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S Nachiappan, A Askari, A Currie, RH Kennedy, O Faiz 30 th June 2014 Tripartite Colorectal Meeting, Birmingham, UK

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Page 1: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

S Nachiappan, A Askari, A Currie, RH Kennedy, O Faiz30th June 2014

Tripartite Colorectal Meeting, Birmingham, UK

Page 2: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

• ↑ local recurrence in rectal cancer• ↓ Long-term cancer specific

survival

• 16% died within 30 days• ↓ Long-term cancer specific

survival

• 4.5% of elective colorectal surgery underwent a reoperation within 28 days• Reoperation often for postop

bleeding & anastomotic leaks

Page 3: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

To detect a possible anastomotic complication during the operation itself & allow remedial action

To prevent a postoperative leak or complication

To prevent a reoperation

To minimise patient morbidity and mortality

Page 4: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

Anastomotic

Integrity

Ensure

Luminal

Patency

No Ischaemia

No Bleeding

No

Mechanical

Disruption

Page 5: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

•Surgical anastomosis

•Colo-colonic

Anastomosis

•Colorectal

anastomosis

•Rectal anastomosis

•Ileorectal

anastomosis

•Intraoperative period

•Intraoperative care

•Peroperative

procedure

•Intraoperative

•Peroperative

•Anastomotic integrity

•Integrity

•Leak

•Dehiscence

•Perfusion

•Ischaemia

•Bleeding

*Latest search performed on 12th June 2013

Page 6: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

Inclusion

• RCTs

• Non-randomised

comparative studies

• Case series

Exclusion

• Animal studies

• Case reports/technical tips

• Unclear postoperative

outcomes

Page 7: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

Clinical

•Symptomatic

•May have had radiological

imaging subsequently

•Reoperation, Drainage or

conservative Mx

Radiological

•Asymptomatic

•Radiological imaging –

planned/routine

•eg. GG Enema at 8

weeks/prior to reversal

Page 8: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

37 studies

Basic mechanical patency tests

(Air/fluid leak)

13

10

Case

series

1

Non-

randomised

study

2

RCT

Endoscopic visualisation

techniques

(intra-op colonoscopy +

leak test)

10

5

Case

series

5

Non-

randomised

studies

Microperfusion techniques

14

11

Case

series

2

Non-

randomised

studies

1

RCT

Page 9: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

Postoperative

Intraoperative

Basic Mechanical

Patency TestsCase series

(10)

n = 816

Positive IOT*

90

13 POL

(7CL, 6RL)77 No POL

Negative IOT

726

47 POL

(26CL, 21RL)679 No POL

Positive IOT Negative IOT

13/90 47/726

14.4% 6.5%

7/90 26/726

7.7% 3.5%

IOT: Intraoperative testPOL: Postoperative leakCL: Clinical leakRL: Radiological leak

* With intraoperative rectifications• 61 sutured only• 20 sutured & defunctioned• 4 redone• 5 defunctioned only

Total Leak (CL+RL) rate▶▶▶

Clinical Leak rate▶▶▶

Page 10: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

Postoperative

Intraoperative

Intraoperative

Basic Mechanical

Patency Tests

Non-

randomised

study (1)

n = 998

IOT

group

825

Positive IOT*

65

5 POL#

Negative IOT

760

29 POL

Control

group

173

14 POL

Tested Non-tested/Control

34/825 14/173

4.1% 8.1%

IOT: Intraoperative testPOL: Postoperative leak

* With intraoperative rectifications• 41 sutured• 10 sutured & defunctioned• 14 redone

Total (Clinical) Leak rate▶▶▶

# All sutured

Page 11: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

Postoperative

Intraoperative

Intraoperative

Basic Mechanical

Patency Tests

RCTs (2)

n = 203

IOT

group

103

Positive IOT*

25

5 POL

(3CL, 2RL)

Negative IOT

78

9 POL

(3CL, 6RL)

Control

group

100

27 POL

(16CL, 11RL)

Tested Non-tested/Control

14/103 27/100

13.6% 27.0%

6/103 16/100

5.8% 16% IOT: Intraoperative testPOL: Postoperative leakCL: Clinical leakRL: Radiological leak

