surgery for rectal cancer op3mizing outcomes · - picture from gordons principles and practice for...

SurgeryforRectalCancerOp3mizingOutcomes

Jose G. Trevino, MD FACS Assistant Professor

Department of Surgery

Disclosures

None

Thank you Dr. Atif Iqbal

Is Rectal Cancer a Different Beast?

Yes

Is Rectal Cancer a Different Beast? •  Anatomy

•  Complications specific to rectal surgery

•  How do we make a difference? •  National Rectal Cancer

Accreditation Program

Netters Atlas of Human Anatomy 2011

Complica3onsofPelvicSurgery•  Presacral bleeding

–  Presacral venous system

•  Autonomic nerve injury –  Urinary & sexual dysfunction

•  Superior hypogastric plexus and/or hypogastric nerve

•  Inferior hypogastric plexus and efferent pathways

Orkin BA. Rectal carcinoma: treatment. In: Beck DE, Wexner SD, eds. Fundamentals of Anorectal Surgery. New York: McGraw-Hill; 1992:260–369

- Picture from Gordons Principles and Practice for surgery of the Colon Rectum and Anus. Third edition

Complica3onsofPelvicSurgery•  Presacral bleeding •  Autonomic nerve injury •  Local recurrence

•  Significant problem: –  Circumferential Resection Margin (CRM) +ve pts à 12 times

higher local recurrent rates 1 à 3 times higher mortality

•  How to decrease it?

–  TME dissection: CRM positivity (25% à 7%)

1. Kusters et al. Patterns of local recurrence in rectal cancer; a study of the Dutch TME trial. EJSO Volume 36, (5)2010, 470–476

Complica3onsofPelvicSurgery•  Bleeding •  Autonomic nerve injury •  Local recurrence •  Ureteral injury

DifferencesinPelvicSurgery•  Bleeding •  Autonomic nerve injury •  Local recurrence •  Ureteral Injury •  Higher costs

–  OR time •  LARs and APRs take longer than colectomies

–  Complications •  Specific to operating in the pelvis •  Approx. $80/min •  OR time adds up

Haug U, Engel S, Verheyen F, Linder R (2014) Estimating Colorectal Cancer Treatment Costs: A Pragmatic Approach Exemplified by Health Insurance Data from Germany. PLoS ONE 9(2): e88407.

DifferencesinPelvicSurgery•  Bleeding •  Autonomic nerve injury •  Local recurrence •  Ureteral injury •  Higher costs •  Longer OR times •  Quality of care? (Inherent)

–  Longer LOS –  Readmissions (dehydration) –  SSIs –  UTIs

Cananythinghelp?•  TME

Cananythinghelp?•  TME •  Laparoscopy

2 Prospective RCT’s since last year: –  ACOSGO Z6051 Trial:

•  Successful resection (82% of lap and 87% of open cases) •  Negative circumferential resection margin in 90% overall (88% of

lap and 92% of open) •  RESULT: Laparoscopic resection compared to open resection

FAILED to meet the criteria for non-inferiority for pathologic outcomes

–  ALaCart Study: •  Successful resection in 82% lap vs. 89% open cases •  Negative CRM margin in 93% lap and 97% open cases •  RESULT: Non-inferiority of laparoscopic surgery was NOT

established

•  Fleshman et al. JAMA 2015 Oct • Stevenson AR et al. JAMA 2015 Oct

Cananythinghelp?•  TME •  Laparoscopy •  Robotic surgery

Robotic vs. Lap: –  Does DaVinci help in the pelvis? à Maybe (Only 1 RCT (n=66) & few meta-analysis):

–  Lower EBL & No difference in OR time in the LAR subset ONLY

Bianchi et al. Laparoscopic and robotic total mesorectal excision in the treatment of rectal cancer. Brief review and personal remarks. Frontiers in Oncology 2014; 4 (98)

