Hypothesis Because of the concerns over the operative platform, accidental
organ injury, and viscerotomy closure, natural orifice transluminal
endoscopic surgery (NOTES) currently remains an experimental technique.
Transanal NOTES for colorectal surgery overcomes all of these issues;
however, all of the reports to date have used hybrid laparoscopic
techniques. We demonstrate herein the first case, to our knowledge,
of pure transanal NOTES colorectal surgery.
Design Case report.
Setting University hospital.
Patient The patient was a 56-year-old woman with a midrectal neoplasia.
Intervention Pure transanal NOTES total mesorectal excision with a coloanal
anastomosis and without a diverting stoma. Using a transanal endoscopic
operation device as a surgical platform, we created a viscerotomy
distal to an endoluminal purse-string suture. We performed a total
mesorectal excision using a “bottom-up” approach. The
sigmoid colon was mobilized by a posterior, retroperitoneal approach
and the colon was divided intraperitoneally. A hand-sewn, side-to-end,
coloanal anastomosis was performed. Because the viscerotomy was incorporated
into the anastomosis, the concerns of both accidental organ damage
and viscerotomy closure were abrogated.
Results The procedure was completed entirely by a transanal fashion.
We successfully mobilized the rectum, mesorectum, and sigmoid colon.
The specimen length was more than 20 cm. The patient required minimal
analgesia and her pain was nonabdominal.
Conclusions To our knowledge, the first pure transanal NOTES total mesorectal
excision with retroperitoneal sigmoid mobilization and coloanal, side-to-end
anastomosis was successfully performed using what we called a Peri-Rectal
Oncologic Gateway for Retroperitoneal Endoscopic Single Site Surgery
(PROGRESSS). This monumental case could pave the way for a new era
in pure transanal NOTES for colorectal surgery.
Despite the initial flurry of interest after the advent of natural
orifice transluminal endoscopic surgery (NOTES), the concerns over
the surgical platform, accidental organ injury, and viscerotomy closure
have hindered the advancement of the technique beyond the arena of
experimental surgery.1,2 Transcolonic NOTES has been performed using animal models for a
number of procedures including peritoneoscopy, cholecystectomy, ventral
hernia repair, and even pancreatectomy.3-6
Since the initial cadaveric and animal experiences with transanal
NOTES for colorectal surgery, researchers have been attempting to
perform these techniques on humans.7-9 Recently,
hybrid NOTES procedures have been performed in humans.10-12 In all
cases, a hybrid laparoscopic technique with 1 to 3 transabdominal
trocars was used, and inferior mesenteric artery ligation and retroperitoneal
and mesocolic mobilization were performed using mostly standard laparoscopic
techniques with patients receiving a diverting stoma.
Pure transanal NOTES for colorectal surgery has remained elusive
until now. After several years of developing transanal NOTES techniques
in animal, cadaveric, and hybrid NOTES/laparoscopic models, we now
present the first case, to our knowledge, of pure transanal total
mesorectal excision (TME) in a female patient.
With internal review board approval, we selected a patient with
an early, low rectal tumor.After careful explanation of the experimental
nature of the surgery, the benefits, risks, and alternatives were
discussed in detail. The patient was a 56-year-old woman. She was
found to have a large, 5-cm-long, posterior, hemicircumferential tumor
of the mid-third of the rectum (Figure
1). Preoperative endorectal ultrasonography showed a T1
carcinoma and a pelvic magnetic resonance image, a T2 tumor (Figure 2), while the histological analysis
demonstrated a tubulovillous adenoma. Despite the biopsy specimen
being negative for carcinoma, because of the large size of the tumor,
the disparity with the radiological staging, the high probability
of discovering a carcinoma, and the difficulty of preserving bowel
continuity after an initial incomplete resection, it was decided at
our oncological multidisciplinary meeting to perform an oncological
rectal resection (ie, a TME). A pure transanal approach seemed a logical
advancement following our experience in the field of NOTES and the
experience of other authors who have demonstrated the benefits of
a transanal approach (combined with a transabdominal approach) for
the mobilization of the distal rectum, (ie, the TATA [transanal transabdominal]
technique).13
The patient underwent our standard preoperative preparation:
3 to 8 days of low-residue diet, admission the day before the procedure,
and enemas the day before the procedure. The patient was positioned
in the lithotomy/Lloyd Davies position. The surgical platform used
was a transanal endoscopic operation (TEO) device (Karl Storz Endoscopy).
