Allaix ME, Arezzo A, Caldart M, Festa F, Morino M. Transanal endoscopic microsurgery for rectal neoplasms: experience of 300 consecutive cases

Article (PDF Available)inDiseases of the Colon & Rectum 52(11):1831-6 · November 2009with18 Reads
DOI: 10.1007/DCR.0b013e3181b14d2d · Source: PubMed
Abstract
Abdominal resection for rectal neoplasms is associated with significant morbidity. Local excision with retractors can be proposed only for distal rectal lesions. With this retrospective review of our prospective series of transanal endoscopic microsurgery procedures, we wanted to verify the advantages of local treatment in terms of disease recurrence and complication rates. Indications for transanal endoscopic microsurgery were adenoma, early carcinoma, rectal ulcers, carcinoid tumors, gastrointestinal stromal tumors, and leiomyosarcoma apparently located in the extraperitoneal rectum. We analyzed operating time, morbidity and mortality rates, length of hospital stay, staging discrepancy, recurrence rate, and oncological outcome. From January 1993 to January 2007, 300 patients underwent transanal endoscopic microsurgery at our institution. The mean operating time was 66 minutes. The peritoneum was inadvertently opened in 13 cases. The overall morbidity rate was 7.7%. The mean hospital stay was five days. Histology demonstrated cancer in 90 patients. At a mean follow-up of 60 months, the recurrence rate was zero in pT1, 24% in pT2, and 50% in pT3. The overall estimated five-year survival rate was 87%, and the disease-free survival rate was 82%. Transanal endoscopic microsurgery is safe and effective in the treatment of adenoma and pT1 carcinoma; it carries a lower morbidity than conventional surgery and a recurrence rate comparable to that of conventional surgery.

Figures

ORIGINAL CONTRIBUTION
Transanal Endoscopic Microsurgery for Rectal
Neoplasms: Experience of 300 Consecutive Cases
Marco Ettore Allaix, M.D. Alberto Arezzo, M.D. Mario Caldart, M.D.
Federico Festa, M.D. Mario Morino, M.D.
Center for Minimally Invasive Surgery, Dipartimento di Discipline Medico Chirurgiche, Universita` di Torino, Torino, Italy
PURPOSE: Abdominal resection for rectal neoplasms is
associated with significant morbidity. Local excision with
retractors can be proposed only for distal rectal lesions.
With this retrospective review of our prospective series of
transanal endoscopic microsurgery procedures, we
wanted to verify the advantages of local treatment in
terms of disease recurrence and complication rates.
METHODS: Indications for transanal endoscopic
microsurgery were adenoma, early carcinoma, rectal
ulcers, carcinoid tumors, gastrointestinal stromal tumors,
and leiomyosarcoma apparently located in the
extraperitoneal rectum. We analyzed operating time,
morbidity and mortality rates, length of hospital stay,
staging discrepancy, recurrence rate, and oncological
outcome.
RESULTS: From January 1993 to January 2007, 300
patients underwent transanal endoscopic microsurgery at
our institution. The mean operating time was 66
minutes. The peritoneum was inadvertently opened in 13
cases. The overall morbidity rate was 7.7%. The mean
hospital stay was five days. Histology demonstrated
cancer in 90 patients. At a mean follow-up of 60 months,
the recurrence rate was zero in pT1, 24% in pT2, and
50% in pT3. The overall estimated five-year survival rate
was 87%, and the disease-free survival rate was 82%.
CONCLUSIONS: Transanal endoscopic microsurgery is
safe and effective in the treatment of adenoma and pT1
carcinoma; it carries a lower morbidity than conventional
surgery and a recurrence rate comparable to that of
conventional surgery.
KEY WORDS: Transanal endoscopic microsurgery; Rectal
adenoma; Rectal adenocarcinoma.
T
he rectum is a challenging district for surgeons due
to limited access and maneuverability. Although ad-
vances in conventional surgery have led to a broader
choice of sphincter-saving procedures, definitive colos-
tomy is still necessary in 10% to 30%
1
of cases. Also, post
-
operative morbidity and mortality rates remain high,
2
in
-
cluding urogenital dysfunction.
3
Transanal excision has
been proposed for local resection of wide-based benign
neoplasms unresectable by colonoscopy and of early stage
malignant neoplasms with favorable prognostic factors.
