Laparoscopic versus OpenLaparoscopic versus OpenInguinal Hernia RepairInguinal Hernia Repair

Michael J. Rosen MD, FACSMichael J. Rosen MD, FACS

Chief, Division of Gastrointestinal and General Chief, Division of Gastrointestinal and General SurgerySurgery

Director, Case Comprehensive Hernia CenterDirector, Case Comprehensive Hernia CenterUniversity Hospitals of ClevelandUniversity Hospitals of Cleveland

Case Western Reserve Medical Center,Case Western Reserve Medical Center,Cleveland, OhioCleveland, Ohio

ObjectiveObjective

• What is an open inguinal repairWhat is an open inguinal repair

• What is a laparoscopic inguinal hernia What is a laparoscopic inguinal hernia repairrepair

• What are reasonable outcome variables What are reasonable outcome variables we should be using to compare these we should be using to compare these two techniquestwo techniques

• What is the data?What is the data?

• WHAT SHOULD YOU BE DOING?WHAT SHOULD YOU BE DOING?

Take Home MessageTake Home Message

• There is no perfect operation for There is no perfect operation for repairing inguinal hernias.repairing inguinal hernias.

• Excellent long term results are often Excellent long term results are often more difficult to achieve then we admit.more difficult to achieve then we admit.

• Probably the best operation for your Probably the best operation for your patient is the one you do best.patient is the one you do best.

Controversies in Inguinal Controversies in Inguinal Hernia RepairHernia Repair

• Repair or no repair?Repair or no repair?

• Mesh or no mesh?Mesh or no mesh?

• What kind of mesh?What kind of mesh?

• Open or laparoscopic?Open or laparoscopic?

• Extraperitoneal or intraperitoneal?Extraperitoneal or intraperitoneal?

What is an open inguinal What is an open inguinal hernia repair?hernia repair?

• Tissue repairsTissue repairs

• Mesh repairsMesh repairs

Tissue Repair

Prosthetics

““These are anterior repairs”These are anterior repairs”

Mesh or no mesh?Mesh or no mesh?

• EU Hernia Trialists CollaborationEU Hernia Trialists Collaboration

• Meta-analysisMeta-analysis

• 58 Trials58 Trials

• 11,174 patients11,174 patients

• Recurrence RatesRecurrence Rates• Mesh repairMesh repair 2.0%2.0%• Non Mesh repairNon Mesh repair 4.9%4.9%

Laparoscopy

Types of laparoscopic inguinal Types of laparoscopic inguinal hernia repairshernia repairs

IPOM: Intra-Peritoneal Onlay Mesh repairIPOM: Intra-Peritoneal Onlay Mesh repairTAPP: Trans-Abdominal Pre-Peritoneal repair TAPP: Trans-Abdominal Pre-Peritoneal repair TEP: Total Extra-Peritoneal repairTEP: Total Extra-Peritoneal repair

Anatomical Considerations of Anatomical Considerations of Inguinal Hernia RepairInguinal Hernia Repair

• Hernia sac reductionHernia sac reduction

• Myopectineal orificeMyopectineal orifice

• Inguinal nerve anatomyInguinal nerve anatomy

What are the appropriate What are the appropriate outcome variablesoutcome variables

• RecurrenceRecurrence

• Postoperative recoveryPostoperative recovery

• CostCost

• Groin painGroin pain

• Learning curveLearning curve

RecurrenceRecurrence

• Physical examPhysical exam

• UltrasoundUltrasound

• CTCT

• HistoryHistory

• AsymptomaticAsymptomatic

• Cord LipomaCord Lipoma

• Complete follow up????Complete follow up????

