Surgical Site Infections after Inguinal Hernia Repairs Performed in Low- and Middle-Human Development Index Countries: A Systematic Review

Abstract

Background:

Inguinal hernias are a common disorder in low- and middle-human development index countries (LMHDICs). Poor access to surgical care and lack of patient awareness often lead to delayed presentations of incarcerated or strangulated hernias and their associated morbidities. There is a scarcity of data on the baseline incidence of surgical site infections (SSIs) after hernia repair procedures in LMHDICs.

Methods:

We performed a systematic review of the literature describing the incidence and management of SSIs after inguinal hernia repair in LMHDICs. We conducted qualitative and quantitative analyses of manuscripts describing patients undergoing hernia repair to establish a baseline SSI rate for this procedure in these settings.

Results:

Three hundred twenty-three abstracts were identified after applying search criteria, and 31 were suitable for the quantitative analysis. The overall pooled SSI rate was 4.1 infections/100 open hernia repairs (95% confidence interval [CI] 3.0–5.3 infections/100 open repairs), which is consistent with infection rates from high-human development index countries. A separate subgroup analysis of laparoscopic hernia repairs found a weighted pooled SSI rate of 0.4 infections/100 laparoscopic repairs (95% CI 0–2.4 infections/100 laparoscopic repairs).

Conclusions:

As surgical access continues to expand in LMHDIC settings, it is imperative to monitor surgical outcomes and ensure that care is provided safely. Establishing a baseline SSI rate for inguinal hernia repairs offers a useful benchmark for future studies and surgical programs in these countries.

Inguinal hernia repair is one of the most common general surgical procedures performed worldwide, accounting for 10%–15% of all operations [1,2]. In parts of Africa, the incidence of inguinal hernias has been reported to be as high as 175/100,000 patient-years, but fewer than 40% of these are repaired [3,4]. Although hernias commonly are treated electively in high-human development index countries (HHDICs), elective repair is less common in low- and middle-human development index countries (LMHDICs). Consequently, patients present with acute symptoms that require emergency surgical management and hospital admission.

A number of barriers to care have been identified, including late presentation because of lack of patient awareness, limited access to surgical equipment, and poor availability of surgeons and anesthesiologists [5]. In some regions, late presentation leads to more than 60% of inguinal hernias being repaired in an emergency setting, with 24% requiring bowel resection [5,6]. As surgical access continues to expand into low-resource settings, there exists a need for widespread monitoring to ensure the safety and efficacy of these procedures in both elective and non-elective settings.

Surgical site infections (SSIs) are an uncommon complication of elective hernia repair but can present significant challenges in post-operative management. Although SSI rates after urgent or emergent repair are higher than after elective repair, bundled care aimed at reduction of SSIs is effective for hernia repair procedures, particularly those that use mesh [7 –11]. Given the expanding global access to surgery, SSI rates after hernia repair may serve as a benchmark to measure the overall quality of care in a specific hospital, country, or region. The goal of this study was to review the literature on hernia repair in LMHDICs and to establish the expected baseline SSI rate after hernia repair in these settings.

Patients and Methods

We performed a systematic review of the published literature describing the incidence and management of SSIs after inguinal or femoral hernia repair in LMHDICs. This review was registered prospectively in the Prospero database (Project No. 42016036658) in accordance with Preferred Reporting Items for Systematic reports and Meta-Analysis (PRISMA) guidelines. The PubMed, Web of Science, and Ovid databases were searched using the terms “inguinal hernia,” “inguinal hernia repair,” “direct inguinal hernia,” “indirect inguinal hernia,” and “herniorrhaphy” both alone and in combination with the names of countries of interest (Supplement). The countries included in the search terms were those recognized in the low- or middle-human development index by the United Nations Development Programme (UNDP) 2015 [12]. All studies published between January 2000 and March 2016 found through the search criteria were subjected to initial review to ensure capture of all relevant studies. Papers not written in English were translated using Google Translate and included for further review.