* With intraoperative rectifications• 25 sutured

Total Leak rate▶▶▶

Clinical Leak rate▶▶▶

Page 12: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

37 studies

Basic mechanical patency tests

(Air/fluid leak)

13

10

Case

series

1

Non-

randomised

study

2

RCT

Endoscopic visualisation

techniques

(intra-op colonoscopy +

leak test)

10

5

Case

series

5

Non-

randomised

studies

Microperfusion techniques

14

11

Case

series

2

Non-

randomised

studies

1

RCT

Page 13: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

Postoperative

Intraoperative

Endoscopic visualisation

(Intraoperative

colonoscopy)Case series

(5)

n = 713

Positive IOT*

57

12 POAC(6CL, 1staple line

bleed, 1 pelvic

collection, 4 ileus)

45 No POAC

Negative IOT

656

7 POAC

(7CL)649 No POAC

Positive IOT Negative IOT

12/57 7/656

21.1% 1.1%

6/57 7/656

10.5% 1.1%

IOT: Intraoperative testPOAC: Postoperative anast complicationCL: Clinical leakRL: Radiological leak

• With intraoperative rectifications• 10 suturing only• 14 haemostasis • 20 redone• 2 defunctioned only• 11 unknown

POAC rate▶▶▶

Clinical leak rate▶▶▶

Page 14: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

Postoperative

Intraoperative

Endoscopic visualisation

(Intraoperative

colonoscopy)

Non-

randomised

studies (5)

n = 950

IOT

group

509

Positive IOT*

70

(56 air leaks, 14 staple

line bleeds

7 POAC

(7 CLs)

Negative IOT

439

32 POAC

(28 CL)

Control

group

441

26 POAC

(17 CL)

Tested Non-tested/Control

39/509 26/441

7.7% 5.9%

35/509 17/441

6.9% 3.9%

IOT: Intraoperative testPOAC Postoperative anast complication

• With intraoperative rectifications• 26 sutured• 8 haemostasis• 1 redone• 5 sutured/haemostasis &

defunctioned• 30 defunctioned

POAC rate▶▶▶

Clinical leak rate▶▶▶

Page 15: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

37 studies

Basic mechanical patency tests

(Air/fluid leak)

13

10

Case

series

1

Non-

randomised

study

2

RCT

Endoscopic visualisation

techniques

(intra-op colonoscopy +

leak test)

10

5

Case

series

5

Non-

randomised

studies

Microperfusion techniques

14

11

Case

series

2

Non-

randomised

studies

1

RCT

Page 16: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)
Page 17: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

First Author Year

Perfusion assessment technique Testing Access

(Operative access)

Study design N

Ambrosetti

1994 Doppler USS Open CS 194

Hallbook

1996

LDF Open CS 30

Vignali

2000 LDF Open CS 55

Seike

2007

LDF

Open CS

86

Boyle

2000 SLDF

Open CS

10

Sheridan 1987 Tissue Oxygen Tension

Open CS

50

Hall 1995 Tissue Oxygen Tension Open CS

62

Karliczek

2010 Visible Light O2 Spectroscopy

Open CS

77

Hirano

2006 Near Infrared O2 Spectroscopy

Open & lap CS

20

Parmeggiani 2012 IOC with Narrow Band Imaging

Transanal RCT

47 (27 vs 20)

Kudszus

2010 Laser Fluorescence ICG

Open & lap Case-Control 402 (201vs 201)

Jafari

2013 NIR ICG

Robotics Case-Control 38 (16 vs 22)

Sherwinter

2012 NIR ICG

Transanal CS

7

Sherwinter

2013 NIR ICG + ALT

Transanal CS

20

LDF = Laser Doppler FlowmetrySLDF = Scanning LDFNIR = Near InfraredICG = Indocyanine greenALT = Air leak test

Page 18: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

First Author Year

Perfusion assessment technique Testing Access

(Operative access)