Study Conversion % p

Hospital days p

Complication % p

Rob Lap Rob Lap Rob Lap

Kim/ Kang 2 3 1 11.7 14.4 0.001 20 27 0.4

Kwak 0 3.4 0.4 - - - 32 27 NS

Baek 7.3 2.2 0.116 6.5 6.6 0.8 22 27 1

Bianchi 0 4 NA 6.5 6 0.4 16 24 0.5

Baik 0 10.5 0.01 5.7 7.6 0.001 11 19 0.02

Patriti 0 19 0.05 11.9 9.6 0.05 31 19 0.05

Cananythinghelp?•  TME •  Laparoscopy •  Robotic surgery •  Ureteral stents

Cananythinghelp?•  TME •  Laparoscopy •  Robotic surgery •  Ureteral stents •  Newer techniques

•  Transanal TME –  Distal third of rectum

• 

•  Role in ‘difficult pelvis’ patients to provide sphincter saving option?

Cananythinghelp?•  TME •  Laparoscopy •  Robotic surgery •  Ureteral stents •  Newer techniques •  Case volumes

•  Significantly more low volume surgeons performed open TME

•  Significantly more high volume surgeons: •  Identified autonomic nerves during dissection (p<0.001) •  Visualized ureters (p<0.001) –  Significantly less time to do the anastomosis –  Had significantly less conversion rates for lap cases

Cheung YM. Surg Endosc. 2009 Dec;23(12):2796-801. Current technique of laparoscopic total mesorectal excision (TME): an international questionnaire among 368 surgeons.

Clinicalprac3cevolumes&outcomes

•  Cochrane review for CRS cases & volumes: –  54 studies with 943,728 pts (51 meta-analysis)

•  Addressed volume-outcome relationship in CRS

–  High volume hospitals –  High volume surgeons –  Colorectal trained surgeons

–  Significantly improved 5 yr survival –  Significantly improved operative mortality –  Significantly lower rates of ostomies and APRs

Shah PR, Joseph A, Haray PN (2005) Laparoscopic colorectal surgery: learning curve and training implications. Postgrad Med J. 81(958):537–540

Clinicalprac3cevolumes&outcomes

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LapAPROpenAPR

Cananythinghelp?•  TME •  Laparoscopy •  Robotic surgery •  Ureteral stents •  Newer techniques •  Case volumes •  A specialized surgeon?

•  Colorectal specialization: –  Edmond, Canada Registry:

•  683 patients, 52 surgeons

•  Improved local recurrence rates and disease-specific survival •  Upheld in multivariate analysis, controlling for confounding variables

SpecializedSurgeon?

VariableColorectalTrained

Pvalue+ -

Lowandmidrectalcancer(%) 71% 62% <0.001

Lowanteriorresec3ons(%) 61% 26% <0.001

Abdominoperinealresec3ons(%) 27% 47% <0.001

Porter et al. Ann Surg 1998

•  Colorectal specialization: –  Patients operated on by General Surgeon were 3.42 times more likely

to develop a local recurrence than those operated on by Colorectal Surgeons

SpecializedSurgeon?

-  Harmon et al. Ann Surg 1999 -  Dorrance et al. Dis Colon Rectum 2000

•  Colorectal specialization •  Good TME dissection à Circumferential margin •  Distal resection margin •  Reconstructive techniques •  High volume •  Other considerations:

–  Type of resection (Lap, Robotic, Transanal endoscopic microsurgery TEM)

–  No resection (complete clinical response CR) –  Timing of resection

SpecializedSurgeon?

Cananythinghelp?•  TME •  Laparoscopy •  Robotic Surgery •  Ureteral stents •  Newer techniques •  Case volumes •  A specialized surgeon •  Quality Improvement Projects

–  Ileostomy related morbidity reduction

QualityImprovementProjects

•  Dehydration after ileostomy creation is the most common indication for readmission.

