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Do All Minimally Symptomatic Men Need to Have Their Inguinal Hernias Repaired? Management of the Asymptomatic Inguinal H

Do All Minimally Symptomatic Men Need to Have Their Inguinal Hernias Repaired? Management of the Asymptomatic Inguinal Hernia. Robert J. Fitzgibbons MD, FACS Harry E. Stuckenhoff Professor of Surgery Creighton University School of Medicine Omaha, Nebraska USA

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Do All Minimally Symptomatic Men Need to Have Their Inguinal Hernias Repaired? Management of the Asymptomatic Inguinal H

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  1. Do All Minimally Symptomatic Men Need to Have Their Inguinal Hernias Repaired? Management of the Asymptomatic Inguinal Hernia Robert J. Fitzgibbons MD, FACS Harry E. Stuckenhoff Professor of Surgery Creighton University School of Medicine Omaha, Nebraska USA Turkish Chapter of the American College of Surgeons Sunday June 3, 2007 Istanbul

  2. In 2007Inguinal Hernia Repair: • Has a Low Recurrence Rate • Is an Outpatient Procedure • Can be Performed Under Local Anesthesia • Is Associated with an Uneventful Recovery in Most Sunday June 3, 2007 Istanbul

  3. Most North American Surgeons Have been Taught That The Indication for Elective Inguinal Herniorrhaphy = The Presence of a Hernia! Regardless of Symptoms Sunday June 3, 2007 Istanbul

  4. Annual Inguinal Herniorrhaphy Rate • US 2800 Per Million • UK 1000 Per Million Sunday June 3, 2007 Istanbul

  5. So the Arguments Go Like This: • Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Too High • The Mortality Rate Associated with a Hernia Accident is Unacceptable • Progression is Inevitable, • Incarceration and or Strangulation is Likely • Operation Becomes More Difficult the Longer it is Delayed Sunday June 3, 2007 Istanbul

  6. Patient Scenario • 65 Year Old Healthy Male With a Unilateral, Easily Reducible Inguinal Hernia • He has No Symptoms and Has Not Had to Alter His Lifestyle in Any Way But His Wife is Worried About His Visible Bulge • He is Retired but Physically Active Sunday June 3, 2007 Istanbul

  7. Surgical Counseling The Dreaded Complication • A Hernia Accident • Strangulation • Bowel Obstruction Sunday June 3, 2007 Istanbul

  8. Surgical Counseling • The Hernia will Inevitably Progress • There Will be a Penalty to Pay in Terms of Recurrence and Complications Because Hernias Become More Difficult to Repair the Longer They Remain Unrepaired • Don’t Wait Until Your Health Declines! Sunday June 3, 2007 Istanbul

  9. Chronic Groin Pain Sunday June 3, 2007 Istanbul

  10. Annals of Surgery 244(2), August 2006 Sweden Sunday June 3, 2007 Istanbul

  11. Fränneby and Others. Annals of Surgery 244(2), August 2006Sweden • Swedish Hernia Register • 3000 Patients with Primary Hernia Repair in 2000 • 2456 Patients (86%) Returned a postal questionnaire • 758 Patients (31%), Some Pain • 144 cases (6%), Interfered with Work or Leisure Activities Sunday June 3, 2007 Istanbul

  12. So Just How Valid are These Arguments For Routine Inguinal Herniorrhaphy? • Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Too High • The Mortality Rate Associated with a Hernia Accident is Unacceptable • Progression is Inevitable, • Incarceration and or Strangulation is Likely • Operation Becomes More Difficult the Longer it is Delayed Sunday June 3, 2007 Istanbul

  13. So Just How Valid are These Arguments For Routine Inguinal Herniorrhaphy? • Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Too High • The Mortality Rate Associated with a Hernia Accident is Unacceptable • Progression is Inevitable, • Incarceration and or Strangulation is Likely • Operation Becomes More Difficult the Longer it is Delayed Sunday June 3, 2007 Istanbul

  14. Adults Short Duration Old Age Femoral Hernia Coexisting Medical Disease Children Young Age Male Right Sided Hernia Risk of a Hernia AccidentWhat is Known Who is at Risk? Rai S, Chandra SS, Smile SR.. A study of the risk of strangulation and obstruction in groin hernias. Aust N Z J Surg 1998 Sep;68(9):650-4.India, 1985-1995 Sunday June 3, 2007 Istanbul

