Laparoscopic Versus Robotic Versus Open Surgery for Rectal Cancer


(a)

Patient population

Intervention

Comparator

Outcomes studied
 
Rectal cancer, post neoadjuvant chemo-radiotherapy

Laparoscopically performed TME

Open TME

Procedure related morbidity

Length of stay, complications – grade 3/4/5, anastomotic leak, reoperation

Oncologic

CRM involvement, distal resection margin involvement, distance to CRM, distance to distal resection margin, LN yield, completeness of TME

Disease specific survival, overall survival, local recurrence

(b)

Patient population

Intervention

Comparator

Outcomes studied
 
Rectal cancer, post neoadjuvant chemo-radiotherapy

Robotically performed TME

Laparoscopically performed TME

Procedure related

Length of stay, complications – grade 3/4/5, anastomotic leak, reoperation, cost, open conversion

Oncologic

CRM involvement, distal resection margin involvement, distance to CRM, distance to distal resection margin, LN yield, completeness of TME

Disease specific survival, overall survival, local recurrence





 

  • B.


    Compared with laparoscopic surgery, does robotic-assisted surgery result in better outcomes after rectal cancer treatment? (Table 46.1b)

     





      Methods/Search Strategy

      Studies reporting short- and long-term results for rectal cancer surgery in which a proportion of patients received neoadjuvant treatment were reviewed. Rectal cancer was defined as a tumor 15 cm or less from the anal verge. Laparoscopic surgery was defined as completion of the pelvic dissection using laparoscopic instruments. Non-conventional laparoscopic techniques were excluded (e.g., hand-assisted or single-port surgery). Robotic surgery was defined as completion of the pelvic dissection using a robotic platform. PubMed, Ovid, Web of Science and Cochrane databases were searched using terms “rectal cancer”, “laparoscopy”, “open”, “robot”, and “robotic” for studies up to December 1, 2015. We sought to review the highest quality evidence with emphasis on Level 1/2 data. For comparison (A), five multicenter RCTs have reported data pertinent to this question and therefore the meta-analysis focused on their results. For comparison (B), no prospective randomized data is available. If multiple reports were published from one institution, the most recent series was evaluated.


      Results: (A): Laparoscopic Surgery Versus Open Surgery for Rectal Cancer



      Description of Studies

      Five multicenter RCTs have been undertaken to evaluate laparoscopic surgery versus open surgery in rectal cancer: the CLASICC, COREAN, COLOR II, ACOSOG Z6051 and ALaCaRT trials [15]. Trial characteristics and results are summarized in Table 46.2. Long-term outcomes are reported by CLASICC, COREAN and COLOR II. Each trial was designed with a slightly different rationale for power calculation and outcome reporting. CLASICC recruited 413 colon and 381 rectal cancer patients and was powered not by an outcome assessment; but on the need to evaluate laparoscopic colorectal surgery in a trial setting by examining differences between treatment arms for a range of endpoints [1]. The COREAN trial recruited 170 patients per arm with tumors ≤10 cm from the anal verge after neoadjuvant chemoradiotherapy [2]. The trial assessed non-inferiority of laparoscopic surgery based on 3-year disease-free recurrence. COLOR II recruited 1044 patients (699 laparoscopic vs. 345 open) with tumors ≤15 cm from the anal verge to assess non-inferiority of laparoscopic surgery based on 3-year local recurrence rates [3]. ACOSOG Z6051 recruited 462 patients (240 laparoscopic vs. 222 open) with tumors ≤12 cm from the anal verge after neoadjuvant treatment [4]. The trial was powered to detect non-inferiority of laparoscopic surgery based on a composite pathological endpoint: completeness of TME, negative circumferential margin (CRM) and negative distal resection margin (DRM). ALaCaRT had a similar design, recruiting 475 patients (238 laparoscopic vs. 237 open) with tumors ≤15 cm from the anal verge to assess non-inferiority of laparoscopic surgery based on a composite pathological endpoint [5].


