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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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Fachtagung SBV TOA, Zürich 2008 NOTES – Chirurgie ohne Narben M. Hagen University Hospital Geneva, Switzerland University of California San Diego
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 • Toreachlowerabdomen: • Stomach • Toreachheart/thorax: • - Oesophagus • Toreachupperabdomen: • Vagina • Rectum • Bladder • Tubes
NOTES 2007/2008 First patients: Rao`s AE 2004 Basic experiments Kalloo`sfirst Publication 2004
Acute and survivalmodels in pigs Transgastricaccess Peritonealcavity exploration Liverbiposy Gastricclosure Kalloo AN, GastrointestEndosc. 2004 Jul;60(1):114-7
NOTES 2007/2008 First patients: Rao`s AE 2004 Basic experiments Kalloo`sfirst Publication 2004
NOTES: First Patients Reddy & Rao « Per oral transgastricendoscopicappendectomy in human. » 45th AnnualConference of the Society of Gastrointestinal Endoscopy of India; February, 2004; Jaipur, India.
NOTES 2007/2008 First patients: Rao`s AE 2004 Basic experiments Kalloo`sfirst Publication 2004
NOTES: Further Research • Tuballigation • Cholecystectomie • Gastrojejunostomie • Oophorectomie • Tubectomie • Splenectomie • Nephrectomie • Pankreaticresection
NOTES 2007/2008 First patients: Rao`s AE 2004 Basic experiments Kalloo`sfirst Publication 2004
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”
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
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
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-Patent1994 US Patent 5297536 Wilk Peter, 1994 • Method for use in • intra-abdominal surgery
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 • 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 • 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 The NOTES-concept : Human ingenuity and technological advance can continue to reduce the trauma and discomfort of effective surgery
Transvaginal gastric bypass Geneva, Switzerland 2007 - 2008
Transrectal ventral hernia repair Geneva, Switzerland 2008
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 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 • Endoscopic Veress Needle + Overtube Cannula • Reduced instrument exchanges • (Re)intubation pathway • Insufflation and desufflation • Supports scope shaft EthiconEndosurgery, USA
Flexible endoscopic suturing devices USGI, USA
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
Development of platforms for NOTES I USGI, USA
Development of platforms for NOTES II USGI, USA Boston Scientific, USA
Magnetic retraction, external hand magnet controlled dissection with hydraulically elevated cautery knife D. Scott, USA
Project "ARAKNES" Array of robots augmenting the Kinematics of Endo-luminal surgery
“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 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? 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 ?
“We must not say every mistake is a foolish one” Cicero (106 BC – 43 BC)
The effect of NOTES - Less invasive - New approaches - More invasive - New, effectiveinstrumentsforintralumenalmanipulation
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 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 • 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