DS techniques
consecutive TME performed by a surgeon for mid-low RC (<10 cm
from the anal verge). Supplementary Table S3 shows how many
cases were LOREC and therefore included in this analysis. Addi-
tionally, the distribution of AL between LOREC and non-LOREC
cases in each group is reported.
In conclusion, transanal transection and double-pursestring SS
anastomosis was associated with a lower AL rate after MI-TME for
RC. The benefits of S anastomosis over DS shown by our study
warrant, in our opinion, a prospective multicentric trial—using the
same strict inclusion criteria—to confirm our short-term results
and to scrutinize long-term and functional outcomes.
Funding/Support
This research did not receive any specific funding from any
agencies in the public, commercial, or not-for-profit areas.
Conflict of interest/Disclosure
Antonino Spinelli has acted as a consultant/teacher/speaker for
Ethicon and Takeda. Michele Carvello has acted as a speaker for
Pfizer and Takeda. Caterina Foppa, Annalisa Maroli, Matteo Sacchi,
Marco Gramellini, and Marco Montorsi have no disclosures.
Supplementary materials
Supplementary materials associated with this article can be found
in the online version, at https://doi.org/10.1016/j.5urg.2023.02.018.
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