laparoscopic vs open colorectal surgery

1. Journal club
Dr Sujan Shrestha
MCh first year
GI surgery

2. Title
Disease-free Survival and Local Recurrence for
Laparoscopic Resection Compared With Open
Resection of Stage II to III Rectal Cancer
Follow-up Results of the ACOSOG Z6051 Randomized
Controlled Trial

3. Impact factor = 9.2 Published on 2018
If you haven’t made the patient impotent that means you have not cured the patient off rectal ca
Miles
Golliger
Heald

4. Introduction
• Surgical resection remains the most important treatment modality for
rectal cancer in terms of a curative resection, staging, prognosis, and
subsequent therapeutic decisions
Monson JR, Weiser MR, Buie WD, et al. f Dis Colon
Rectum. 2013.

5. Introduction
• The critical nature of surgical technique in the management of rectal
cancer has been shown by Quirke and Heald.
• Minimally invasive treatment of rectal cancer improves short- term
outcomes for patients in the areas of pain, recovery, complications,
and quality of life.
• There are several studies regarding its oncological safety in rectal ca.
Nagtegaal ID, Quirke P. J Clin Oncol.
2008

6. • The American College of Surgeons Oncology Group (ACOSOG) Z6051
randomized controlled trial(pathological outcomes)
Laparoscopic treatment of rectal cancer (LAP) did not meet criteria
for noninferiority.
• The Laparoscopic Assisted Resection versus Open Resection on
Pathologic Outcomes in Rectal Cancer (ALaCaRT) Study from Australia
simultaneously confirmed this finding (pathological outcomes)
Introduction
Fleshman J, Branda M, Sargent DJ, et al. The ACOSOG Z6051 randomized clinical trial.
JAMA. 2015
Stevenson ARL, Solomon MJ, Lumley JW, et al. The ALaCaRT randomized clinical trial.
JAMA. 2015

7. • The secondary and clearly more relevant outcomes of the Alliance
(ACOSOG) Z6051 RCT are the DFS and local and regional recurrence
(LR) rates at 2 years.
Introduction

8. • This was a multicenter balanced randomized trial conducted in the
United States and Canada
Method
• Aged 18 years or older,
• Body mass index of 34 or less,
• ECOG performance score less than 3
• Histologically proven adenocarcinoma of the rectum at or below 12 cm above
the anal verge
• Clinical stage II, IIIA, IIIB.
• All patients completed fluorouracil- based chemoradiotherapy or radiotherapy
alone (neoadjuvant)
• Operation was to have been performed within 4 to 12 weeks of the final
radiation treatment (duration)
Inclusion criteria

9. • History of invasive pelvic malignancy within 5 years,
• Psychiatric or addictive disorders
• Severe incapacitating disease (American Society of Anesthesiologists
classification IV or V),
• Systemic disease that would preclude use of a laparoscopic approach (eg,
cardiovascular, renal, hepatic),
• Conditions that would limit the success of laparoscopic resection (multiple
previous laparotomies or severe adhesions).
Exclusion criteria
Method

10. Intervention
• Standard laparoscopic and open approaches were used according to
preferences of the individual surgeons.
• The number and pattern of laparoscopic or robotic ports were left to
the preference of the surgeon.
• The hybrid technique was used in the open resection arm.
Method

11. Common to both
• Surgeons were instructed to perform proximal ligation of the feeding vessels
• They were to mobilize the splenic flexure of the colon for all cases
• TME principle followed in each cases.
• Distal margin was determined to be adequate if the line of transection was
 5 cm below the tumor for upper rectal lesions,
 2 cm below the line of transection for middle rectal lesions, and
 If the frozen or fixed section of the distal margin was tumor free (>1 mm) for low rectal lesions.
Method

12. Between October
2008 and
September 2013
Method

13. Outcomes
The primary outcome
• Distal margin (>1 mm between the closest tumor to the cut edge of the tissue),
• Circumferential radial margin (>1 mm between the deepest extent of tumor invasion into the mesorectal
fat and the inked surface on the fixed specimen),
• TME quality
Secondary outcomes
• Disease-free survival and
• Rate of local recurrence
Method

14. Method

15. Method

16. Statistical
analysis
• Equivalence margin(non inferiority margin was
6%)
• A single interim analysis for futility for the
primary end point was planned and conducted
after 240 patients were accrued, using an
O’Brien-Fleming stopping boundary.
• All categorical variables were analysed with the
χ2 test
• Continuous comparisons were conducted with
the Wilcoxon rank sum test.
• The analysis was generated with SAS version
9.3.

