5
TEMS: results of a specialist centre S. M. Flexer A. C. Durham-Hall M. A. Steward J. M. Robinson Received: 19 July 2013 / Accepted: 20 December 2013 Ó Springer Science+Business Media New York 2014 Abstract Introduction Transanal endoscopic microsurgery (TEMS) is becoming more widespread due to the increasing body of evidence to support its role. Previous published data has reported recurrence rates in excess of 10 % for benign polyps after TEMS. Methods Bradford Royal Infirmary is a tertiary referral centre for TEMS and early rectal cancer in the UK. Data for all TEMS operations were entered into a prospective database over a 7-year period. Demographic data, com- plications and recurrence rates were recorded. Both benign adenomas and malignant lesions were included. Results A total of 164 patients (65 % male), with a mean age of 68 years were included; 114 (70 %) of the lesions resected were benign adenomas, and 50 (30 %) were malignant lesions. Median polyp size was 4 (range 0.6–14.5) cm. Mean length of operation was 55 (range 10–120) min. There were no recurrences in any patients with a benign adenoma resected; two patients with malig- nant lesions developed recurrences. Three intra-operative complications were recorded, two rectal perforations (repaired primarily, one requiring defunctioning stoma), and a further patient suffered a blood loss of [ 300 ml requiring transfusion. Six patients developed strictures requiring dilation either endoscopically or under anaes- thetic in the post-operative period. Conclusions We have demonstrated that TEMS procedures performed in a specialist centre provide low rates of both recurrence and complication. Within a specialist centre, TEMS surgery should be offered to all patients for rectal lesions, both benign and malignant, that are amenable to TEMS. Keywords Transanal endoscopic microsurgery (TEMS) Á Rectal polyp Á Rectal cancer Outcomes in the treatment of rectal cancer have improved dramatically over the last decade [13]. Improved out- comes are linked to the introduction of total mesorectal excision (TME), which has led to reduced rates of local recurrence. However, TME is major surgery and is asso- ciated with significant morbidity and mortality [4]. In early-stage rectal cancer (BT2), there is a move towards organ-preserving surgery, for which transanal endoscopic microsurgery (TEMS) lends itself [5]. TEMS was introduced by Buess et al. in 1984 [6] as a novel way to treat rectal adenomas. Since then, TEMS has been introduced to many colorectal units as the primary treatment for rectal adenomas over 2 cm in size and up to 18 cm from the anal verge. Studies have shown TEMS to be a safe and effective treatment for rectal adenomas and superior to both transanal excision (TE) and endoscopic mucosal resection (EMR) [714]. Recurrence rates in a number of reported series for benign adenomas resected with TEMS range from 1.7 to 13 %, with follow-up between 7.4 and 67.5 months [1426]. The Bradford Royal Infirmary is a specialist tertiary referral centre for the treatment of rectal adenomas and early rectal cancer. TEMS is performed for both benign and malignant rectal lesions, and our results have been collected prospectively since 2005. The aim of this study is to report the experience of our single institution and to contribute to the growing body of evidence for the use of TEMS for both benign and malignant rectal lesions. S. M. Flexer (&) Á A. C. Durham-Hall Á M. A. Steward Á J. M. Robinson Department of Surgery, Bradford Teaching Hospitals NHS Foundation Trust, West Yorkshire, UK e-mail: susiefl[email protected] 123 Surg Endosc DOI 10.1007/s00464-013-3407-4 and Other Interventional Techniques

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Page 1: TEMS: results of a specialist centre

TEMS: results of a specialist centre

S. M. Flexer • A. C. Durham-Hall • M. A. Steward •

J. M. Robinson

Received: 19 July 2013 / Accepted: 20 December 2013

� Springer Science+Business Media New York 2014

Abstract

Introduction Transanal endoscopic microsurgery (TEMS)

is becoming more widespread due to the increasing body of

evidence to support its role. Previous published data has

reported recurrence rates in excess of 10 % for benign

polyps after TEMS.

Methods Bradford Royal Infirmary is a tertiary referral

centre for TEMS and early rectal cancer in the UK. Data

for all TEMS operations were entered into a prospective

database over a 7-year period. Demographic data, com-

plications and recurrence rates were recorded. Both benign

adenomas and malignant lesions were included.

Results A total of 164 patients (65 % male), with a mean

age of 68 years were included; 114 (70 %) of the lesions

resected were benign adenomas, and 50 (30 %) were

malignant lesions. Median polyp size was 4 (range

0.6–14.5) cm. Mean length of operation was 55 (range

10–120) min. There were no recurrences in any patients

with a benign adenoma resected; two patients with malig-

nant lesions developed recurrences. Three intra-operative

complications were recorded, two rectal perforations

(repaired primarily, one requiring defunctioning stoma),

and a further patient suffered a blood loss of [300 ml

requiring transfusion. Six patients developed strictures

requiring dilation either endoscopically or under anaes-

thetic in the post-operative period.

