CHAPTER 01.pdf · surgery generated an increased interest among surgical and gastroenterological...

10
CHAPTER GENERAL INTRODUCTION AND OUTLINE OF THIS THESIS S. Velthuis

Transcript of CHAPTER 01.pdf · surgery generated an increased interest among surgical and gastroenterological...

Page 1: CHAPTER 01.pdf · surgery generated an increased interest among surgical and gastroenterological communities to further reduce surgical trauma through ‘scarless’ surgery. These

CHAPTERGENERAL INTRODUCTION

AND OUTLINE OF THIS THESIS

S. Velthuis

Page 2: CHAPTER 01.pdf · surgery generated an increased interest among surgical and gastroenterological communities to further reduce surgical trauma through ‘scarless’ surgery. These

EVOLUTION  OF  MINIMALLY  INVASIVE  COLORECTAL  SURGERY  

 

Laparoscopic  surgery  was  introduced  in  the  1990s  in  order  to  improve  patient  outcomes.    As  with  

all  new  procedures,  surgeons  started  with  relatively  simple  procedures  like  appendectomies  and  

hysterectomies.  Extensive  research  showed  many  benefits  of  laparoscopic  surgery  for  the  patient  

with  respect  to  time  to  recovery,  duration  of  hospital  stay,  perioperative  pain  and  morbidity  and  

cosmetic  results.    

 

Consequently,  the  range  of  abdominal  surgical  procedures  performed  by  laparoscopy  has  grown  

enormously.  For  certain  procedures  such  as  cholecystectomy,  laparoscopy  has  already  replaced  

open  surgery  as  the  standard  of  care.1-­‐5  

 

The  clear  advantages  of  laparoscopic  surgery  generated  an  increased  interest  among  surgical  and  

gastroenterological  communities  to  further  reduce  surgical  trauma  through  ‘scarless’  surgery.  

These  advances  in  minimally  invasive  surgery  include  the  development  of  natural  orifice  

translumenal  endoscopic  surgery,  laparoendoscopic  single-­‐site  surgery  and  the  recent  

development  of  transanal  minimally  invasive  surgery.      

 

 

NATURAL  ORIFICE  TRANSLUMENAL  ENDOSCOPIC  SURGERY  

 

Although  the  first  colpotomy  to  perform  a  hysterectomy  was  already  described  in  18136,  most  

research  on  NOTES  took  place  in  recent  years  since  Kalloo  et  al.  described  diagnostic  and  

therapeutic  flexible  transgastric  peritoneoscopy  in  porcine  models  in  2004.7-­‐9  In  NOTES  the  

surgeon  accesses  the  peritoneal  cavity  through  a  hollow  viscus,  instead  of  the  abdominal  wall,  to  

perform  diagnostic  and  therapeutic  procedures.    

 

Initially  the  transgastric  route  was  evaluated,  first  in  porcine  models,  later  in  human.  More  

recently,  other  orifices  such  as  the  vagina,  urethra  and  anus  are  used  as  an  entrance  to  incise  

respectively  the  posterior  vaginal  wall,  the  bladder  and  the  rectum  or  colon.10        

 

 

Page 3: CHAPTER 01.pdf · surgery generated an increased interest among surgical and gastroenterological communities to further reduce surgical trauma through ‘scarless’ surgery. These

1

11

INTR

OD

UCT

ION

AN

D T

HES

IS O

UTL

INE

EVOLUTION  OF  MINIMALLY  INVASIVE  COLORECTAL  SURGERY  

 

Laparoscopic  surgery  was  introduced  in  the  1990s  in  order  to  improve  patient  outcomes.    As  with  

all  new  procedures,  surgeons  started  with  relatively  simple  procedures  like  appendectomies  and  

hysterectomies.  Extensive  research  showed  many  benefits  of  laparoscopic  surgery  for  the  patient  

with  respect  to  time  to  recovery,  duration  of  hospital  stay,  perioperative  pain  and  morbidity  and  

cosmetic  results.    

 

Consequently,  the  range  of  abdominal  surgical  procedures  performed  by  laparoscopy  has  grown  

enormously.  For  certain  procedures  such  as  cholecystectomy,  laparoscopy  has  already  replaced  

open  surgery  as  the  standard  of  care.1-­‐5  

 

The  clear  advantages  of  laparoscopic  surgery  generated  an  increased  interest  among  surgical  and  

gastroenterological  communities  to  further  reduce  surgical  trauma  through  ‘scarless’  surgery.  

These  advances  in  minimally  invasive  surgery  include  the  development  of  natural  orifice  

translumenal  endoscopic  surgery,  laparoendoscopic  single-­‐site  surgery  and  the  recent  

development  of  transanal  minimally  invasive  surgery.      

 

 

NATURAL  ORIFICE  TRANSLUMENAL  ENDOSCOPIC  SURGERY  

 

Although  the  first  colpotomy  to  perform  a  hysterectomy  was  already  described  in  18136,  most  

research  on  NOTES  took  place  in  recent  years  since  Kalloo  et  al.  described  diagnostic  and  

therapeutic  flexible  transgastric  peritoneoscopy  in  porcine  models  in  2004.7-­‐9  In  NOTES  the  

surgeon  accesses  the  peritoneal  cavity  through  a  hollow  viscus,  instead  of  the  abdominal  wall,  to  

perform  diagnostic  and  therapeutic  procedures.    