17. Results
Only 2 procedure planned
preoperatively

18. Results
One missed by physician
Ineligible
5 FU(OXPAL IN 5/7)
5 FU

19. Results
72.9 %
19.1%
13.02%
81.5%
13.5%
4.95%

20. Results
NOT MENTIONED
NOT PURE LAPROSCOPIC PRE LAP MOBILIZATION LAP?
WHY STOMA?
WHY COLO OR ILEO?

21. Results
MIGHT BE GROSS
EXAMINATION
NODES

22. Results

23. Results
TYPE OF COMPLICATION NOT MENTIONED

24. Results
PATIENT WITH OR
WITHOUT STOMA?
NON GI OPERATIONS

25. Results
ONLY FIRST RECURRANCE
OVERALL RECURRANCE
NOT MUTUALLY EXCLUSIVE

26. Results
Pathology

27. Results

28. Results

29. Discussion
• Does laparoscopic rectal surgery has same outcomes when compared
with open?
• Comparison made based on
Pathological specimen(TME, CRM, Distal margin).(2015)
Disease free survival and local recurrences.(2018)

30. • The laparoscopic resection failed to meet the criterion for
noninferiority for pathologic outcomes compared with open
resection.
• For the modified intent-to-treat population, the 1-sided 95% CI for
the difference in rates was −10.8% to infinity , demonstrating that a
6% or greater decrease(or less than -6%) in the rate of successful
resection could not be excluded. The per-protocol analysis had
similar findings, with P for noninferiority = .41 and a 1-sided 95% CI of
−11.0% to infinity .
Discussion

31. • The possible explanation of the result favoring open
 Rigid laparoscopic instrument difficult to manipulate in narrow
pelvis.
• But, Two-year DFS and LR rates were not found to be different
between patients treated with laparoscopic and open.
• These results are reassuring for patients undergoing proctectomy via
a minimally invasive approach. (also for mis surgeons)
Discussion

32. • Positive CRM is the most important factor in the composite score of
an unsuccessful operation.
• APR was significantly related lower DFS, and higher LR than LAR and
LAR and CAA.
Discussion

33. Conclusion
• Among patients with stage II or III rectal cancer, the use of laparoscopic
resection compared with open resection failed to meet the criterion for
noninferiority for pathologic outcomes.
• Laparoscopic-assisted resection of rectal cancer was not found to be
significantly different to open resection of rectal cancer based on the
outcomes of DFS and local/regional recurrence.

34. Critical appraisal
• Multicentric study
• Randomized control trial
• Clear and informative title
• Objectives well explained and achievable
• Operation performed by qualified surgeon.
• Pathologist was blinded.
• Reasonable topic in this MIS ERA.
Strength of the study

35. • Methodology not well explained
 Complete open or lap mobilization plus open.
 Included hand assisted and robotic assisted in laparoscopic group.
 Neoadjuvant therapy protocol not well explained.
 Reason for altered surgical approach not explained.
 Reason for stoma not explained (why colo, why ileo).
 Nature of postoperative complications not explained.
• Discussion was not informative and was too vague.
• Their final result was contradicting.
Critical appraisal
WEAKNESS OF THE STUDY
• 2015 – failed to show noninferiority
• 2018 - showed noninferior
 Provides collective picture that their pathological
outcomes not associated with DFS and LR.

36. Literature review
Published in 2015 in JAMA
.March 2010 and November 2014.
.Twenty-six accredited surgeons from 24 sites in
Australia and New Zealand
.randomized 475 patients(237/238)
.T1-T3 rectal adenocarcinoma less than 15 cm
from the anal verge.
The primary endpoint was a composite of oncological factors
indicating an adequate surgical resection.
• A successful Resection in 194 patients (82%) in the laparoscopic and 208 patients (89%) in the open
surgery group (risk difference of −7.0% )
• The CRM was clear in 222 patients (93%) in Lap and in 228 patients (97%) in the open surgery group,
• The distal margin was clear in 236 patients (99%) in the lap and in 234 patients (99%) in the open.
• Total mesorectal excision was complete in 206 patients (87%) in the lap and 216 patients (92%) in the
open.
• The conversion rate from laparoscopic to open surgery was 9%.
CONCLUSIONS: Among patients withT1-T3 rectal tumors, noninferiority of laparoscopic surgery compared with open surgery
for successful resection was not established.
AUSTRALIA

37. Literature review
Lancet Oncol
2010
• April 4, 2006, and Aug 26, 2009
• cT3N0–2 mid or low rectal cancer
• open surgery (n=170) or laparoscopic surgery (n=170)
• Involvement of the circumferential resection margin, macroscopic quality of the total mesorectal
excision specimen, number of harvested lymph nodes, and perioperative morbidity did not differ
between the two groups.
• 1.2 % was the conversion rate
Interpretation Laparoscopic surgery after preoperative chemoradiotherapy for mid or low rectal cancer is
safe and has short-term benefits compared with open surgery; the quality of oncological
resection was equivalent.
KOREA (ASIA)

38. Literature reviewEUROPE Lancet Oncol 2013
• A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries.
• Rectal cancer within 15 cm from the anal verge
• Jan 20, 2004, and May 4, 2010
• 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364)
• Completeness of the resection was not different between groups [88%] VS
[92%] .
• Positive circumferential resection margin (<2 mm) was noted in (10%) in the
lap and (10%) in the open .
• Median tumour distance to distal resection margin did not differ significantly
between the groups .Interpretation In selected patients with rectal cancer treated by skilled surgeons, laparoscopic
surgery resulted in similar safety, resection margins, and completeness of
resection to that of open surgery, and recovery was improved after laparoscopic surgery.

39. CONCLUSION
• Laparoscopic surgery is safe alternative to open surgery in lower
rectal cancer.
• Laparoscopic surgery is comparable to open in terms of pathological
specimen adequacy, local recurrence and DFS in lower rectal cancer.
• Adequate training in colorectal surgery is baby step for proper TME
surgery of lower to mid rectal cancers.