Conclusions We have demonstrated that TEMS procedures

performed in a specialist centre provide low rates of both

recurrence and complication. Within a specialist centre, TEMS

surgery should be offered to all patients for rectal lesions, both

benign and malignant, that are amenable to TEMS.

Keywords Transanal endoscopic microsurgery (TEMS) �Rectal polyp � Rectal cancer

Outcomes in the treatment of rectal cancer have improved

dramatically over the last decade [1–3]. Improved out-

comes are linked to the introduction of total mesorectal

excision (TME), which has led to reduced rates of local

recurrence. However, TME is major surgery and is asso-

ciated with significant morbidity and mortality [4]. In

early-stage rectal cancer (BT2), there is a move towards

organ-preserving surgery, for which transanal endoscopic

microsurgery (TEMS) lends itself [5].

TEMS was introduced by Buess et al. in 1984 [6] as a

novel way to treat rectal adenomas. Since then, TEMS has

been introduced to many colorectal units as the primary

treatment for rectal adenomas over 2 cm in size and up to

18 cm from the anal verge. Studies have shown TEMS to

be a safe and effective treatment for rectal adenomas and

superior to both transanal excision (TE) and endoscopic

mucosal resection (EMR) [7–14]. Recurrence rates in a

number of reported series for benign adenomas resected

with TEMS range from 1.7 to 13 %, with follow-up

between 7.4 and 67.5 months [14–26].

The Bradford Royal Infirmary is a specialist tertiary

referral centre for the treatment of rectal adenomas and

early rectal cancer. TEMS is performed for both benign

and malignant rectal lesions, and our results have been

collected prospectively since 2005. The aim of this study is

to report the experience of our single institution and to

contribute to the growing body of evidence for the use of

TEMS for both benign and malignant rectal lesions.

S. M. Flexer (&) � A. C. Durham-Hall �M. A. Steward � J. M. Robinson

Department of Surgery, Bradford Teaching Hospitals NHS

Foundation Trust, West Yorkshire, UK

e-mail: [email protected]

123

Surg Endosc

DOI 10.1007/s00464-013-3407-4

and Other Interventional Techniques

Page 2: TEMS: results of a specialist centre

Methods

Data was collected prospectively on an Microsoft� Excel

database for all patients undergoing TEMS from April

2005 to October 2012 at the Bradford Royal Infirmary.

Pre-operative procedure

Patients were assessed initially by flexible sigmoidoscopy

to characterise the lesion and to obtain histology. Patients

with histology showing high-grade dysplasia (HGD), sus-

picious features or adenocarcinoma proceed to further

investigations, including computed tomography (CT), pel-

vic magnetic resonance imaging (MRI) and an endorectal

ultrasound scan (ERUS). Lesions that demonstrated

malignant histology were staged according to the TNM

classification.

Patients with adenomas [2 cm in size and up to 18 cm

from the anal verge were offered TEMS. Patients with T1

or T2 node-negative cancers were offered TEMS as part of

the Transanal Endoscopic Microsurgery and Radiotherapy

(TREC) in Early Rectal Cancer trial or if unfit for major

resection [27].

Operative procedure

All patients underwent standard pre-operative assessment,

pre-operative bowel preparation with Picolax� [28], pro-

phylactic anticoagulation, prophylactic antibiotics and

general anaesthetic with muscle relaxation.

The operations were carried out by two consultant

colorectal surgeons trained in TEMS. The Richard Wolfe

TEM instrument system [29] was used by one consultant

and the Storz Transanal Endoscopic Operating system

[30] by the second consultant due to operating prefer-

ence. The procedure was carried out as described by

Buess et al. [6], and full thickness excisions were per-

formed in all cases.

Histology

TEMS specimens were pinned out by the operating surgeon

and sent fresh to the pathology laboratory. Pathologists

reported all specimens to include dimensions, depth of

excision, cell type, depth of invasion, evidence of lym-

phovascular invasion and Kikuchi level of invasion.

Post-operative

Patients commenced a normal diet post-operatively and

were discharged on the first day post-operatively or once

they had a bowel motion. Patients were prescribed a course

of metronidazole and lactulose for 7 days.

Follow-up

Patients were followed up with flexible sigmoidoscopy at

6 weeks, 3 months, 12 months and then as clinically

indicated. Endoscopic reports were reviewed along with

any relevant histology and collated into the database.

As this study was conducted in a tertiary referral centre,

a number of patients (N = 44) were followed-up by their

referring hospital, therefore, full follow-up data are absent

for these 44 patients.