 

Initially  the  transgastric  route  was  evaluated,  first  in  porcine  models,  later  in  human.  More  

recently,  other  orifices  such  as  the  vagina,  urethra  and  anus  are  used  as  an  entrance  to  incise  

respectively  the  posterior  vaginal  wall,  the  bladder  and  the  rectum  or  colon.10        

 

 

Page 4: CHAPTER 01.pdf · surgery generated an increased interest among surgical and gastroenterological communities to further reduce surgical trauma through ‘scarless’ surgery. These

12

Advantages  

NOTES  avoids  the  need  for  abdominal  incisions  which  may  reduce  postoperative  pain,  may  

facilitate  a  shorter  hospital  stay,  may  limit  postoperative  complications  such  as  wound  infections  

and  incisional  hernias,  and  improves  cosmetic  results.  Therefore,  NOTES  could  be  the  next  major  

paradigm  shift  in  surgery.10    

 

Challenges  in  clinical  practice  

Despite  the  potential  advantages  of  NOTES,  critics  expressed  concerns  about  its  safety  and  

implementation  in  clinical  care.  As  a  result,  a  working  group  consisting  of  expert  laparoscopic  

surgeons  from  the  SAGES  (Society  of  American  Gastrointestinal  Endoscopic  Surgeons)  and  

members  of  the  ASGE  (American  Society  for  Gastrointestinal  Endoscopy)  came  together  for  a  

meeting  in  2005.  This  meeting  led  to  the  development  of  the  Natural  Orifice  Surgery  Consortium  

for  Assessment  and  Research  (NOSCAR).  With  ‘The  White  Paper’  they  published  a  document  that  

would  serve  as  a  guide  for  the  responsible  development  of  NOTES  and  they  identified  ten  

potential  barriers  that  will  impact  the  safety  of  NOTES  (table  1).11  

The  amount  of  publications  on  NOTES  has  shown  a  significant  growth  since  2005.  However,  

widespread  implementation  of  NOTES  has  still  not  occurred  due  to  the  mentioned  potential  

barriers.  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table  1.  Potential  barriers  to  clinical  practice11  

Access  to  peritoneal  cavity  

Gastric  (intestinal)  closure  

Prevention  of  infection  

Development  of  suturing  device  

Spatial  orientation  

Development  of  a  multitasking  platform  

Control  of  intraperitoneal  haemorrhage  

Compression  syndromes  

Training  other  providers  

Management  of  iatrogenic  intraperitoneal  complications  

Physiologic  untoward  events  

 

 

LAPAROENDOSCOPIC  SINGLE-­‐SITE  SURGERY  

 

During  extensive  research  on  NOTES  new  ideas  emerged.  The  design  of  a  single,  multichannel  port  

led  to  a  sidetrack  of  NOTES:  laparoendoscopic  single-­‐site  surgery  (LESS).  LESS  is  known  by  many  

different  names  and  refers  to  a  laparoscopic  access  technique  that  uses  a  single  incision,  usually  

the  umbilicus,  but  also  a  future  ileo-­‐  or  colostomy  site  or  transanally  in  case  of  transanal  minimally  

invasive  surgery  (TAMIS).    

 

The  indications  for  LESS  are  similar  to  those  for  multiport  laparoscopic  surgery.  Frequently  

performed  procedures  are  cholecystectomy12,  appendectomy13,  inguinal  hernia  repair14,  

salpingectomy15,  tubal  ligation16,  nephrectomy17,  and  colon  resection18.    

 

Compared  to  conventional  laparoscopy,  the  laparoscopic  single-­‐site  approach  is  considered  more  

challenging  due  to  several  technical  factors.  These  technical  factors  include  loss  of  triangulation  

and  loss  of  depth  perception,  reduced  range  of  motion  of  the  instruments,  limited  extracorpeal  

working  space  with  ‘clashing’  of  the  instruments,  and  a  suboptimal  view  as  the  result  of  difficult  

instrument  and  camera  position.19    

 

Laparoendoscopic  single-­‐site  techniques  are  still  in  development  in  many  abdominal  and  pelvic  

surgery  fields,  sometimes  in  combination  with  other  novel  devices,  like  robotic  surgery.  In  2008,  

Page 5: CHAPTER 01.pdf · surgery generated an increased interest among surgical and gastroenterological communities to further reduce surgical trauma through ‘scarless’ surgery. These

1

13

INTR

OD

UCT

ION

AN

D T

HES

IS O

UTL

INE

Advantages  

NOTES  avoids  the  need  for  abdominal  incisions  which  may  reduce  postoperative  pain,  may  

facilitate  a  shorter  hospital  stay,  may  limit  postoperative  complications  such  as  wound  infections  

and  incisional  hernias,  and  improves  cosmetic  results.  Therefore,  NOTES  could  be  the  next  major  

paradigm  shift  in  surgery.10    

 

Challenges  in  clinical  practice  

Despite  the  potential  advantages  of  NOTES,  critics  expressed  concerns  about  its  safety  and  

implementation  in  clinical  care.  As  a  result,  a  working  group  consisting  of  expert  laparoscopic  

surgeons  from  the  SAGES  (Society  of  American  Gastrointestinal  Endoscopic  Surgeons)  and  

members  of  the  ASGE  (American  Society  for  Gastrointestinal  Endoscopy)  came  together  for  a  

meeting  in  2005.  This  meeting  led  to  the  development  of  the  Natural  Orifice  Surgery  Consortium  

for  Assessment  and  Research  (NOSCAR).  With  ‘The  White  Paper’  they  published  a  document  that  

would  serve  as  a  guide  for  the  responsible  development  of  NOTES  and  they  identified  ten  

potential  barriers  that  will  impact  the  safety  of  NOTES  (table  1).11  

The  amount  of  publications  on  NOTES  has  shown  a  significant  growth  since  2005.  However,  

widespread  implementation  of  NOTES  has  still  not  occurred  due  to  the  mentioned  potential  

barriers.  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table  1.  Potential  barriers  to  clinical  practice11  