Nevertheless, transanal resection allows comfortable ac-
cess only to the distal rectum, which explains in part the
high rates of local recurrence.
4,5
Transanal endoscopic mi
-
crosurgery (TEM), proposed 25 years ago by Buess,
6,7
can
be considered a viable alternative in select cases because it
combines the advantages of minimally-invasive local treat-
ment with large full-thickness local resection and im-
proved visualization. This study presents the results of a
retrospective analysis of a large clinical series with up to 15
years of follow-up.
MATERIALS AND METHODS
This study is a retrospective analysis of a prospective data-
base created in January 1993. Indications for TEM were
benign rectal lesions judged unsuitable for endoscopic re-
moval, early rectal cancer, and invasive or metastatic rectal
carcinoma treated with palliative intent. Inclusion criteria
were depending on anatomic restrictions assessed by rigid
rectoscopy to locate the lesion along the circumference and
to measure its distance from the anal verge. Lesions were
considered suitable for TEM treatment only when located
within 12 cm of the anal verge on the anterior wall, 15 cm
on the lateral walls, and 20 cm on the posterior wall, these
being the limits of insertion of the peritoneum on the rectal
wall.
Address of correspondence: Prof. Mario Morino, Center for Minimally
Invasive Surgery, Dipartimento di Discipline Medico Chirurgiche, Uni-
versita` di Torino, Corso Dogliotti 14, 10126 Torino, Italy. Email:
mario.morino@unito.it
Dis Colon Rectum 2009; 52: 1831–1836
DOI: 10.1007/DCR.0b013e3181b14d2d
©The ASCRS 2009
DISEASES OF THE COLON &RECTUM VOLUME 52: 11 (2009) 1831
The procedure was performed with original Richard
Wolf (Knittlingen, Germany) TEM equipment, according
to the standard technique described by Buess.
6,7
In all
cases, a full-thickness excision was made on the rectal wall
to the perirectal fatty tissue, and the wound was closed with
one or more running sutures secured with silver clips. All
patients had a urinary catheter in place at the time of sur-
gery, which was removed 72 hours after surgery in cases of
anterior wall dissection, or 24 hours after surgery in all
other cases. In cases of benign lesions, follow-up consisted
of digital examination and rectoscopy every three months
for the first year, then every six months. In cases of malig-
nant lesions, tumor marker assays were performed every
3 months for the first year and every 12 months there-
after; additionally, full colonoscopy was performed at 12
months, and endoscopic ultrasound (EUS) and computed
tomography (CT) were performed at 6, 12, and 24 months.
Local recurrence was defined as any recurrence diagnosed
more than six months after the TEM procedure and con-
firmed by biopsy.
We entered into the database information about pa-
tient characteristics, preoperative assessment, lesion loca-
tion and histology, perioperative complications, and fol-
low-up. Quantitative data are given as the mean, median,
and range. Overall and disease-free survival rates were cal-
culated using the Kaplan–Meier method. Patients with a
minimum follow-up of 12 months were included in the
analysis.
RESULTS
Between January 1993 and January 2007, 300 patients (185
males; mean age, 65.3 11.6 (range, 25–94; median, 66)
years) with rectal disease underwent TEM. The preopera-
tive indications were 222 adenomas, 47 carcinomas, 4 rec-
tal ulcers, 2 carcinoid tumors, 1 gastrointestinal stromal
tumor (GIST), and 1 leiomyosarcoma. In addition, 5 ade-
nomas and 18 carcinomas had previous attempts at endo-
scopic removal that resulted in unclear margins; these were
referred for TEM for safe completion of the previous pro-
cedures. The distance between the lower edge of the neo-
plasm and the anal verge ranged between 2 and 20 (mean,
7.5 2.5; median, 7) cm. Twenty-six uT2 and six uT3
lesions were treated by TEM for different reasons: 8 pa-
tients had benign histologies of biopsy samples on two oc-
casions preoperatively, 13 were judged ineligible for ab-
dominal resection due to their general condition, 5 refused
the risk of temporary or definitive stomas, 3 received neo-
adjuvant radiotherapy and chemotherapy with apparent
downstaging, and 3 had synchronous liver metastases and
were treated with palliative intent.