Results

Patient demographics and histology

In the study period between April 2005 and October 2012, a

total of 164 TEMS procedures were performed. Mean age

was 69 years and 65 % were male. Mean operating time was

55 (range 10–120) min. Median polyp diameter was 4 (range

0.6–14.5) cm. Patient demographics are shown in Table 1.

Post-operative histology is shown in Table 2. There

were 114 (69.5 %) patients with benign histology and 50

(30.5 %) patients with malignant histology. A total of 19

patients (11.59 %) had benign histology pre-operatively

but were shown to have malignant tissue on histology post-

operatively. A further eight (4.9 %) patients had malig-

nancy on their initial histology and only inflammation/scar

tissue on their post-TEMS histology. These patients had

undergone pre-operative radiotherapy. All patients who

had malignant histology at any point were analysed in the

malignant group.

Histology of the TEMS specimens with adenocarcinoma

had the T stage, presence of lymphovascular invasion, and

Kikuchi level recorded and are presented in Table 3. A

number of specimens could not be fully analysed, hence

some data are missing; T stage (6), lymphovascular inva-

sion (14) and Kikuchi level (22). This is due to the frag-

mentation of specimens, making reporting of these

characteristics difficult for pathologists.

Table 1 Patient demographics in benign and malignant TEMS

groups

Patients Benign

(N = 114)

Malignant

(N = 50)

Average age (years) 68.0 (38–91) 69.5 (30–86)

Men 68 (60) 38 (76)

Median maximum diameter (mm) 4.2 4

Intra-operative complications 3 (1.83) 0

Post-operative complications 9 (5.49) 1 (0.61)

Data are presented as n (range) or n (%) unless otherwise indicated

Surg Endosc

123

Page 3: TEMS: results of a specialist centre

Operative complications

There were no patient deaths at 30 days (mortality 0 %).

The TEMS operative complication rate was 1.83 %

(3/164), including perforation (N = 2), one required pri-

mary repair via TEMS and laparoscopy, and one primary

repair with laparoscopic formation of colostomy. One

patient had an intra-operative blood loss [300 ml and

required transfusion (N = 1).

Post-operative complications

Post-operative complications are shown in Table 4. The

post-operative complication rate was 6.10 % and included

rectal strictures (N = 6), bleeding (N = 2), ileus (N = 1)

and sphincter weakness (N = 1). Four of the six patients

who developed strictures required dilatation under sedation

at endoscopy, and two patients required general anaesthesia

and dilation. Two patients with bleeding presented within

4 weeks of procedure and required endoscopic treatment

under sedation. One patient readmitted with an ileus had

malignant polyp and was managed conservatively. One

patient with sphincter laxity was treated conservatively and

symptoms resolved within 6 months.

Recurrence

Of the 164 patients, 11 (6.7 %) went on to require further

surgery after review of TEMS histology. In all cases, the

histology showed adenocarcinoma with at least Sm3 level

of invasion assessed by the Kikuchi criteria [31]. Of these

patients, ten underwent an abdominoperineal excision of

the rectum (APER) and one patient had an anterior resec-

tion (AR) performed.

A number of patients were followed-up at their local

hospital. We do not have follow-up data available for these

patients, as they were referred to Bradford only for TEMS

treatment (N = 44) and therefore cannot be included in the

analysis.

Active follow-up with invited endoscopy was conducted

at 6 weeks, 3 months and 12 months post-TEMS for the

remaining 122 patients. Endoscopy records were followed-

up for a mean 29 (range 1–84) months to pick up patients

undergoing further endoscopic investigation in our insti-

tution. Endoscopy findings are presented in Table 5.

Overall recurrence rate was 1.22 %. The recurrences

occurred in one patient who underwent TEMS in 2006 for

adenocarcinoma polyp. TEMS histology showed complete

Table 2 Histology of TEMS specimens

Post-operative histology N (%)

Adenocarcinoma 42 (25.6)

HGD 46 (28.1)

Middle-grade dysplasia 7 (4.3)

Low-grade dysplasia 52 (31.7)

Inflammation/scar tissue 13 (7.9)a

Not available 4 (2.4)

