Health-Process-Evidence-based Clinical Practice Guidelines
Department of Surgery
Jose
Mario Amado M. Pingul, MD
Edgardo
P. Penserga, MD, FPCS
Jose Ravelo T. Bartolome, MD, FPCS
Harry
L. Go, MD, FPCS
Reynaldo
O. Joson, MD, MHA, MHPEd, MS Surg
Ospital
ng Maynila Medical Center
August,
2002
A health-process-evidence-based clinical
practice guidelines (HPE-CPG) on patients with inguinal hernia formulated by
the staff of the Department of Surgery of Ospital ng Maynila Medical Center
(OMMC). This particular HPE-CPG
contains four clinical questions formulated from a list of problem- or
case-based learning issues encountered in the day-to-day management of patients
with inguinal hernia in OMMC and during preoperative and postoperative
conferences. Answers to the formulated clinical questions were searched in
electronic Medline by a technical working group as well as all the resident
staff of the department. After the search for external evidences was done,
answers were formulated by processing the external evidences based on the
management of a patient process and World Health Organization concept of health
and primary health care approach. If
there were no available external evidences, experience and informal data were
utilized. The formulated answers were then presented to the department staff
and concurrence was arrived at by consensus.
Keywords:
clinical practice guidelines, inguinal hernia
Introduction
This is a
health-process-evidence-based clinical practice guidelines (HPE-CPG) on
patients with inguinal hernia formulated by the staff of the Department of
Surgery of Ospital ng Maynila Medical Center (OMMC). This particular HPE-CPG contains only 4 clinical questions. More clinical questions will be added in the
near future.
HPE-CPG
are guidelines that are health-based, meaning based on the World Health Organization
(WHO) concept of health and primary health care approach (PHCA). The WHO concept of health is biopsychosocial
well-being, not merely the absence of disease.
PHCA means appropriate, effective, essential health care made
universally available to communities by means acceptable and accessible to them
at a cost that the community can afford.
HPE-CPG
are guidelines that are also process-based, meaning based on management of a
patient process. See algorithm of management of a patient process in the
appendix.
HPE-CPG
are guidelines that are also evidence-based, meaning based on evidence-based
health care and medicine approach, which in turn means a conscientious,
explicit, and judicious use of current best evidence in making decisions about
the care of individual patients and integrating individual clinical expertise
with the best available external clinical evidence from systematic research.
Methods
Clinical questions were formulated
from a list of problem- or case-based learning issues encountered in the day to
day management of patients with inguinal hernia in OMMC and during the
preoperative and postoperative conferences
(8-9 am) and case presentation and discussion conferences (9-10 am)
every Tuesday.
Four
clinical questions, 3 on diagnosis, and 1 on treatment, were formulated,
namely:
Diagnosis:
Q-1. What is the most
reliable sign of inguinal hernia?
Q-2 What to do if a
patient has a history of on and off bulge in the inguinal area but there is no
inguinal bulge?
Q-3. What to
do if there is an inguinal bulge which cannot be flattened with pressure on the
bulge towards the peritoneal cavity and there is a question whether the bulge
is a hernia or a mass? What should be the recommended paraclinical diagnostic
procedure based on benefit/risk/cost/availability comparison?
Treatment:
Q-4. What is the best
surgical treatment for an indirect inguinal hernia in a young adult? Open
heniorrhaphy without mesh grafting?
Open herniorrhaphy with mesh grafting? Or Lap herniorrhaphy?
Answers
to the formulated clinical questions were searched by a technical working group
as well as all the resident staff of the department. The search concentrated on the Internet, particularly Medline,
from 1966 onwards. Meta-analysis papers were given priority in the search. After the search for external evidences was
done, answers were formulated by processing the external evidences based on the
management of a patient process and WHO concept of health and primary health
care approach. If there were no
available external evidences, experience and informal data were utilized. The
formulated answers were then presented to the department staff and concurrence
was arrived at by consensus.
There
was a debate held among the residents on the question which is the best surgical
treatment for indirect inguinal hernias in June, 2002. The debate itself and the evidences gathered
for use in the debate contributed to the formulation of this HPE-CPG on
inguinal hernia.
The
questions and answers were also given through email to various general surgeons
in other hospitals in the country to get comments and feedback. The answers gotten were considered in the
formulation of this HPE-CPG.