•  It affects: –  Length of Stay –  Readmission –  Reimbursement à era of assessment of quality and outcome measures

•  Historic rates range from 10% to 40%

TheIssue

• MeanLOS:17days• LOSIndex:2.4• Readmissionrate:65%

2011 2012

IleostomyPhoneCallProtocolIns3tuted

Quality-metricoutcomecomparisonofpreandpost-interven:ongroups:Pre-

Interven:onPost-

Interven:onpvalue

Allileostomypa:ents:

-30-dayreadmissionrate(%) 65% 16% 0.004Readmissionpopula:on:

RESULTS

4.3

3

2.5

3

3.5

4

4.5

Pre-Intervention Post_Intervention

LengthofStay(days)

CostAnalysisfortheinterven:on:

*AssumestheaveragewageofaNursePrac33onerinFloridabeing$87,653perannumwith2,000workinghours/yearand~15minutes/dayrequiredtocompletetheques3onnaire

Costanalysis Cost/annumOverallCostSavings

CostReduc:on:

$63,821

- 49%decreaseinre-admissions $48,821- >1daydecreaseinhospitalstayfor

readmissions $15,000

Costofadministra:on:

Costofadministeringques:onnairethroughNursePrac::onersinthefuture:

$2,030* $61,791

OpportunityCostGain:

Poten:algainbytheupstreamchoiceofanalterna:veinthefreedhospitalbeds $112,114

TotalCostSavings: $173,905

Timeline

• MeanLOS:17days• LOSIndex:2.4• Readmissionrate:65%

2011 2012

• MeanLOS:12.3days• LOSIndex:1.33• Readmissionrate:29%

IleostomyPhoneCallProtocolIns3tuted

Timeline

•MeanLOS:17days• LOSIndex:2.4•Readmissionrate:65%

2011 2012 Jan2015 Oct2016

•MeanLOS:12.3days• LOSIndex:1.33•Readmissionrate:29%

•MeanLOS:7.8days• LOSIndex:0.94•Readmissionrate:*

•MeanLOS:4.8days• LOSIndex:0.58•Readmissionrate:30%

Post-operativePhoneCallProtocolInstituted

EarlyDCProtocol(PICCline+IVF)Instituted

ERASProtocolInstituted

Dec2015

•MeanLOS:11.7days• LOSIndex:1.07•Readmissionrate:28%

Timeline

•MeanLOS:17days• LOSIndex:2.4•Readmissionrate:65%

2011 2012 Jan2015 Oct2016

•MeanLOS:12.3days• LOSIndex:1.33•Readmissionrate:29%

•MeanLOS:7.8days• LOSIndex:0.94•Readmissionrate:*

•MeanLOS:4.8days• LOSIndex:0.58•Readmissionrate:30%

Post-operativePhoneCallProtocolInstituted

EarlyDCProtocol(PICCline+IVF)Instituted

ERASProtocolInstituted

Dec2015

•MeanLOS:11.7days• LOSIndex:1.07•Readmissionrate:28%

Timeline

• MeanLOS:17days• LOSIndex:2.4• Readmissionrate:65%

2011 2016

• MeanLOS:5days• LOSIndex:0.58• Readmissionrate:30%

• LOSforReadmission:13.7days• Dehydra3on-relatedreadmissionrate:65%• %ofreadmissionsduetodehydra3on:80%• Meancost(Indexprocedure):$49,359• Meancost(Readmission):$88,858

• LOSforReadmission:3.8days• Dehydra3on-relatedreadmissionrate:12%• %ofreadmissionsduetodehydra3on:37%• Meancost(Indexprocedure):$22,030• Meancost(Readmission):$19,588

Cananythinghelp?•  TME •  Laparoscopy •  Robotic Surgery •  Ureteral stents •  Newer techniques •  Case volumes •  A Good Surgeon •  Quality Improvement Projects

–  Ileostomy related morbidity reduction –  Prediction of difficult cases

Predic3onofa‘difficult’pelviccase•  20 cases each of ‘Routine’ and ‘Difficult’ pelvic dissections:

–  Significant findings

Routine n (%)

