Abstract
Background:
Because of the poor local medical conditions, and because the surgical site infection (SSI) rate after hernia repair in sub-Saharan Africa is higher than in developed countries, deployed surgeons within Role 2 usually perform non-mesh inguinal herniorrhaphy. Regarding antimicrobial prophylaxis, the latter currently is not recommended in non-mesh inguinal hernia repairs. Our study aimed at assessing the relevance of antibiotic prophylaxis in non-mesh inguinal hernia repair within a Role 2 surgical structure deployed in sub-Saharan Africa.
Methods:
From January 1 to December 31, 2019, we conducted a non-randomized prospective study in a French Role 2 military surgical structure deployed to Abidjan, Republic of Côte d'Ivoire. We included all patients presenting with uncomplicated inguinal hernia. All subjects underwent open herniorrhaphy through a groin incision. The primary endpoint was the occurrence of an SSI.
Results:
We recorded 120 open hernia repairs. Antimicrobial prophylaxis was administered in 70 interventions (60%). An SSI was reported in 13 cases (11%). Multivariable logistic regression analysis of SSI occurrence, according to the administration of intra-operative antimicrobial prophylaxis, showed a 0.219 odds ratio with a 95% confidence interval of 0.05–0.84 and p = 0.028. This finding was in favor of its significant protective effect on the risk of SSI after open non-mesh inguinal hernia repair, taking into account the American Society of Anesthesiologists score, Body Mass Index, and recurrence status.
Conclusion:
Administration of intra-operative antimicrobial prophylaxis in open non-mesh inguinal hernia repair in remote and poor medical settings, for example during deployment conditions as in our study, was associated with a reduction of the SSI rate.
Inguinal hernia is a common ailment, affecting 27% and 3% of males and females, respectively [1]. Although most often benign, it may become incarcerated or even strangulated. Strangulation can lead to necrosis of the affected tissue and potentially the death of the patient. Inguinal hernia surgical repair should be recommended at the onset of symptoms.
In sub-Saharan Africa, as part of the medical civic action program, deployed French military surgical teams regularly provide healthcare to local populations within forward surgical structures called “Role 2” according to the North American Treaty Organization definition [2]. Because of the poor local medical conditions, deployed surgeons usually perform non-mesh inguinal herniorrhaphy. The surgical site infection (SSI) rate after hernia repair is higher than in developed countries, with a cumulative incidence ranging from 2.5% to 30.9% [3]. Among the reported risk factors are the poor hospital and surgical settings as well as inappropriate healthcare practices (lack of care protocols, lack of patient preparation, insufficient intra-operative asepsis, absence of appropriate waste management, or prolonged peri-operative hospital length of stay [LOS]) and underlying co-morbidities of patients [3,4]. Regarding antimicrobial prophylaxis, this currently is not recommended in non-mesh inguinal hernia repair [4]. Nevertheless, Role 2 surgical teams routinely prescribe antibiotic prophylaxis in all cases of inguinal hernia repair when deployed in Africa. However, certain surgical teams, on the basis of recent recommendations of the French Society of Anesthesia & Intensive Care Medicine (FSAIC), do not use antimicrobial prophylaxis routinely [5]. Our study aimed at assessing the relevance of antibiotic prophylaxis in non-mesh inguinal hernia repair within a Role 2 surgical structure deployed in sub-Saharan Africa.
Patients and Methods
From January 1 to December 31, 2019, we conducted a non-randomized prospective study in a French Role 2 military surgical structure deployed in Abidjan, Republic of Côte d'Ivoire (RCI). We included all patients presenting with inguinal or crural hernia, recurrent or not, and uncomplicated (non-strangulated). All subjects underwent open herniorrhaphy through a groin incision, and surgeons were free to choose among three techniques (Bassini, Shouldice, or McVay). The deployed physicians also were free to prescribe or not prescribe antibiotic prophylaxis. Indeed, even in French Role 2 structures deployed in Africa, elective hernia repair can be considered clean surgery without breaking aseptic protocols, which led us to assess the relevance for antibiotic prophylaxis in non-mesh inguinal hernia repair in remote and poor medical settings in sub-Saharan Africa. Thus, the decision to use antibiotic prophylaxis was made jointly by the anesthesiologist and the surgeon. Some physicians, based on the French Society of Anesthesia & Intensive Care Medicine recommendations, did not prescribe antibiotic prophylaxis because there was no use of a prosthesis for hernia repair. Others, despite these national recommendations, felt that antibiotic prophylaxis should be used because of the poor local conditions.