Postoperative recoveryPostoperative recovery

• Discharge from hospitalDischarge from hospital

• Return to workReturn to work• Self employedSelf employed• Factory worker on disabilityFactory worker on disability

• ““Feeling better”Feeling better”

• Return to full activity 85 vs 25 yoReturn to full activity 85 vs 25 yo

• Activity restrictionsActivity restrictions

CostCost

• To patientTo patient

• To surgeonTo surgeon

• To hospitalTo hospital

• To surgery centerTo surgery center

• Indirect CostsIndirect Costs

• Direct CostsDirect Costs

• To SocietyTo Society

Groin PainGroin Pain

Groin PainGroin Pain

• At restAt rest

• During full activityDuring full activity

• Foreign body sensationForeign body sensation

• Severe disabling painSevere disabling pain

• Specific questionnaireSpecific questionnaire

• Sought out, or wait to determine if Sought out, or wait to determine if patient complainspatient complains

Learning CurveLearning Curve

• Understanding inguinal anatomyUnderstanding inguinal anatomy• AnteriorAnterior• PosteriorPosterior

• Two handed laparoscopic skill setTwo handed laparoscopic skill set

• Only if doing redo’s and bilateralOnly if doing redo’s and bilateral• ? Harder group?? Harder group?

THE DATATHE DATA

LichtensteinLichtenstein

• 4000 cases4000 cases

• 4 recurrences4 recurrences

• Complications minorComplications minor• <1% infection, seroma, hematoma<1% infection, seroma, hematoma• 1 testicular atrophy1 testicular atrophy• 1 Chronic Neuralgia1 Chronic Neuralgia

Amid, Shulman, Lichtenstein; Surgery Today 1995

Mesh Plug (PerFix)Mesh Plug (PerFix)

• 2403 repairs2403 repairs• 2060 Primary repairs and 343 recurrent2060 Primary repairs and 343 recurrent

• RecurrencesRecurrences• 3 (0.14%) Primary3 (0.14%) Primary• 8 (2.3 %) Recurrent 8 (2.3 %) Recurrent

• ComplicationsComplications• Urinary retention 0.3%Urinary retention 0.3%

Rutkow and Robins

TAPP ResultsTAPP ResultsPhillips et al. Surg Endosc 95Phillips et al. Surg Endosc 95

1944 laparoscopic TAPP procedures1944 laparoscopic TAPP proceduresComplicationComplication No.No.RecurrenceRecurrence 19(1%)19(1%)ComplicationsComplications 141(7%)141(7%)HematomaHematoma 4545NeuralgiaNeuralgia 3535Urinary RetentionUrinary Retention 2020Testicular PainTesticular Pain 1111Chronic PainChronic Pain 66SBOSBO 44Vasc. InjuryVasc. Injury 11

Technique ComparisonTechnique Comparison

Telik et al. 1994Telik et al. 1994

1514 hernia repairs…..recurrence1514 hernia repairs…..recurrence

TAPP 553TAPP 553 0.7% 0.7%

TEP 457TEP 457 0.4%0.4%

IPOM 320IPOM 320 2.2%2.2%

Plug & Patch 194Plug & Patch 194 22%22%

TAPP vs TEPTAPP vs TEP

Millikan et al. 1994Millikan et al. 1994

Prospective randomized trialProspective randomized trial

60 TAPP, 60 TEP60 TAPP, 60 TEP

Recurrence rate Recurrence rate - overall 1.7%- overall 1.7%

TAPP 3.4%TAPP 3.4% TEP 0.0%TEP 0.0%

Ramshaw et al. 1996Ramshaw et al. 1996

300 TAPP, 300 TEP300 TAPP, 300 TEP

Recurrence 2.0% TAPP, 0.3% TEPRecurrence 2.0% TAPP, 0.3% TEP

Complications: 2 enterotomies in TEP (prior Complications: 2 enterotomies in TEP (prior incisions)incisions)

Laparoscopic vs. OpenLaparoscopic vs. OpenRandomized Controlled TrialRandomized Controlled Trial

EvidenceEvidence• 507 open versus 487 Laparoscopic507 open versus 487 Laparoscopic

• More infections in open 1%More infections in open 1%

• More pain in openMore pain in open

• More seroma’s and hematoma’s in LapMore seroma’s and hematoma’s in Lap

• Faster return to normal activites in Lap Faster return to normal activites in Lap GroupGroup

