Transcript Hamburg Presentation 32699 - Amerikan Cerrahlar Koleji

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
In 2007
Inguinal 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
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
Annual Inguinal
Herniorrhaphy Rate
 US
2800 Per Million
 UK 1000 Per Million
Sunday June 3, 2007 Istanbul
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
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
Surgical Counseling
The Dreaded Complication
 A Hernia Accident
Strangulation
Bowel
Obstruction
Sunday June 3, 2007 Istanbul
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
Chronic Groin Pain
Sunday June 3, 2007 Istanbul
Annals of Surgery 244(2), August 2006
Sweden
Sunday June 3, 2007 Istanbul
Fränneby and Others. Annals of Surgery
244(2), August 2006
Sweden
 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
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
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
Risk of a Hernia Accident
What is Known
Who is at Risk?
Adults
 Short Duration
 Old Age
 Femoral Hernia
 Coexisting Medical
Disease
Children
 Young Age
 Male
 Right Sided Hernia
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
Risk of a Hernia Accident
What is Not Known
The INCIDENCE
Sunday June 3, 2007 Istanbul
Risk of a Hernia Accident
What 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
Sunday June 3, 2007 Istanbul
A vs. Surgeon B
Therefore Only Historical
Data Available
Sunday June 3, 2007 Istanbul
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
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
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
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
The Lifetime Risk
of a Hernia Accident
Males
1980
18 yr
1/5.49
72 yr
1/27.03
Sunday June 3, 2007 Istanbul
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
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
Sunday June 3, 2007 Istanbul
Operative Mortality for Patients with
Obstructed Inguinal Hernias
Authors
Beller & Colp(1926)
Frankau(1931)
Guillen & Aldrete(1970)
Anderson &
Ostberg(1972)
Sunday June 3, 2007 Istanbul
Mortality Rate
10.9%
19.7%
13.2%
13.8%
Sunday June 3, 2007 Istanbul
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
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
Sunday June 3, 2007 Istanbul
Cumulative Probability of an Inguinal
Hernia Becoming Irreducible
N= 699
30% 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
But
Incarceration ≠ Strangulation
Many Men with Chronically Incarcerated
Inguinal Hernias are Minimally Symptomatic
Sunday June 3, 2007 Istanbul
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
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
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.
Sunday June 3, 2007 Istanbul
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.
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
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
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
Watchful Waiting vs Repair of Inguinal Hernia in Minimally
Symptomatic Men: A Randomized Clinical Trial JAMA
2006;295:285-292
PERIOPERATIVE COMPLICATIONS
MONTHS BETWEEN RANDOMIZATION
AND SURGERY
6
N=288
>6
N=65
Intraoperative (%)
3(1.04)
0.00
Postoperative
Hernia site infection
Wound hematoma
Scrotum hematoma
Orchitis
Seroma
Groin neuralgia
Leg neuralgia
Urinary retention
Urinary infection
Other
5(1.74)
15(5.21)
11(3.82)
5(1.74)
2(0.69)
2(0.69)
1(0.35)
7(2.43)
0(0.00)
12(4.17)
1(1.54)
6(9.23)
3(4.62)
0(0.00)
1(1.54)
0(0.00)
0(0.00)
0(0.00)
1(1.54)
2(3.08)
Total
49(17.01)
14(21.54)
Sunday June 3, 2007 Istanbul
P
TOTAL
N=353
1.00
3(.85)
1.00
0.2431
0.7280
0.5890
0.4580
1.00
0.1841
0.3572
0.1841
1.00
0.3754
6(1.70)
21(5.95)
14(3.97)
5(1.42)
3(0.85)
2(0.57)
1(0.28)
7(1.98)
1(0.28)
14(3.97)
63(17.85)
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
No Longer a Valid Argument!



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
Sunday June 3, 2007 Istanbul
 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)
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
Ann Surg 2006;244: 167–173
Sunday June 3, 2007 Istanbul
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
Problems with the
O’Dwyer Study
 Recruitment
 160
Patients (Original Design = 250)
 Older Age
 55
Problems
Group
Years or Older
 More Advanced
 Visable
 Short
1
Hernia
bulge Required
Follow/up
Year
Sunday June 3, 2007 Istanbul
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
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
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
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
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
Problems with the
O’Dwyer Study
“There Were 3 Serious Adverse Events in
the Observation Group : 1 Patient Had an
Acute Hernia, 1 Had a Postoperative
Stroke, and 1 Had a Myocardial Infarction
and Died Postoperatively. The Patient With
the Acute Hernia had It Reduced at Another
Hospital.”
Sunday June 3, 2007 Istanbul
Problems with the
O’Dwyer Study

This is a SICK Group of Patients



2 Of the Operation Patients Died Before they
could be Operated (1 of Cancer,1 Cardiac)
9 More have Already Died
The Mean Time for Operation in the
“Immediate Operation Group” was 103
Days
Sunday June 3, 2007 Istanbul
Caveats
 Be
Careful With Extrapolation
 Moderately
Symptomatic Male??
 Do Not Extrapolate to Woman!!
Sunday June 3, 2007 Istanbul
Sunday June 3, 2007 Istanbul
Sunday June 3, 2007 Istanbul
Men
Women
Sunday June 3, 2007 Istanbul
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