The titles and abstracts retrieved from all three databases were screened for duplicates and then reviewed for relevance prior to obtaining full-text manuscripts. Eligible articles were reviewed independently by two blinded reviewers, who each evaluated them using following criteria: Study location, type of study, sample size, patient age and gender, type of hernia, laterality of hernia, type of hernia repair, use of mesh, hernia recurrence, frequency of SSI, grade of infection, use of prophylactic antibiotics, microbiological profile, morbidity of infection, need for re-operation, and cost of infection. Disagreement between reviewers was resolved through discussion with a third reviewer. Exclusion criteria included abstracts without full text available, studies that did not specify whether SSIs occurred, and studies describing only pediatric patients (defined as those ≤18 years of age). Studies were categorized as operating in elective or non-elective settings; in studies that described operating in both settings, a study was considered non-elective if >50% of cases were non-elective. In studies that did not specify whether procedures were performed as open or laparoscopic, all procedures were categorized as open because of the infrequently reported use of laparoscopy in these settings [13]. Missing data were requested from study authors and incorporated when possible. Additional studies were sought by examining the bibliographies of all studies identified during the search.

Established definitions for superficial, deep, and organ-space SSIs were used [14,15]. For the qualitative analysis, we did not set a sample size minimum, as we did not expect to find a large number of articles. For the quantitative analysis, studies that had fewer than 30 patients were excluded in concordance with the rule-of-threes sample size based on an assumed infection rate of 10% in these settings [16,17]. Weighted pooled SSI rates and 95% confidence intervals (CIs) were calculated from the studies that met the minimum sample size requirement. Statistical analysis was performed using STATA^® (Version 14.1). This was an Investigational Review Board-exempt study, as all articles were publically available.

Results

Three hundred twenty-three abstracts were identified through the initial database search (Fig. 1). After removing 133 duplicates, 190 abstracts remained. Of these, 102 were excluded because of non-relevance. Full-text manuscripts were obtained for the remaining 88 studies (27% of the initial total), of which 50 were excluded for the following reasons: insufficient SSI data (n = 29), SSI data not specific to hernias (n = 10), only pediatric population (n = 8), duplicative study (n = 1), unable to translate study (n = 1), and single-case report (n = 1). Thirty eight manuscripts ultimately met all inclusion criteria for qualitative analysis (Table 1) [18 –55]. The five studies that covered laparoscopic repairs exclusively, one study of exclusively emergency hernia repairs, and one study with a sample size <30 were excluded from the quantitative analysis. As such, all calculated pooled infection rates are based on a subset of 31 studies with a sample size of ≥30 that met all the inclusion criteria.

FIG. 1.

Preferred Reporting Items for Systematic reports and Meta-Analysis (PRISMA) diagram of report selection.

Table 1.

Description of the 38 Studies that Met All Inclusion Criteria and Were Reviewed for This Study