Results
There were no papers that were able to
directly answer the 4 questions. However, there were papers that contained data
that could be used in answering the questions based on the management of a
patient process and WHO concept of health and primary health care approach.
There
were 5 nonrandomized control studies on paraclinical diagnostic papers which
were used in answering Q-2 and Q-3 (1-5).
There were 4 meta-analysis papers which were used in answering Q-4
(6-9).
Formulated answers to clinical
questions (concurred by consensus)
Diagnosis:
Q-1. What is the most
reliable sign of inguinal hernia?
Physician’s
detection of a bulge in the inguinal area which becomes more prominent on
increasing the intraabdominal pressure and which can be flattened by pressing
the bulge towards the peritoneal cavity (this is a pathognomonic sign of
inguinal hernia)
Q-2. What to do if a
patient has a history of on and off bulge in the inguinal area but there is no
inguinal bulge?
Check
on reliability of the history. If
reliable, a diagnosis of inguinal hernia is made. Physician should explain to the patient or relative what
constitutes a reliable sign of inguinal hernia. If history is not reliable, patient or relative is advised to
monitor, look for the reliable sign of inguinal hernia and report back to physician.
Herniogram,
ultrasound, CT scan, and MRI are some paraclinical diagnostic procedures that
can be done. Unless there is urgency in
the diagnosis of hernia, monitoring is a more practical paraclinical diagnostic
procedure to adopt.
Q-2.1 If there
is urgency in the diagnosis of hernia, among herniography, ultrasound, CT scan,
and MRI, what should be the recommended paraclinical diagnostic procedure based
on benefit/risk/cost/availability comparison?
Ultrasound,
because the diagnostic benefit is acceptable; it is least invasive, in fact,
non-invasive, cheapest, and most readily available (See table 1).
Table 1. Comparison of the different paraclinical
diagnostic procedure based on benefit, risk, cost, and availability.
|
|
Benefit |
Risk |
Cost |
Availability |
|
Herniography |
Sensitivity = 96% Specificity = 98.4%
(1) |
Invasive Reaction to dye Complication rate =
1% (5) |
PhP 5000 |
Not readily
available |
|
Ultrasound |
Sens = 92.7% Spec = 81.5%
(2) Sens = 85.7% Spec = 95% (3) |
Practically none in
terms of pain and discomfort |
PhP 1000 |
Most readily
available |
|
CT Scan |
Sens = 83% Spec = 67-83%(4) |
Radiation |
PhP 3000 |
Available |
|
MRI |
Sens = 94.5% Spec = 96.3%
(2) |
Reaction to dye |
PhP 8000 |
Not readily
available |
Sens – Sensitivity,
Spec – Specificity, CT Scan – Computerized Tomography Scan,
MRI – Magnetic
Resonance Imaging.
Q-3. What to
do if there is an inguinal bulge which cannot be flattened with pressure on the
bulge towards the peritoneal cavity and there is a question whether the bulge
is a hernia or a mass? Assuming there is a need for a paraclinical diagnostic
procedure. What should be the recommended paraclinical diagnostic procedure
based on benefit/risk/cost/availability comparison?
Ultrasound.
It can identify a mass as well as a hernia.
It has acceptable diagnostic benefit, is least invasive, cheapest, and
most readily available (See table 1).
Treatment:
Q-4. What is the best
surgical treatment for an indirect inguinal hernia in a young adult? Open
heniorrhaphy without mesh grafting?
Open herniorrhaphy with mesh grafting? Lap herniorrhaphy?
There
was one meta-analysis paper (45 randomised trials and 26 non-randomised
trials/prospective cohort studies) that tried to answer this question. It ended with “no conclusions can be drawn
from the literature.” The reasons
given are: lack of agreed method for assessing severity of hernias; failure to
take confounding into account in non-randomised studies; variation in length of
follow-up; poor external validity; lack of objective measures of outcome; and
inadequate statistical power.(6)
There were 3 other meta-analysis papers which did not provide conclusive
answers. (7-9)
With
no papers that can validly and reliably answer the question, data were
collected for a benefit/risk/cost/availability comparison of the three surgical
methods (See table 2).
