surgical management of inguinal hernia prepared for: agency for healthcare research and quality...

Surgical Management of Inguinal HerniaPrepared for:

Agency for Healthcare Research and Quality (AHRQ)

www.ahrq.gov

Agency for Healthcare Research and Quality Comparative Effectiveness Review (CER) Process

Background Clinical Questions Addressed in the CER Clinical Bottom Line: Summary of CER Results Conclusions Gaps in Knowledge Resources for Shared Decisionmaking

Outline of Material

Topics are nominated through a public process, which includes submissions from health care professionals, professional organizations, the private sector, policymakers, the public, and others.

A systematic review of all relevant clinical studies is conducted by independent researchers, funded by AHRQ, to synthesize the evidence in a report summarizing what is known and not known about the select clinical issue. The research questions and the results of the report are subject to expert input, peer review, and public comment.

The results of these reviews are summarized into a Clinician Research Summary and a Consumer Research Summary for use in decisionmaking and in discussions with patients. The Research Summaries and the full report are available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm.

Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review (CER) Development

Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm.

The strength of evidence ratings are classified into four broad ratings:

Strength of Evidence Ratings

AHRQ Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Available at www.effectivehealthcare.ahrq.gov/methodsguide.cfm.Owens DK, Lohr KN, Atkins D, et al. J Clin Epidemiol. 2010 May;63(5):513-23. PMID: 19595577.Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm.

An inguinal hernia is a protrusion of abdominal contents into the inguinal canal through an abdominal wall defect.

Approximately 4.5 million people in the United States have an inguinal hernia.

Around 500,000 new inguinal hernias are diagnosed annually. The lifetime risk of inguinal hernia is about 25 percent in males

and 2 percent in females. Inguinal hernia can affect all ages, but the risk for one increases

with age. Approximately 20 percent of hernia cases are bilateral.

Background: Inguinal Hernias in Adults

Abramson JH, et al. J Epidemiol Community Health. 1978;32:59-67. Available at http://www.ncbi.nlm.nih.gov/pubmed/95577.Everhart, JE, ed. Digestive diseases in the United States: epidemiology and impact. Washington, DC: US Government Printing Office, 1994; NIH publication no. 94-1447.Goroll AH, et al. Primary care medicine: office evaluation and management of the adult patient, 5th ed. Philadelphia, Lippincott Williams & Wilkins; 2005:431-434.Nicks BA. Hernias. Medscape Reference: Drugs, Diseases, and Procedures. Last Updated June 6, 2012. Available at http://emedicine.medscape.com/article/775630-overview. Accessed April 30, 2013.Rutkow IM. Surg Clin North Am. 1998;78:941-951. Available at http://www.ncbi.nlm.nih.gov/pubmed/9927978. Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm.

The incidence of inguinal hernia in children ranges from 0.8 to 4.4 percent.

It is 10 times as common in boys as in girls. It is more common in infants born before 32 weeks’

gestation (13% prevalence) and in infants weighing less than 1,000 grams at birth (30% prevalence).

Background: Inguinal Hernias in Children

Brandt ML. Pediatric hernias. Surg Clin North Am. 2008 Feb;88(1):27-43, vii-viii. PMID: 18267160.Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm.

A direct inguinal hernia protrudes through the inguinal floor—defined by Hesselbach's triangle, the pubic tubercle, the lateral border of the rectus, and the inguinal ligament—and accounts for one-third of all inguinal hernias.

An indirect inguinal hernia protrudes through the internal inguinal ring and may descend through the inguinal canal and accounts for about two-thirds of all inguinal hernias.

Direct hernias typically develop only in adulthood and are more likely to recur than indirect hernias.

Direct and Indirect Inguinal Hernias

Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, et al. JAMA. 2006 Jan 18;295(3):285-92. PMID: 16418463.Simons MP, Aufenacker T, Bay-Nielson M, et al. Hernia. 2009 Aug;13(4):343-403. PMID: 19636493.Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm.

If the hernia is severe enough to restrict blood supply to the intestine, it is termed a strangulated hernia; immediate corrective surgery of this type of hernia is necessary.

Most inguinal hernias, however, are less dangerous, and elective surgery is often performed to correct the defect.

Symptoms include abdominal pain and a lump in the groin area, which is most easily palpated during a cough.

Some inguinal hernias, however, are asymptomatic and are only detected by palpation during a cough.