Access  to  peritoneal  cavity  

Gastric  (intestinal)  closure  

Prevention  of  infection  

Development  of  suturing  device  

Spatial  orientation  

Development  of  a  multitasking  platform  

Control  of  intraperitoneal  haemorrhage  

Compression  syndromes  

Training  other  providers  

Management  of  iatrogenic  intraperitoneal  complications  

Physiologic  untoward  events  

 

 

LAPAROENDOSCOPIC  SINGLE-­‐SITE  SURGERY  

 

During  extensive  research  on  NOTES  new  ideas  emerged.  The  design  of  a  single,  multichannel  port  

led  to  a  sidetrack  of  NOTES:  laparoendoscopic  single-­‐site  surgery  (LESS).  LESS  is  known  by  many  

different  names  and  refers  to  a  laparoscopic  access  technique  that  uses  a  single  incision,  usually  

the  umbilicus,  but  also  a  future  ileo-­‐  or  colostomy  site  or  transanally  in  case  of  transanal  minimally  

invasive  surgery  (TAMIS).    

 

The  indications  for  LESS  are  similar  to  those  for  multiport  laparoscopic  surgery.  Frequently  

performed  procedures  are  cholecystectomy12,  appendectomy13,  inguinal  hernia  repair14,  

salpingectomy15,  tubal  ligation16,  nephrectomy17,  and  colon  resection18.    

 

Compared  to  conventional  laparoscopy,  the  laparoscopic  single-­‐site  approach  is  considered  more  

challenging  due  to  several  technical  factors.  These  technical  factors  include  loss  of  triangulation  

and  loss  of  depth  perception,  reduced  range  of  motion  of  the  instruments,  limited  extracorpeal  

working  space  with  ‘clashing’  of  the  instruments,  and  a  suboptimal  view  as  the  result  of  difficult  

instrument  and  camera  position.19    

 

Laparoendoscopic  single-­‐site  techniques  are  still  in  development  in  many  abdominal  and  pelvic  

surgery  fields,  sometimes  in  combination  with  other  novel  devices,  like  robotic  surgery.  In  2008,  

Page 6: CHAPTER 01.pdf · surgery generated an increased interest among surgical and gastroenterological communities to further reduce surgical trauma through ‘scarless’ surgery. These

14

the  Laparoendoscopic  Single-­‐Site  Surgery  Consortium  for  Assessment  and  Research  (LESSCAR)  was  

formed  to  coordinate  and  advance  the  technique  of  LESS  in  a  cohensive  and  safe  manner.19    

 

 

TAMIS  /  taTME  

 

Transanal  endoscopic  microsurgery  (TEM)  was  successfully  introduced  in  1983  by  Buess  et  al.20  to  

resect  rectal  adenomas  and  selected  early  stage  rectum  carcinomas.  This  technique  initially  

required  a  large  rigid  proctoscope  and  was  regarded  as  relatively  technically  challenging  and  

expensive.  Atallah  et  al.21  demonstrated  the  possibility  to  use  a  single-­‐port  to  gain  endoscopic  

access  for  the  resection  of  rectal  tumours.  The  endoscopic  access  of  the  rectum  by  using  a  single-­‐

port  and  laparoscopic  instruments  is  termed  transanal  minimally  invasive  surgery  (TAMIS)  and  

created  new  possibilities  in  the  minimally  invasive  treatment  of  rectum  carcinomas.    

 

The  introduction  of  the  total  mesorectal  excision  (TME)  for  rectum  carcinomas  by  Heald  in  1982  

and  its  subsequent  worldwide  standardisation  has  led  to  significant  improvements  in  oncological  

outcomes.22-­‐24  The  cornerstone  of  TME  is  dissection  of  the  presacral  plane,  also  known  as  the  ‘holy  

plane’  and  removal  of  an  intact  mesorectum.25  Especially  in  case  of  low  rectal  cancer  (about  0-­‐5  

centimetres  from  anal  verge)  it  is  often  challenging  to  achieve  a  complete  mesorectal  excision,  

regardless  of  the  use  of  an  open  or  laparoscopic  technique.26    

 

To  potentially  improve  oncological  outcomes,  transanal  TME  (taTME)  or  TAMIS  TME  has  been  

developed,  which  is  still  practically  a  combination  of  single-­‐  or  multiport  laparoscopy  and  NOTES.  

In  2013,  Heald  stated  that  transanal  TME  would  revolutionise  the  practice  of  rectal  cancer  

surgery.26  In  taTME,  rectal  cancer  is  approached  from  distal  through  the  anus  instead  of  proximal  

through  the  abdomen  as  in  traditional  TME.  Small  patient  series  have  demonstrated  feasibility  of  

this  technique  and  showed  the  ability  to  perform  complete  mesorectal  excisions  with  adequate  

circumferential  resection  margins  (CRM).27-­‐36  

 

 

 

 

OUTLINE  OF  THIS  THESIS  

 

This  thesis  focuses  on  the  advances  in  minimally  invasive  surgery  and  its  implementation  in  clinical  

practice.    It  represents  the  growth  in  surgical  techniques  from  a  ‘simple’  cholecystectomy  towards  

complex  rectal  cancer  surgery.      

