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Laparoscopic versus Open Inguinal Hernia Repair. Michael J. Rosen MD, FACS Chief, Division of Gastrointestinal and General Surgery Director, Case Comprehensive Hernia Center University Hospitals of Cleveland Case Western Reserve Medical Center, Cleveland, Ohio. Objective.
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Laparoscopic versus OpenInguinal Hernia Repair Michael J. Rosen MD, FACS Chief, Division of Gastrointestinal and General Surgery Director, Case Comprehensive Hernia Center University Hospitals of Cleveland Case Western Reserve Medical Center, Cleveland, Ohio
Objective • What is an open inguinal repair • What is a laparoscopic inguinal hernia repair • What are reasonable outcome variables we should be using to compare these two techniques • What is the data? • WHAT SHOULD YOU BE DOING?
Take Home Message • There is no perfect operation for repairing inguinal hernias. • Excellent long term results are often more difficult to achieve then we admit. • Probably the best operation for your patient is the one you do best.
Controversies in Inguinal Hernia Repair • Repair or no repair? • Mesh or no mesh? • What kind of mesh? • Open or laparoscopic? • Extraperitoneal or intraperitoneal?
What is an open inguinal hernia repair? • Tissue repairs • Mesh repairs
Mesh or no mesh? • EU Hernia Trialists Collaboration • Meta-analysis • 58 Trials • 11,174 patients • Recurrence Rates • Mesh repair 2.0% • Non Mesh repair 4.9%
Types of laparoscopic inguinal hernia repairs • IPOM: Intra-Peritoneal Onlay Mesh repair • TAPP: Trans-Abdominal Pre-Peritoneal repair • TEP: Total Extra-Peritoneal repair
Anatomical Considerations of Inguinal Hernia Repair • Hernia sac reduction • Myopectineal orifice • Inguinal nerve anatomy
What are the appropriate outcome variables • Recurrence • Postoperative recovery • Cost • Groin pain • Learning curve
Recurrence • Physical exam • Ultrasound • CT • History • Asymptomatic • Cord Lipoma • Complete follow up????
Postoperative recovery • Discharge from hospital • Return to work • Self employed • Factory worker on disability • “Feeling better” • Return to full activity 85 vs 25 yo • Activity restrictions
Cost • To patient • To surgeon • To hospital • To surgery center • Indirect Costs • Direct Costs • To Society
Groin Pain • At rest • During full activity • Foreign body sensation • Severe disabling pain • Specific questionnaire • Sought out, or wait to determine if patient complains
Learning Curve • Understanding inguinal anatomy • Anterior • Posterior • Two handed laparoscopic skill set • Only if doing redo’s and bilateral • ? Harder group?
Lichtenstein • 4000 cases • 4 recurrences • Complications minor • <1% infection, seroma, hematoma • 1 testicular atrophy • 1 Chronic Neuralgia Amid, Shulman, Lichtenstein; Surgery Today 1995
Mesh Plug (PerFix) • 2403 repairs • 2060 Primary repairs and 343 recurrent • Recurrences • 3 (0.14%) Primary • 8 (2.3 %) Recurrent • Complications • Urinary retention 0.3% Rutkow and Robins
TAPP ResultsPhillips et al. Surg Endosc 95 1944 laparoscopic TAPP procedures Complication No. Recurrence 19(1%) Complications 141(7%) Hematoma 45 Neuralgia 35 Urinary Retention 20 Testicular Pain 11 Chronic Pain 6 SBO 4 Vasc. Injury 1
Technique Comparison Telik et al. 1994 1514 hernia repairs…..recurrence TAPP 553 0.7% TEP 457 0.4% IPOM 320 2.2% Plug & Patch 194 22%
TAPP vs TEP Millikan et al. 1994 Prospective randomized trial 60 TAPP, 60 TEP Recurrence rate - overall 1.7% TAPP 3.4% TEP 0.0% Ramshaw et al. 1996 300 TAPP, 300 TEP Recurrence 2.0% TAPP, 0.3% TEP Complications: 2 enterotomies in TEP (prior incisions)
Evidence • 507 open versus 487 Laparoscopic • More infections in open 1% • More pain in open • More seroma’s and hematoma’s in Lap • Faster return to normal activites in Lap Group • PROBLEM: only 3% of open inguinal hernias were tension free
VA Trial • 14 VA hospitals • 2164 Patients • 1696 completed 2 years of follow up
Methods • All repairs used mesh • Open – Lichtenstein • Laparoscopic • 90% TEP • 10% TAPP • Mesh size not standardized • Some mesh split, some not
Methods • Patients followed for two years • Physical exam performed by blinded surgeon • When recurrence detected it was confirmed by independent Surgeon
Results • Recurrence • Open 41/834 4.9% • Lap 87/862 10.1% • In recurrent Hernia repair • Open 11/78 14.1% • Lap 8/81 10.0%
Lap vs. Open “Experienced Surgeons”… Primary Repairs Recurrence at 2 years Open 4.1% Laparoscopic 5.1% Recurrent Hernias Recurrence at 2 years Open 17.2% Laparoscopic 3.6% Neumayer et al. NEJM 2004; 350: 1819-1827.
Results • Less Experienced Surgeons • Primary repair • Lap 12.3 % • Open 2.5 %
Learning Curve • Lap Chole 50 cases • Lap Gastric Bypass 75 – 100 • Lap Hernia 250 ???
Results • Complications 36% • Open 33.4 • Lap 39.0 • Intraoperative, Immediate postoperative and Life threatening complications significantly higher in Lap Patients
Results • Pain • Lap less painful • Daily Activities • Lap 4 days Open 5 days • Sexual Activity • 14 days both groups
VA Trial Analysis Outcome Measures Surgical Costs Postoperative Costs Quality adjusted life years (QALY) Incremental cost per QALY gained
QALY • Quality adjusted life years • Life expectancy + Quality of Life • Less pain, early return to normal activities favorable • Complications and recurrence rate have negative effect • 0= death • 1= perfect health
Incremental Cost Effectiveness Ratio • The cost of an additional year of life gained in perfect health • Most insurers and payers agree that $50,000 is acceptable
Results • Laparoscopic operative costs • $638 dollars more then open • QALY and ICER • Unilateral Lap- Cost effective • Unilateral Recurrent Lap-Cost effective • Bilateral Lap- Not cost effective
TEP versus LichtensteinRandomized Controlled Trial • Eker HH • Presented at American Surgical Association • 2010 meeting • N=660 • Erasmus Medical Center • Rotterdam Netherlands • Outcome: post op pain, recurrence, complications
Results • TEP • Less post op pain until 6 weeks • Reduced inguinal sensibility (7% v 30%) • Faster recovery of daily activities • Less absence from work • Complications more common with TEP • 6% v 2% • Recurrence and Costs EQUAL • Mean follow up 66 months
Cochrane Database ReviewLaparoscopic versus Open Inguinal Hernia • 41 published trials • 7161 patients • Sample size 38-994 • Follow up 6 weeks to 36 months McCormak et al. Cochrane Database Syst Rev 2003