Difficult n (%) p value

Males 6(30%) 14(70%) 0.01BMI >30 1(11%) 8(89%) 0.008Any Preop Radiation 11(42%) 15(58%) 0.3

XRT within 3 months 9 (60%) 6 (40%) 0.5

XRT beyond 3 months 2 (18%) 9 (82%) 0.03

EBL (mL) 271 746 0.01

Hospital Stay (days) 7.4 11.3 0.02

OR time

< 5 hrs 8(80%) 2(20%)0.02

> 5 hrs 12(40%) 18(60%)

Measurements Routine (mean)

Difficult (mean) p value

PelvicInlet

AP(mm) 127 101 <0.00001

Lat(mm) 125 89 <0.00001

Pelvicoutlet

AP(mm) 108 81 <0.00001

Lat(mm) 107 80 <0.00001

MidPelvis

AP(mm) 129 100 <0.00001

Lat(mm) 116 91 <0.00001

PelvicVolume

Bonyvolume(cm3) 535 383 <0.00001

Soj3ssuevolume 348 165 <0.00001

PelvicLength

Promtococcyx(mm) 125 134 0.06

Promtopelvicfloor 123 140 <0.00001

PelvicDepth

Anterior(mm) 40 45 0.08

Posterior(mm) 125 134 0.06

Sacrococcygealcurve(mm) 128 189 <0.00001

Pubistolevators(mm) 49 58 0.002

Anorectalangle 132 116 0.001

Rectalmassdiameter(mm) 37 34 0.2

Results:Predic3onModel•  Made a practical prediction model for a difficult pelvic case:

–  We chose 3 easily acquired factors with the strongest association with a ‘Difficult case’. A model was reached where p<0.00001, R2 (co-efficient of determination) was 0.98

–  Called it ‘Pelvic Surgery Difficulty Index’ (PSDI)

PSDI Score p value

Male sex 1

<0.0001 History of neoadjuvant XRT 1

Length from promontory to pelvic floor > 130 mm 1

Total score Maximum of 3

Valida3onofPredic3onModel•  Validated in another cohort of 347 patients

•  Higher scores were significantly associated with: –  Increased blood loss (0=211 ml vs. 3=412 ml) –  Longer operative time (0=217 min vs 3=289 min) –  Longer hospital stay (0=6 days vs 3=10.8 days) –  Higher postoperative morbidity:

•  More autonomic nerve injury: –  Sexual dysfunction –  Short and long-term urinary dysfunction

•  ? Higher Cost ($13,433 vs $30,442, p=0.06)

•  Validated PSDI model: –  High sensitivity (0.95) and specificity (0.90) –  Goodness of fit tests (Pearson and Deviance) being insignificant, demonstrating

a well-fitting model (p<0.0001)

Cananythinghelp?•  TME •  Laparoscopy •  Robotic surgery •  Ureteral stents •  Newer techniques •  Case volumes •  A Good Surgeon? •  Quality Improvement Projects

–  Ileostomy related morbidity reduction –  Prediction of difficult cases –  Re-admission prediction model

Re-admissionpredic3onmodel•  All ileostomy pts from 2013-2016 (86 patients):

–  26% re-admitted –  Mean cost of re-admission: $13,839

–  Major cause of re-admission was ‘dehydration’ from: 1.  High ileostomy output (45%) 2.  Ileus (18%)

–  Factors associated with re-admission: •  Baseline steroid use •  History of diabetes •  History of depression •  Complications of bowel obstruction and high ostomy output during the index admission •  Lack of postoperative ostomy teaching •  Lack of discharge planning by social workers •  Discharge with a PICC line

Re-admissionpredic3onmodel•  Predictive model to stratify patient’s risk of readmission after the index procedure was

developed:

•  Sensitivity: 73% and specificity: 77% •  Modification of the variables identified may help decrease the

readmission rate: –  Preoperative weaning of steroid use –  Better preoperative control of comorbidities –  Dedicated postoperative ostomy teaching and –  Ensuring social work participation in discharge planning

