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Fachtagung SBV TOA, Zürich 2008. NOTES – Chirurgie ohne Narben. M. Hagen. University Hospital Geneva, Switzerland University of California San Diego. What is NOTES?. N atural O rifice T ranslumenal E ndoscopic S urgery :

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notes chirurgie ohne narben
Fachtagung SBV TOA, Zürich 2008

NOTES – Chirurgie ohne Narben

M. Hagen

University Hospital Geneva, Switzerland

University of California San Diego

what is notes
What is NOTES?
  • Natural OrificeTranslumenalEndoscopicSurgery:
  • Intentional punctureofoneoftheviscera (e.g., stomach, rectum, vagina, urinarybladder) toaccessthe abdominal cavity
  • With an endoscope (flexible orstiff)
  • Toperform an intraabdominaloperation
  • Pearl JP, Ponsky JL: J GastrointestSurg. 2007 Dec 5
notes access sites
NOTES access sites
  • Toreachlowerabdomen:
  • Stomach
  • Toreachheart/thorax:
  • - Oesophagus
  • Toreachupperabdomen:
  • Vagina
  • Rectum
  • Bladder
  • Tubes
notes
NOTES

2007/2008

First patients: Rao`s AE

2004

Basic experiments

Kalloo`sfirst

Publication 2004

slide5
Acute and survivalmodels in pigs

Transgastricaccess

Peritonealcavity exploration

Liverbiposy

Gastricclosure

Kalloo AN, GastrointestEndosc. 2004 Jul;60(1):114-7

notes6
NOTES

2007/2008

First patients: Rao`s AE

2004

Basic experiments

Kalloo`sfirst

Publication 2004

notes first patients
NOTES: First Patients

Reddy & Rao

« Per oral transgastricendoscopicappendectomy in human. »

45th AnnualConference of

the Society of Gastrointestinal

Endoscopy of India;

February, 2004;

Jaipur, India.

notes8
NOTES

2007/2008

First patients: Rao`s AE

2004

Basic experiments

Kalloo`sfirst

Publication 2004

notes further research
NOTES: Further Research
  • Tuballigation
  • Cholecystectomie
  • Gastrojejunostomie
  • Oophorectomie
  • Tubectomie
  • Splenectomie
  • Nephrectomie
  • Pankreaticresection
notes10
NOTES

2007/2008

First patients: Rao`s AE

2004

Basic experiments

Kalloo`sfirst

Publication 2004

notes media reaction
NOTES: Media reaction

Jaques Marescaux

Le Monde

Mark Besslar

New York Times

“The patient was grateful but wanted to point out that she had only gone in for a flu shot”

slide12
NOTES before NOTES I

Ott, Ventroscopia. ZhurnalAkusherstva I ZhenskikhBoleznel. 1901;15:1045–1049

Dimitri OskarovichOttperformed the first endoscopicexamination of the abdominal cavitythrough a posterior vaginal incision using a headmirror and speculum:

1st VENTROSCOPY

1901

1900 1950 1990 2000 2002 2004 2006 2008

slide13
NOTES before NOTES II

Decker A, Cherry T. Culdoscopy, a new method in diagnosis of pelvicdisease. Amer J Surg. 1944;64:40–44

Culdoscopy

1944

1900 1950 1990 2000 2002 2004 2006 2008

slide14
NOTES before NOTES I

Tsin DA, J Am AssocGynecolLaparosc. 2001 Aug;8(3):438-41

OperativeCuldolaparoscopy (MA-NOS)

2001

1900 1950 1990 2000 2002 2004 2006 2008

the wilk patent 1994
The Wilk-Patent1994

US Patent 5297536

Wilk Peter, 1994

  • Method for use in
  • intra-abdominal surgery
rationale for notes
Rationale for NOTES
  • No abdominal wall incisions
  • No wound infections and hernias
  • Less pain
  • Less adhesions

Is NOTES less invasive than any other kind of surgery???

  • NO scars  perfect cosmetic outcomes

www.noscar.org

geneva cosmesis study
Geneva Cosmesis Study
  • Onsight poll at "day of open wards“ + ongoing interviews
  • Questionnaire:
  • Importance of cosmetic issues in abdominal surgery
  • Satisfaction with previous scars
  • Favoritism of scarless surgery
  • Favoritism of scarless surgery if risks are increased
  • Accepted percentage of risk rise
  • Importance of further research and investments

Questions answered on VAS from 0 to more than 100% or 1 to 10

conclusion geneva cosmesis study
Conclusion Geneva cosmesis study
  • People strongly favor the idea of scarless abdominal surgery
  • No differences between genders have been found
  • Certain risks are accepted in order to achieve scarless surgery
  • Further research and investments seems important

 People have a desire for NOTES!!!

rationale for notes ii
Rationale for NOTES II

The NOTES-concept :