Study design N

Ambrosetti

1994 Doppler USS Open CS 194

Hallbook

1996

LDF Open CS 30

Vignali

2000 LDF Open CS 55

Seike

2007

LDF

Open CS

86

Boyle

2000 SLDF

Open CS

10

Sheridan 1987 Tissue Oxygen Tension

Open CS

50

Hall 1995 Tissue Oxygen Tension Open CS

62

Karliczek

2010 Visible Light O2 Spectroscopy

Open CS

77

Hirano

2006 Near Infrared O2 Spectroscopy

Open & lap CS

20

Parmeggiani 2012 IOC with Narrow Band Imaging

Transanal RCT

47 (27 vs 20)

Kudszus

2010 Laser Fluorescence ICG

Open & lap Case-Control 402 (201vs 201)

Jafari

2013 NIR ICG

Robotics Case-Control 38 (16 vs 22)

Sherwinter

2012 NIR ICG

Transanal CS

7

Sherwinter

2013 NIR ICG + ALT

Transanal CS

20

LDF = Laser Doppler FlowmetrySLDF = Scanning LDFNIR = Near InfraredICG = Indocyanine greenALT = Air leak test

Page 19: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

First Author Year

Perfusion assessment technique Testing Access

(Operative access)

Study design N

Ambrosetti

1994 Doppler USS Open CS 194

Hallbook

1996

LDF Open CS 30

Vignali

2000 LDF Open CS 55

Seike

2007

LDF

Open CS

86

Boyle

2000 SLDF

Open CS

10

Sheridan 1987 Tissue Oxygen Tension

Open CS

50

Hall 1995 Tissue Oxygen Tension Open CS

62

Karliczek

2010 Visible Light O2 Spectroscopy

Open CS

77

Hirano

2006 Near Infrared O2 Spectroscopy

Open & lap CS

20

Parmeggiani 2012 IOC with Narrow Band Imaging

Transanal RCT

47 (27 vs 20)

Kudszus

2010 Laser Fluorescence ICG

Open & lap Case-Control 402 (201vs 201)

Jafari

2013 NIR ICG

Robotics Case-Control 38 (16 vs 22)

Sherwinter

2012 NIR ICG

Transanal CS

7

Sherwinter

2013 NIR ICG + ALT

Transanal CS

20

LDF = Laser Doppler FlowmetrySLDF = Scanning LDFNIR = Near InfraredICG = Indocyanine greenALT = Air leak test

Page 20: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

First Author Year

Perfusion assessment technique Testing Access

(Operative access)

Study design N

Ambrosetti

1994 Doppler USS Open CS 194

Hallbook

1996

LDF Open CS 30

Vignali

2000 LDF Open CS 55

Seike

2007

LDF

Open CS

86

Boyle

2000 SLDF

Open CS

10

Sheridan 1987 Tissue Oxygen Tension

Open CS

50

Hall 1995 Tissue Oxygen Tension Open CS

62

Karliczek

2010 Visible Light O2 Spectroscopy

Open CS

77

Hirano

2006 Near Infrared O2 Spectroscopy

Open & lap CS

20

Parmeggiani 2012 IOC with Narrow Band Imaging

Transanal RCT

47 (27 vs 20)

Kudszus

2010 Laser Fluorescence ICG

Open & lap Case-Control 402 (201vs 201)

Jafari

2013 NIR ICG

Robotics Case-Control 38 (16 vs 22)

Sherwinter

2012 NIR ICG

Transanal CS

7

Sherwinter

2013 NIR ICG + ALT

Transanal CS

20

LDF = Laser Doppler FlowmetrySLDF = Scanning LDFNIR = Near InfraredICG = Indocyanine greenALT = Air leak test

Page 21: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

First Author Year

Perfusion assessment technique Testing Access

(Operative access)

Study design N

Ambrosetti

1994 Doppler USS Open CS 194

Hallbook

1996

LDF Open CS 30

Vignali

2000 LDF Open CS 55

Seike

2007

LDF

Open CS

86

Boyle

2000 SLDF

Open CS

10

Sheridan 1987 Tissue Oxygen Tension

Open CS

50

Hall 1995 Tissue Oxygen Tension Open CS

62

Karliczek

2010 Visible Light O2 Spectroscopy

Open CS

77

Hirano

2006 Near Infrared O2 Spectroscopy

Open & lap CS

20

Parmeggiani 2012 IOC with Narrow Band Imaging

Transanal RCT

47 (27 vs 20)