Intraoperative Results
The mean operating time was 66.4 42.8 (range, 15–240;
median, 60) minutes. The intraoperative complication was
inadvertent opening of the peritoneum in 13 (4.3%) cases.
Ten patients were treated with direct suturing, and three
required conversion to laparoscopic (two cases) or lapa-
rotomic (one case) anterior resection. The conversion rate
was 1.0% (3/300). Intraoperative bleeding was always neg-
ligible; no intraoperative blood transfusion was required.
Postoperative Results
There was no 30-day mortality. The 30-day morbidity rate
was 7.7% (23/300) (Table 1). None of the patients required
a loop ileostomy. No urinary retention was observed. The
mean length of hospital stay was 5.0 (range, 2–14) days.
Pathology Results and Staging
The mean surface area removed was 12.9 9.5 (range,
2–56; median, 10) cm
2
. Histological examination of the
surgical specimens demonstrated an adenoma in 184 cases,
a carcinoma in 90, carcinoid tumors in 2, leiomyosarcoma
in 1, and GIST in 1. Four rectal ulcers were completely
excised with no evidence of dysplasia. Of the 23 patients
who underwent TEM with radical intent following incom-
plete endoscopic polypectomy without histologically-
proven clear resection margins, 18 showed no residual dis-
ease and the remaining 5 had a diagnosis of adenoma. In
the 43 patients with a preoperative diagnosis of adenoma,
the definitive diagnosis was adenocarcinoma, with a dis-
crepancy rate of 19.4% (43/222).
Postoperative staging of resected adenocarcinomas
was as follows: 38 pT1, 37 pT2, and 15 pT3. Positive resec-
tion margins were detected in 9.8%, 2.6%, 16.2%, and
46.7% of patients with adenoma, pT1, pT2, and pT3
carcinoma, respectively. No specimen fragmentation
occurred.
In all, 178 patients underwent preoperative EUS for
staging (Table 2). EUS understaged 22 (12.3%) and over-
TABLE 1. Postoperative morbidity and treatment in 23 of 300
consecutive patients who underwent transanal endoscopic
microsurgery
Type Treatment
11 rectal bleeding 3 endoscopic hemostasis
3 transrectal packing
5 blood transfusion
5 suture dehiscence 3 medical therapy
1 TEM
1 abdominal surgery
4 rectovaginal fistula 2 transvaginal surgical suture
2 total parenteral nutrition
1 parietal abscess antibiotic therapy
1 major incontinence biofeedback therapy
1 rectovesical fistula abdominal surgery
1832 ALLAIX ET AL:LONG-TERM RESULTS OF A LARGE SERIES
staged 18 (10.1%) lesions. Of the 47 preoperatively diag-
nosed rectal cancers resected by TEM in the patients who
had undergone EUS, 13 (27.6%) were understaged and 6
(12.7%) were overstaged. Specifically, in the 15 patients
who had been referred to TEM for a suspected pT2 or pT3
carcinoma, an adenoma or a pT1 tumor was detected; in
the 16 patients referred for TEM for a suspected adenoma
or pT1 carcinoma, a pT2 or pT3 tumor was detected.
Oncologic Outcomes
Over a mean follow-up period of 82 39 (range, 12–189;
median, 100) months, 11 patients (6%) operated on for a
rectal adenoma relapsed. Recurrence was observed in 6 of
18 patients with an adenoma, 1 of 6 with pT2, and 4 of 6
with pT3 tumors with positive resection margins. A second
TEM procedure was performed in eight patients, laparo-
scopic anterior resection with coloanal anastomosis was
performed in one patient, and abdominoperineal resection
was performed in one patient. All were disease-free in fur-
ther follow-up. One patient refused a second TEM proce-
dure and was lost at follow-up.
Three patients underwent palliative TEM because of
synchronous unresectable liver metastasis and were ex-
cluded from the follow-up analysis. No dropouts were ob-
served among the cancer patients.