Cananythinghelp?•  TME •  Laparoscopy •  Robotic Surgery •  Ureteral stents •  Newer techniques •  Case volumes •  A Good Surgeon •  Quality Improvement Projects •  Clinical Trials

ClinicalTrialsPROSPECT Trial: TNT Trial:

•  Why? –  All the reasons mentioned already

Na3onalCoCAccreditedRectalCancerCentersofExcellence

•  Why? –  All the reasons mentioned already –  Multi-disciplinary effort:

•  GI •  Radiology à MRI •  Med Onc •  Rad Onc à Preoperative Radiation Therapy •  Pathology •  Surgery

Na3onalCoCAccreditedRectalCancerCentersofExcellence

•  Why? •  Radiology à MRI •  MRI: Potential CRM involvement can be demonstrated on

preoperative MRI à Highly correlated with histological specimen

Na3onalCoCAccreditedRectalCancerCentersofExcellence

MRI-involvedCRM

MRI-clearCRM Pvalue

5yroverallsurvival 42% 62% <0.01

5yrdiseasefreesurvival 47% 67% <0.05

Localrecurrence 20% 7% <0.001

Taylor et al. Am J Clin Oncol 2014 CRM and Preoperative MRI

•  Why? –  All the reasons mentioned already –  Multi-disciplinary effort –  Poor state of Rectal Cancer care in the US:

Na3onalCoCAccreditedRectalCancerCentersofExcellence

•  Poor state of Rectal Cancer care in the US: –  Vast majority of surgery for rectal cancer performed by non-specialists

in low volume hospitals

–  Rates of permanent colostomy variable and excessive1: •  40% surgeons ONLY performed APRs (nonrestorative resections) !!! •  APR surgeons had higher mortality rates and longer lengths of stay •  Restorative (LAR) surgeons were specialized by virtue of more pouch and

anorectal procedures •  Another study with data from 21 states showed 50% cases were APR’s with

only 20% of counties had colostomy rates of <40%2

–  Suboptimal adherence to evidence based guidelines

–  Oncologic outcomes are very poor compared to Europe

Na3onalCoCAccreditedRectalCancerCentersofExcellence

1.  Ricciardi et al. Dis Colon Rectum 2011 2.  Ricciardi et al. Dis Colon Rectum 2010

•  Why? –  All the reasons mentioned already –  Multi-disciplinary effort –  Poor state of Rectal Cancer care in the US –  Europe: Been there, done that !

Na3onalCoCAccreditedRectalCancerCentersofExcellence

•  European story à Results: –  Lower rates of LR and permanent colostomy –  More patients receiving evidence based care with adherence to

guidelines –  Increased recruitment to clinical trials –  Improved monitoring of standards and outcomes –  Rectal Cancer outcomes now exceed those of Colon Cancer in Europe

Na3onalCoCAccreditedRectalCancerCentersofExcellence

1.  Khani & Smedh et al. Colorectal Dis 2010 2.  Burlow et al. Colorectal Dis 2010 3.  Ortiz H et al. Colorectal Dis 2013

•  Where are we? –  OSTRICH:

•  Consortium for Optimizing Surgical Treatment of Rectal Cancer •  Established in 2011 •  Broad representation of pertinent societies:

–  ACS, CoC, ASCRS, SSO, SSAT, SAGES, CAP, ACR •  Highlighted the need for Rectal Cancer COE through multiple publications

and collaborations

Na3onalCoCAccreditedRectalCancerCentersofExcellence

•  Where are we at UF? –  UF à OSTRICH Member

–  Established standardized evidence based protocols for Rectal Cancer: •  Pathology reporting •  MRI reporting •  Treatment algorithms

–  Leading a multi-disciplinary effort: •  > 6 Departments •  To establish RC-COE at UF

Na3onalCoCAccreditedRectalCancerCentersofExcellence

THANKYOU