Human ingenuity and technological advance can continue to reduce the trauma and discomfort of effective surgery

slide22
Transvaginal gastric bypass

Geneva, Switzerland 2007 - 2008

slide23
Transrectal ventral hernia repair

Geneva, Switzerland 2008

notes perform with what
NOTES: Perform with what?
  • Currenttechnology:
  • Flexible endoscopes
  • Rigid Scopes
  • Limited numberof flexible instrumentation
  • Limited hemostaticdevices
    • Cautery
    • Bands
    • Clips
  • Overtubes
  • Guidewires
  • Stents
  • Balloons

BUT:

 All instrumentation not designedforintraabdominalsurgery

technical problems of notes
Technical problems of NOTES

Access to abdominal cavity

Pneumoperitoneum

Intra-peritoneal navigation

Orientation

Stable platform

Tissue manipulation

Specimen extraction

Access site closure

No specific NOTES instrumentation on the market!!!

access endoscopic trocar
Access: Endoscopic Trocar
  • Endoscopic Veress Needle + Overtube Cannula
  • Reduced instrument exchanges
  • (Re)intubation pathway
  • Insufflation and desufflation
  • Supports scope shaft

EthiconEndosurgery, USA

closure tas tissue apposition system
Closure: TASTissue Apposition System
  • T-tag applier + knotting element
  • 2.8 mm channel
  • Closure of porcine colon perforation demonstrates equivalency to surgery with advantages for adhesion formation

EthiconEndosurgery, USA

slide31
Development of platforms for NOTES II

USGI, USA

Boston Scientific, USA

slide32
Magnetic retraction, external hand magnet controlled dissection with hydraulically elevated cautery knife

D. Scott, USA

project araknes
Project "ARAKNES"

Array of robots augmenting the Kinematics of Endo-luminal surgery

slide35
“Every day you may make progress. Every step may be fruitful....You know you will never get to the end of the journey. But this, so far from discouraging, only adds to the joy and glory of the climb.”

Sir Winston Churchill

British politician (1874 - 1965)

the state of notes 11 2008
The State of NOTES – 11/2008

Extreme skepticism has been replaced with optimism

Acute feasibility in animals, across a wide range of procedures, is proven; human cases are starting to be performed with ethical approval in prestigious institutions (Worldwide experience ~ 300 cases).

Questions of “can we” yielded to “should we” and are now yielding to questions of “how can we do this responsibly?”

“Killer applications” are becoming clearer with cholecystectomy and bariatric procedures being targeted

NOSCAR has been formed, bridging SAGES and ASGE with new European and Latin American associations

does notes have a future
Does NOTES have a future?

NOTES, by addressing “Sources of Invasion”, represents the next logical progression of surgical development, a key step along the MIS continuum

Endoscopically-Assisted Laparoscopy

Laparoscopic/ Sustaining Improvements

Intra-lumenal

Non-Invasive

Open

“Hybrids”

NOTES

Laparoscopically-Assisted Endoscopy

  • Sources of Invasion
  • Abdominal wall incisions
  • Post-op recovery/RTNA
  • General anesthesia
  • Financial burden
  • Site of care
  • Infrastructure requirements
  • Clinician skill level

Cholecystectomy

?

Appendectomy

?

Ventral Hernia

?

Diagnostic Peritoneoscopy

?

the effect of notes
The effect of NOTES

- Less invasive

- New approaches

- More invasive

- New, effectiveinstrumentsforintralumenalmanipulation

results total population i
Results: Total population I

Importance of cosmetic issues in abdominal surgery: 7,4 (mean)

VAS

1

X

10

Satisfaction with previous scars: 7 (mean)

VAS

1

X

10

Favoritism of scarless surgery: 8,9 (mean)

VAS

1

X

10

Favoritism of scarless surgery if risks are increased: 4,5 (mean)

VAS

1

X

10

results total population ii
Results: Total population II

Accepted percentage of risk rise: 21% (mean)

0%

X

100 %

Importance of further research: 7,6 (mean)

VAS

1

X

10

Importance of further investments: 8 (mean)

VAS

1

X

10

notes in humans perhaps 300 cases world wide
NOTES in humans: perhaps 300 cases world-wide
  • Hydrabad: Rao/Reddy Appendectomy, liver biopsy, tubal ligation: 22 cases.
  • Brazil: Galvao and Amino: Endoscopically-assisted transgastric and transvaginal laparoscopic cholecystectomy 10 cases. Zorron 4 transvaginal cholecystectomies and a transgastric laparoscopy for cancer
  • Ohio: Transgastric peritoneoscopy before Whipples (Melvin) (n=16)
  • New York: lap-assisted transvaginal chole (Stevens – GI, Besslar – Bariatric surgeon) (n=3)
  • Oregon Transgastric cholecystectomy (Swanstrom) (n=4)
  • Argentina and San Diego (Horgan) Transvaginal cholecystectomy (n=4) Transgastric cholecystectomy (n=2) Transgastric appendicectomy (n=2)
  • Mayo Clinic Transvesical (urinary bladder) peritoenoscopy (n=1) Gettman
  • Chicago (Soper) Transgastric cholecystectomy (n=2)
  • Brazil. (Branco) Transvaginal hybrid nephrectomy (n=1)
  • Zorron data base of 150 cases in South America mostly cholecystectomy
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