Symptoms of Inguinal Hernias

Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, et al. JAMA. 2006 Jan 18;295(3):285-92. PMID: 16418463.Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm.

Surgical repair of inguinal hernias is the most commonly performed general surgical procedure in the United States.

About 770,000 surgical repairs were performed in 2003.

Most repairs (87%) are performed on an outpatient basis.

The primary goals of surgery are to: Repair the hernia Minimize the chance of recurrence Return the patient to normal activities quickly Improve quality of life Minimize postsurgical discomfort and the adverse effects of

surgery

Surgical Repair of Inguinal Hernias

Rutkow IM. Surg Clin North Am. 2003 Oct;83(5):1045-51, v-vi. PMID: 14533902.Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm.Zhao G, Gao P, Ma B, et al. Ann Surg. 2009 Jul;250(1):35-42. PMID: 19561484.

Surgical repairs of inguinal hernia generally fall into three categories: Open repair without a mesh implant (i.e., sutured) Open repair with a mesh Laparoscopic repair with a mesh

Several procedures have been employed within each of these categories.

The nearly universal adoption of mesh (except in pediatric cases) means that the most relevant questions about hernia repair involve various mesh procedures.

Types of Surgical Repair for Inguinal Hernias

Brandt ML. Surg Clin North Am. 2008 Feb;88(1):27-43, vii-viii. PMID: 18267160.Rutkow IM. Surg Clin North Am. 2003 Oct;83(5):1045-51, v-vi. PMID: 14533902.Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm.

Example:Open Mesh-Based Repair of an Inguinal Hernia

Before After

Mesh

Example: Laparoscopic Mesh-Based Repairof an Inguinal Hernia

Laparoscope

Small cuts aremade to insertthe tools

Kugel® patch repair: An oval-shaped mesh is held open by a memory recoil ring and inserted behind the hernia defect and held in place with a single suture.

Lichtenstein technique: A tension-free open repair wherein mesh is sutured in front of the hernia defect (anteriorly).

Mesh plug technique: A preshaped mesh plug is introduced into the hernia weakness during surgery and a piece of flat mesh is put on top of the hernia.

Open preperitoneal mesh technique: A tension-free repair wherein mesh is sutured posteriorly.

Open Mesh-Based Repair of Inguinal Hernias(1 of 2)


PROLENE™ Hernia System: A one-piece mesh device constructed of an onlay patch connected to a circular underlay patch by a mesh cylinder.

Read-Rives repair: A tension-free repair wherein mesh is placed just over the peritoneum.

Stoppa technique: A large polyester mesh is interposed in the preperitoneal connective tissue between the peritoneum and the transversalis fascia to prevent visceral sac extension through the myopectineal orifice.

Trabucco technique: A hernia repair procedure that involves placing a single preshaped mesh without using sutures.

Open Mesh-Based Repair of Inguinal Hernias(2 of 2)


Intraperitoneal onlay mesh technique: A mesh is placed under the hernia defect intra-abdominally to circumvent a groin dissection.

Totally extraperitoneal technique: The peritoneal cavity is not entered, and a mesh is used to cover the hernia from outside the preperitoneal space.

Transabdominal preperitoneal technique: A laparoscopic repair procedure wherein the surgeon enters the peritoneal cavity, incises the peritoneum, enters the preperitoneal space, and places the mesh over the hernia; the peritoneum is then sutured and tacked closed.

Laparoscopic Mesh-Based Repair Procedures for Inguinal Hernias


Surgical mesh products are typically made from polypropylene or polyester.

Other available materials include: Polytetrafluoroethylene Polyglactin Polyglycolic acid Polyamide

Surgical Mesh Products for Hernia Repair

Mohamed H, Ion D, Serban MB, et al. J Med Life. 2009 Jul-Sep;2(3):249-53. PMID: 20112467.Robinson TN, Clarke JH, Schoen J, et al. Surg Endosc. 2005 Dec;19(12):1556-60. PMID: 16211441.Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm.

Seven important properties of mesh are:

1. Withstands physiologic stresses over time

2. Conforms to the abdominal wall

3. Mimics normal tissue healing

4. Resists the formation of bowel adhesions and erosions into visceral structures

5. Does not induce allergic reaction or foreign body reactions

6. Resists infection

7. Is noncarcinogenic

Properties of Mesh Products for Hernia Repair

Mohamed H, Ion D, Serban MB, et al. J Med Life. 2009 Jul-Sep;2(3):249-53. PMID: 20112467.Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm.