  15. Risk of a Hernia AccidentWhat is Not Known The INCIDENCE Sunday June 3, 2007 Istanbul

  16. Risk of a Hernia AccidentWhat is Not Known What is the Problem? • Surgeons are Taught That All Inguinal Hernias Should be Repaired to Prevent Complications. Therefore No Whole Groups of Patients With Hernias Untreated Exist • Variability of Surgeon Practice Patterns • Surgeon A vs. Surgeon B Sunday June 3, 2007 Istanbul

  17. Therefore Only Historical Data Available Sunday June 3, 2007 Istanbul

  18. 2 Unique Data Bases • Paul Berger’s Truss Clinic • Berger P: Résultats de ľExamen de Dix Mille Observations de Hernies. Paris, Extrait du neuvième congres francais de chirurgie 1895,1896 • Cali Colombia • Neutra R, Velez A, Ferreda R, Galan R. Risk of incarceration of inguinal hernia in Cali, Columbia. Chron Dis 1981;34:561-564. Sunday June 3, 2007 Istanbul

  19. Berger’s Truss Clinic • 1880 - 1884 • Elective Herniorrhaphy Shunned • 8633 Patients • 242 Hernia Accidents = Probability of Hernia Accident Per Year Is 0.0037 Sunday June 3, 2007 Istanbul

  20. Cali Colombia • One Year (1965 – 1966) Government Initiative To Aggressively Examine A Stratified Random Sample Of Its Civilian Population To Determine The Frequency Of Common Conditions Such As Inguinal Hernia • Hospital Records = Probability Of Hernia Accident Per Year Is 0.0038 Sunday June 3, 2007 Istanbul

  21. Cumulative Probability of an Accident =1 – (1 – p)e p = probability of an accident per hernia patient per year (0.00375) e = life expectancy* • *National Center for Health Statistics: Vital statistics of the United States, 1980. Life tables, 2(6). DHHS Publ. No. (PHS) 84-1104, 1984. • National Center for Health Statistics: Vital statistics of the United States, 2001. Life tables, 52(14), 2004. Sunday June 3, 2007 Istanbul

  22. The Lifetime Risk of a Hernia Accident Sunday June 3, 2007 Istanbul

  23. Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA 2006;295:285-292 • One Hernia Accident Within Two Year Follow-up 4 Months After Randomization (0.3%) • One Additional Hernia Accident at 4 Years • Overall Accident Rate 0.0018 Events/ Patient Year Sunday June 3, 2007 Istanbul

  24. So Just How Valid are These Arguments For Routine Inguinal Herniorrhaphy? • Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Too High • The Mortality Rate Associated with a Hernia Accident is Unacceptable • Progression is Inevitable, • Incarceration and or Strangulation is Likely • Operation Becomes More Difficult the Longer it is Delayed Sunday June 3, 2007 Istanbul

  25. Sunday June 3, 2007 Istanbul

  26. Authors Beller & Colp(1926) Frankau(1931) Guillen & Aldrete(1970) Anderson & Ostberg(1972) Mortality Rate 10.9% 19.7% 13.2% 13.8% Operative Mortality for Patients with Obstructed Inguinal Hernias Sunday June 3, 2007 Istanbul

  27. Sunday June 3, 2007 Istanbul

  28. Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA 2006;295:285-292 No Herniorrhaphy Related Mortality Sunday June 3, 2007 Istanbul

  29. So Just How Valid are These Arguments For Routine Inguinal Herniorrhaphy? • Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Too High • The Mortality Rate Associated with a Hernia Accident is Unacceptable • Progression is Inevitable, • Incarceration and or Strangulation is Likely • Operation Becomes More Difficult the Longer it is Delayed Sunday June 3, 2007 Istanbul

  30. Sunday June 3, 2007 Istanbul

  31. Cumulative Probability of an Inguinal Hernia Becoming Irreducible 30% by 10 Years N= 699 Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9. Sunday June 3, 2007 Istanbul

  32. But Incarceration ≠ Strangulation Many Men with Chronically Incarcerated Inguinal Hernias are Minimally Symptomatic Sunday June 3, 2007 Istanbul

  33. Cumulative Probability of an Inguinal Hernia Becoming Irreducible • Vs. Emergency Surgery • 10 patients • 1 with infarcted small bowel • 1 with infarcted omentum • No Deaths or Serious Complication Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9. Sunday June 3, 2007 Istanbul

  34. Cumulative Probability of Pain 90% with Pain by 10 Years Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9. Sunday June 3, 2007 Istanbul

  35. Cumulative Probability of Pain • Leisure Activities Affected in Only 29% • Only 13% of Employed Patients had to Take Time Off Work Because of Hernia-related Symptoms. Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9. Sunday June 3, 2007 Istanbul