 

In  chapter  2  we  evaluate  our  experience  with  single-­‐incision  laparoscopic  (SILS)  right  colectomy  

for  colon  cancer  in  a  two-­‐centre  study.  In  a  prospective  case-­‐controlled  study  of  100  patients,  SILS  

right  colectomy  is  compared  to  the  conventional  multiport  laparoscopic  right  colectomy.  During  

this  study,  some  of  the  surgeons  experienced  an  increased  physical  burden  with  SILS  when  

compared  to  multiport  laparoscopy,  mainly  due  to  clashing  of  the  instruments.  This  observation  

resulted  in  chapter  3,  an  ergonomic  study  in  which  the  differences  in  physical  workload  between  

SILS  and  multiport  laparoscopy  was  evaluated  in  surgeons  and  surgical  residents.    

 

From  single-­‐incision  laparoscopy  we  progressed  to  our  first  hybrid-­‐NOTES  procedures.  In  The  

Netherlands,  we  were  the  first  to  perform  a  hybrid-­‐transvaginal  cholecystectomy  on  a  regular  

basis.  Chapter  4  shows  the  clinical  and  cosmetic  outcomes  after  one  year  of  performing  

transvaginal  cholecystectomy.  In  chapter  5  we  demonstrate  the  clinical  and  cosmetic  results  of  a  

case-­‐controlled  study  comparing  single-­‐incision,  transvaginal  and  multiport  laparoscopic  

techniques  for  cholecystectomy.    

 

In  chapter  6  we  describe  the  use  of  a  single-­‐port  platform  for  the  endoscopic  excision  of  rectum  

tumours  as  an  initial  step  towards  the  development  of  transanal  TME.  Chapter  7  describes  the  

surgical  technique  and  the  short-­‐term  and  pathological  results  of  the  first  five  consecutive  patients  

who  underwent  a  transanal  TME  for  rectal  cancer.  Chapter  8  is  a  descriptive  article  about  taTME,  

which  was  published  in  a  well-­‐read  Dutch  medical  journal  to  obtain  more  awareness  about  this  

new  technique  among  Dutch  physicians.  To  further  investigate  the  oncological  quality  of  taTME,  a  

matched  case-­‐controlled  study  comparing  the  specimens  after  taTME  and  multiport  TME  was  

performed  (chapter  9).  In  chapter  10  we  focussed  on  the  presence  and  clinical  significance  of  

peritoneal  bacterial  contamination  after  taTME.  The  transition  to  NOTES  has  been  a  slow  process,  

partly  because  of  concerns  about  bacterial  translocation.  In  case  of  taTME  this  would  be  

translocation  from  the  rectum  to  the  intraperitoneal  space  during  the  procedure.    In  chapter  11  

Page 7: CHAPTER 01.pdf · surgery generated an increased interest among surgical and gastroenterological communities to further reduce surgical trauma through ‘scarless’ surgery. These

1

15

INTR

OD

UCT

ION

AN

D T

HES

IS O

UTL

INE

the  Laparoendoscopic  Single-­‐Site  Surgery  Consortium  for  Assessment  and  Research  (LESSCAR)  was  

formed  to  coordinate  and  advance  the  technique  of  LESS  in  a  cohensive  and  safe  manner.19    

 

 

TAMIS  /  taTME  

 

Transanal  endoscopic  microsurgery  (TEM)  was  successfully  introduced  in  1983  by  Buess  et  al.20  to  

resect  rectal  adenomas  and  selected  early  stage  rectum  carcinomas.  This  technique  initially  

required  a  large  rigid  proctoscope  and  was  regarded  as  relatively  technically  challenging  and  

expensive.  Atallah  et  al.21  demonstrated  the  possibility  to  use  a  single-­‐port  to  gain  endoscopic  

access  for  the  resection  of  rectal  tumours.  The  endoscopic  access  of  the  rectum  by  using  a  single-­‐

port  and  laparoscopic  instruments  is  termed  transanal  minimally  invasive  surgery  (TAMIS)  and  

created  new  possibilities  in  the  minimally  invasive  treatment  of  rectum  carcinomas.    

 

The  introduction  of  the  total  mesorectal  excision  (TME)  for  rectum  carcinomas  by  Heald  in  1982  

and  its  subsequent  worldwide  standardisation  has  led  to  significant  improvements  in  oncological  

outcomes.22-­‐24  The  cornerstone  of  TME  is  dissection  of  the  presacral  plane,  also  known  as  the  ‘holy  

plane’  and  removal  of  an  intact  mesorectum.25  Especially  in  case  of  low  rectal  cancer  (about  0-­‐5  

centimetres  from  anal  verge)  it  is  often  challenging  to  achieve  a  complete  mesorectal  excision,  

regardless  of  the  use  of  an  open  or  laparoscopic  technique.26    

 

To  potentially  improve  oncological  outcomes,  transanal  TME  (taTME)  or  TAMIS  TME  has  been  

developed,  which  is  still  practically  a  combination  of  single-­‐  or  multiport  laparoscopy  and  NOTES.  

In  2013,  Heald  stated  that  transanal  TME  would  revolutionise  the  practice  of  rectal  cancer  

surgery.26  In  taTME,  rectal  cancer  is  approached  from  distal  through  the  anus  instead  of  proximal  

through  the  abdomen  as  in  traditional  TME.  Small  patient  series  have  demonstrated  feasibility  of  

this  technique  and  showed  the  ability  to  perform  complete  mesorectal  excisions  with  adequate  

circumferential  resection  margins  (CRM).27-­‐36  

 

 

 

 

OUTLINE  OF  THIS  THESIS  

 

This  thesis  focuses  on  the  advances  in  minimally  invasive  surgery  and  its  implementation  in  clinical  

practice.    It  represents  the  growth  in  surgical  techniques  from  a  ‘simple’  cholecystectomy  towards  

complex  rectal  cancer  surgery.      