What is the comparative effectiveness of: Laparoscopic versus open repair in adults with

painful hernia (primary, bilateral, and recurrent hernia)?

Different types of repair for the pediatric population? Surgery versus watchful waiting in adults with a pain-

free or minimally symptomatic inguinal hernia? Different types of open surgery? Different types of laparoscopic surgery? Different mesh materials? Different mesh-fixation approaches?

Is there an association between surgical experience and hernia recurrence?

Clinical Questions Addressed in theComparative Effectiveness Review


Outcomes of Interest Outcomes

Hernia recurrence Hospital-related

information (length of hospital stay and hospital/office visits)

Return to daily activities Return to work Quality of life Patient satisfaction Short-term pain (≤1 month

after surgery) Intermediate-term pain (>1

and <6 months after surgery)

Long-term pain (≥6 months after surgery)

Adverse effects Infection Perception of a foreign

body Small-bowel

perforation/obstruction Hematoma Epigastric vessel injury Urinary retention Spermatic cord injury


Patient Population The typical adult in the studies included in this

review was: A man in his mid 50s Who was of average weight (median body mass index

of 25.3 kg/m2; interquartile rage of 25.0–26.7) Who had an elective repair of a primary unilateral

inguinal hernia

About a quarter of the men worked in physically strenuous jobs; for these men, a durable repair is important to prevent a recurrence.

Results: Overview of the Patient Population


Total included studies: N = 151 Open versus laparoscopic repair in adults:

Primary hernias; n = 38 Bilateral hernias; n = 6 Recurrent hernias; n = 8

Open versus laparoscopic high ligation for pediatric hernias; n = 2

Repair versus watchful waiting in adults with pain-free hernias; n = 2

Open mesh-based procedures; n = 21 Laparoscopic procedures; n = 11 Mesh materials; n = 32 Fixation methods; n = 23 Surgical experience and hernia recurrence; n = 32

Results: Overview of Studies Included in the Comparative Effectiveness Review


Thirty-eight studies met the inclusion criteria. The most commonly compared procedures include:

TAPP repair versus Lichtenstein (n = 14) TEP repair versus Lichtenstein (n = 14) TAPP repair versus mesh plug (n = 3) TEP repair versus mesh plug (n = 3) TAPP repair/TEP repair versus Lichtenstein (n = 4)

Clinical Bottom Line: Laparoscopic Versus Open Repair of Painful Primary Hernias in Adults—Included Studies


Abbreviations: TAPP = transabdominal preperitoneal; TEP = totally extraperitoneal

OutcomeSurgery Favored

Calculated Differences(95% CI) SOE

Hernia recurrence

Open surgery

RR = 1.43 (1.15 to 1.79); 2.49% recurrence after open versus 4.46% recurrence after laparoscopy

Low

Length of hospital stay

Approximateequivalence

Summary difference in means =-0.33 days (-0.52 to -0.14)

Low

Return to normal daily activities

Laparoscopic

SWMD in days = -3.9 (-5.6 to -2.2)

High

Return to work Laparoscopic

SWMD in days = -4.6 (-6.1 to -3.1)

High

Clinical Bottom Line: Laparoscopic Versus Open Repair of Painful Primary Hernias in Adults (1 of 2)

Abbreviations: 95% CI = 95-percent confidence interval; RR = relative risk; SOE = strength of evidence; SWMD = summary weighted mean difference


OutcomeSurgery Favored

Calculated Differences (95% CI)

SOE

Long-term pain Laparoscopic

OR = 0.61 (0.48 to 0.78)

Moderate

Epigastric vessel injury

Open OR = 2.1 (1.1 to 3.9) Low

Hematoma Laparoscopic

OR = 0.70 (0.55 to 0.88)

Low

Wound infection Laparoscopic

OR = 0.49 (0.33 to 0.71)

Moderate

Clinical Bottom Line: Laparoscopic Versus Open Repair of Painful Primary Hernias in Adults (2 of 2)


Abbreviations: 95% CI = 95-percent confidence interval; OR = odds ration; SOE = strength of evidence

Patients with bilateral hernias return to work about 2 weeks sooner after laparoscopic (TAPP or TEP) repair versus open (Lichtenstein or Stoppa) repair.Strength of Evidence = Low

Evidence was inconclusive for all other outcomes and adverse effects for laparoscopic versus open repair of bilateral hernias.