      Table 46.2
      Perioperative and oncologic outcomes from published multicenter randomized controlled trials comparing laparoscopic versus open surgery for rectal cancer (laparoscopic/open)
































































































































































































































































      Trial

      CLASICC (Rectal cancers)

      COREAN

      COLOR II

      ACOZOG Z6051

      ALaCaRT

      Design

      Phase 3 multicenter RCT

      Non-inferiority phase 3 multicenter RCT

      Non-inferiority phase 3 multicenter RCT

      Non-inferiority phase 3 multicenter RCT

      Non-inferiority phase 3 multicenter RCT

      Number of centers

      27

      3

      30

      35

      24

      Location

      United Kingdom

      South Korea

      Europe

      North America

      Australia and NZ

      Number (lap/open)

      253/128 (ITT)

      160/132 (ATG)

      170/170

      699/345

      240a/222

      238/235

      Time period

      1996–2002

      2006–2009

      2004–2010

      2008–2013

      2010–2014

      Site of tumors
       
      Mid-low rectum <10 cm from AV

      ≤15 cm of AV

      ≤12 cm from AV

      Within 15 cm of AV

      Treatment group

      Lap

      Open

      Lap

      Open

      Lap

      Open

      Lap

      Open

      Lap

      Open

      % receiving neoadjuvant treatment

      58

      60

      100

      100

      59

      58

      100

      100

      50

      49

      BMI median (meanb)

      26

      25b

      24.1

      24.1

      26.1

      26.5b

      26.4

      26.8b

      27

      26

      Perioperative outcomes

      Conversion

      34
       
      1
       
      16
       
      11
       
      9
       

      LOS (days)

      11

      13

      8

      9

      8

      9

      7.3

      7.0

      8

      8b

      Mean operative time (min)
       
      244

      197

      240

      188

      266

      220

      210

      190b

      Complications

      Grade 3/4 (%)

      Grade 5 (%)
       
      0.0

      0.0

      1.1

      1.7

      21.7

      0.8

      21.1

      0.9

      18.5

      0.4

      26.4

      0.8

      Anastomotic leak (%)

      10

      7

      1.2

      0

      13

      10

      2.1

      2.3

      3

      3

      Reoperation (%)
       
      1.8

      1.8

      6

      6

      5

      2.3
       

      Oncological outcomes

      CRM negative ≤1 mm (%)

      84

      86

      97.1

      95.9

      93

      91

      87.9

      92.3

      93

      97

      DRM negative (%)

      No difference
         
      98.3

      98.2

      99

      99

      Complete/nearly complete TME (%)
       
      91.8

      88.2

      97

      98

      92.1

      95.1

      97

      99

      Composite endpoint
           
      82

      87

      82

      89

      Mean LN yield
       
      17

      18

      13

      14

      17.9

      16.5
       

      Distance DRM (mm)
       
      20

      20

      30

      30b

      32

      31b

      26

      30

      Distance to CRM (mm)
       
      9

      8

      10

      10b

      10.5

      12.8b

      10

      12

      3 year DFS

      OS

      LR

      70.9

      74.6

      9.7

      70.4

      66.7

      10.1

      79.2

      91.7

      2.6

      72.5

      90.4

      4.9

      74.8

      86.7

      5.0

      70.8

      83.6

      5.0
         


      Data presented as median unless otherwise stated

      RCT randomized controlled trial, NZ New Zealand, TME total mesorectal excision, AV anal verge, BMI body mass index, LOS length of stay, ITT intention to treat, ATG actual treatment group, CRM circumferential resection margin, DRM distal resection margin, LN lymph node, DFS disease free survival, OS overall survival, LR local recurrence

      aIncludes 34 Robot assisted procedures

      bMean


      Short Term Outcomes



      Length of hospital stay (LOS)