Patients were then followed up every other day until complete surgical wound healing. The following demographic characteristics and peri-operative features were recorded: Age, gender, American Society of Anesthesiologists (ASA) score, Body Mass Index (BMI), relevant medical and surgical history, type of operation (inguinal, inguino-scrotal, or crural) and side of the hernia, use of antimicrobial prophylaxis (cefazolin 2 g), type of anesthesia (general or spinal), complementary anesthesia (transverse abdominal plane (TAP) block or local infiltration), operation duration, morbidity, complications (Clavien-Dindo classification from 0 to 5), surgical wound healing, SSI (sample collection, responsible microorganism, antimicrobial treatment, incision care, surgical debridement), pain or discomfort relief, and recurrence. All microbiological samples were analyzed at the Role 2 deployable laboratory.
The primary endpoint was the occurrence of an SSI defined by local signs (redness, swelling, pus or discharge, tenderness), associated or not with fever, and, when possible, bacteriological confirmation. Secondary endpoints were the operation duration and revision surgery for surgical debridement. Data were entered in Microsoft® Excel. Statistical analysis was made using the Fisher exact test (p < 0.05) and χ2 test for univariable analysis. Multivariable logistic regression analysis was performed with the χ2 test followed by the Hosmer-Lemeshow test.
Results
As shown in Table 1, we recorded 120 open hernia repairs—inguinal (n = 99), inguinoscrotal (n = 20), and femoral (n = 1)—using the different herniorrhaphy techniques. The majority of patients were male (n = 118; 98%). Their mean age was 40.5 years (standard deviation 1.57). Regarding relevant medical and surgical history, twenty (17%) and seven (5.8%) patients had a surgical history of contralateral and ipsilateral open hernia repair, respectively; six were suffering from hypertension, two from human immunodeficiency virus infection, and one from diabetes mellitus. The predominant ASA score was 1 (n = 89; 74.2%). Concerning the hernia side, 77 interventions (64%) were performed on the right and 43 (36%) on the left. The mean operation duration was 53.9 minutes [range 25–120 minutes]. Antimicrobial prophylaxis was administered in 70 cases (60%). Spinal and general anesthesia was performed in 85 (71%) and 35 (29%) of cases, respectively. Only 48 patients (41%) received complementary regional or local anesthesia.
Demographics of Study Sample
An SSI was reported in 13 cases (11%). However, because of the remote medical settings, bacteriologic analysis was possible in only four cases: Staphylococcus aureus (n = 3) and Klebsiella pneumoniae (n = 1) were recovered. The SSI management was based on incision care (cleaning, abscess packing) in 85% of cases (n = 11), with these same cases having a Clavien-Dindo classification <3. The remaining two patients had a major post-operative complication (≥ 3 score) requiring revision surgery for debridement and drainage. Oral antibiotic therapy was prescribed in three cases (15%) in addition to incision care.
According to univariable analysis, there was a significant difference in the SSI rate (p = 0.03) between the group that received antibiotic prophylaxis and the one that did not (5.8% versus 19.5%, respectively). Antimicrobial prophylaxis seemed to be a protective factor (odds ratio [OR] 0.253) (Tables 1 and 2). Furthermore, there was a significant difference (p = 0.017) between overweight patients (BMI ≥25) and the others regarding the SSI rate (26% versus 7.5%, respectively). Excessive weight thus appeared to be an SSI risk factor (OR = 4.33) (Tables 1 and 2). Regarding the six patients with hypertension, three suffered from an SSI with a significant statistical association (p = 0 .018). Apart from these findings, we found no significant statistical association between SSI and the other features, particularly the ASA score and recurring hernia.
Univariable Analysis of Surgical Site Infection Risk Factors
Based on published studies [1, 3–11] and the findings of our univariable analysis, we decided to include in the multivariable model the ASA score, the BMI, and the recurring hernia status. Multivariable logistic regression analysis of SSI occurrence, according to the administration of intra-operative antimicrobial prophylaxis, showed a 0.219 OR with a 95% confidence interval [CI] [0.05–0.84] and p = 0.028. This finding was in favor of a significant protective effect on the risk of SSI after open non-mesh inguinal hernia repair, taking into account the ASA score, BMI, and recurrence status.
Discussion
Our study showed that intra-operative antimicrobial prophylaxis in open non-mesh inguinal hernia repair had a protective effect against SSI in remote and deficient healthcare settings, such as in a military surgical structure deployed in sub-Saharan Africa (Abidjan, RCI, in our cases). In sub-Saharan African countries, the reported SSI rate in gastrointestinal surgery was 19% in accordance with the SSI rate in our study. Indeed, this quite high hernia repair SSI rate without antibiotic prophylaxis can be explained by factors extrinsic to the patient and to the surgery such as patient preparation and air/surfaces quality of the operating room in a Role 2 structure [3].