a Eight patients had pre-operative malignant histology

Table 3 Characteristics of 42 adenocarcinoma specimens

Adenocarcinoma characteristics n

T stage

T1 11

T2 20

T3 5

Not available 6

Lymphovascular invasion

Yes 4

No 24

Not available 14

Kikuchi level

Sm1 4

Sm2 5

CSm3 11

Not available 22

Table 4 Complications for all patients (N = 164) undergoing TEMS

at our institution

Complication n (%) Management

Perforation 2 (1.2) 1 primary repair, 1 primary

repair plus colostomy

Bleeding—intra-operative 1 (0.61) Transfusion

Bleeding—post-operative 2 (1.2) Endoscopic treatment

Stenosis 6 (3.7) 4 endoscopic dilatation,

2 dilatation under general

anaesthesia

Ileus 1 (0.61) Conservative management

Temporary incontinence 1 (0.61) Resolved spontaneously

Table 5 Findings on endoscopy follow-up

Endoscopy findings N Management

Normal 89 Surveillance

Recurrence 2 Further surgery

Stitch granuloma 22 Biopsy

TEM site ulcer 2 Conservative treatment

Rectal polyp elsewhere

to TEM scar

6 Snare polyp excision

at endoscopy

TEMS transanal endoscopic microsurgery

Surg Endosc

123

Page 4: TEMS: results of a specialist centre

resection with Sm1 level. The patient had a recurrence

detected 60 months later on endoscopy with a tubulovil-

lous adenoma displaying low-grade dysplasia; repeat

TEMS was performed, which showed complete excision on

histology. The second recurrence occurred in a patient with

benign histology from the original TEMS in 2011 and who

developed a recurrent polyp 15 months later with moder-

ately differentiated adenocarcinoma on histology.

Other findings at follow-up endoscopy include stitch

granuloma (N = 21), TEMS-site ulcer (N = 2) and small

rectal polyps seen distant from TEMS site (N = 6).

Discussion

The results from our institution show an overall compli-

cation rate of 7.93 % and an overall recurrence rate of

1.22 %, demonstrating TEMS to be an effective and safe

treatment option for rectal adenomas, both benign and

malignant.

Of interest, the recently published Dutch TREND study

reported significantly higher recurrence and complications

rates for resection of benign adenomas [8]. This was a

retrospective study looking at both TEMS and EMR across

a number of units in Holland (a total of eight units per-

forming TEMS). They reported on 219 patients undergoing

TEMS and 73 patients undergoing EMR for rectal adeno-

mas. The TREND study reported a much greater incidence

of both operative complication rates (24 %) and recurrence

rates (10.2 %) for TEMS than our own experience [8].

Other studies have findings that are more consistent with

our experience of TEMS. A UK-based prospective audit of

262 patients undergoing TEMS for both benign and

malignant lesions demonstrated a complication rate of

13 % and a 30-day mortality rate of 0.8 % [32].

Many patients who present with rectal adenomas, both

benign and malignant, are elderly and have multiple co-

morbidities. In these cases, the surgical burden of radical

resection is high. A Cochrane review of TME for rectal

cancer reported morbidity rates as high as 29 % [4]. TEMS

offers a significantly lower risk of both surgical mortality

and morbidity. TEMS also significantly reduces the risk of

stoma formation, which can be a heavy burden for the

elderly patient. In this study, the stoma formation rate was

only 0.61 % and this was a temporary stoma with reversal

planned.

The role of TEMS has expanded since its first induction

to include the treatment of early rectal cancer (BT2). The

cancer-specific 5-year survival rate for T1 resection by

TEMS has been reported as 94 %, and TEMS has become

accepted as a curative treatment option for BT1 rectal

cancers [15, 33–35]. Favourable characteristics of a rectal

tumour for TEMS resection include size B3 cm, lying in

the extraperitoneal rectum, confined to superficial submu-

cosa (BSm1), no adverse features on histology, such as

poor differentiation, lymphovascular invasion, tumour

budding and peri-neural invasion [5]. If adverse features

are present on histology, then patients should be offered

completion surgery.

Studies are currently in progress to evaluate the role of

TEMS in treating more advanced rectal cancer. The current

CARTS study proposes to investigate the role of neoadjuvant

chemoradiation therapy followed by rectum saving surgery

(TEMS) for patients with T1–3 N0 M0 rectal cancer 10 cm

from the anal verge [36]. Patients will receive neoadjuvant

chemoradiation therapy, and TEMS will be performed

8–10 weeks after the neoadjuvant therapy. Primary outcome

measures will be pathological response after chemoradiation

therapy and TEMS. The secondary outcome measures will

be local recurrence rate and quality of life [36].

The current phase II TREC trial compares radical sur-

gery verses radiotherapy and local excision of early rectal

cancer [27]. This trial will hopefully inform on the role of

TEMS in more advanced rectal cancer and be useful to

guide practice when expanded to a phase III trial.

Conclusion

The results from our institution are encouraging and show

TEMS is a safe and effective treatment for rectal polyps

and early rectal cancer. Previous studies have shown

superiority of TEMS over TE and EMR for benign rectal

polyps [8–14]. Future studies such as the CARTS and

TREC trials will inform further on the role of TEM for

varying stages of rectal cancer [27, 36].

Disclosures S. M. Flexer, A. C. Durham-Hall, M. A. Steward and J.

M. Robinson have no conflicts of interest or financial ties to disclose.

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