 

In  chapter  2  we  evaluate  our  experience  with  single-­‐incision  laparoscopic  (SILS)  right  colectomy  

for  colon  cancer  in  a  two-­‐centre  study.  In  a  prospective  case-­‐controlled  study  of  100  patients,  SILS  

right  colectomy  is  compared  to  the  conventional  multiport  laparoscopic  right  colectomy.  During  

this  study,  some  of  the  surgeons  experienced  an  increased  physical  burden  with  SILS  when  

compared  to  multiport  laparoscopy,  mainly  due  to  clashing  of  the  instruments.  This  observation  

resulted  in  chapter  3,  an  ergonomic  study  in  which  the  differences  in  physical  workload  between  

SILS  and  multiport  laparoscopy  was  evaluated  in  surgeons  and  surgical  residents.    

 

From  single-­‐incision  laparoscopy  we  progressed  to  our  first  hybrid-­‐NOTES  procedures.  In  The  

Netherlands,  we  were  the  first  to  perform  a  hybrid-­‐transvaginal  cholecystectomy  on  a  regular  

basis.  Chapter  4  shows  the  clinical  and  cosmetic  outcomes  after  one  year  of  performing  

transvaginal  cholecystectomy.  In  chapter  5  we  demonstrate  the  clinical  and  cosmetic  results  of  a  

case-­‐controlled  study  comparing  single-­‐incision,  transvaginal  and  multiport  laparoscopic  

techniques  for  cholecystectomy.    

 

In  chapter  6  we  describe  the  use  of  a  single-­‐port  platform  for  the  endoscopic  excision  of  rectum  

tumours  as  an  initial  step  towards  the  development  of  transanal  TME.  Chapter  7  describes  the  

surgical  technique  and  the  short-­‐term  and  pathological  results  of  the  first  five  consecutive  patients  

who  underwent  a  transanal  TME  for  rectal  cancer.  Chapter  8  is  a  descriptive  article  about  taTME,  

which  was  published  in  a  well-­‐read  Dutch  medical  journal  to  obtain  more  awareness  about  this  

new  technique  among  Dutch  physicians.  To  further  investigate  the  oncological  quality  of  taTME,  a  

matched  case-­‐controlled  study  comparing  the  specimens  after  taTME  and  multiport  TME  was  

performed  (chapter  9).  In  chapter  10  we  focussed  on  the  presence  and  clinical  significance  of  

peritoneal  bacterial  contamination  after  taTME.  The  transition  to  NOTES  has  been  a  slow  process,  

partly  because  of  concerns  about  bacterial  translocation.  In  case  of  taTME  this  would  be  

translocation  from  the  rectum  to  the  intraperitoneal  space  during  the  procedure.    In  chapter  11  

Page 8: CHAPTER 01.pdf · surgery generated an increased interest among surgical and gastroenterological communities to further reduce surgical trauma through ‘scarless’ surgery. These

16

we  demonstrate  our  short-­‐term  clinical  and  oncological  results  regarding  the  first  80  performed  

taTME  procedures  for  rectum  carcinomas.    

 

To  date,  no  randomised  controlled  trial  has  been  designed  to  compare  the  clinical  and  oncological  

outcomes  of  taTME  with  multiport  laparoscopic  TME.    

Chapter  12  comprises  a  description  of  the  study  protocol  for  a  future  multicentre  randomised  

clinical  trial  comparing  transanal  TME  and  traditional  laparoscopic  TME  for  mid  and  low  rectal  

cancer  on  behalf  of  the  COLOR  III  study  group.    

 

The  general  discussion  (chapter  13)  summarizes  the  main  results  of  this  thesis  and  discusses  

future  perspectives  on  personalised  surgery.    

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

REFERENCES    

1. Jayne  DG,  Guillou  PJ,Thorpe  H,  et  al.  Randomized  trial  of  laparoscopic-­‐assisted  resection  of  colorectal  carcinoma:  3-­‐year  results  of  the  UK  MRC  CLASICC  Trial  Group.  J  Clin  Oncol.  Jul  20  2007;25(21):3061-­‐3068.  

2. Veldkamp  R,  Kuhry  E,  Hop  WC,  et  al.  Laparoscopic  surgery  versus  open  surgery  for  colon  cancer:  short-­‐term  outcomes  of  a  randomized  trial.  Colon  cancer  Laparoscopic  or  Open  Resection  Study  Group  (COLOR).  Lancet  Oncol.  2005  Jul;6(7):477-­‐84.  

3. Van  der  Pas  MH,  Haglind  E,  Cuesta  MA,  et  al.  Laparoscopic  versus  open  surgery  for  rectal  cancer  (COLOR  II):  short-­‐term  ouctomes  of  a  randomized,  phase  3  trial.  Colorectal  cancer  Laparoscopic  or  Open  Resection  II  (COLOR  II)  Study  Group.  Lancet  Oncol.  2013  Mar;14(3):210-­‐8.  

4. Keus  F,  Gooszen  HG,  van  Laarhoven  CJ.  Open,  small-­‐incision,  or  laparoscopic  cholecystectomy  for  patients  with  symptomatic  cholecystolithiasis.  An  overview  of  Cochrane  Hepato-­‐Biliary  Group  reviews.  Cochrane  Database  Syst  Rev.  2010(1):CD008318  

5. Clinical  Outcomes  of  Surgical  Therapy  Study  G.  A  Comparison  of  laparoscopically  assisted  and  open  colectomy  for  colon  cancer.  N  Engl  J  Med.  May  13  2004;350(20):2050-­‐2069.  

6. Nau  P,  Ellison  EC,  Muscarella  P  et  al.  A  review  of  130  human  enrolled  in  transgastric  NOTES  procotols  at  a  single  institution.  Surg  Endosc.  2011(25):4;1004-­‐1011.  