After positioning the TEO device, we performed an initial proctoscopy,
identified the level of the tumor, and placed a purse-string suture
distal to it (to prevent any fecal and/or cell contamination during
the case). The rectum was then scored circumferentially and a posterior
rectotomy, performed from the 2-o'clock to the 10-o'clock positions.
The initial plane of dissection was at the 6-o'clock position, just
posterior to the Waldeyer fascia. Once adequate space was created
posteriorly, the TEO device was advanced through the viscerotomy and
used as a retractor to aid with the dissection of the remainder of
the posterior and lateral rectum. At the proximal portion of the Waldeyer
fascia,the “Holy Plane” was entered. This plane was then
continued proximally to the sacral promontory. At this point, we changed
from the “short” to the “long” TEO device
(Figure 3). Dissection was
continued laterally, paying particular attention to avoid the pelvic
nerves and ureters. Once the posterolateral portion of the rectum
was completely mobilized, the division of the anterior portion of
the viscerotomy was completed. Then the rectovaginal plane was dissected
up to the level of the peritoneal reflection and then through the
peritoneum, into the pouch of Douglas. The rectum was then advanced
cephalad, through the peritoneal defect, via the pouch of Douglas,
into the peritoneal cavity. This cephalad mobilization then allowed
for the adequate tenting of the sigmoid mesentery and peritoneal attachments.
The sigmoid mesocolon was then mobilized anteriorly from the retroperitoneum
using the plane between the Gerota fascia and Toldt fascia until the
root of the mesosigmoid, at the level of the left colic artery, was
reached. The medial and lateral attachments of the mesosigmoid were
divided as high as possible including along the descending colon.
Once adequate length was mobilized, the specimen was delivered transanally.
With the specimen now pulled transanally, the TEO device was reinserted
transanally, parallel to the bowel. This allowed for further mobilization
of the proximal bowel. The resection site was then identified. The
superior hemorrhoidal artery was ligated and divided distal to the
left colic artery (a “low-tie” technique). Subsequently,
the sigmoid mesentery was ligated and divided and the bowel, transected
with an articulating linear stapling device. The specimen was then
delivered and the standard of the TME, inspected. The Lone Star retractor
(Cooper Surgical) was then inserted, and a side-to-end, coloanal anastomosis
was fashioned transanally with 3/0 polyglyconate sutures.
The patient received our enhanced recovery program and standard
analgesia was offered (in the form of paracetamol and oral opiates).
Sips of fluid were allowed the night of surgery and diet was commenced
the next day. The patient was encouraged to mobilize as much as possible.
The procedure was successfully completed. It was performed completely
by a pure transanal NOTES approach. No abdominal incisions, trocars,
“grasping” needles, or proximal stomas were used. The
whole procedure was completed within 190 minutes. There was minimal
blood loss, no fecal soilage, and no adverse incident during the case.
In the initial postoperative period, the patient required only
paracetamol for pain control. She had only mild, vague abdominal pain
on questioning and on examination had a soft, nontender abdomen. She
was easily able to mobilize.
On day 3, the patient began not feeling well. A computed tomography
scan demonstrated a small pelvic collection. A computed tomography–guided
drain was placed and this revealed a simple hematoma. Direct microbiological
analysis demonstrated no bacteria but after culture, a contamination
of Escherichia coli, but no other anaerobe,
was found in the hematoma. This incident did result in a delayed patient
discharge.
The histological analysis revealed a very large polyp (4 × 3 × 2.2
cm after histological fixation [specimens are 50% larger prior to
fixation]) that was a tubulovillous adenoma with low-grade dysplasia.
The specimen length was 20 cm and included 16 lymph nodes. There was
no invasive nature demonstrated despite what the magnetic resonance
image and endoanal ultrasonography had reported.
Transanal perirectal dissection is not new and has recently
been combined with single-port access approaches.13,14 The mobilization of the
retroperitoneal attachments of the mesosigmoid and descending mesocolon
before freeing lateral and medial attachments of the mesocolon is
new. It is a technique we have developed and evaluated in both porcine
and cadaveric models.15 Since the
development of NOTES, there have been many challenges. The main concerns
that have hindered the widespread adoption of the technique are the
surgical platform, accidental organ injury, and the viscerotomy closure.