Clinical Bottom Line:Surgical Repair of Bilateral Hernias



OutcomeSurgery Favored Results (95% CI) SOE

Return to daily activities

Laparoscopic

SWMD = -7.4 days (-11.4 to -3.4)

High

Long-term pain

Laparoscopic

OR = 0.24 (0.08 to 0.74)

Moderate

Re-recurrence rates

Laparoscopic (TAPP or TEP)

RR = 0.82 (0.70 to 0.96); 7.5% for laparoscopic vs. 12.3% for open repair

Low

Clinical Bottom Line: Laparoscopic Versus Open Repair of Recurrent Hernias


Abbreviations: 95% CI = 95-percent confidence interval; OR = odds ratio; RR = relative risk; SOE = strength of evidence; SWMD = summary weighted mean difference; TAPP = transabdominal preperitoneal; TEP = totally extraperitoneal

Open Versus Laparoscopic High Ligation for Pediatric Hernias (Ages 3 Months to 15 Years)

Chan KL, Hui WC, Tam PK. Surg Endosc. 2005 Jul;19(7):927-32. PMID: 15920685. Koivusalo AI, Korpela R, Wirtavuori K, et al. Pediatrics. 2009 Jan;123(1):332-7. PMID: 19117900. Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm.

Laparoscopic repair is favored for three outcomes, although some of the differences may not be clinically relevant: Long-term overall patient/parent satisfaction

(difference in satisfaction points = 1.00; 95% CI, 0.47 to 1.53)Strength of Evidence: Low

Length of hospital stay (summary difference = 1 hour; 95% CI, 0.5 to 1.8)Strength of Evidence: Moderate

Long-term cosmesis (difference in satisfaction points = 0.25; 95% CI, 0.12 to 0.38)Strength of Evidence: Low

The time to return to daily activities was equivalent.Strength of Evidence: Low

Mesh repair may improve a patient’s overall health status at 12 months more than watchful waiting (difference in mean SF-36 scores = 7.3; 95% CI, 0.4 to 14.3).Low strength of evidence

There is not enough information to know if there are differences in adverse effects.

Clinical Bottom Line: Pain-Free Primary Hernias—Repair Versus Watchful Waiting in Adults


Twenty-one studies were included. The most commonly compared procedures were:

Lichtenstein versus mesh plug (n = 7) Lichtenstein versus the PROLENE™ Hernia System

(PHS; n = 5) Lichtenstein versus the open preperitoneal mesh

technique (n = 3) Mesh plug versus the PHS (n = 2) Lichtenstein versus the Kugel® Mesh Patch (n = 2)

Studies were typically conducted between 2000 and 2010.

Comparative Effectiveness of Open Mesh-Based Repair Procedures


Rates of recurrence were approximately equivalent.Strength of Evidence: Moderate

Patients who have the Lichtenstein repair may return to work about 4 days earlier (95% CI, 1 to 7).Strength of Evidence: Moderate

Lichtenstein repair is associated with lower rates of seroma than mesh plug repair (OR = 0.39; 95% CI 0.16 to 0.94).Strength of Evidence: Moderate

Comparative Effectiveness of Open Mesh-Based Repair Procedures—Lichtenstein Versus Mesh Plug


Short-term pain outcomes were similar for these open repair procedures: Mesh plug versus the PROLENE™ Hernia System (PHS)

Strength of Evidence: Moderate Lichtenstein versus the PHS

Strength of Evidence: Moderate Lichtenstein versus open preperitoneal mesh

Strength of Evidence: Low Lichtenstein versus the Kugel® Mesh Patch

Strength of Evidence: Low

Intermediate-term pain was also similar for Lichtenstein versus Kugel Mesh Patch repair. Strength of Evidence: Low

Comparative Effectiveness of Other Open Mesh-Based Repair Procedures


Transabdominal preperitoneal (TAPP) repair may offer a 1.4-day earlier return to work; however, this may not be clinically significant.Strength of Evidence: Moderate

Short-term pain outcomes were similar.Strength of Evidence: Moderate

Intermediate-term and long-term pain outcomes were similar.Strength of Evidence: Low

Research on comparative adverse effects between TAPP and totally extraperitoneal repairs was inconclusive for hematoma, urinary retention, and wound infection.