Study	Source	Design	Country	Method of Repair	Use of Mesh	Sample Size	All SSIs (%)	Deep/Mesh SSIs (%)
Groin hernias in patients 50 years of age and above: Pattern and outcome of management in 250 consecutive patients	Adesunkanmi et al. 2000	Prospective observational	Nigeria	Open	None	288	36 (13)	NA
Prospective randomized comparison of two preoperative skin preparation techniques in a developing world country^b	Meier et al. 2001	Randomized intervention	Nigeria	Open	None	208	17 (8)	NA
Experience with preperitoneal hernioplasty using Stoppa's procedures in the Ivory Coast	Diarra et al. 2001	Prospective observational	Ivory Coast	Stoppa	All	239	1 (0)	NA
Inguinal herniorrhaphy with an undetached strip of external oblique aponeurosis: A new approach used in 400 patients	Desarda et al. 2001	Retrospective	India	Open	None	459	4 (1)	NA
Prognosis of strangulated hernia in adult with necrosis of small bowel: A 34 cases report^a	Harouna et al. 2001	Retrospective observational	Niger	Open	None	34	16 (47)	NA
Safety of daycare hernia repair in Jos, Nigeria	Ramyil et al. 2000	Randomized	Nigeria	Open	None	138	11 (8)	NA
Inguinal hernia in Nigeria	Awojobi et al. 2004	Prospective observational	Nigeria	Open	Not specified	3863	166 (4)	NA
A randomized, double-blind, placebo-controlled trial to determine effectiveness of antibiotic prophylaxis for tension-free mesh herniorrhaphy	Perez et al. 2005	Randomized	Philippines	Open	All	360	12 (3)	2 (1)
Prospective randomized study of internal oblique aponeurotic flap repair for tension-free reinforcement of the posterior inguinal wall: A new technique	Jani et al. 2005	Randomized	India	Open	Some	100	1 (1)	0
Commercial mesh versus Nylon mosquito net for hernia repair. A randomized double-blind study in Burkina Faso	Freudenberg et al. 2006	Randomized	Burkina Faso	Open	All	40	0	NA
Economical inguinal hernioplasty for resource poor countries: Experience in Zambia	Desai et al. 2007	Prospective observational	Zambia	Open	All	35	0	NA
Outcome of Lichtenstein operation: A prospective evaluation of sixty-four patients	Shrestha et al. 2006	Prospective non-randomized	Nepal	Open	All	64	1 (2)	NA
Study of efficacy of bilayer mesh device versus conventional polypropelene hernia system in inguinal hernia repair: early results^b	Chauhan et al. 2007	Randomized	India	Open	All	84	3 (4)	NA
Repair of inguinal hernia by a simple technique: a preliminary observation^b	Giri et al. 2007	Prospective non-randomized	India	Open	None	106	2 (2)	0
Total extraperitoneal (TEP) mesh repair of inguinal hernia in the developing world: Comparison of low-cost indigenous balloon dissection versus direct telescopic dissection: A prospective randomized controlled study^a	Misra et al. 2008	Randomized	India	Laparoscopic	All	84	0	0
Indirect inguinal hernia in Nigerian older children and young adults: Is herniorrhaphy necessary?	Osifo et al. 2008	Prospective observational	Nigeria	Open	None	326	0	0
Morbidity and mortality associated with inguinal hernia in Northwestern Nigeria	Mbah et al. 2007	Retrospective observational	Nigeria	Open	None	253	12 (5)	5 (2)
Day-case surgery for inguinal hernia: A multi-specialist private hospital experience in Nigeria	Obalum et al. 2008	Prospective observational	Nigeria	Open	None	87	8 (9)	0
The use of sterilised polyester mosquito net mesh for inguinal hernia repair in Ghana	Clarke et al. 2009	Case series observational	Ghana	Open	All	106	2 (2)	0
Impact of closed-suction drain in preperitoneal space on the incidence of seroma formation after laparoscopic total extraperitoneal inguinal hernia repair^a	Ismail et al. 2009	Retrospective case control	India	Laparoscopic	All	1753	0	0
Factors influencing morbidity and mortality in elderly population undergoing inguinal hernia surgery	Malik et al. 2010	Retrospective observational	Pakistan	Open	Some	212	18 (8)	NA
Outcomes of giant inguinoscrotal hernia repair with local lidocaine anesthesia	Osifo et al. 2010	Prospective observational	Nigeria	Open	None	136	6 (4)	0
Cost-effectiveness of groin hernia surgery in the Western Region of Ghana	Shillcutt et al. 2010	Prospective non-randomized	Ghana	Open	All	129	2 (2)	NA
Evaluation of tension-free mesh inguinal hernia repair in Nigeria: A preliminary report	Arowolo et al. 2011	Prospective observational	Nigeria	Open	All	30	2 (7)	0
Inguinal mesh hernioplasty under local anaesthesia	Shaikh et al. 2012	Prospective observational	Pakistan	Open	All	108	3 (3)	NA
Do hernia operations in African international cooperation programmes provide good quality?	Gil et al. 2012	Prospective case control	Cameroon	Open	All	524	5 (1)	NA
Surgical management of inguinal hernias at Bugando Medical Centre in northwestern Tanzania: Our experiences in a resource-limited setting	Mabula et al. 2012	Prospective observational	Tanzania	Open	Some	544	24 (4)	NA
Outcome of laparoscopic inguinal hernia repair in a South African private practice setting^a	McGuire et al. 2012	Retrospective observational	South Africa	Laparoscopic	All	384	5 (1)	0
Management of recurrent inguinal hernia at a tertiary care hospital of southern Sindh, Pakistan	Memon et al. 2013	Prospective observational	Pakistan	Open	All	62	2 (3)	1 (2)
Comparative study between Lichtenstein procedure and modified darn repair in treating primary inguinal hernia: A prospective randomized controlled trial	Abd el Maksoud et al. 2014	Randomized	Egypt	Open	Some	227	10 (4)	1 (0)
Surgical repair of giant inguinoscrotal hernias in an austere environment: Leaving the distal sac limits early complications^a	Savoie et al. 2014	Prospective observational	Cote d'Ivoire	Open	None	25	3 (12)	0
Inguinal mesh hernioplasties: A rural private clinic experience in South Eastern Nigeria	Enyinnah et al. 2013	Prospective observational	Nigeria	Open	All	81	2 (2)	2 (2)
Surgical site infection following hernia repair in the day care setting of a developing country: A retrospective review.	Pardhan et al. 2013	Retrospective observational	Pakistan	Open	All	104	8 (8)	NA
Outcome of totally extra-peritoneal laparoscopic hernioplasty at a tertiary care hospital Larkana^a	Shaikh et al. 2013	Prospective observational	Pakistan	Laparoscopic	All	182	1 (1)	NA
Assessing the impact of short-term surgical education on practice: A retrospective study of the introduction of mesh for inguinal hernia repair in sub-Saharan Africa	Wang et al. 2014	Prospective observational	Ghana	Open	Some	1132	17 (2)	NA
Laparoscopic inguinal hernia repair: A prospective evaluation at Eastern Nepal^a	Shakya et al. 2014	Prospective observational	Nepal	Laparoscopic	All	55	3 (5)	1 (2)
The usefulness of international cooperation in the repair of inguinal hernias in sub-Saharan Africa	Gil et al. 2015	Prospective observational	Mali	Open	All	1033	83 (8)	21 (2)
A randomized trial of low-cost mesh in groin hernia repair	Lofgren et al. 2016	Randomized	Uganda	Open	All	291	10 (3)	0