No recurrent disease was detected among the 38 pa-
tients with pT1 cancer at a mean follow-up of 60 33
(range, 14 –162; median, 51) months. Of the 49 patients
with histologically-assessed pT2 and pT3 cancers, 8 (4 pT2
and 4 pT3) underwent immediate abdominal surgery, 22
(17 pT2 and 5 pT3) underwent chemoradiotherapy, and
19 (16 pT2 and 3 pT3) only received follow-up because
they had either declined further surgery or adjuvant ther-
apy or were deemed ineligible on account of age or co-
morbidity. Local and/or distant recurrence was observed
in 15 cases: 9 of 37 (24.3%) with pT2 cancer and 6 of 12
(50%) with pT3 cancer. Three of the eight patients who
underwent salvage surgery, one with pT2 cancer and two
with pT3 cancer, developed a local recurrence. Recurrence
was diagnosed for these patients at 15, 6, and 29 months.
All died of the disease (Table 3).
The overall 5-year survival rate of the cancer patients
was 87.6%, and the disease-free rate was 82.2%. Stratified
by tumor stage, the overall (Fig. 1) and disease-free (Fig. 2)
survival rates were both 100% for pT1; 87.7% and 76.7%,
respectively, for pT2; and 44.4% and 38.9%, respectively,
for pT3 (P 0.001). All of these estimated survival rates
take into consideration not just the results of TEM, but also
data from patients with additional treatments such as che-
moradiotherapy and salvage surgery.
None of the patients with malignant neoplasms other
than carcinoma showed recurrence at follow-up.
DISCUSSION
Abdominal surgery has long been considered the appro-
priate surgical treatment for rectal neoplasms. Neverthe-
less, anterior rectal resection and total mesorectal excision
are burdened by high morbidity and mortality rates,
2
in
-
cluding urogenital dysfunctions.
3
Transanal surgery with
retractors, although less invasive, is associated with a con-
sistent incidence of recurrence, especially for tumors of the
upper and medium rectum.
4,5,8,9
Twenty-five years ago, the introduction of transanal
endoscopic microsurgery (TEM) afforded the advantage of
combining a less invasive transanal approach with low re-
currence rates thanks to enhanced visualization of the sur-
gical field which allowed more precise dissection. Initially
proposed as a technique for excision of benign rectal neo-
plasms, TEM indications were extended to include “low
TABLE 2. Staging discrepancy between preoperative
endoscopic ultrasound and histology
adenoma/pT1 pT2 pT3 Total
u-T0/u-T1 130 13 3 146
u-T2 13 (1 post RT) 7 (2 post RT) 6 26
u-T3 2 3 1 6
Total 145 23 10 178
RT radiotherapy.
TABLE 3. Oncological outcomes
Recurrence
Postoperative treatment n (months) Treatment Follow-up
pT1 Postoperative RT-CT 3 0 all disease-free
Salvage surgery 0 0
No treatment 35 0
pT2 Preoperative RT 5 0 all disease-free
Postoperative RT-CT 16 4 (12, 12, 10, 70) 1 AR, 3 none 1 disease-free, 3 dead
Salvage surgery 4 1 (15) APR CT dead
No treatment 12 4 (12, 12, 10, 13) 2 RT, 1 APR, 1 AR 3 disease-free, 1 dead
pT3 Postoperative RT-CT 5 2 (14,13) 1 RT, 1 APR 1 dead, 1 disease-free
Salvage surgery 4 2 (6, 29) 2 CT 2 dead
No treatment 3 2 (12, 4) none 2 dead
RT radiotherapy; CT chemotherapy; AR anterior resection; APR abdominoperineal resection.
DISEASES OF THE COLON &RECTUM VOLUME 52: 11 (2009) 1833
risk” pT1 rectal adenocarcinomas
10
with curative intent
11
and more invasive rectal adenocarcinomas with palliative
intent. To date, only one randomized study
12
has com
-
pared the outcome after anterior resection (26 patients)
with TEM (24 patients) for T1 rectal tumors. At a mean
follow-up of 46 months, local recurrence (4%) and 5-year
survival (96%) rates were similar in the two groups. These
data suggest that TEM may offer some advantages over
anterior resection for T1 tumors and achieve similar onco-
logical results.
Patients who have T1 tumors with favorable patho-
logic features may undergo local excision alone with ac-
ceptable oncological outcomes,
13
whereas those with un
-
favorable criteria will require radical surgery or adjuvant
treatment.