Pure transanal NOTES specifically for colorectal surgery overcomes
many of the problems and concerns that impede the adoption of NOTES
for the following reasons: (1) the anus is an easily accessible natural
orifice with a short distance to the site of operation; (2) the TEO
system provides a solid surgical platform that can easily be manipulated
as required (Figure 3); (3)
because the viscerotomy is made in a section of bowel being removed,
there is no accidental organ injury; (4) the viscerotomy is incorporated
into the anastomosis (or removed in the case of a circular stapling
technique) so the concern of an additional viscerotomy closure site
is removed; (5) the technique allows for in-line operating but is
adaptable to retroflexed views if required; (6) it uses currently
available laparoscopic instrumentation; and (7) it uses a surgeon's
innate laparoscopic abilities.
Previous attempts at this technique have used hybrid laparoscopic
techniques, with all patients receiving defunctioning stomas. Sylla
et al10 performed a hybrid transanal
rectal resection for a T2N2 adenocarcinoma 6 cm from the anal verge
on a 76-year-old female patient with a body mass index of 20 (calculated
as weight in kilograms divided by height in meters squared) who had
had neoadjuvant chemoradiotherapy. The setup used was a transanal
TEO device with a 1 × 5-mm trocar in the right lower
quadrant and 2 × 2-mm “needle-port” trocars
situated at the umbilicus and the right lower quadrant. The inferior
mesenteric artery was ligated at its origin with an Endo GIA (Covidien)
(inserted transanally) and a hand-sewn, end-to-end, coloanal anastomosis
(proximal sigmoid to distal anorectal cuff with a coloplasty pouch)
was performed. The patient also had a defunctioning ileostomy performed.
Zorron et al11 also performed hybrid
techniques but used 2 different methods. In the first method, they
performed perirectal NOTES access with TME using a standard flexible
colonoscope. This technique was performed on a 54-year-old male patient
with a 90% stenosing tumor 8 cm from the anal verge. The anastomosis
was formed with a circular stapling device in a standard laparoscopic
fashion. The pelvis was drained and a defunctioning colostomy, constructed.
The second technique used a transanal single-port access (using a
TriPort [Olympus]) for the dissection of the TME. This was performed
on a 73-year-old female patient with an obstructing tumor 4 cm from
the anal verge. She had previously undergone a defunctioning loop
transverse colostomy. An end-to-end, hand-sewn, coloanal anastomosis
(with coloplasty pouch) was then performed. In both cases, the proximal
colonic mobilization and inferior mesenteric artery ligation were
performed using a standard laparoscopic 3-port technique. Tuech et
al12 have performed a combined transanal
and transabdominal single-port access approach. They used a single-port
access device (Endorec; Aspide Medical) to perform a transanal TME
and subsequently performed the mobilization of the descending colon,
splenic flexure, and inferior mesenteric artery ligation using another
single-port access device through the future ileostomy site. This
was performed for a T1 tumor 3 cm from the dentate line in a female
patient. The anastomosis was fashioned using a hand-sewn technique.
In all but one of these cases, the patients had advanced tumors (either
obstructing or with lymph node metastases), they all had 1 or 3 laparoscopic
ports inserted, and they all had defunctioning stomas created.
Our procedure was successfully completed in a purely transanal
NOTES fashion. There were no abdominal incisions and no insertion
of any transabdominal trocars or any other transabdominal “grasping”
devices. A purely transanal approach could avoid the transabdominal
complications of pain and hemorrhage with improved cosmesis. The whole
procedure took 190 minutes. The patient had minimal pain postoperatively
and required only paracetamol intermittently. She was able to mobilize
the evening of surgery, tolerated fluid the night of surgery, and
resumed diet the next day (as expected). Her bowels opened on postoperative
day 2. Unfortunately, she developed a pelvic hematoma. This was picked
up on computed tomography scan after the patient was not feeling well
on day 3. After this was drained, she made an uneventful recovery.
She voluntarily only mentioned pain from her drain site and not her
abdomen. She did not have any difference in continence or defecation
after the procedure. We are prospectively evaluating functional outcome
and quality of life in our series.