Studies that were excluded from the pooled surgical site infection rate for the following reasons: only laparoscopic repairs, only repairs performed in emergency settings, and a sample size of <30 (in concordance with the rule-of-three sample size and based on the assumption of an infection rate of 10% in these settings),

Studies that specified the number of patients operated on but not the number of procedures (i.e., whether repairs were unilateral or bilateral). In these studies, all patients were assumed to have had unilateral repairs.

SD = standard deviation; SSI = surgical site infection.

Of the studies that were included in the qualitative analysis, 30 (79%) were prospective, 7 (18%) were retrospective, and 1 (3%) was a case series. There were 23 (60%) observational studies, 9 (24%) randomized interventions, 4 (11%) non-randomized interventions, and 2 (5%) case control studies. Twenty-four studies (63%) were conducted in African WHO countries, 10 (26%) in Southeast Asian WHO countries, and 4 (11%) in Eastern Mediterranean WHO countries. The most common countries of origin for these studies were Nigeria (n = 10; 26%), India (n = 6; 16%), Pakistan (n = 5; 13%), Ghana (n = 3, 8%), and Nepal (n = 2; 5%); twelve other countries contributed one study each. A majority of studies (n = 32; 84%) were based on data from a single institution.

Use of mesh differed among studies, with 21 (55%) using mesh in all repairs, 5 (13%) using mesh in some repairs, and 11 (29%) not using any mesh; one study did not report mesh use. Twenty-five studies (65%) specified that peri-operative antibiotics were given to all patients, whereas 12 studies (32%) did not describe antibiotic use and one paper (3%) explicitly stated that antibiotics were not given. Microbiological data were scarce, with only four studies (11%) reporting the causative organism of SSIs and just one (3%) identifying bacterial resistance. Two studies (5%) described the costs associated with the procedure and SSI management.

Of the 31 studies included in the final quantitative analysis, 13,886 inguinal and femoral hernia repairs were described, with a median of 137 repairs (range 25–3,863 hernia repairs) per study. Fourteen studies specified the types of hernias, with a total of 4,863 indirect inguinal, 2,366 direct inguinal, and 52 femoral. Twenty-three studies specified the laterality of the repairs, with a total of 1,634 right sided, 1,064 left sided, and 2,221 bilateral. Among the 35 studies that reported sex data, hernia repairs were performed on 7,423 (93%) males and 563 (7%) females. Three studies described the number of patients who were operated on but did not specify the number of procedures (i.e., if repairs were unilateral or bilateral). The authors of the three studies were contacted for clarification, but no additional information was obtained on the number of procedures or laterality. As such, these papers were included in the quantitative analysis under the assumption that all repairs were unilateral; they have been marked in Table 1. Twenty-four of the 31 studies specified the urgency of the hernia repair. Of these, 17 reported only electively performed repairs, and the remaining 7 reported 30% or fewer cases that were performed non-electively. Twenty-five studies reported the duration of follow-up, with a median time of six months (range one week to six years); only four studies reported follow-up shorter than four weeks. Eight studies described the percentage of patients who were enrolled at various follow-up time points.