  36. Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA 2006;295:285-292 Two Year Primary Outcomes:No differences in Pain or Physical function WW 5.1% TFR3.2% , Difference 2.86%;95% Confidence Interval, -0.04% -5.72%, P=.52 WW ↑ .29 Points TFR ↑ .13% , Difference .16;95% Confidence Interval, -1.2 – 1.5 Sunday June 3, 2007 Istanbul

  37. Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA 2006;295:285-292 Likelihood of a Hernia Repair in WW Sunday June 3, 2007 Istanbul

  38. So Just How Valid are These Arguments For Routine Inguinal Herniorrhaphy? • Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Too High • The Mortality Rate Associated with a Hernia Accident is Unacceptable • Progression is Inevitable, • Incarceration and or Strangulation is Likely • Operation Becomes More Difficult the Longer it is Delayed Sunday June 3, 2007 Istanbul

  39. Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA 2006;295:285-292 PERIOPERATIVE COMPLICATIONS Sunday June 3, 2007 Istanbul

  40. Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA 2006;295:285-292 • No Difference In Recurrence Rate • No Difference in Satisfaction with Care (97%) Sunday June 3, 2007 Istanbul

  41. Conventional Anterior, Non-prosthetic Marcy Bassini Moloney Darn Shouldice McVay Cooper’s Ligament Repair Miscellaneous Repairs Conventional Preperitoneal, Non Prosthetic Historical Interest Bassini Conventional Anterior, Prosthetic Lichtenstein Tension Free Hernioplasty Mesh Plug And Patch Conventional Preperitoneal, Prosthetic The Anterior Approach Read-rives The Posterior Approach Wantz /Stoppa/Rives (Giant Prosthetic Reinforcement Of The Visceral Sac) Nyhus /Condon (iliopubic Tract Repair) Kugel/Ugahary Combination Anterior and Preperitoneal, Prosthetic The Bilayer Prosthetic Repair Laparoscopic Inguinal Herniorrhaphy Transabdominal Preperitoneal (TAPP) Totally Extraperitoneal (TEP) Intraperitoneal Onlay Mesh Procedure (IPOM) No Longer a Valid Argument! Sunday June 3, 2007 Istanbul

  42. In Summary • Mortality For Strangulation is Not as Great as Once Thought • Increasing Morbidity Under Observation is Not Inevitable • There Isn't a Significant Penalty for Waiting • Watchful Waiting is an Acceptable Alternative to Routine Operation for a Minimally Symptomatic Inguinal Hernia Sunday June 3, 2007 Istanbul

  43. Ann Surg 2006;244: 167–173 Sunday June 3, 2007 Istanbul

  44. Problems with the O’Dwyer Study Conclusions Repair of an Asymptomatic Inguinal Hernia: • Does Not Affect the Rate of Long-term Chronic Pain • May Be Beneficial to Patients in Improving Overall Health • May Reduce Potentially Serious Morbidity Sunday June 3, 2007 Istanbul

  45. Problems with the O’Dwyer Study • Recruitment Problems • 160 Patients (Original Design = 250) • Older Age Group • 55 Years or Older • More Advanced Hernia • Visable bulge Required • Short Follow/up • 1 Year Sunday June 3, 2007 Istanbul

  46. Problems with the O’Dwyer Study Conclusions Repair of an Asymptomatic Inguinal Hernia: • Does Not Affect the Rate of Long-term Chronic Pain Sunday June 3, 2007 Istanbul

  47. Problems with the O’Dwyer Study Conclusions Repair of an Asymptomatic Inguinal Hernia: • Does Not Affect the Rate of Long-term Chronic Pain (But the WW Group Did Not Have to Endure an Operation!!!) Sunday June 3, 2007 Istanbul

  48. Problems with the O’Dwyer Study Conclusions Repair of an Asymptomatic Inguinal Hernia: • Does Not Affect the Rate of Long-term Chronic Pain • May Be Beneficial to Patients in Improving Overall Health • May Reduce Potentially Serious Morbidity Sunday June 3, 2007 Istanbul

  49. Problems with the O’Dwyer Study On An Intention-to-treat Analysis, There Was a Consistent Trend to Improvement of About 5 Points in All of the SF-36 Dimensions (Except Emotional Role) in the Operation Group Compared With the Observation Group Sunday June 3, 2007 Istanbul

  50. Problems with the O’Dwyer Study Conclusions Repair of an Asymptomatic Inguinal Hernia: • Does Not Affect the Rate of Long-term Chronic Pain • May Be Beneficial to Patients in Improving Overall Health • May Reduce Potentially Serious Morbidity Sunday June 3, 2007 Istanbul

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