One of the difficulties with a bottom-up approach is that the
sacral and fascial propria layers are fused distally and posteriorly
to form the Waldeyer fascia. While it is possible to separate these
layers during a traditional TME (through an open or laparoscopic approach)
and remain in the Holy Plane, unfortunately, the same cannot be said
for the bottom-up approach. During this approach, the plane just posterior
to the Waldeyer fascia is initially used until the true Holy Plane
can be entered more proximally. While this portion of the operation
does not represent a true TME (because the dissection is just posterior
to the correct plane), it is, however, still oncological. This was
evident on general inspection of the specimen and also in the identification
of 16 lymph nodes on histological examination (≥12 lymph nodes
required for accurate staging).16 We
did not perform a “high tie” in this procedure. Since
its conception more than a century ago, there has been no conclusive
evidence to show superiority over the alternate “low-tie”
technique.17,18 Concerns
about the involvement of apical nodes that would be “missed”
in a low-tie technique were addressed by Kanemitsu et al,19 who demonstrated that no pT1 tumors of
the sigmoid colon or rectum had any evidence of apical lymph node
metastatic disease.19
The current ways of dealing with early rectal cancers are resectional
surgery (in the form of a TME), transanal endoscopic microsurgery
(TEM), and possible endoscopic techniques (eg, endoscopic mucosal
resection). When TEM was compared with resectional surgery, it was
reported to be safer with similar outcomes.20 Transanal endoscopic microsurgery was demonstrated
to have a shorter operative time and hospital stay with lower morbidity,
reoperation, stoma formation, and mortality rates. The local recurrence
rate was much higher (24%) compared with TME (0%). There was no significant
difference in overall or cancer-specific survival. While TEM does
appear to be comparable with resection surgery without the morbidity
risk, the recurrence rate of approximately 25% is very high and the
outcomes for recurrences are very poor. Doornebosch et al21 have demonstrated that the 3-year outcomes
for recurrent T1 rectal cancers, initially treated by TEM, were 58%
for cancer-specific survival and 31% for overall survival. When endoscopic
mucosal resection was compared with TEM for large polyps (not cancer),
it was shown that while it was achievable as a day case procedure
(as compared with TEM, which required admission for 3 days), the recurrence
rate was 3 times that of TEM.22 Therefore,
while novel and potentially less invasive ways of dealing with early
rectal cancers exist, the recurrence rates are very high with potentially
disastrous oncological outcomes. For this reason, resectional surgery
(TME) still remains the gold standard.
One of the main concerns for this approach to colorectal surgery
is the risk of infection from transrectal surgery. The effects of
transrectal surgery on inducing infection can be seen in the results
of both TATA surgery and natural orifice specimen extraction. The
TATA procedure has recently been reported to have a pelvic abscess
rate of only 2.5%.23 In natural orifice
specimen extraction, recent reports of peritoneal fluid contamination
levels have demonstrated that in patients whose colons were opened
(for transanal extraction) vs divided (by a linear stapling device)
the contamination rates were 100% and 88.9%, respectively, though
no increase of clinical complications was reported.24,25
One of the main factors in the successful completion of this
operation was the ability to use high-definition cameras and screens.
This system was found to be far superior to standard-definition systems
of the past. In fact, standard laparoscopic and endoscopic video equipment
would not allow for adequate definition of the tissue planes required
for a bottom-up TME. It is essential to develop tools particular to
the surgical technique being performed because this allows for standardization
of the technique. We are currently developing novel surgical platforms
and instrumentation to further develop pure transanal NOTES as well
as working with “augmented reality” to try and develop
the image-guided techniques of the future.
The potential advantage of this approach is that it combines
the perioperative benefits of a minimally invasive approach with the
oncological benefits of major resectional surgery. This case is a
monumental achievement that highlights years of surgical research
and development. While the development of NOTES has otherwise slowed,
its application in pure transanal colorectal surgery is intuitive.
Correspondence: Joël Leroy,
MD, FRCS, IRCAD/EITS, 1 Place de l’Hôpital, 67091 Strasbourg,
France (joel.leroy@ircad.fr).
Accepted for Publication: August 21,
2012.
Published Online: November 19, 2012.
doi:10.1001/jamasurg.2013.685
Author Contributions:Study concept and design: Leroy, Barry, and Melani. Acquisition of data: Leroy and Barry. Analysis and interpretation of data: Leroy, Barry,
Mutter, and Marescaux. Drafting of the manuscript: Leroy and Barry. Critical revision of the manuscript
for important intellectual content: Leroy, Barry, Melani, Mutter,
and Marescaux. Administrative, technical, and material
support: Leroy. Study supervision:
Melani, Mutter, and Marescaux.
Conflict of Interest Disclosures: None
reported.
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