1. Minimally Invasive Surgery for Rectal Cancer Long Term Results
John H Marks MD
Chief Section of Colon and Rectal Surgery
Main Line Health System

2. Speakers Disclosures
Covideon- educational grant support, consultant, speakers bureau
Wolfe- consultant, speakers bureau
Stryker- consultant, speakers bureau
Glaxo Smith Kline- consultant
Zassi- consultant, honoraria
Surgiquest- Scientific Advisory Board
Adolor- speakers bureau

3. Section of Colon and Rectal Surgery Main Line Health System
Lankenau Hospital and
Lankenau Institute For Medical Research Wynnewood, PA

4. Lap Rectal Surgery
The Learning Curve-
Laparoscopic Colorectal Surgery

5. Morris Franklin MD-
Franklin ME Jr. LAPAROSCOPIC COLON RESECTION (LETTER). Surgical Laparoscopy, Endoscopy &Percutaneous Techniques. 1992; 2(2):183
Phillips EH, Franklin ME, Carrol BJ, Fallas MJ, Ramos R, Rosenthal D: LAPAROSCOPIC COLECTOMY. Annals of Surgery Dec 216(6):

6. Advocates for Open Colon Surgery

7. Rectal Cancer TME Surgery?

9. Can we do Lap TME?

10. Top Questions Rectal Cancer Therapy
Radiation
Chemotherapy
Surgery
Short Course Radiation?
Post-op?
Bolus?
Preop? r
Agents?
Laparoscopy????
Selective?
High Dose?
Not Needed?
TME

11. TME

12. Laparoscopic Rectal Cancer
Med-Line Review
164 articles
3 randomized controlled trials (individual)
N=17 vs. 17 (Leung 2000)
N=203 vs. 200 (Leung 2004)
N=82 vs. 89 (Zhou 2004)
1 meta-analysis
1 Cochrane analysis
CLASICC Trial- waiting

13. Laparoscopic Rectal Cancer
Med-Line Review
articles
(10 Review articles: 20%)
articles
7 original series
4 review articles (36%)
No New Prospective Studies
CLASICC Trial- waiting

14. Laparoscopic Rectal Cancer
Level 1A Evidence =

15. Laparoscopic Rectal Cancer
Will we ever have Level I A evidence?
Is it needed?
How address hierarchy of questions for rectal cancer?

16. Lap Rectal Cancer Studies
Author
Resection
Year
Design
Lap
Open
Mean F/U (mo)
Tsang
LAR
2006
PNR
105 --
26.9
Kim
LAR/APR
257 30
Morino
2005 98 93
46.3/49.7
Barlehner
194 46
Dulcucq
218 57
CLASICC PR
253
128
3/3
Bretagnol
144 18
Leung
2004
203
200
52.7/49.2
Zhou 82 89
Breukink 25 Wu
2003
Leroy
102 36
100
45.7
2002

17. APR RATES Open Laparoscopic 27% 25% MRC CLASICC Trial
Guillou PJ et al. Lancet 2005;365:

18. Laparoscopic Conversion Rate Overall
Conversion Rates
MRC CLASICC Trial
Laparoscopic Conversion Rate Overall
34%
Year %
Year %
Guillou PJ et al. Lancet 2005;365:

19. Positive Circumferential Margins
R-0 Resection Rates
MRC CLASICC Trial
Positive Circumferential Margins
Open- 14%
Laparoscopic- 16%
Guillou PJ et al. Lancet 2005;365:

20. Laparoscopic vs. Open Total Mesorectal Excision for Rectal Cancer (Cochrane Review)
Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007

21. Type of Studies Grade 1b (individual randomised trial) – 3
Grade 2b (individual cohort study) – 12
Grade 3b (individual case-control study) – 5
Grade 4 (case-series) – 28
Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007

22. Mortality No Difference Level 1b evidence (3 studies)
No difference between lap vs. open
Level 2b evidence (13 studies)
Mortality 0-2.5%
Level 3b evidence (2 studies)
Mortality 0% in both groups
Level 4 evidence (19 studies)
Mortality 0-25%; 25% due to one study with only 4 patients of whom 1 patient died
Breukink S, Pierie J, Wiggers T; 2007; The Cochrane Collaboration

23. Morbidity No Difference level 1b evidence (3 studies)
6.1% to 29% for the lap group and 12.4% to 35% for the open group
1 study found significant difference between lap and open group (6.1% vs. 12.4%; p=0.016)
Level 2b evidence (9 studies)
20% to 37.6% morbidity
1 study did not find any significant difference between the two groups (p=0.26)
Level 3b evidence (1 study)
No significant difference between lap vs. open (p=0.26)
Level 4 evidence (3 studies)
2 of the studies found significantly less morbidity in the lap group and 1 did not find a difference
Breukink S, Pierie J, Wiggers T; 2007; The Cochrane Collaboration

