Open Mesh versus Laparoscopic Mesh Repair of Inguinal Hernia

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Neumayer. "Open Mesh Versus Laparoscopic Mesh Repair of an Inguinal Hernia". NEJM. 2004. 350(18):1819-1827.
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Clinical Question

Among men with inguinal hernias, is a mesh-based laparoscopic repair approach equivalent to a traditional open technique in terms of preventing recurrence at two years?

Bottom Line

Although subsequent evidence and current guidelines indicate the Neumayer VA study findings of increased risk with laparoscopic approach to inguinal hernia repair was likely hampered by a patient population with high comorbidities (thereby exacerbating risk of general anesthesia in the laparoscopic group), this remains one of the few large RCTs available to directly compare laparoscopic and open techniques.

Major Points

Inguinal hernia repair is the most common operation worldwide, and therefore its optimal management has significant quality of life and economic implications. To this day, there is no evidence based consensus among the multitude of options to repair an inguinal hernia. Laparoscopic approaches traditionally allow for less time in hospital, reduced pain, and faster return to normal activities. However, these benefits must be weighed against the complications of general anesthesia (whereas open approaches can typically be performed under local anesthesia). The Open mesh versus Laparoscopic Mesh Repair of an Inguinal Hernia trial is the largest trial available that sought to address the question of whether a laparoscopic approach offered an equivalent recurrence rate compared to an open approach.

Guidelines

2018 International guidelines for groin hernia management [1] Given adequate surgical experience, there is no evidence of differences between laparoscopic/endoscopic techniques and the open Lichtenstein technique (see The Tension-Free Hernioplasty in terms of perioperative complications, reoperations, and long-term surgical associated pain. Consensus analysis is still hampered by technique and study heterogeneity. Specifically referenced, in a meta-analysis comparing laparoscopic techniques TEP and TAPP vs. the open Lichtenstein technique, the significance of increased rates of hernia recurrence with laparoscopic technique becomes non-significant removed when the Neumayer VA study is excluded.

Design

  • Prospective RCT
  • N= 1,983 underwent operation (3,518 screened, 2,164 assigned)
    • Open inguinal hernia repair (n=994 completed)
    • Laparoscopic inguinal hernia repair (n=989)
  • Setting: Multicenter VA medical centers
  • Enrollment: 1999-2001
  • Mean follow-up: 2 years, 85.5% follow-up (1,696/1,983)
  • Analysis: Intention to treat (although per protocol analysis commented on)
    • Recurrence rate compared with O’Brien-Fleming boundaries to allow for continuously monitored patients
    • Multiple linear regression analysis for secondary outcomes
    • Time to event secondary outcomes analyzed with cox regression analysis
  • Trial stopped early due to sufficient power to detect differences in primary outcome
  • Primary outcome: Hernia recurrence within 2 years
  • Secondary outcomes: Long term complications, Life-threatening complications, Patient centered (pain, functional status, activity levels) assessed at multiple time points
  • Subgroup logistic regression analysis of primary outcome stratified by primary or recurrent hernia, unilateral/bilateral hernia, study site
  • Full study design details can be found at [2]

Population

Inclusion Criteria

  • Men
  • Age ≥ 18 years
  • Inguinal hernia (primary or recurrent)

Exclusion Criteria

  • ASA class IV, V
  • history of surgical repair with mesh
  • contraindications to general anesthesia
  • bowel obstruction or strangulation
  • peritonitis
  • bowel perforation
  • local/systemic infection
  • contraindications to pelvic laparoscopy
  • life expectancy < 2 years
  • participation in a separate RCT

Baseline Characteristics

Listed for Laparoscopic Group

  • Age (yr) 58.6±12.8
  • Race (%)
    • White 75.9
    • Black 22.1
    • Asian 0.1
    • Multiracial 2.6
    • No response 1.3
  • Duration of hernia (%)
    • <6 weeks 9.0
    • 6 wk to 1 year 49.3
    • >1 year 35.2
    • Unknown 6.5
  • Hernia (%)
    • Unilateral 82.3
    • Bilateral 17.7
    • Primary 90.3
    • Recurrent 8.7
  • Coexisting conditions (%)
    • Congestive heart failure 0.5
    • Prior myocardial infarction 0.2
    • Hypertension 34.3
    • Severe chronic obstructive pulmonary disease 4.9
    • Chronic cough 9.1
    • Prostatism 17.9
    • Diabetes 6.2
    • Smoking 40.4
    • Alcohol consumption >2 drinks/day 13.8
  • ASA class (%)
    • I 34.7
    • II 46.8
    • III 18.5

