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Transanal Total Mesorectal Excision

Satish K WarrierTransanal TME program

Peter MacCallum Cancer Centre,Alfred Heatlh

Epworth HealthcareAustralia

Disclosures

• Ethicon• Applied Medical

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Epworth Cleveland Fellowship

Satish WarrierEugene OngPhil SmartJenny Ryan

Ameera DeanVlad Bolshinsky

Not Non- inferior

• A La Ca RT failed to show pathological equivalence

• Similar result from the American ACOSOG Z6051 study

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Not all rectal cancers are the same

Obese patients

Low rectal cancers

Narrow pelvis

Low rectal Cancers Are difficult !!

APPEAR- Anterior Perineal PlanEfor ultralow Anterior Resection

Sir Norman WilliamsSurgical solution for low rectal cancersIncision in the anterior perineum. Transperineal delivery to do low components of surgerySurgical “No Mans Land”

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Transanal Transabdominal (TaTAprocedure)

Gerald Marks

John Marks

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Laparoscopy in Australia

Russel Stitz

Single port Colorectal Surgery

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Evolution of TEMS

1985 TEMS platform to perform transanalEndoscopic surgery.

Higher polyps could be removed and with more accuracy

In Victoria, Chip Farmer…

Buess G. Endoscopy 1985

Gerhard Buess

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TAMIS platform

Matt Albert

Technical challenges with laparoscopy in pelvis• Narrow Pelvis

• Male pelvis

• Low tumor

• Anterior tumor

• Obese patient

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Antonio Lacey Pat Sylla

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Bile duct injury

Lessons from the past !!

• Introduction of new techniques can be fraught with danger

• Classical examples:– Transition to new views:

• Laparoscopic cholecystectomy• Laparoscopic hernia repair (preperitoneal repair_

– VASCULAR INJURY

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What challenges face surgeons ?

•Technical issues

•Understanding new views of anatomy from below

•Keeping the patient safe

•Keeping the surgeon safe and establishing a collaborative network

IDEALFramework

for new technologies

McCulloch et al. Lancet 2009

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- Idea Proof of concept

- Development Safety & efficacy

- Exploration Efficacy

- Assessment Comparative effectiveness

- Long term follow up Quality assurance

IDEAL Framework for Surgical Innovation

McCulloch et al. Lancet 2009

Stage 1IDEA

Stage 2a DEVELOPMENT

Stage 2b EXPLORATION

Stage 3 ASSESSMENT

Stage 4 LONG TERM MONITORING

Initial report

Innovation may be planned, accidental or forced

Focus on explanation and description

“Tinkering”(rapid iterative modification of technique and indications)

Small experience from one centre

Focus on technical details and feasibility

Technique now more stable

Replication by others

Focus on adverse effects and potential benefits

Learning curves important

Definition and quality parameters developed

Gaining wide acceptance

Considered as possible replacement for current treatment

Comparison against current best practice (RCT if possible)

Monitoring late and rare problems, changes in use & quality of surgical performance

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The 20% tipping point

Developm

ent

Idea

Exploration

Assessm

ent

LongtermFU

The 20% tipping point

Developm

ent

Idea

Exploration

Assessm

ent

LongtermFU

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The 20% tipping point

Developm

ent

Idea

Exploration

Assessm

ent

LongtermFURegistry

The 20% tipping point

Developm

ent

Idea

Exploration

Assessm

ent

LongtermFU

RCTCOLOR III

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REGISTRY RCTEffectiveness EfficacyObservational Randomized“real world” Controlled /

Selection critereaHypothesis generating

Hypothesis driven

Large N Small NFlexible Powered

Accreditation Process

Colorectal Surgeon

Colorectal Surgeon

CoursesCourses

ProctorshipProctorship

Colorectal surgeon laparoscopic rectalSingle portTAMIS/ TEMS/ TEO

Live case/sCadaveric workshopDidactic Lectures

Ideally 2-3 casesConsider uptake with >1 surgeon

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Transanal TME summit

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• 634 rectal cancers• 67% males• Abdominal/ perineal conversion (6.3%/2.8%)• Intact mesorectum 85%, minor defect 11%, major 4%

• Conclusion: Safe to do oncologically.

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PMCC Lacy Veltcamp

Rasulov

Chen Atallah Nicola

Number 20 140 80 22 50 50 32BMI (mean) 31.2 25.2 27.5 26 24.1 26 25.1Hospital stay (mean)

9 6 8 8 7.4 4.5 7.78

Operating time mins

330 166 204 320 182 267 195

Distance AV cm (median)

6.5 7.6 5.3 6.5 5.8 4.4 4

CRM +ve (%) 0 6.4% 2.5% 5% 4% 4% 3.1%Incomplete TME (%)

0 0.7% 3% 18% NR 2% 6.2%

LN harvest ( mean) 13.4 14.7 14 17 16.7 18% 17

Australasian Uptake

65

42

16

36

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Technique uptake

0

3

6

9

12

15

Jul-13 Nov-13 Mar-14 Jul-14 Nov-14 Mar-15 Jul-15 Nov-15

Patient demographics

Sex, n (%)Male 100 (62.9%)Female 59 (37.1%)

Age in years, mean ± SD (range) 62.0 ± 14.8 (14-88)ASA, median (range) 2 (1-3)BMI, mean ± SD (range) 27.6 ± 5.4 (17-46)

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Indication for surgery

Rectal cancer 131 (82.4%)High 6Mid 57Low 68

Rectal polyp 4 (2.5%)IBD 15 (9.4%)

UC 10Crohn’s 5

Faecal incontinence 3 (1.9%)Other 6 (3.8%)

Outcomes

• Mean combined operating time 284 minutes (100-525 minutes)

• Five cases (3.2%) converted• 4x significant intra-operative complications

– Rectal perforation (2)– Avulsion of marginal upon conduit delivery (1)– Urethral injury (1)

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Outcomes

LOS (days), median (range) 7 (3-44)Postoperative mortality at 30/7 0 (0)Postoperative morbidity 46 (29.1%)Anastomotic leak 6 (5%)Pelvic collection 2 (1.3%)

Oncologic Outcomes

98 percent with intact or near intact mesorectum

Quality of TME specimenIntact 117

(89.3%)Minor

defects8 (6.1%)

Major defects

2 (1.5%)

Missing 4 (3.1%)Number of LNs harvested

Mean ± SD 16.2 ± 9.4

Distal margin (mm)Positive

DRM0 (0%)

Missing 5 (3.8%)Circumferential resection margin

PositiveCRM

3 (2.3%)

Missing 6 (4.6%)

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Conclusion

• Safe & controlled introduction of a new technique using formalised pathway

• Outcomes comparable to best published data

This formalised pathway, and the results obtained, set the standard for the introduction of

taTME into colorectal surgery practice

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Conclusions

• Transanal Total Mesorectal Excision can be performed safely

• Has been introduced safely into Australasia with a recommended training program

• Awaiting functional Data.

Robot taTME Cecil Approach

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Peter MacCallum Cancer Centre