24. Blood Loss Less in Laparoscopy No Transfusion Difference
Level 1b evidence (3 studies)
2 of the studies found significantly less blood loss in the open group compared to the lap group
Level 2b evidence (3 studies)
56 to 436 ml blood loss in the lap group
Level 3b evidence (1 study)
Found less blood in lap group compared to open group (250 vs. 1000ml; p<0.001)
Level 4 evidence (3 studies)
2 of the studies found significantly less blood loss in the lap group
Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007

25. Distal Margins R-0 Resections Lymph Nodes Lap group = Open group
Pathology
Distal Margins
R-0 Resections
Lymph Nodes
Lap group = Open group
Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007

26. 3-Year and 5-Year Disease-Free Survival Rates
No Difference
level 1b evidence (1 study)
5-year disease-free survival rate of 75.3% in the lap group and 78.3% in the open group
level 2b evidence (5 studies)
3 studies reported 67-88% survival rate of 5 years in lap
2 studies reported 63-75% survival rate of 5 years in lap
level 3b evidence (1 study)
92% survival rate of 3 years in both lap and open group
level 4 evidence (2 studies)
% survival rate of 5 years in lap
Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007

27. No Difference Local Recurrence level 1b evidence (1 study)
6.6% local recurrence rate in the lap group and 4.1% in the open group with a follow-up of 52.7 vs months
level 2b evidence (8 studies)
3.75% to 6.8% local recurrence reported between 16 and 45.7 months
level 3b evidence (4 studies)
0% to 6% local recurrence; no significant difference
level 4 evidence (17 studies)
0% to 24.1% local recurrence
5 studies compared recurrence rate between the two groups and found no significant difference
Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007

28. Postoperative Course
The postoperative period of laparoscopic surgery offers the most benefits compared to open surgery
There is evidence that laparoscopy results in an earlier return of normal diet, less pain, less narcotic use, and shorter hospital stay

29. Conclusion No immediate differences in oncological outcomes
Less blood loss with laparoscopy
Clinically measurable short-term advantages in lap group vs. open group
Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007

30. Hand-assisted lap surg 58 (56.3%) Lap surg 45 (43.7%)
Long-term outcomes of patients undergoing curative laparoscopic surgery for mid and low rectal cancer Dis Colon Rectum Jul;52(7):
N=185 total Lap Rectal
N=103 mid to low cancers
Hand-assisted lap surg 58 (56.3%)
Lap surg (43.7%)
Milsom JW, de Oliveira O Jr, Trencheva KI, Pandey S, Lee SW, Sonoda T

31. Results R0 resection rate= 100%
Mean follow-up time months
Conversion rate was 2.9%
R0 resection rate= 100%
The anastomotic leak rate was 7.8% (n = 8).
No 30-day mortality
LR= 5% at five years.
Overall survival was 91%
Disease-free survival was 73.1%
Milsom JW, de Oliveira O Jr, Trencheva KI, Pandey S, Lee SW, Sonoda T

32. CONCLUSION:
Laparoscopic surgical techniques for mid and low rectal cancer seem safe and feasible with acceptable oncologic and long-term outcomes. Further studies, comparing laparoscopic and open methods, are warranted.
Milsom JW, de Oliveira O Jr, Trencheva KI, Pandey S, Lee SW, Sonoda T

33. Laparoscopic versus open surgery for rectal cancer: long-term oncologic results Ann Surg Jul;250(1):54-61
Assess long-term oncologic outcome after laparoscopic versus open surgery for rectal cancer and to evaluate the impact of conversion
Two Periods of time:
= Open N= 233
= Lap N= 238
Laurent C, Leblanc F, Wütrich P, Scheffler M, Rullier E

34. Results:
Lap Open Pvalue Mortality 0.8% 2.6%; 0.17 Morbidity 22.7% 20.2%; 0.51 R0 Resection 92.0% 94.8% 0.22
Laurent C, Leblanc F, Wütrich P, Scheffler M, Rullier E

35. Results: Lap Open Pvalue At 5 years: Local recurrence 3.9% 5.5% 0.371
Cancer-free survival % % 0.52
Conversion=15%
no negative impact mortality, local recurrence, and survival
Laurent C, Leblanc F, Wütrich P, Scheffler M, Rullier E

36. CONCLUSIONS
The efficacy of laparoscopic surgery in a team specialized in rectal excision for cancer (open and laparoscopic surgery) is suggested with similar long-term local control and cancer-free survival than open surgery
Moreover, conversion had no negative impact on survival.
Laurent C, Leblanc F, Wütrich P, Scheffler M, Rullier E

37. after Chemoradiation Therapy
Laparoscopic TATA
Transanal-Abdominal-Transanal Radical Proctosigmoidectomy with Coloanal Anastomosis
after Chemoradiation Therapy
For Rectal Cancer
Distal 3cm
Thank you for the priveledge of presenting our data on laparoscopic TATA , a sphincter preserving technique for cancers in the distal 3cm of the rectum that would otherwise require an APR
John Marks, Gerald Marks, Ben Mizrahi
Section of Colorectal Surgery
The Lankenau Hospital and Institute for Medical Research
Wynnewood, PA

38. Goals Rectal Cancer Management
Reduce local recurrence
Increase survival
Maintain normal function
Avoiding a permanent colostomy
Goals of rectal cancer management are controlling the cancer and maintaining QOL 38

