NOTES

1
NOTES Chirurgie ohne Narben
Fachtagung SBV TOA, Zürich 2008

• M. Hagen

University Hospital Geneva, Switzerland University
of California San Diego
2
What is NOTES?

• Natural Orifice Translumenal Endoscopic Surgery
• Intentional puncture of one of the viscera (e.g.,
  stomach, rectum, vagina, urinary bladder) to
  access the abdominal cavity
• With an endoscope (flexible or stiff)
• To perform an intraabdominal operation
• Pearl JP, Ponsky JL J Gastrointest Surg. 2007
  Dec 5

3
NOTES access sites

• To reach lower abdomen
• Stomach
• To reach heart/thorax
• - Oesophagus

• To reach upper abdomen
• Vagina
• Rectum
• Bladder
• Tubes

4
NOTES
2007/2008
First patients Raos AE 2004
Basic experiments
Kalloos first Publication 2004
5
Acute and survival models in pigs Transgastric
access Peritoneal cavity exploration Liver
biposy Gastric closure
Kalloo AN, Gastrointest Endosc. 2004
Jul60(1)114-7
6
NOTES
2007/2008
First patients Raos AE 2004
Basic experiments
Kalloos first Publication 2004
7
NOTES First Patients

• Reddy Rao
•  Per oral transgastric endoscopic appendectomy
  in human. 

• 45th Annual Conference of
• the Society of Gastrointestinal
• Endoscopy of India
• February, 2004
• Jaipur, India.

8
NOTES
2007/2008
First patients Raos AE 2004
Basic experiments
Kalloos first Publication 2004
9
NOTES Further Research

• Tubal ligation
• Cholecystectomie
• Gastrojejunostomie
• Oophorectomie
• Tubectomie
• Splenectomie
• Nephrectomie
• Pankreatic resection

10
NOTES
2007/2008
First patients Raos AE 2004
Basic experiments
Kalloos first Publication 2004
11
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
12
NOTES before NOTES I
Ott, Ventroscopia. Zhurnal Akusherstva I
Zhenskikh Boleznel. 19011510451049
Dimitri Oskarovich Ott performed the first
endoscopic examination of the abdominal cavity
through a posterior vaginal incision using a head
mirror and speculum 1st VENTROSCOPY
1901
1900 1950 1990 2000 2002 2004 2006 2008
13
NOTES before NOTES II
Decker A, Cherry T. Culdoscopy, a new method in
diagnosis of pelvic disease. Amer J Surg.
1944644044
Culdoscopy
1944
1900 1950 1990 2000 2002 2004 2006 2008
14
NOTES before NOTES I
Tsin DA, J Am Assoc Gynecol Laparosc. 2001
Aug8(3)438-41
Operative Culdolaparoscopy (MA-NOS)
2001
1900 1950 1990 2000 2002 2004 2006 2008
15
The Wilk-Patent 1994
US Patent 5297536 Wilk Peter, 1994

• Method for use in
• intra-abdominal surgery

16
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
17
Importance of cosmetics
18
Importance of cosmetics
19
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
20
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!!!
21
Rationale for NOTES II
The NOTES-concept Human ingenuity and
technological advance can continue to reduce the
trauma and discomfort of effective surgery
22
Transvaginal gastric bypass
Geneva, Switzerland 2007 - 2008
23
Transrectal ventral hernia repair
Geneva, Switzerland 2008
24
NOTES Perform with what?

• Current technology
• Flexible endoscopes
• Rigid Scopes
• Limited number of flexible instrumentation
• Limited hemostatic devices
• Cautery
• Bands
• Clips

• Overtubes
• Guidewires
• Stents
• Balloons

BUT ? All instrumentation not designed for
intraabdominal surgery
25
Gastroenterologists NOTES
26
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!!!
27
Access Endoscopic Trocar

• Endoscopic Veress Needle Overtube Cannula
• Reduced instrument exchanges
• (Re)intubation pathway
• Insufflation and desufflation
• Supports scope shaft

Ethicon Endosurgery, USA
28
Flexible endoscopic suturing devices
USGI, USA
29
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

Ethicon Endosurgery, USA
30
Development of platforms for NOTES I
USGI, USA
31
Development of platforms for NOTES II
USGI, USA
Boston Scientific, USA
32
Magnetic retraction, external hand magnet
controlled dissection with hydraulically elevated
cautery knife
D. Scott, USA
33
Robots for NOTES

34
Project "ARAKNES"
Array of robots augmenting the Kinematics of
Endo-luminal surgery
35
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)
36
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

37
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
?
38
The future is hard to predict
39
We must not say every mistake is a foolish
one Cicero (106 BC 43 BC)
40
The effect of NOTES
- Less invasive - New approaches
- More invasive - New, effective instruments for
intralumenal manipulation
41
Protecting valuables!
42
Thank you very much for your attention!
43
Results Total population I
Importance of cosmetic issues in abdominal
surgery 7,4 (mean)
VAS
1
10
X
Satisfaction with previous scars 7 (mean)
VAS
1
10
X
Favoritism of scarless surgery 8,9 (mean)
VAS
1
X
10
Favoritism of scarless surgery if risks are
increased 4,5 (mean)
VAS
1
10
X
44
Results Total population II
Accepted percentage of risk rise 21 (mean)
0
100
X
Importance of further research 7,6 (mean)
VAS
1
10
X
Importance of further investments 8 (mean)
VAS
1
10
X
45
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) (n16)
• New York lap-assisted transvaginal chole
  (Stevens GI, Besslar Bariatric surgeon) (n3)
• Oregon Transgastric cholecystectomy (Swanstrom)
  (n4)
• Argentina and San Diego (Horgan) Transvaginal
  cholecystectomy (n4) Transgastric
  cholecystectomy (n2) Transgastric appendicectomy
  (n2)
• Mayo Clinic Transvesical (urinary bladder)
  peritoenoscopy (n1) Gettman
• Chicago (Soper) Transgastric cholecystectomy
  (n2)
• Brazil. (Branco) Transvaginal hybrid nephrectomy
  (n1)
• Zorron data base of 150 cases in South America
  mostly cholecystectomy