Make your own free website on Tripod.com

 

Health-Process-Evidence-based Clinical Practice Guidelines

 

Department of Surgery

 

Ospital ng Maynila Medical Center

 

 

Patients with Inguinal Hernia

 

 

 

 

 

 

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

 

 

 

 

 

 

Department of Surgery

 

Ospital ng Maynila Medical Center

 

August, 2002

 

 

 

 

 

 

Clinical Practice Guidelines in Inguinal Hernias

 


Abstract

 

            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

 

Search 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:

 

  1. Since lap herniorrhaphy is not readily available and open herniorrhaphy with or without mesh are readily available, the latter should be relied on as practical and effective options.
  2. Open herniorrhaphy without mesh should be used for small hernia defect.  The size of hernia defect is NOT yet well defined.  
  3. For large hernia defect, a mesh graft should be used.
  4. Since there are no data in the literature that define the size of a hernia in which a mesh is indicated, based on experience of the senior surgeons, a 4-cm width at the base of the inguinal bulge is recommended to be used as a cut-off.  This needs to be validated.

 


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:

 

  1. What is the best surgical treatment for inguinal hernias in the elderly males?
  2. What are the indications for repairing the inguinal floor after a high ligation of a hernial sac?
  3. What is the best method to repair the inguinal floor?
  4. How soon after a herniorrhaphy without mesh or with mesh can a patient resume strenuous activity?
  5. What is the best way to manage a recurrent inguinal hernia?

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.