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The Modern Management of Adhesions. Michael C Parker BSc MS FRCS FRCS(Ed) Darent Valley Hospital Dartford, Kent, UK SCAR Panel Member Hungary 24 th April 2004. Adhesions after colorectal surgery. Do we need to prevent?. Yes. Do we need to treat?. Paradox of surgery…

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the modern management of adhesions

The Modern Management of Adhesions

Michael C Parker BSc MS FRCS FRCS(Ed)

Darent Valley Hospital

Dartford, Kent, UK

SCAR Panel Member

Hungary 24th April 2004

adhesions after colorectal surgery

Adhesions after colorectal surgery

Do we need to prevent?

Yes

Do we need to treat?

slide3

Paradox of surgery…

    • …the method proposed to treat adhesions is the one that induces adhesions

Need for clinical & cost-effective agents to reduce adhesion development

formation of a d he sions

Influencing factorsduring surgery

Injury

Ischaemia

Infection

GI contents

Bleeding

Abrasion

Inflammation

Desiccation

Fibrin

Heat

deposition

Light

Electrocautery

Sutures

Fibres

Glove powder

Adhesions

Formation of Adhesions
protection against a d he sions

Steps to reduce adhesions during surgery

  • Increase vascular permeability
  • Reduce infection risk
  • Avoid GI contamination
  • Minimise tissue handling
    • Careful technique
    • Microsurgery
  • Reduce drying of tissues
    • Lubrication
  • Limit use of cautery
  • Limit use of sutures
  • Avoid materials with fibres
  • Use starch-free gloves
Protection against adhesions

Injury

Bleeding

inflammation

Fibrin

deposition

Adhesions

adhesion reduction strategies
Adhesion reduction strategies
  • Careful surgical technique
  • Minimise Inflammatory response
  • Augmentation of fibrinolysis
  • Adhesion-reduction agents
applying adjuvants solutions drugs
Applying adjuvants:solutions/drugs

NSAIDs

  • Most widely studied; clinical efficacy is questionable

Corticosteroids

  • Poor efficacy; associated with immunosuppression and delayed wound healing

Fibrinolytics

  • Risk of impaired wound healing and/or bleeding

Risberg B. Eur J Surg Suppl. 1997

adhesion reduction agents the ideal agent
Safety

Easy to use

General surgery

Gynaecological surgery

Open

Laparoscopic

Efficacy

Operation site

Throughout the cavity

Economical

Adhesion Reduction Agents: The ideal agent

According to recent surveys of surgeons the four key attributes are:

ESHRE 2002 Survey, EACP 2002 Survey

adhesion reduction agents
Adhesion Reduction Agents

Key issues

  • Toxicity
  • Handling
  • Limited efficacy
  • Clinical outcomes
  • Cost
adhesion reduction agents11
Adhesion Reduction Agents

* Withdrawn from US market

most widely used adhesion prevention adjuvants
Most Widely Used Adhesion Prevention Adjuvants
  • Crystalloid instillates
    • Lactated Ringer’s
    • Saline
    • Hartmann’s Solution
  • Limitations:
  • Absorbed within 24 hours
  • They don’t prevent adhesions!
interceed barrier oxidized cellulose gynecare

Interceed Barrier(Oxidized Cellulose, Gynecare)

First FDA approved adhesion reduction adjuvant

Most clinical studies (24)

Widely applicable

all intraperitoneal locations

all surgical procedures

Compatible with laparoscopy

Limited use in colorectal surgery

Limitations:

Blood oozing renders it ineffective

Irrigants must be removed

Technical application challenges!

seprafilm membrane ha cmc genzyme

Seprafilm Membrane (HA+CMC, Genzyme)

Widely applicable

covers all intraperitoneal locations

all surgical procedures

Used in general surgery

Limitations:

Handling

Residual irrigation fluid must be removed

Cannot be used via laparoscopy

Cannot use at site of anastomosis

Cost!!

need mean 4.4 sheets in colorectal surgery!!!*

Beck et al Dis Colon Rectum 2003;46:1310-1319

spraygel polyethylene glycol polymer confluent
SprayGel(Polyethylene Glycol Polymer, Confluent)
  • Polymerization
  • Methylene blue to show where it is used
spraygel
SprayGel

