A Randomized Trial of Low-Cost Mesh in Groin Hernia Repair

Chisom Anosike, LECOM School of Pharmacy

Repair of a groin hernia is suggested to be one of the most regularly performed surgical worldwide.  It is stated that the surgical outcomes for inguinal hernia have been improved by the routine use of prosthetic mesh.  It has been suggested that mosquito meshes, which are similar to commercial meshes, are currently used as a low-cost alternative in hernia repair. [1]

It is recommended that improvements in the delivery of inguinal hernia surgery in the future will depend on the development of improved prosthetic mesh materials to decrease the occurrence of chronic groin pain, which is currently higher than recurrence rates. [2]

A Randomized Trial of Low-Cost Mesh in Groin Hernia Repair
Design Double-blind, randomized, controlled trial; N = 302
Objective To assess the outcomes of groin hernia repair performed with the use of a low-cost lightweight mesh as compared with a commercial lightweight mesh in a low-income country in sub-Saharan Africa
Study Groups Commercial mesh (n = 151)

Low-cost mesh (n = 151)

Methods Patients in the intervention group received a low-cost mesh composed of 100% polyethylene.  The mechanical properties of the polyethylene normally serves as a mosquito net and are similar to those of widely available commercial surgical meshes.  The control group received a commercial 100% polypropylene mesh.  Both were lightweight meshes and the pore size was similar in the two meshes (1.5 mm and 1.9 mm, respectively).  The low-cost mesh was washed with water and mild detergent and cut it into pieces 10 cm by 15 cm in size, packed the pieces individually, and autoclaved them at 121°C for 20 minutes.
Duration February 2012 to October 2013
Primary Outcome Measure Hernia recurrence at 1 year and postoperative complications
Baseline Characteristics  

Characteristic

Low-cost mesh

(n= 150)

Commercial mesh

(n = 149)

Age (year) 45.1 46.4
ASA classification score of 1 – no. (%) 132 (88.0) 132 (88.6)
Body-mass index 21.5 20.8
Scrotal hernia- no. (%) 58 (38.7) 59 (39.6)
Smoker- no. (%) 12 (8.0) 15 (10.1)
Inguinal Pain Questionnaire (IPQ) score 3.4 3.4
Self-assessed health status score 59.5 58.2
Results A relapse of hernia transpired in one patient (0.7%) assigned to the low-cost mesh and in no patients assigned to the commercial mesh (absolute risk difference, 0.7 percentage points; 95% confidence interval [CI], −1.2 to 2.6).  Postoperative complication occurred in 44 patients (30.8%) receiving the low-cost mesh and in 44 patients receiving the commercial mesh (29.7%) (absolute risk difference, 1.0 percentage point; 95% CI, −9.5 to 11.6).   Hematoma or swelling in the groin or scrotum was the most common postoperative complication in each group, followed by impaired wound healing and superficial infection.
Adverse Events Common Adverse Events: N/A
Serious Adverse Events: There was one postoperative death of a patient assigned to the low-cost mesh.
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions This study showed that a low-cost mesh can be used in hernia repair with excellent clinical outcomes that do not differ significantly from those achieved with commercial mesh.  These results support the use of low-cost mesh for hernia repair in resource-scarce settings, after appropriate training of the staff performing the procedures.

This study has several limitations that may skew the results in the real world. First, the results cannot be applied to any available low-cost mesh or to settings that do not have procedures in place to guarantee safety.  The careful attention to details in this study is not routine in the general health care system in most countries.  The use of the alternative mesh requires correct preparation, including sterilization.  Second, the inclusion criteria resulted in a population that is not illustrative of the average patient with groin hernia in sub-Saharan Africa.  Third, due to cost and feasibility issues, the current study used a superiority design, and thus the findings cannot be interpreted to show non-inferiority of low-cost mesh repair to commercial mesh repair; however, recurrence was very uncommon in both groups at one year.  Finally, this study had only one year of follow-up, and recurrence rates would be expected to increase over time. [1]

References

  1. Löfgren J, Nordin P, Ibingira C, Matovu A, Galiwango E, Wladis A. A Randomized Trial of Low-Cost Mesh in Groin Hernia Repair. N Engl J Med. 2016;374(2):146-53.
  2. Kingsnorth A. Treating inguinal hernias. BMJ. 2004;328(7431):59-60.
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