14
More recently, several authors
15–18
have pro
-
posed that patients with pT2 tumors receive a combination
of preoperative chemoradiotherapy and local resection by
TEM with radical intent.
This retrospective analysis of a prospective consecu-
tive series reports what may be the largest experience with
TEM for excision of benign and malignant rectal tumors.
Our analysis confirms that the procedure is safe and carries
low postoperative mortality and morbidity rates. In line
with previous studies that reported complication rates be-
tween 2% and 30%,
11,19–22
only 23 of 300 patients (7.7%)
experienced complications in our series, and no deaths oc-
curred. The most common local complications, bleeding
and dehiscence, were managed conservatively in the ma-
jority of cases. Also noteworthy was the occurrence in four
patients of rectovaginal fistulas; therefore, special care
should be taken when performing an anterior full-thick-
ness resection in female patients. When a diagnosis of ma-
lignancy is not suspected at preoperative workup, a muco-
sectomy could be considered in case of anterior lesions.
The standard indication for TEM with curative intent
is the treatment of adenomas and pT1 neoplasms of the
rectum. With these indications, our recurrence rate was 11
of 222 (4.9%), which is comparable to that reported in
smaller series. Other authors have compared TEM with
transanal local excision according to Parks. Local excision
was associated with a higher recurrence rate, ranging be-
tween 10% and 27%.
21–24
The higher recurrence risk of
conventional transanal surgery is most likely due to the
lower rate of complete excision with tumor-free mar-
gins
4,22,25–27
in conventionally-treated patients. These re
-
sults derive from small retrospective studies and have not
yet been confirmed by multicenter cohort studies.
Appropriate patient selection is key to obtaining satis-
factory results with TEM. It is crucial to accurately evaluate
the depth of tumor invasion and lymph node metastasis.
So far, no recurrence has been observed among the 38 pT1
cancers confirmed at histology. EUS, with an overstaging
risk of approximately 10%, appears to be the most accurate
preoperative diagnostic tool for investigating tumor inva-
sion of the wall.
28
This was also confirmed in our series, in
which we noted a 12% risk of understaging and a 10% risk
of overstaging among all lesions; the risks were 27% and
12%, respectively, when restricted only to detected can-
cers. Furthermore, 43 of 222 (19.3%) suspected adenomas,
detected by tissue sampling and EUS, were found to be
adenocarcinomas in the pathology examinations.
An important factor to consider in staging discrepancy
in our series is the long period of recruitment: over the
years, we have observed consistent improvement in EUS
results. The limited reliability of preoperative diagnosis
and staging resulted in a high number of pT2 and pT3
discovered in pathology examination. In those cases in
which abdominal surgery was not contraindicated, pa-
FIGURE 1. Overall survival rate of cancer patients stratified by
tumor stage, including data of patients with additional treatments
such as chemoradiotherapy and salvage surgery.
FIGURE 2. Disease-free survival rate of cancer patients stratified by
tumor stage, including data of patients with additional treatments
such as chemoradiotherapy and salvage surgery.
1834 ALLAIX ET AL:LONG-TERM RESULTS OF A LARGE SERIES
tients were promptly referred for more radical treatments
including anterior resection, total mesorectal excision, or
even abdominoperineal resection. Of the eight patients
who underwent immediate salvage surgery, three died of
disease-related causes; this mortality rate is in line with that
reported elsewhere. In all other cases unsuitable for ab-
dominal surgery, the patients were either referred to adju-
vant therapy (radiotherapy and chemotherapy) if not con-
traindicated, or just followed-up.
The role of TEM in the treatment of invasive carci-
noma remains more controversial. Traditionally, local sur-
gery has been used for palliation.
29
More recently, TEM in
combination with neoadjuvant treatment has yielded
promising results.
30
In our series, only three patients un
-
derwent neoadjuvant treatment for downstaging and
downsizing uT2 cancers in order to become eligible for
TEM with curative intent. Histology demonstrated that
only one lesion was downstaged to pT1 cancer. Neverthe-
less, all three patients are presently free of disease. Further
data will be needed to confirm this preliminary clinical
experience.