      No differences in LOS were seen in the COREAN, ACOSOG Z6051, or ALaCaRT trials. In contrast, CLASICC and COLOR II reported lower LOS in the laparoscopic group (CLASICC: 11 vs. 13 days; COLOR II: 8 vs. 9 days). The COREAN trial demonstrated a trend towards reduced LOS in the laparoscopic arm (8 vs. 9 days P = 0.056), but unlike ALaCaRT and ACOSOG Z6051, consistently better short-term outcomes were also observed for the laparoscopic group (e.g. earlier passing of flatus, earlier defecation, and resumption of normal diet). The equivocal short-term outcomes for treatment groups in ACOSOG Z6051 and ALaCaRT may relate to the use of hybrid approaches permitted in the open arms.


      Complications, Anastomotic Leak and Reoperation Rates

      Clavien-Dindo grade 3/4/5 complication were comparable for open and laparoscopic surgery in the ACOSOG Z6051 and ALaCaRT trials. The COREAN and COLOR II trials reported similar rates of infectious and noninfectious complications and short-term mortality in each trial arm. CLASICC reported higher perioperative morbidity and mortality in patients converted from laparoscopic to open surgery. Complication rates for laparoscopic, open and converted rectal cancer operations were 32 %, 37 % and 59 %, respectively. No trial reported a difference in anastomotic leak or reoperation rates.


      Short Term Outcomes Summary

      Mean LOS after rectal cancer surgery ranged from 7 to 9 days across the treatment arms. Although two trials reported reduced LOS with laparoscopic surgery, we conclude that LOS is comparable for each approach. Rates of complications, anastomotic leaks and reoperation are also equivocal.


      Conclusion

      The assessed short-term outcomes are comparable for laparoscopic and open surgery.

      GRADE: HIGH QUALITY


      Oncologic Outcomes



      Circumferential resection margin involvement

      Excepting CLASICC, all trials reported non-involved CRM rates in excess of 87 %, underlining the technical skills of the surgeons participating in this study. No trial was powered based solely on CRM assessment. Clear CRM rates were comparable in all five trials (Table 46.2). In a subgroup analysis of anterior resections, CLASICC reported a nonsignificant trend towards higher CRM involvement for laparoscopy (12 % vs. 6 % based on 16 positive CRMs in 129 laparoscopic versus 4 positive CRMs in 64 open resections). Distance to CRM was comparable in COREAN, COLOR II and ALaCaRT. However, ACOSOG Z6051 reported reduced distance to CRM with laparoscopy (10.8 vs. 12.8 mm, P = 0.03).


      Distal margin

      DRM involvement was low (1–2 %) and incidence was equivalent where it was reported (Table 46.2) [1, 4, 5].


      Complete/nearly complete TME

      No differences in rates of complete/nearly complete TME were reported where this outcome was assessed (Table 46.2) [15].


      Composite pathological outcomes

      Both ACOSOG Z6051 and the ALaCaRT trials used a composite pathological assessment as their primary outcome measure. Both trials were powered based on the assumption that 90 % of rectal cancer resections are oncologically complete (CRM negative, DRM negative, and complete/nearly complete TME). ACOSOG Z6051 stated non-inferiority would be declared if the lower border of the 95 % CI for difference between groups was >6 %. ALaCaRT set a similar non-inferiority threshold of >8 %. In ACOSOG Z6051, a complete specimen was achieved in 81.7 % of laparoscopic versus 86.9 % of open resections (5.2 % difference, lower bound 95 %, CI −10.8). For ALaCaRT, a complete specimen was achieved in 82 % of laparoscopic versus 89 % of open resections (7.0 % difference, lower bound 95 %, CI −12.4). For each trial, non-inferiority was not established.

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    1. Aug 23, 2017 | Posted by in ABDOMINAL MEDICINE | Comments Off on Laparoscopic Versus Robotic Versus Open Surgery for Rectal Cancer

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