Table 2. Comparison of the three surgical methods
based on mortality, morbidity, recurrence, chronic pain, return to usual
activity, cost, and availability.
|
Parameter
for comparison |
Open
without mesh |
Open
with mesh |
Lap
herniorrhaphy |
|
Mortality |
~ 0 |
~ 0 |
~ 0 |
|
Morbidity |
Almost
the same in all 3 |
||
|
Recurrence |
|
Less with mesh compared
to without mesh OR 0.43, 95% CI
0.34-0.55; P <.001) |
Less with mesh compared to without
mesh OR 0.43, 95% CI
0.34-0.55; P <.001) |
|
Chronic pain |
No pain of mesh |
Pain of mesh |
Pain of mesh |
|
Return to usual
activity |
Almost
the same in all 3 |
||
|
Cost |
No cost of lap
instruments and mesh (most affordable) |
Cost of mesh |
Cost of lap
instruments + cost of mesh |
|
Availability |
No problem with
availability |
Mesh is available
most of the time |
Not available (and in most
centers in the Philippines) |
In terms of benefit, specifically,
in terms of recurrence, herniorrhaphy using mesh is better than one
without. In terms of risk or morbidity,
there was no significant difference among the three methods.
Recommendations:
Discussion
The methods used in the formulation
of the above HPE-CPG can be considered modifications and simplification of the
standard evidence-based clinical practice guidelines formulation. Modifications in the sense that the World
Health Organization concept of health and primary health care approach and the
management of a patient process were integrated into the standard
evidence-based health care and medicine approach in coming out with the
guidelines. Simplifications, in the
sense that they don’t involve a lot of sophisticated statistical computations. Moreover, they utilize simple processes of
problem-solving and decision-making in the management of a patient (such as
pattern recognition and prevalence for clinical diagnosis and analysis and
comparison of benefit/risk/cost/availability factors for paraclinical
diagnostic procedures and treatment).
The
HPE-CPG was agreed upon by the staff not by votation but by consensus. The consensus is expected to promote
support and usage of the guidelines by all staff.
The
HPE-CPG also considered the opinions of experts outside OMMC and those
practicing in other areas of the country.
This process is expected not only to strengthen the guidelines but also
promote applicability in other areas of the country.
The
HPE-CPG will undergo validation studies, especially on the 4th
question on treatment, specifically on the size of the hernia as a determinant
for use of mesh. There will be constant
revision and addition, at least once every 3 years, in consideration of the
validation studies and changes in the institution and community, both local and
international.
Other clinical questions need to be answered in the future:
References:
Paraclinical Diagnostic Procedures
1.
Sutcliffe JR, Taylor OM, Ambrose NS, Chapman AH. The use,
value and safety of herniography. Clin Radiol 1999; 54(7):468-72.
2.
van den Berg JC, de Valois JC, Go PM, Rosenbusch G.
Detection of groin hernia with physical examination, ultrasound, and MRI
compared with laparoscopic findings. Invest Radiol 1999; 34(12):739-43.
3.
Kervancioglu R, Bayram MM, Ertaskin I, Ozkur A.
Ultrasonographic evaluation of bilateral groins in children with unilateral
inguinal hernia. Acta Radiol
2000;41(6):653-7.
4.
Hojer A-M, Riggaard H, Jess P. CT in the diagnosis of abdominal wall hernia: A preliminary
study. Eur Radiol 1997; 7: 1416-18.
5.
Jones RL, Wingate JP. Herniography in the investigation of
groin pain in adults. Clin Radiol 1998;
53: 805-8.
Treatment
6.
Cheek CM, Black NA, Devlin HB, Kingsnorth AN, Taylor RS,
Watkin DF. Groin hernia surgery: a systematic review. Ann R Coll Surg Engl
1998; 80 Suppl 1:S1-80.
7.
Chung RS, Rowland DY.Meta-analyses of randomized controlled
trials of laparoscopic vs conventional inguinal hernia repairs. Surg Endosc
1999; 13(7):689-94
8.
Go PM. Overview of randomized trials in laparoscopic
inguinal hernia repair. Semin Laparosc Surg 1998; 5(4):238-41.
9.
The EU Hernia Trialists Collaboration. Repair of groin hernia
with synthetic mesh: meta-analysis of randomized controlled trials. Ann Surg
2002; 235(3):322-32.