In conclusion, TEM allows excision of benign rectal
neoplasms with a low morbidity rate and has results com-
parable to those of conventional abdominal surgery. TEM
also permits the curative treatment of malignant neo-
plasms that are histologically confirmed as pT1 carcino-
mas. In line with these observations, histologic diagnosis
and preoperative staging are essential for an accurate selec-
tion of patients. We hold that such patients should be re-
ferred to specialized medical centers in which surgeons,
endoscopists, gastroenterologists, and pathologists are ex-
perienced with TEM. When indicated, this innovative sur-
gical technique can provide the potential benefit of a min-
imally invasive procedure, but without the risks associated
with abdominal rectal surgery. Moreover, the analysis of
this consecutive series of patients undergoing TEM sug-
gests that the technique is safe and effective in the treat-
ment of adenomas and pT1 carcinomas, with a recurrence
rate comparable to that of conventional surgery.
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1836 ALLAIX ET AL:LONG-TERM RESULTS OF A LARGE SERIES
    • "TEM: using a TEO apparatus; Conventional: using a regular Park's anal retractor. p = 0.043, logistic regression utmost, in accord with the vast majority of studies that report complications as generally minor [3, 4, 6, 8, 10, 16, 25]. One study of complications in a select group of patients submitted to neoadjuvant CRT reported much higher incidence and severity [25]. "
    [Show abstract] [Hide abstract] ABSTRACT: Purpose Transanal endoscopic microsurgery (TEM) is a safe and efficient minimally invasive treatment for rectal benign and early malignant neoplasia, but postoperative complications may be severe. We aimed to evaluate the risk factors related to the incidence, severity, and time course of postoperative complications of TEM. Methods This is a prospective study of postoperative complications in 53 patients (>18 years old) with benign or early rectal neoplasia who underwent TEM with curative intention or, for higher stages, palliation. Outcome measures included age, sex, American Society of Anesthesiologists score, neoadjuvant chemoradiotherapy, lesion height and size, pathologic margins, tumor histology, and suture type. Results Overall morbidity was 50 %. Temporary fecal incontinence was the most frequent complication (17.3 %). Complication rates of Clavien–Dindo grades I and II were 21.1 % and those of grades III and IV 3.8 %. Of patients with complications, more had lesions under the first rectal valve than over the first valve (61.54 % vs 38.46 %, p = 0.04). Patients submitted to chemoradiotherapy had a 24-fold greater chance of presenting grade II complications (p = 0.002). When the surgical defect was treated using the TEM device to perform the suture, the chance of having grade III complications was reduced 16-fold (p = 0.04). Fifty-three percent of complications occurred in the first 10 days and 95 % within 20 days. Conclusions Postoperative complications after transanal endoscopic microsurgery for the treatment of rectal neoplasia are frequent, acceptable, and usually controllable with pharmacologic treatment. Over time the nature of complications is continuous, centered on the first 20 days after surgery.
    Article · Feb 2016
    • "Preoperative assesssment consisted of rigid rectoscopy with biopsy, complete colonoscopy, endoscopic ultrasound and magnetic resonance imaging (MRI). The criteria for local excision were the same as those used for non-circumferential lesions[3,4]. The Transanal Endoscopic Operation ® system (TEO, Karl Storz, Tuttlingen, Germany) was used in all cases. "
    Full-text · Article · Jan 2016
    • "InFigure 1-a, a commercial TEM system is shown along with the instrumentation typically used. A 5 mm 30° optics and three rigid 5 mm instruments are introduced through dedicated ports on the front of the rectoscope [37]. One instrument is used for grasping the lesion and exposing it, and another is used for cutting the tissue with a high frequency dissector (as schematized inFigure 1-b); the third tool is used mainly for suction and aspiration procedures. "
    [Show abstract] [Hide abstract] ABSTRACT: In this paper a simple but effective measuring system for endoluminal procedures is presented. The device allows measuring forces during the endoluminal manipulation of tissues with a standard surgical nstrument for laparoscopic procedures. The force measurement is performed by recording both the forces applied directly by the surgeon at the instrument handle and the reaction forces on the access port. The measuring system was used to measure the forces necessary for appropriate surgical manipulation of tissues during transanal endoscopic microsurgery (TEM). Ex-vivo and in-vivo measurements were performed, reported and discussed. The obtained data can be used for developing and appropriately dimensioning novel dedicated instrumentation for TEM procedures.
    Full-text · Article · Aug 2015
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