Kudszus

2010 Laser Fluorescence ICG

Open & lap Case-Control 402 (201vs 201)

Jafari

2013 NIR ICG

Robotics Case-Control 38 (16 vs 22)

Sherwinter

2012 NIR ICG

Transanal CS

7

Sherwinter

2013 NIR ICG + ALT

Transanal CS

20

LDF = Laser Doppler FlowmetrySLDF = Scanning LDFNIR = Near InfraredICG = Indocyanine greenALT = Air leak test

Page 22: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

Basic mechanical patency testing (leak testing) is beneficial & reduces postoperative anastomotic leak rates

A normal/negative intraoperative endoscopic visualisation test (intraoperative endoscopy) is associated with highly infrequent postoperative anastomotic complications

Greater use of intraoperative endoscopy to assess anastomosis, may prevent/reduce rates of anastomotic dehiscence.

Microperfusion assessment techniques are currently still experimental but hold potential for reducing anastomotic complications.

Page 23: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

Academic Supervisors

◦ Mr Omar Faiz

◦ Professor Charles Vincent

Surgical Consultants and colleagues

Page 24: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

S Nachiappan, A Askari, A Currie, RH Kennedy, O Faiz30th June 2014

Tripartite Colorectal Meeting, Birmingham, UK

Page 25: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

The decision to divert is dependent on several factors

Patient age/ comorbidities/ ability to withstand the sequelae of a leak

Elective/emergency setting

Intraoperative parameters

Height of anastomosis

Possible adjuvant chemotherapy

In the review

◦ Basic:

CS = 5 out of 10 = 36 patients out of 150 patients

NRCT = 0 out of 1

RCT= 1 out of 2= 18 out of 143 patients

◦ IOC:

CS = Info not available in most

NRCT = Info not available in most

Page 26: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

I was not able to ascertain total numbers of defunctioning ileostomies made prior to intraoperative test.

However what I noted was that patients who did have an ileostomy formed as a result of the◦ IOT/rectification,

Had no leak or

had a attenuated effect from any subsequent leaks.

The question I suppose would be whether we defunction anyone where we have concerns?

But there is the morbidity of an ileostomy we need to take note of as well.

So if we can target the specific patients who are at risk of a leak - and defunction them

And avoid defunctioning those at minimal risk, that would be ideal.

In this sense, intraoperative assessment of the anastomosis gives the surgeon◦ more information at that point itself

and ◦ allows an immediate rectification/action

to be taken at the same sitting/operation

Page 27: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

The older studies routinely bowel prepped the patients, especially for the left sided resections

However, with the introduction of ERAS, this has reduced substantially.

For the purposes of this review. I did not look at bowel prep specifically

Of note studies: Cochrane review in 2011 noted no significant benefit of bowel prep.

Selective use in rectal surgery may be beneficial, but no significant effect was found.

KF Guenaga, D Matos

◦ Database Syst Rev, 2011

Page 28: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

How was bleeding stopped?

◦ Endoluminally – APC

◦ Transabdominally with sutures

Li et al - Use of routine intraoperative endoscopy in elective laparoscopic colorectal surgery: can it further avoid anastomotic failure? Surg Endosc 2009

Routine IOE for patients undergoing elective laparoscopic colorectal surgerywith distal anastomosis can detect abnormalities at or around the anastomosis.

Although the RIOE group had fewer postoperative anastomotic complications, due to the small sample size, the 5.7-fold increase in anastomotic failure did not translate into significantly better postoperative outcomes than the SIOE group experienced.

A larger-scale single or multicenterprospective randomized study or a metaanalysis including similar studies is necessary for further investigation of this issue.

Page 29: ACPGBI | Advancing knowledge and treatment of bowel ......Intraoperative Intraoperative Basic Mechanical Patency Tests RCTs (2) n = 203 IOT group 103 Positive IOT* 25 5 POL (3CL, 2RL)

Important point

◦ Currently: it is mostly subjective and comparisons are made with a control eg the caecum

◦ The fluorescence for example can be measured and this is an area which has been exploited by laser fluouresence and ICG technology

◦ Some authors have suggested subjective scoring systems too