39. Materials & Methods Prospective rectal cancer database since 1976
Prospective laparoscopic database since (N=1089)
102 patients treated with laparoscopic TATA
All TME
Inclusion criteria:
Curative surgery
Mobile tumors in the distal 3cm following neoadjuvant therapy
79 patients for study
Using a prospective rectal cancer database and a prospective laparoscopic database, we identified 102 patients that were treated by laparoscopic TATA.
Of these, 79 patients were eligible for the study 39

40. Pretreatment Tumor Characteristics
Methods
Level in rectum from anorectal ring:
< 3.0 cm = 100%
Mean = 1.2cm( cm)
All tumors were in distal 3 cm of the rectum
and 30% were below the 1 cm level
<1cm: 30%

41. Laparoscopic TME Completion Rate
Results
Conversion to Open = 2.5%
N=2
Only 2 patients were converted
Surg Endo: Accepted for Publication

42. Morbidity and Mortality
Results
No Mortalities
Minor Morbidities 18.9%
Major Morbidities 11%
Immediate:
2 failed anastomosis requiring stoma
Delayed
4 full-thickness rectal prolapse with repair
1 ischemic neorectum with successful reanastomosis
2 bowel obstructions
There were no perioperative mortalities
And major morbidity rate of 11%

43. Operative Data Mean EBL: 367cc Positive distal margin: N=1 (1.2%)
Results
Mean EBL: 367cc
Positive distal margin: N=1 (1.2%)
BMI: ( )
# of Trocars:
3: (11%)
4: 47 (60%)
5: 19 (24%)
6: 2 (3%)
Mean estimated blood loss was 367cc
And even with BMIs up to 47

44. TATA: Transanal Portion

47. Lifetime normal sphincter function: 90%
Stoma Rate
N=79
Results
Lifetime normal sphincter function: 90%
Neorectal loss due to:
2 + margins
2 failed anastomosis
2 were not reversed due to comorbidities
1 stoma secondary to bowel obstruction
1 recurrence
90% of patients lived their life without a permament colostomy
*All had temporary diverting ostomy following TATA

48. Oncologic Outcomes Local Recurrence: 2.5% KM5YAS: 97%
Results
Local Recurrence: 2.5%
KM5YAS: 97%
Distant Metastasis: 10.1%
Our local recurrence rate is a surprisingly LOW 2.5%
(PAUSE)
Five year survival is 97%
Surg Endo: Accepted for Publication

49. Comparison of outcome of open and laparoscopic resection for stage II and stage III rectal cancer Ann Surg Oncol Jun;16(6): Epub 2009 Mar 17 Law WL, Poon JT, Fan JK, Lo SH. Department of Surgery, University of Hong Kong Medical Centre
Compare survival of patients laparoscopic and open resection for stage II and III rectal cancer
Open resection: n = 310
Laparoscopic resection: n = 111
June 2000 to December 2006

50. Results: No Diferrence: Lap Better:
Age, gender, medical morbidities, ASA class, type of operation, morbidity, mortality, pathologic staging
Lap Better:
Blood loss, length of stay
Law WL, Poon JT, Fan JK, Lo SH. Department of Surgery, University of Hong Kong Medical Centre

51. Cancer Results:
Median follow-up = 34 months No difference in local recurrence rates 5-year actuarial survivals were: 71.1% in the laparoscopic 59.3% open groups (P = .029)
Law WL, Poon JT, Fan JK, Lo SH. Department of Surgery, University of Hong Kong Medical Centre

52. Cancer Results: Multivariate analysis:
Better survival: laparoscopic resection
(P = .03, hazards ratio: 0.558, 95% confidence interval: ).
Poor prognostic factors:
Lymph node metastasis
poor differentiation
perineural invasion
postop complications
no chemotherapy
Law WL, Poon JT, Fan JK, Lo SH. Department of Surgery, University of Hong Kong Medical Centre

53. CONCLUSIONS:
Laparoscopic resection for locally advanced rectal cancer is associated with more favorable overall survival when compared with open resection
Law WL, Poon JT, Fan JK, Lo SH. Department of Surgery, University of Hong Kong Medical Centre

54. Randomized Clinical Trial Comparing Laparoscopic and Open Surgery
Future
Prospective trials and
long-term follow-up are needed
COLOR II
Randomized Clinical Trial Comparing
Laparoscopic and Open Surgery
For Rectal Cancer

55. Future
Prospective trials and
long-term follow-up are needed

56. ACOSOG Z6051- Lap vs Open Rectal Resection

57. ACOSOG Z6051- Lap vs Open Rectal Resection
Accrual Goal= 480
240 each arm
Endpoints:
Circumferential margins > 1mm
Distal margin > 2cm, > 1 cm distal rectum
Complete TME

58. “If there is no struggle, there is no progress!”
Frederick Douglas ( )

59. Airplane Problem or Pilot Problem???

60. Conclusions: ACOSOG trial will put this question to rest
Technically can certainly be done
No reports show anything worse laparoscopically
Better short term outcomes:
Pain
EBL