Antimicrobial prophylaxis recommendations for inguinal hernia repair have been evolving these last two decades (Table 3) [6–12]. However, there are no clear recommendations regarding this practice in tropical and remote settings. Thus, it should be discussed according to the infection risk assessment in the particular healthcare environment and patient characteristics. In accordance with the European Hernia Society guidelines, a setting was considered at risk when the SSI rate was higher than 5% [11]. Furthermore, inguinal hernia mesh repair often was questioned in poor medical settings, especially because of the theoretically higher risk of SSI. Although according to a Cochrane review database, this practice probably reduced the rate of hernia recurrence and visceral and neurovascular injuries [1]. Few studies on hernia mesh repair in tropical settings have been published.
Antibiotic Prophylaxis Guideline for Inguinal Hernia Repair in Adults
In a retrospective Beninese series from 2011, 41 patients underwent open abdominal-wall reconstruction (inguinal, umbilical, epigastric, or incisional hernia) by mesh repair [13]. All subjects received broad-spectrum antimicrobial prophylaxis. Post-operative morbid complications were observed in three cases (7.3%): SSI in an HIV-positive patient (treated by antibiotics), seroma (treated by drainage), and an umbilical recurrence. Because of the low post-operative morbidity and recurrence rates, the authors recommended mesh repair as first-line treatment for abdominal wall surgery associated with routine antimicrobial prophylaxis. In 2014, in a 1,101 hernia repair series in sub-Saharan Africa, comparing open mesh and non-mesh techniques, all patients received antibiotic prophylaxis: Intra-operatively for mesh intervention and post-operatively for non-mesh herniorrhaphy. There was no statistically significant difference regarding the SSI rate: 2.2% and 4.6% for the mesh and non-mesh groups, respectively (p = 0.55) [14].
In 2017, a series of 184 patients underwent open hernia mesh repair using low-cost mesh made from sterilized nylon mosquito nets. All patients received intra-operative antimicrobial prophylaxis. A 2.9% rate of mesh infection was observed and treated by antibiotics and incision care nursing. No revision surgery was required [15]. Thus, through these three studies, even though they had poor design, mesh hernia repair associated with appropriate antibiotic prophylaxis seemed feasible in Africa, similar to what was recommended in France.
Regarding the association of a high SSI rate and poor medical settings, two studies were reported in sub-Saharan Africa. The first was conducted in Nigeria in 2008, with 151 inguinal hernia repairs, most performed in emergency situations. It included 48 herniotomies (removal of the hernial sac without repair of the posterior wall of the inguinal canal), 130 Bassini repair techniques, 12 Shouldice repair procedures, and nine mesh hernioplasties, all without antimicrobial prophylaxis. The authors reported 14 SSIs (6.2%) that were treated conservatively [16]. The second was a non-randomized prospective series, conducted between 2014 and 2016, by French forward surgical teams deployed in sub-Saharan Africa and included 119 patients who underwent a non-mesh inguinoscrotal hernia repair (Bassini or Shouldice) without antimicrobial prophylaxis. Among the endpoints, the authors compared complication and recurrence rates in patients undergoing local or spinal anesthesia. The surgeons reported global rates of post-operative abdominal wall hematoma and SSI of 6.7% and 3.4%, respectively [17].
Despite the low numbers and poor design of these five studies in sub-Saharan Africa, antibiotic prophylaxis seemed to reduce the post-operative SSI rate in both mesh and non-mesh hernia repairs. In these tropical settings, several factors have to be considered, such as the remote location of healthcare structures (delaying or limiting the treatment in cases of post-operative complications), the lack of specialized healthcare staff (sometimes inducing inappropriate healthcare practices), and the poor condition of the patients with underlying co-morbidities [4].
Our study had some limitations. First, it was not a prospective randomized controlled trial, which probably could have induced inherent selection bias. Second, three factors were not included in the multi-variable analysis, although the Fisher exact test result was lower than 0.40: The side of surgery (SSI was associated with the left side), the absence of local anesthesia, and the hypertension co-morbidity (already included in the ASA physical status classification system and usually not considered with SSI). This probably generated random confounding biases. Third, this study is valid only for Role 2 structures deployed in sub-Saharan Africa and is not applicable to other local surgical facilities benefiting from better control of air and surface quality.
Conclusion
Administration of intra-operative antimicrobial prophylaxis in open non-mesh inguinal hernia repair in remote and poor medical settings, for example, during deployment conditions as in our study, was associated with a reduction of the SSI rate. As a result, and independent of patient-related risk factors, we recommend this preventive practice in mesh and non-mesh inguinal hernia repair in tropical or deficient healthcare conditions, in order to decrease the SSI risk. In addition, based on the Cochrane review database, highlighting the advantages of mesh inguinal hernia repair, it would be beneficial to conduct a prospective study regarding SSI prevalence in mesh inguinal hernia repair with or without antimicrobial prophylaxis, in similar tropical and remote conditions.
Footnotes
Ethical Approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Funding Information
No funding was received for the writing of this article.
Author Disclosure Statement
All the authors have no conflicts of interest.