A total of 468 SSIs were reported in the 11,369 repairs, with a median of five SSIs (range 0–166 SSIs) per study, which corresponds to a weighted, pooled SSI rate of 4.1 infections/100 repairs (95% CI 3.0–5.3 infections/100 repairs). No fatal infections were reported. Of the 14 studies that delineated superficial vs. deep or mesh infections, 3,166 infections (99%) were superficial and 32 infections (1%) were deep or involved the mesh (Table 2).

Table 2.

Summary of Pooled Infection Rates from the 31 Studies that Met Inclusion Criteria for Quantitative Analysis

Subgroup	Number of Studies	Pooled SSI Rate (%)	95% CI	Range
All quantitative studies^a	31	4.1	3.0–5.3	0–13
Use of mesh
Never	9	4.8	2.0–7.6	0–13
Sometimes	5	3.2	0.5–5.8	1–8
Always	16	4.1	2.9–5.4	0–8
Not specified	1	4.3	–	–
Acuity of repair
Elective	24	4.9	3.6–6.3	0–13
Not specified	7	1.5	0.3–2.6	0–4
Use of antibiotics
Always	22	2.9	1.5–4.2	0–13
Never	1	8.0	–	–
Not specified	8	5.1	3.2–7.1	2–8
Laparoscopic studies^b	5	0.4	0–2.4	0–5

Seven studies that met the inclusion criteria for qualitative analysis were excluded from the pooled SSI rate calculations because they were all laparoscopic procedures (n = 5), all emergency procedures (n = 1), or had a sample size of <30 (n = 1).

These studies were excluded from the overall pooled SSI rate calculations, as the studies used to derive the pooled SSI rate all performed open repairs.

CI = confidence interval; Lap. = laparoscopic; SSI = surgical site infection.

A subgroup comparison analysis was performed according to the use of mesh in these 31 studies. In the nine studies that reported no mesh use, 96 infections were reported in 2,001 repairs, which corresponds to a weighted, pooled SSI rate of 4.8 infections/100 repairs (95% CI 2.0–7.6 infections/100 repairs). In the 16 studies that reported mesh use in all patients, 136 infections were reported in 3,290 repairs, which corresponds to a weighted, pooled SSI rate of 4.1 infections/100 repairs with mesh (95% CI 2.9–5.4 infections/100 repairs).

A separate analysis of the five studies of exclusively laparoscopic procedures revealed nine SSIs in 2,458 procedures, which corresponds to a weighted, pooled SSI rate of 0.4 infections/100 repairs (95% CI 0–2.4 infections/100 laparoscopic repairs). Of the nine total infections in the laparoscopic group, eight were superficial, and one was a deep/mesh infection.

Discussion

Rates of SSI after hernia repair procedures in HHDICs range from one to seven infections/100 repairs in series reporting both elective and emergency cases [56 –58]. The pooled SSI rate of the LMHDICs studies in this review was 4.1 infections/100 repairs, which is in line with the range described in HHDICs. The similarity in reported SSI rates in studies describing elective hernia repair in LMHDICs and HHDICs is encouraging. As surgical access continues to expand into low-resource settings, hernia repair offers a potential comparator for ongoing evaluations of the quality of care. Surgical programs in LMHIDCs may show great variability in the types of procedures that are offered, but elective hernia repair is likely to be ubiquitous. Thus, elective hernia repair procedures offer a potential standardized benchmark to compare the safety and efficacy of global surgery programs.

Studies describing patients who present acutely with obstruction, perforation, or strangulation were rare, likely leading to an underestimation of the burden of SSI after non-elective hernia repair in our review. The one study in this analysis that examined a series of 34 patients presenting with strangulated inguinal hernia reported an SSI rate of 47% and an overall mortality rate of 40% [22]. In contrast, an HHDIC series that included 6,277 emergency hernia repairs (of a total of more than 100,000 repairs) reported 185 deaths, for an overall mortality rate of 2.9% [59]. A similar study in an HHDIC described a mortality rate of 10% for emergency presentations of incarcerated or strangulated inguinal/femoral, inguinal, ventral, or umbilical hernias [60 –63].