7. Kalloo  AN,  Singh  VK,  Jagannath  SB,  et  al.  Flexible  transgastric  peritoneoscopy:  a  novel  approach  to  diagnostic  and  therapeutic  interventions  in  the  peritoneal  cavity.  Gastrointest  End.  2004(60);1:114-­‐117.  

8. Moreira-­‐Pinto  J,  Lima  E,  Correia-­‐Pinto  J,  et  al.  Natural  orifice  transluminal  endoscopy  surgery:  a  review.  World  J  of  Gastroent.  2011(17);33:3795-­‐3801.  

9. Merrifield  BF,  Wagh  MS,  Thompson  CC.  Peroral  transgastric  organ  resection:  a  feasibility  study  in  pigs.  Gastroint  End.  2006(63);4:693-­‐697.  

10. Mohan  HM,  O’Riordan  JM,  Winter  DC.  Natural-­‐orifice  translumenal  endoscopic  surgery  (NOTES):  minimally  invasive  evolution  or  revolution?  Surg  Laparosc  Endosc  Percut  Tech.  2013;23:244-­‐250.  

11. Deborah  EB.  ASGE/SAGES  Working  Group  on  Natural  Orifice  Translumenal  Endoscopic  Surgery:  white  paper  October  2005.  Gastroint  End.  2006(63);2:199-­‐203.  

12. Wang  D,  Wang  Y,  Ji  ZL.  Laparoendoscopic  single-­‐site  cholecystectomy  versus  conventional  laparoscopic  cholecystectomy:  a  systematic  review  of  randomized  controlled  trials.  ANZ  Journal  of  Surgery  2012;82(5):303-­‐310.    

13. Teoh  AY,  Chiu  PW,  Wong  TC  et  al.  A  double-­‐blinded  randomized  controlled  trial  of  laparoendoscopic  single-­‐site  access  versus  conventional  3-­‐port  appendectomy.  Ann  of  Surg.  2012;256(6):909-­‐916.  

14. Siddiqui  MR,  Kovzel  M,  Brennan  SJ,  et  al.  The  role  of  the  laparoendoscopic  single  site  totally  extraperitoneal  approasch  to  inguinal  hernia  repairs:  a  review  and  meta-­‐analysis  of  the  litereature.  Can  J  Surg.  2014  Apr;57(2):116-­‐26.  

15. Calcagno  M,  Pastore  M,  Montanino  M,  et  al.  Laparoendoscopic  single-­‐site  salpingectomy  for  treatment  of  ectopic  pregnancy.  Int  J  Gynaecolol  Obstet  2012  Jan;116(1):81.  

16. Gargiulo  AR,  Nezhat  C.  Robot-­‐assisted  laparoscopy,  natural  orifice  transluminal  endoscopy,  and  single-­‐site  laparoscopy  in  reproductive  surgery.  Semin  Reprod  Med  2011  Mar;29(2):155-­‐68.  

17. Fan  X,  Lin  T,  Xu  K  et  al.  Laparoendoscopic  single-­‐site  nephrectomy  compared  with  conventional  laparoscopic  nephrectomy:  a  systematic  review  and  meta-­‐analysis  of  comparative  studies.  Eur  Urol  2012  Oct;62(4):601-­‐12.    

18. Diana  M,  Dhumane  P,  Cahili  RA,  et  al.  Minimal  invasive  single-­‐site  surgery  in  colorectal  procedures:  current  state  of  the  art.  J  Minim  Access  Surg  2011  Jan;  7(1):52-­‐60.  

19. Gill  IS,  Advincula  AP,  Monish  A,  et  al.  Consensus  statement  of  the  consortium  for  laparoendoscopic  single-­‐site  surgery.  Surg  Endosc  2010  24:762-­‐768.  

20. Buess  G,  Mentges  K,  Starlinger  M,  et  al.  Technique  and  results  of  transanal  endoscopic  microsurgery  in  early  rectal  cancer.  Am  J  Surg.  1992  Jan;163(1):63-­‐9.  

21. Atallah  S,  Albert  M,  Larach  S.  Transanal  minimally  invasive  surgery:  a  giant  leap  forward.  Surg  Endosc.  2010  Sep;24(9):2200-­‐5.  

22. Heald  RJ,  Husband  EM,  Ryall  RD.  The  mesorectum  in  rectal  cancer  surgery.  The  clue  to  pelvic  recurrence?  Br  J  Surg.  1982  Oct;69(10):613-­‐6.  

23. Martling  AL,  Holm  T,  Rutqvist  LE,  Moran  BJ,  Heald  RJ,  Cedemark  B  (2000)  Effect  of  a  surgical  training  programme  on  outcome  of  rectal  cancer  in  the  County  of  Stockholm.  Stockholm  Colorectal  Cancer  Study  Group,  

Page 9: CHAPTER 01.pdf · surgery generated an increased interest among surgical and gastroenterological communities to further reduce surgical trauma through ‘scarless’ surgery. These

1

17

INTR

OD

UCT

ION

AN

D T

HES

IS O

UTL

INE

we  demonstrate  our  short-­‐term  clinical  and  oncological  results  regarding  the  first  80  performed  

taTME  procedures  for  rectum  carcinomas.    

 

To  date,  no  randomised  controlled  trial  has  been  designed  to  compare  the  clinical  and  oncological  

outcomes  of  taTME  with  multiport  laparoscopic  TME.    

