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 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? Despite how common inguinal hernia repairs are the surgeon is faced with many unanswered questions in choosing the best procedure for their patients. First question is should an asymptomatic hernia even be fixed at all, in an elderly patient, probably not, younger patients I do fix them..

What is an open inguinal hernia repair? Tissue repairs Mesh repairs

Bassini repair 1887, McVay repair 1958, Shouldice repair 1940’s Tissue Repair

Prosthetics

“These are anterior 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%

Laparoscopy Laparoscopy early 1990’s

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

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?

THE DATA

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 Recurrences Complications 2060 Primary repairs and 343 recurrent Recurrences 3 (0.14%) Primary 8 (2.3 %) Recurrent Complications Urinary retention 0.3% Rutkow and Robins

TAPP Results Phillips 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)

Laparoscopic vs. Open Randomized Controlled Trial

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

Laparoscopic versus Open Randomized Controlled Trial

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 In recurrent Hernia repair 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 Daily Activities Sexual Activity Lap less painful 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 QALY and ICER $638 dollars more then open QALY and ICER Unilateral Lap- Cost effective Unilateral Recurrent Lap-Cost effective Bilateral Lap- Not cost effective

TEP versus Lichtenstein Randomized 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 Complications more common with 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 Review Laparoscopic 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

Cochrane Review Results Longer OR times for Laparoscopic Complications Visceral injuries Lap 0.3% Open 0.04% Vascular injuries Lap 0.3% Open 0.2% Length of Stay no different Return to full function quicker for laparoscopic

Cochrane Review Results Persistent Pain Lap 14% Open 19% Persistent Numbness Lap 7% Open 13% Recurrence Rate (p=0.16) Lap 3% Open 3%

Lessons Laparoscopic repair has less pain and quicker return to daily activity Comes with a cost Higher recurrence rate Higher major complication rate Very high Learning Curve

What should you do? Primary Unilateral Inguinal Hernia Open tension free Laparoscopic inguinal is acceptable Might be appropriate to overcome learning curve with more straight forward cases Watch recurrence rates carefully Makes more sense in young patients who will benefit from early return to full activity

What should you do? Bilateral or Recurrent Inguinal Hernia Open approach is acceptable if laparoscopic is not available Laparoscopic approach is ideal if you have the skills and experience

What should you do? Bottom line: The safest most durable repair you can.