Care of patients with acutely complicated hernias underscores several potential action items for reducing morbidity and death associated with inguinal hernias in LMHDIC settings. First, symptomatic hernias should be repaired early, as the ability to detect and act on progressive disease may be challenging. The ability to rescue a patient who presents in extremis from a strangulated hernia is likely to be lower in an LHMDIC health system, so early elective repair could greatly decrease morbidity and mortality rates. Second, patient education is critical; if patients in LMHDICs are able to recognize the symptoms of an incarcerated hernia and present to a surgical center in a timely fashion, morbidity may be decreased. Third, task shifting/sharing with non-physician providers in elective hernia repair may provide an opportunity to both expand the surgically trained healthcare provider workforce and improve access to hernia repair [64].

Elective hernia repairs are a critical intervention for patients in LMHDICs that is cost-effective compared with other common public health interventions [65]. One Ghanaian study reported an average of 9.3 disability-adjusted life-years (DALYs) averted per hernia repair at a cost of $120.02 for the provider and $102.88 for the patient, for a cost-effectiveness of $12.88 per DALY averted [40]. This compares favorably with other cost-effectiveness ratios for the WHO's Expanded Program on Immunization ($12.96–$25.93 per DALY) and bed netting for prevention of malaria ($6.48–$22.04 per DALY). Unfortunately, none of the studies commented on the cost of SSI management. Future investigators are encouraged to examine the costs associated with the prevention, treatment, and sequelae of SSIs to better understand the economic burden of this relatively common complication in LMHDIC settings.

Lichtenstein tension-free mesh repair is the gold standard for elective hernia repair in HHDICs [66,67]. Among the studies, there was no significant difference in all SSIs, superficial SSIs, or deep/mesh SSIs between those authors who reported using mesh and those who did not. One group of investigators commented that, at a per-patient total cost of $3.13, mesh was cost-effective for hernia repair [41]. Others have proposed that surgical mesh be provided to LMHDICs at reduced cost, in a fashion similar to pharmaceuticals for human immunodeficiency virus infection, tuberculosis, and malaria [68], or to explore the use of sterilized mosquito netting as both a safe and a cost-effective alternative in LMHDIC settings where standard surgical mesh is either unavailable or cost-prohibitive [69 –71]. However, healthcare providers must balance the cost effectiveness and similar SSI rates against patients' limited ability to return to a hospital for management of deep and mesh-related complications. Surgeons who use mesh in these LMHDIC settings must ensure that patients recognize the early signs of infection and have a plan for follow-up care in resource-constrained settings.

This review has several limitations. First, only a small number of LMHDICs were captured in this sample. Of the 83 countries listed by the UNDP, 17 were captured by studies in this review, with only four studies from the Eastern Mediterranean region. Therefore, the results may not be generalizable to all LMHDIC regions. Second, there may be selection bias, as authors may choose not to publish series with high SSI rates in both elective and emergency settings. Third, there was a lack of uniformity in reporting of repair technique details, such as use of mesh, use of antibiotic, acuity of repair, and definitions of superficial, deep, and organ-space infections. This again limits the ability to compare results between studies and to generalize these findings to other settings. Finally, the under-representation of emergent compared with elective hernia repairs in the available literature likely results in an underestimation of the incidence of SSIs, associated morbidity, and death in LMHDIC settings.

Hernia repair is a cornerstone operation that is ideally suited to be a comparator when evaluating the incidence of SSIs in LMHDICs. Establishing a baseline incidence of common post-operative complications, such as SSIs, is one key step toward ensuring the delivery of excellent healthcare in LMHDICs. We found that the rate of SSIs following hernia repair procedures in LMHDICs is nearly the same as that in HHDICs. However, this study also highlights the need for rigorous monitoring programs and standardized hospital-based reporting systems to ensure that operations meet appropriate quality standards. This study establishes an important baseline for expected SSI rates after elective inguinal hernia repair, providing a foundation by which to gauge future SSI prevention measures in LMHDICs.

Footnotes

Author Disclosure Statement

No competing financial interests exist for any of the authors.

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