Chapter  12  comprises  a  description  of  the  study  protocol  for  a  future  multicentre  randomised  

clinical  trial  comparing  transanal  TME  and  traditional  laparoscopic  TME  for  mid  and  low  rectal  

cancer  on  behalf  of  the  COLOR  III  study  group.    

 

The  general  discussion  (chapter  13)  summarizes  the  main  results  of  this  thesis  and  discusses  

future  perspectives  on  personalised  surgery.    

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

REFERENCES    

1. Jayne  DG,  Guillou  PJ,Thorpe  H,  et  al.  Randomized  trial  of  laparoscopic-­‐assisted  resection  of  colorectal  carcinoma:  3-­‐year  results  of  the  UK  MRC  CLASICC  Trial  Group.  J  Clin  Oncol.  Jul  20  2007;25(21):3061-­‐3068.  

2. Veldkamp  R,  Kuhry  E,  Hop  WC,  et  al.  Laparoscopic  surgery  versus  open  surgery  for  colon  cancer:  short-­‐term  outcomes  of  a  randomized  trial.  Colon  cancer  Laparoscopic  or  Open  Resection  Study  Group  (COLOR).  Lancet  Oncol.  2005  Jul;6(7):477-­‐84.  

3. Van  der  Pas  MH,  Haglind  E,  Cuesta  MA,  et  al.  Laparoscopic  versus  open  surgery  for  rectal  cancer  (COLOR  II):  short-­‐term  ouctomes  of  a  randomized,  phase  3  trial.  Colorectal  cancer  Laparoscopic  or  Open  Resection  II  (COLOR  II)  Study  Group.  Lancet  Oncol.  2013  Mar;14(3):210-­‐8.  

4. Keus  F,  Gooszen  HG,  van  Laarhoven  CJ.  Open,  small-­‐incision,  or  laparoscopic  cholecystectomy  for  patients  with  symptomatic  cholecystolithiasis.  An  overview  of  Cochrane  Hepato-­‐Biliary  Group  reviews.  Cochrane  Database  Syst  Rev.  2010(1):CD008318  

5. Clinical  Outcomes  of  Surgical  Therapy  Study  G.  A  Comparison  of  laparoscopically  assisted  and  open  colectomy  for  colon  cancer.  N  Engl  J  Med.  May  13  2004;350(20):2050-­‐2069.  

6. Nau  P,  Ellison  EC,  Muscarella  P  et  al.  A  review  of  130  human  enrolled  in  transgastric  NOTES  procotols  at  a  single  institution.  Surg  Endosc.  2011(25):4;1004-­‐1011.  

7. Kalloo  AN,  Singh  VK,  Jagannath  SB,  et  al.  Flexible  transgastric  peritoneoscopy:  a  novel  approach  to  diagnostic  and  therapeutic  interventions  in  the  peritoneal  cavity.  Gastrointest  End.  2004(60);1:114-­‐117.  

8. Moreira-­‐Pinto  J,  Lima  E,  Correia-­‐Pinto  J,  et  al.  Natural  orifice  transluminal  endoscopy  surgery:  a  review.  World  J  of  Gastroent.  2011(17);33:3795-­‐3801.  

9. Merrifield  BF,  Wagh  MS,  Thompson  CC.  Peroral  transgastric  organ  resection:  a  feasibility  study  in  pigs.  Gastroint  End.  2006(63);4:693-­‐697.  

10. Mohan  HM,  O’Riordan  JM,  Winter  DC.  Natural-­‐orifice  translumenal  endoscopic  surgery  (NOTES):  minimally  invasive  evolution  or  revolution?  Surg  Laparosc  Endosc  Percut  Tech.  2013;23:244-­‐250.  

11. Deborah  EB.  ASGE/SAGES  Working  Group  on  Natural  Orifice  Translumenal  Endoscopic  Surgery:  white  paper  October  2005.  Gastroint  End.  2006(63);2:199-­‐203.  

12. Wang  D,  Wang  Y,  Ji  ZL.  Laparoendoscopic  single-­‐site  cholecystectomy  versus  conventional  laparoscopic  cholecystectomy:  a  systematic  review  of  randomized  controlled  trials.  ANZ  Journal  of  Surgery  2012;82(5):303-­‐310.    

13. Teoh  AY,  Chiu  PW,  Wong  TC  et  al.  A  double-­‐blinded  randomized  controlled  trial  of  laparoendoscopic  single-­‐site  access  versus  conventional  3-­‐port  appendectomy.  Ann  of  Surg.  2012;256(6):909-­‐916.  

14. Siddiqui  MR,  Kovzel  M,  Brennan  SJ,  et  al.  The  role  of  the  laparoendoscopic  single  site  totally  extraperitoneal  approasch  to  inguinal  hernia  repairs:  a  review  and  meta-­‐analysis  of  the  litereature.  Can  J  Surg.  2014  Apr;57(2):116-­‐26.  

15. Calcagno  M,  Pastore  M,  Montanino  M,  et  al.  Laparoendoscopic  single-­‐site  salpingectomy  for  treatment  of  ectopic  pregnancy.  Int  J  Gynaecolol  Obstet  2012  Jan;116(1):81.  

16. Gargiulo  AR,  Nezhat  C.  Robot-­‐assisted  laparoscopy,  natural  orifice  transluminal  endoscopy,  and  single-­‐site  laparoscopy  in  reproductive  surgery.  Semin  Reprod  Med  2011  Mar;29(2):155-­‐68.  

17. Fan  X,  Lin  T,  Xu  K  et  al.  Laparoendoscopic  single-­‐site  nephrectomy  compared  with  conventional  laparoscopic  nephrectomy:  a  systematic  review  and  meta-­‐analysis  of  comparative  studies.  Eur  Urol  2012  Oct;62(4):601-­‐12.    