• PROBLEM: only 3% of open inguinal PROBLEM: only 3% of open inguinal hernias were tension freehernias were tension free

Laparoscopic versus Open Laparoscopic versus Open Randomized Controlled TrialRandomized Controlled Trial

VA TrialVA Trial

• 14 VA hospitals14 VA hospitals

• 2164 Patients 2164 Patients

• 1696 completed 2 years of follow up1696 completed 2 years of follow up

MethodsMethods

• All repairs used meshAll repairs used mesh

• Open – LichtensteinOpen – Lichtenstein

• LaparoscopicLaparoscopic• 90% TEP90% TEP• 10% TAPP10% TAPP• Mesh size not standardizedMesh size not standardized• Some mesh split, some notSome mesh split, some not

MethodsMethods

• Patients followed for two yearsPatients followed for two years

• Physical exam performed by blinded Physical exam performed by blinded surgeonsurgeon

• When recurrence detected it was When recurrence detected it was confirmed by independent Surgeonconfirmed by independent Surgeon

ResultsResults

• RecurrenceRecurrence• Open Open 41/834 41/834 4.9%4.9%• Lap Lap 87/862 87/862 10.1%10.1%

• In recurrent Hernia repairIn recurrent Hernia repair• Open Open 11/78 11/78 14.1%14.1%• Lap Lap 8/81 8/81 10.0%10.0%

Lap vs. Open Lap vs. Open

Neumayer et al. NEJM 2004; 350: 1819-1827.Neumayer et al. NEJM 2004; 350: 1819-1827.

““Experienced Surgeons”…Experienced Surgeons”…

Primary RepairsPrimary Repairs Recurrence at 2 yearsRecurrence at 2 yearsOpenOpen 4.1%4.1%LaparoscopicLaparoscopic 5.1%5.1%

Recurrent HerniasRecurrent Hernias Recurrence at 2 yearsRecurrence at 2 yearsOpenOpen 17.2%17.2%LaparoscopicLaparoscopic 3.6%3.6%

ResultsResults

• Less Experienced Surgeons Less Experienced Surgeons

• Primary repairPrimary repair• Lap 12.3 %Lap 12.3 %• Open 2.5 %Open 2.5 %

Learning CurveLearning Curve

• Lap Chole 50 casesLap Chole 50 cases

• Lap Gastric Bypass 75 – 100Lap Gastric Bypass 75 – 100

• Lap Hernia 250 ???Lap Hernia 250 ???

ResultsResults

• Complications 36%Complications 36%

• Open 33.4Open 33.4

• Lap 39.0Lap 39.0

• Intraoperative, Immediate postoperative Intraoperative, Immediate postoperative and Life threatening complications and Life threatening complications significantly higher in Lap Patientssignificantly higher in Lap Patients

ResultsResults

• PainPain• Lap less painfulLap less painful

• Daily ActivitiesDaily Activities• Lap 4 days Open 5 daysLap 4 days Open 5 days

• Sexual ActivitySexual Activity• 14 days both groups14 days both groups

VA Trial AnalysisOutcome Measures

Surgical CostsPostoperative CostsQuality adjusted life years (QALY)Incremental cost per QALY gained

QALYQALY

• Quality adjusted life yearsQuality adjusted life years

• Life expectancy + Quality of LifeLife expectancy + Quality of Life

• Less pain, early return to normal Less pain, early return to normal activities favorableactivities favorable

• Complications and recurrence rate have Complications and recurrence rate have negative effectnegative effect

• 0= death0= death

• 1= perfect health1= perfect health

Incremental Cost Incremental Cost Effectiveness RatioEffectiveness Ratio

• The cost of an additional year of life The cost of an additional year of life gained in perfect healthgained in perfect health

• Most insurers and payers agree that Most insurers and payers agree that $50,000 is acceptable$50,000 is acceptable

ResultsResults

• Laparoscopic operative costsLaparoscopic operative costs• $638 dollars more then open$638 dollars more then open