Interventions

  • Open repair via the Lichenstein method with mesh
  • Laparoscopic repairs by either a trans abdominal preperitoneal approach or by a totally extraperitoneal approach with mesh
  • Standardized post-operative instructions (pain limited activity)
  • Bilateral hernias repaired simultaneously with initial site chosen randomly
  • Follow-up at 2 weeks, 3 months, annually
  • Hernia recurrence determined by an independent surgeon, ultrasound, or intraoperatively

Outcomes

Comparisons are Laparoscopic vs. Open repair

Primary Outcomes

Recurrence
10.1% vs. 4.9% (OR 2.2; 95% CI 1.5-3.2)

Secondary Outcomes

Intraoperative Complications
4.8% vs. 1.9% (HR 2.6; 95% CI 1.5-4.7)
Immediate Postoperative Complications
24.6% vs. 19.4% (HR 1.4; 95% CI 1.1-1.7)
Life threatening Complications
1.1% vs. 0.1% (HR 11.2, 95% CI 1.3-95.3)
Long Term Complications
18.0% vs. 17.4% (HR 1.1, 95% CI 0.8-1.5)
Death
3.2% vs 3.4% (adjusted OR 1.0, 95% CI 0.6-1.6, p-value non-significant)

Patient Centered Outcomes

  • Presented are mean differences in visual analogue scale, laparoscopic vs. open repair
Day of Surgery
Laparoscopic group 10.2mm less painful (95% CI 4.8-15.6)
2 week assessment
Laparoscopic group 6.1mm less painful (95% CI 1.7-10.5)
  • No differences beyond 2 week visit (3 months and beyond)
  • Please see figure 2

Subgroup Analysis

  • Adjusted OR calculated from logistic-regression analysis
  • Laparoscopic Recurrence rate based on surgical experience
    • <250 repairs: Recurrence rate >10% (58 surgeons)
    • >250 repairs: Recurrence rate <5% (20 surgeons)
  • No differences in open recurrence rate

Comparisons are Laparoscopic vs. Open repair

Highly Experienced Surgeon Primary Repair Recurrence Rate
5.1% (13/253) vs. 4.1% (26/653) (adjusted OR 1.3, 95% CI 0.6-2.7)
Less Experienced Surgeon, Primary Repair Recurrence Rate
12.3% (65/528) vs. 2.5% (3/121) (adjusted OR 7.4, 95% CI 2.1-26.6)
Highly Experienced Surgeon Recurrent Repair Recurrence Rate
3.6% (1/28) vs. 17.2% (11/64) (adjusted OR 0.3, 95% CI 0.1-1.0)
Less Experienced Surgeon, Recurrent Repair Recurrence Rate
insufficient to analyze
  • More surgeons became “highly experienced” (>250 operations) in the laparoscopic techniques compared with the open throughout the course of the study (P = 0.013)

Adverse Events

(add more)

  • 9.8% (97/989) of patients assigned to laparoscopic repair underwent open herniorrhaphy. The authors report that “approximately” 50% converted due to patient preference/technical factors prior to operation, while the other 50% converted intraoperatively
  • 1.6%(16/994) of patients assigned to open repair instead underwent a laparoscopic repair

Criticisms

  • High rates of hernia recurrences (10.1%) and life threatening complications (1.1% laparoscopic group)
  • Large amount of secondary endpoints obscures statistical significance
  • High baseline morbidity in patient population may increase complication rate
  • Heterogeneity in laparoscopic group (transabdominal preperitonal or total extraperitoneal approach) without subgroup analysis obscures clinical interpretation, as there are differing opinions on the outcomes in these two approaches.

Funding

  • Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development
  • Author holding of patents for laparoscopic-related techniques and consulting for laparoscopic equipment

Further Reading

  1. HerniaSurge Group International guidelines for groin hernia management. Hernia 2018. 22:1-165.
  2. Neumayer L et al. Tension-free inguinal hernia repair: the design of a trial to compare open and laparoscopic surgical techniques. J. Am. Coll. Surg. 2003. 196:743-52.