18. Diana  M,  Dhumane  P,  Cahili  RA,  et  al.  Minimal  invasive  single-­‐site  surgery  in  colorectal  procedures:  current  state  of  the  art.  J  Minim  Access  Surg  2011  Jan;  7(1):52-­‐60.  

19. Gill  IS,  Advincula  AP,  Monish  A,  et  al.  Consensus  statement  of  the  consortium  for  laparoendoscopic  single-­‐site  surgery.  Surg  Endosc  2010  24:762-­‐768.  

20. Buess  G,  Mentges  K,  Starlinger  M,  et  al.  Technique  and  results  of  transanal  endoscopic  microsurgery  in  early  rectal  cancer.  Am  J  Surg.  1992  Jan;163(1):63-­‐9.  

21. Atallah  S,  Albert  M,  Larach  S.  Transanal  minimally  invasive  surgery:  a  giant  leap  forward.  Surg  Endosc.  2010  Sep;24(9):2200-­‐5.  

22. Heald  RJ,  Husband  EM,  Ryall  RD.  The  mesorectum  in  rectal  cancer  surgery.  The  clue  to  pelvic  recurrence?  Br  J  Surg.  1982  Oct;69(10):613-­‐6.  

23. Martling  AL,  Holm  T,  Rutqvist  LE,  Moran  BJ,  Heald  RJ,  Cedemark  B  (2000)  Effect  of  a  surgical  training  programme  on  outcome  of  rectal  cancer  in  the  County  of  Stockholm.  Stockholm  Colorectal  Cancer  Study  Group,  

Page 10: CHAPTER 01.pdf · surgery generated an increased interest among surgical and gastroenterological communities to further reduce surgical trauma through ‘scarless’ surgery. These

Basingstoke  Bowel  Cancer  Research  Project.  Lancet.  356:93-­‐96.  

24. Kapiteijn  E,  Putter  H,  Van  de  Velde  CJ  (2002)  Cooperative  investigators  of  the  Dutch  ColoRectal  Cancer  Group:  impact  of  the  introduction  and  training  of  total  mesorectal  excision  on  recurrence  and  survival  in  rectal  cancer  in  The  Netherlands.  Br  J  Surg  89:1142–1149.  

25. Heald  RJ.  The  ‘holy  plane’  of  rectal  surgery.  J  R  Soc  Med  1988  81:503-­‐533.  

26. Heald  RJ  (2013)  A  new  solution  to  some  old  problems:  transanal  TME.  Tech  Coloproctol  17:257–258.  

27. Marks  J,  Mizrahi  B,  Dalane  S,  Nweze  I,  Marks  G  (2010)  Laparoscopic  transanal  abdominal  transanal  resection  with  sphincter  preservation  for  rectal  cancer  in  the  distal  3  cm  of  the  rectum  after  neoadjuvant  therapy.  Surg  Endosc  24:2700–2707    

28. Zorron  R,  Philips  HN,  Coelho  D,  Flach  L,  Lemos  FB,  Vassallo  RC  (2012)  Perirectal  NOTES  access:  ‘‘down-­‐to-­‐up’’  total  mesorectal  excision  for  rectal  cancer.  Surg  Innov  19:11–19  

29. McLemore  EC,  Coker  AM,  Devaraj  B  et  al  (2013)  TAMIS-­‐assisted  laparoscopic  low  anterior  resection  with  total  mesorectal  excision  in  a  cadaveric  series.  Surg  Endosc  27:3478–3484.    

30. Rouanet  P,  Mourregot  A,  Azar  CC  et  al  (2013)  Transanal  endoscopic  proctectomy:  an  innovative  procedure  for  difficult  resection  of  rectal  tumors  in  men  with  narrow  pelvis.  Dis  Colon  Rectum  56:408–415    

31. Lacy  AM,  Rattner  DW,  Adelsdorfer  C  et  al  (2013)  Transanal  natural  orifice  transluminal  endoscopic  surgery  (NOTES)  rectal  resection:  ‘‘down-­‐to-­‐up’’  total  mesorectal  excision  (TME)-­‐shortterm  outcomes  in  the  first  20  cases.  Surg  Endosc  27:3165–3172.    

32. Sylla  P,  Bordeianou  LG,  Berger  D  et  al  (2013)  A  pilot  study  of  natural  orifice  transanal  endoscopic  total  mesorectal  excision  with  laparoscopic  assistance  for  rectal  cancer.  Surg  Endosc  27:3396–3405  

33. Cahill  RA  (2013)  Single  port  surgery  for  rectal  cancer-­‐going  up  or  down?  Dis  Colon  Rectum  56:1199–1200    

34. Wolthuis  AM,  van  Overstraeten  ADB,  D’Hoore  A  (2014)  Dynamic  article:  transanal  rectal  excision:  a  pilot  study.  Dis  Colon  Rectum  57:105–109  

35. Zorron  R,  Philips  HN,  Wynn  G,  Neto  MP,  Coelho  D,  Vassallo  RC  (2014)  ‘‘Down-­‐to-­‐up’’  transanal  NOTES  Total  mesorectal  excision  for  rectal  cancer:  preliminary  series  of  9  patients.  J  Minim  Access  Surg  10:144–150  

36. Atallah  S,  Martin-­‐Perez  B,  Albert  M  et  al  (2014)  Transanal  minimally  invasive  surgery  for  total  mesorectal  excision  (TAMIS–TME):  results  and  experience  with  the  first  20  patients  undergoing  curative-­‐intent  rectal  cancer  surgery  at  a  single  institution.  Tech  Coloproctol  18:473–480.