Laparoscopic Kit

Requires specialised air pump

Open Surgery Kit

spraygel17
SprayGel
  • 5 kits needed for complete peritoneal coverage!!!*

*Korell Adhesions News & Views 2004 in press

spraygel18
SprayGel

Limitations

  • complex set-up
  • time consuming
  • limited efficacy & safety data
  • US regulatory study halted
  • cost……
spraygel19
SprayGel

Limitations

  • complex set-up
  • time consuming
  • limited efficacy & safety data
  • US regulatory study halted
  • cost……
    • particularly 5 kits!*

*Korell Adhesions News & Views 2004 in press

surgiwrap polylactide copolymer film macropore

SurgiWrap (polylactide copolymer film, Macropore)

Peritoneal replacement film

Suture in place

Remains for ~6 months

Excreted through lungs

Limitations:

Data – limited safety and efficacy

Handling??

Cost!!

adept i codextrin 4 solution
Adept - icodextrin 4% solution
  •  1,4 linked glucose polymer
  • Icodextrin 4% solution
    • isosmolar
    • biocompatible
    • well-established safety profile at 7.5% concentration
    • >36,000 patient years safety data from renal use
    • ~50,000 patients treated with Adept
    • persists in peritoneal cavity
    • reduces adhesion formation through physical action
    • ‘hydroflotation’
adept hydroflotation mechanism
Adept hydroflotation mechanism

Hosie et al Drug Delivery 2001

slide24

Adept use- Irrigation- minimum 100mls/30mins

- Laparoscopy through the scope

- Laparotomy via a syringe

Laparoscopy

Laparotomy

- Instillation- 1000ml at closure

adept icodextrin 4 shire pharmaceuticals

Adept (Icodextrin 4%, Shire Pharmaceuticals)

Used as an irrigant and an instillate

Covers all intraperitoneal locations

Easy to use

laparoscopic clinical studies

laparotomy registry feedback

Not constrained by oozing

Residual irrigation solution is not a problem

Extensive safety experience at 7.5%

ARIEL Registry of routine use in >4,600 patients

feedback of use and safety good

Promising early results

Modest cost

Limitations:

Limited clinical data at present – extensive work in progress

surgical procedures and adjuvant use
Surgical procedures and adjuvant use

O = not used/recommended

cost comparison
Cost comparison*

SurgiWrap estimate ~£150 (€225)/sheet

*UK sterling prices € equivalent

cost comparison29
Cost comparison*

SurgiWrap estimate ~£150 (€225)/sheet

*UK sterling prices € equivalent

prophylaxis

Prophylaxis?

Adoption of routine prophylaxis

depends on impact of strategy on

adhesion-related readmissions

and cost of strategy

cost effectiveness
Cost-effectiveness
  • Costs of adhesion-related Small Bowel Obstruction
    • Conservatively treated £1,606 (mean stay 7 days)
    • Surgically treated £4,677 (mean stay 16 days)
  • Adhesion reduction technologies may reduce costs

Menzies, Parker et al. Ann Roy Coll Surg Engl. 2001

modelling cost effectiveness lower abdominal surgery
Modelling cost effectiveness- lower abdominal surgery

If adhesion-related readmissions are reduced by the routine use of an adhesion reduction agent, what’s the cost impact?

  • Assume agent costs £200
  • Assume agent costs £50
  • What efficacy is required to payback the cost of using an anti-adhesion agent at 3 years???

Wilson et al. Colorectal Dis. 2002

slide34

£70,000

Control

64%

£60,000

£50,000

£200

£40,000

£30,000

£20,000

£10,000

£0

1

2

3

4

5

6

7

8

9

0

Years since surgery

Cumulative cost of adhesion-related readmissions following lower abdominal surgery

Cumulative cost/100 patients

Wilson et al Colorectal Dis 2002

slide35

Cumulative cost of adhesion-related readmissions following lower abdominal surgery

£70,000

Control

16%

£60,000

£50

£50,000

Cumulative cost/100 patients

£40,000

£30,000

£20,000

£10,000

£0

1

2

3

4

5

6

7

8

9

0

Years since surgery

Wilson et al Colorectal Dis 2002

modelling cost effectiveness lower abdominal surgery36
Modelling cost effectiveness- lower abdominal surgery