• QALY and ICERQALY and ICER

• Unilateral Lap- Cost effectiveUnilateral Lap- Cost effective

• Unilateral Recurrent Lap-Cost effectiveUnilateral Recurrent Lap-Cost effective

• Bilateral Lap- Not cost effectiveBilateral Lap- Not cost effective

TEP versus LichtensteinTEP versus LichtensteinRandomized Controlled TrialRandomized Controlled Trial

• Eker HHEker HH

• Presented at American Surgical Presented at American Surgical AssociationAssociation

• 2010 meeting2010 meeting

• N=660N=660

• Erasmus Medical CenterErasmus Medical Center

• Rotterdam NetherlandsRotterdam Netherlands

• Outcome: post op pain, recurrence, Outcome: post op pain, recurrence, complicationscomplications

ResultsResults

• TEPTEP• Less post op pain until 6 weeksLess post op pain until 6 weeks• Reduced inguinal sensibility (7% v 30%)Reduced inguinal sensibility (7% v 30%)• Faster recovery of daily activitiesFaster recovery of daily activities• Less absence from workLess absence from work

• Complications more common with TEPComplications more common with TEP• 6% v 2%6% v 2%

• Recurrence and Costs EQUALRecurrence and Costs EQUAL• Mean follow up 66 monthsMean follow up 66 months

Cochrane Database ReviewCochrane Database ReviewLaparoscopic versus Open Laparoscopic versus Open

Inguinal HerniaInguinal Hernia• 41 published trials41 published trials

• 7161 patients7161 patients

• Sample size 38-994Sample size 38-994

• Follow up 6 weeks to 36 monthsFollow up 6 weeks to 36 months

McCormak et al. Cochrane Database Syst Rev 2003

Cochrane ReviewCochrane ReviewResultsResults

• Longer OR times for LaparoscopicLonger OR times for Laparoscopic

• ComplicationsComplications• Visceral injuriesVisceral injuries Lap 0.3% Open 0.04%Lap 0.3% Open 0.04%• Vascular injuriesVascular injuries Lap 0.3% Open 0.2%Lap 0.3% Open 0.2%

• Length of Stay no differentLength of Stay no different

• Return to full function quicker for Return to full function quicker for laparoscopiclaparoscopic

Cochrane ReviewCochrane ReviewResultsResults

• Persistent PainPersistent Pain• Lap 14%Lap 14% Open 19%Open 19%

• Persistent NumbnessPersistent Numbness• Lap 7%Lap 7% Open 13%Open 13%

• Recurrence Rate (p=0.16)Recurrence Rate (p=0.16)• Lap 3%Lap 3% Open 3%Open 3%

LessonsLessons

• Laparoscopic repair has less pain and Laparoscopic repair has less pain and quicker return to daily activityquicker return to daily activity

• Comes with a costComes with a cost

• Higher recurrence rate Higher recurrence rate

• Higher major complication rateHigher major complication rate

• Very high Learning CurveVery high Learning Curve

What should you do?What should you do?

• Primary Unilateral Inguinal HerniaPrimary Unilateral Inguinal Hernia• Open tension freeOpen tension free• Laparoscopic inguinal is acceptableLaparoscopic inguinal is acceptable

Might be appropriate to overcome learning curve Might be appropriate to overcome learning curve with more straight forward caseswith more straight forward cases

Watch recurrence rates carefullyWatch recurrence rates carefully Makes more sense in young patients who will Makes more sense in young patients who will

benefit from early return to full activitybenefit from early return to full activity

What should you do?What should you do?• Bilateral or Recurrent Inguinal HerniaBilateral or Recurrent Inguinal Hernia

• Open approach is acceptable if Open approach is acceptable if laparoscopic is not availablelaparoscopic is not available

• Laparoscopic approach is ideal if you have Laparoscopic approach is ideal if you have the skills and experiencethe skills and experience

What should you do?What should you do?

• Bottom line:Bottom line:

• The safest most durable repair you can.The safest most durable repair you can.