Comparative Effectiveness of Laparoscopic Repair Procedures—TAPP Versus TEP


Hernia recurrence occurred at similar rates with polypropylene mesh versus combination materials.*Strength of Evidence: Moderate

Long-term pain after surgery was similar for standard polypropylene mesh when compared with biologic mesh or light-weight polypropylene mesh.Strength of Evidence: Low

Evidence on comparative adverse effects for the different types of mesh materials was inconclusive.

*Descriptions of the combination-material mesh analyzed for this outcome can

be found in the full report.

Comparative Effectiveness of Mesh Materials


After laparoscopic surgery, hernia recurrence rates were similar for tacks or staples versus no fixation. Strength of Evidence: Moderate

Mesh fixed with sutures versus glue during open or laparoscopic surgery had similar: Recurrence rates

Strength of Evidence: Moderate Long-term pain outcomes

Strength of Evidence: Low Mesh fixed with fibrin glue during transabdominal

preperitoneal repair resulted in less long-term pain than when the mesh was fixed with staples.Strength of Evidence: Moderate

Data on adverse effects were either missing or inconclusive.

Comparative Effectiveness of Fixation Methods

Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm

Thirty-two studies reported on this association. The length of the learning curve for TEP or TAPP

repair could not be estimated due to problems associated with not accounting for followup time, not accounting for the evolution of procedures over time, and selective outcome reporting.

Generally, the risk of recurrence decreases when a more experienced surgeon performs a repair, but there were not enough congruent studies to perform a meta-analysis.


Association Between Laparoscopic Surgical Experience and Hernia Recurrence


The typical adult in the studies included in this review was a man in his mid 50s, of average weight (median body mass index, 25.3 kg/m2; interquartile range, 25.0–26.7), who had an elective repair of a primary unilateral inguinal hernia.

It is unclear how these results apply to: Women Men of other age groups

About a quarter of the men with hernias worked in physically strenuous jobs; for these men, a durable repair is important to prevent a recurrence.

Conclusions: Patient Population


Laparoscopic repair of an inguinal hernia is associated with: Faster recovery times Less risk of long-term pain A lower risk of another hernia recurrence after a

previous recurrence

Open hernia repair may be associated with: Fewer internal injuries Lower recurrence rates in the context of primary

inguinal hernia

Conclusions: Laparoscopic Versus Open Repair of Inguinal Hernias in Adults


Low-strength evidence suggests that choosing to repair a pain-free hernia with a Lichtenstein or tension-free mesh repair over watchful waiting may improve quality of life.

However, this finding may not be applicable to other types of repair procedures (e.g., laparoscopic repair).

The evidence on adverse effects was inconclusive.

Conclusions: Watchful Waiting Versus Repair for Pain-Free Inguinal Hernias


Research found most of the meshes or fixation methods to be equivalent in their effectiveness and risk of adverse effects with only a few exceptions.

Conclusions: Mesh Material and Fixation Methods


How the surgeon's experience influences surgical outcomes such as recurrence and pain

The comparative effectiveness and adverse effects of laparoscopic repair versus watchful waiting for pain-free or minimally symptomatic inguinal hernias in adults

The comparative effectiveness and adverse effects of contralateral exploration/repair versus watchful waiting in the pediatric population

More evidence on several outcomes related to the comparisons of mesh products and fixation methods including recurrence rates, perception of a foreign body, long-term pain, and infection rates

Clarification in future studies of whether the population includes emergent as well as elective surgeries and whether or not the findings apply equally to both populations

Gaps in Knowledge


If repair or watchful waiting is the right decision for their pain-free or minimally symptomatic inguinal hernia

How to choose between open or laparoscopic surgery if the option is available

What to expect from open or laparoscopic repair as far as outcomes and adverse effects, including the risk of long-term chronic pain

What to do if the hernia recurs

Shared Decisionmaking: What To Discuss With Your Patients

Resource for Patients Surgery for an Inguinal Hernia,

A Review of the Research for Adults is a free companion to this continuing medical education activity. It can help patients talk with their health care professionals about the decisions involved with the care and maintenance of an inguinal hernia.

It provides information about: Types of operative

treatments Current evidence of

effectiveness and harms Questions for patients to ask

their doctor

surgical management of inguinal hernia prepared for: agency for healthcare research and quality...

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