Routine use of an anti-adhesion agent costing £50 will payback the investment cost if it reduces adhesion-related readmissions by only 16% after 3 years

Agents costing £200 or more are unlikely to payback

the costs of usage

Wilson et al. Colorectal Dis. 2002

slide37

Modeled cumulative cost savingsin the UK

Lower abdominal surgery (158,000 ops per year) SCAR

£150

£125

£50 product (assume 25% efficacy)

Saving £71m

£100

£75

£50

£25

Cumulative cost savings (Millions)

£0

-£25

-£50

-£75

-£100

-£125

-£150

1

2

3

4

5

6

7

8

9

Loss £142m

£200 product (assume 25% efficacy)

Time since start of adhesion-reduction treatment policy with product (years)

use of anti adhesion agents
Routine prophylaxis

vs ‘High Risk’ Surgery

Adhesiolysis

Small bowel resection

Formation of stoma

Hartmann’s procedure

Anterior resection

Abdomino-perineal excision

Colectomy

Surgical treatment of peritonitis & fistulae

Use of anti-adhesion agents

Or do nothing???

implications of doing nothing
Implications of doing nothing
  • Adhesions are inevitable
  • High risk of adhesion-related problems
    • Small bowel obstruction
    • Female infertility
    • Chronic and debilitating pelvic pain
    • Reoperative complications

Do we tell our patients when we obtain consent?

informed consent
Informed consent

International Adhesions Society Patient Survey*

  • In only 10.4% of cases adhesions mentioned as part of informed consent process
    • 14.4% adhesions discussed but not part of consent
  • Adhesiolysis patients
    • 54% given some information before surgery
    • 46% given specific information about anti-adhesion agents
  • In non-adhesiolysis procedures only 10% patients advised about adhesions
  • Only 6% given information on anti-adhesion agents

Wiseman, Adhesions News & Views 4 2003 and PAX Meeting 2003

medico legal consequences
Medico-legal consequences

Most common claims

  • Failure to diagnose / delay in diagnosis
  • Failure to take precautions to prevent
  • Bowel damage at adhesiolysis
  • Infertility / risk of infertility
  • Chronic abdominal / pelvic pain
  • Starch granuloma (gloves)

1995-1999 UK MDU received 77 adhesion-related claims

    • Average settlements £50,765

Before SCAR

Before we knew the real extent of the problem

Before we had newer anti-adhesion agents

Ellis H, Journal of the Royal Society of Medicine 2001

where are we now
Where are we now?
  • Adhesions continue to be a significant burden
    • For the patient:
      • pain, SBO, infertility, re-operative complications
    • For the surgeon
      • increased workload, lengthy and complex procedures, medicolegal consequences
    • For the healthcare system
      • increased workloads, costs, bed stay
where are we now43
Where are we now?
  • Any advances in surgery have had little impact
  • Action on adhesions has received low priority
    • even in high risk procedures
  • New developments in anti-adhesion agents
    • not all are difficult or costly to use
    • emerging evidence of efficacy
adopt use of anti adhesion agents in high risk surgery
Adhesiolysis

Small bowel resection

Formation of stoma

Hartmann’s procedure

Anterior resection

Abdomino-perineal excision

Colectomy

Surgical treatment of peritonitis & fistulae

Adopt use of anti-adhesion agents in ‘High Risk’ surgery
acknowledgments
Acknowledgments

Fellow SCAR Panel Members

Prof Harold Ellis, UMDS, London

Malcolm Wilson, Christie Hospital, Manchester

Don Menzies, Colchester Hospital, Colchester

Jeremy Thompson, Chelsea & Westminster Hospital, London

Brendan Moran, North Hampshire Hospital, Hampshire

Adrian Lower, St Bartholomew's Hospital, London

Rob Hawthorn, Southern General Hospital, Glasgow

Prof Alastair McGuire, City University, London

Graham Sunderland, Southern General Hospital, Glasgow

David Clark, James Boyd, Alan Finlayson, ISD, NHS Scotland, Edinburgh

Prof Ian Ford, Robertson Centre Biostatistics, Glasgow

Alastair Knight & Alison Crowe, Corvus

Shire Pharmaceuticals Group plc