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Table of Contents
ORIGINAL ARTICLE
Year : 2020  |  Volume : 3  |  Issue : 2  |  Page : 56-62

A randomized clinical trial of mesh fixation with cyanoacrylate glue compared to sutures in inguinal hernia repair


Department of General Surgery, Faculty of Medicine, Mansoura University Hospitals, Mansoura University, Mansoura, Egypt

Date of Submission03-Feb-2020
Date of Decision15-Feb-2020
Date of Acceptance20-Feb-2020
Date of Web Publication11-May-2020

Correspondence Address:
Dr. Samy Abbas Elbaz
Department of General Surgery, Faculty of Medicine, Mansoura University Hospitals, Mansoura University, Mansoura
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijawhs.ijawhs_4_20

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  Abstract 


BACKGROUND: The method of mesh fixation in Lichtenstein hernia repair may have an impact on the incidence of chronic groin pain (CGP) after surgery. This study aimed to compare fixation of mesh with N-butyl 2-cyanoacrylate and with sutures in open inguinal hernia repair in terms of CGP, postoperative complications, operation time, and hernia recurrence.
PATIENTS AND METHODS: Adult patients with unilateral uncomplicated inguinal hernia were randomly assigned to one of two equal groups. Group I underwent mesh fixation with cyanoacrylate glue and Group II underwent mesh fixation with polypropylene sutures. The main outcome measures were pain scores at 1, 6, and 12 months of follow-up, hernia recurrence, postoperative complications, and operation time.
RESULTS: Forty patients (39 male) of an average age of 48.2 years were included in the study. Patients in Group I had significantly lower pain scores at 1 week and 6 and 12 months after surgery than Group II. The operation time in Group I was significantly shorter than Group II (51.7 vs. 58.7 min, P = 0.007). No recurrence of hernia was recorded in either group at 12 months. Four patients in Group I experienced complications as compared to two patients in Group II with no significant difference (P = 0.66).
CONCLUSIONS: Fixation of mesh in Lichtenstein repair with cyanoacrylate glue conferred significantly lower pain scores in the early postoperative period and at 6 and 12 months of follow-up than the classical suture fixation. No difference in the hernia recurrence and postoperative complication rates between cyanoacrylate and suture mesh fixation groups was observed.

Keywords: Cyanoacrylate, fixation, inguinal hernia, Lichtenstein, mesh, suture


How to cite this article:
Fouda E, Thabet W, Elsaid M, Emile SH, Elbaz SA. A randomized clinical trial of mesh fixation with cyanoacrylate glue compared to sutures in inguinal hernia repair. Int J Abdom Wall Hernia Surg 2020;3:56-62

How to cite this URL:
Fouda E, Thabet W, Elsaid M, Emile SH, Elbaz SA. A randomized clinical trial of mesh fixation with cyanoacrylate glue compared to sutures in inguinal hernia repair. Int J Abdom Wall Hernia Surg [serial online] 2020 [cited 2022 Sep 27];3:56-62. Available from: http://www.herniasurgeryjournal.org/text.asp?2020/3/2/56/284112




  Introduction Top


Surgery for inguinal hernia is a common surgical practice across the world.[1] Lichtenstein repair, first described more than 30 years ago, has significantly changed hernia surgery. Currently, Lichtenstein technique has become the gold standard treatment for inguinal hernia.[2],[3]

The use of a mesh graft to reinforce the fascia transversalis according to the Lichtenstein technique is a simple procedure and is associated with a very low rate of recurrence and minimal complications.[3],[4],[5] However, chronic pain after Lichtenstein hernia repair has been recorded and recognized as one of the important consequences of the procedure.[6]

Almost half of the patients who had inguinal hernia mesh repair complain of chronic groin pain (CGP) according to several studies.[6],[7] The main causes identified as contributing to groin pain after inguinal hernia repair included inflammatory reaction to the mesh and nerve injury or entrapment by sutures used in hernia repair.[7]

It is worthy to note that sutured repair of inguinal hernia without mesh may also result in similar rates of CGP and this may suggest that nerve irritation inflicted by taking sutures may be the principal mechanism to explain CGP after hernia repair. This also rendered alternative, sutureless techniques for mesh fixation of major interest in inguinal hernia surgery. Nonetheless, only scarce data on the use of staplers,[8] spiral tacks,[9] or tissue adhesives[10],[11],[12] have been published. Fixation of the mesh with adhesive glue may be considered a better option to decrease the severity of pain after hernia repair since it is not associated with nerve irritation or entrapment. Initial reports on different tissue glues reported promising results with a lower degree of postoperative pain.[10],[11],[12],[13],[14]

In this study, we aimed to compare the fixation of synthetic mesh in Lichtenstein hernia repair with either tissue glue (N-butyl 2-cyanoacrylate) or with sutures in regard to CGP, postoperative complications, operation time, and hernia recurrence.


  Patients and Methods Top


Study design and setting

This was a randomized single-blinded controlled study on patients with a primary inguinal hernia who underwent Lichtenstein repair in the general surgery department of our institution in the period of March 2018–September 2018. The study has been approved by the Institutional Review Board of our institution.

Selection criteria

Adult patients of either sex aging <65 years with primary unilateral uncomplicated inguinal hernia were included in the study. We excluded patients with bilateral or sliding inguinal hernia, incarcerated or strangulated hernia, recurrent inguinal hernia, and femoral hernia and patients unwilling to participate in the trial.

Random sequence generation and blinding

Patients were randomized to one of two equal groups: Group I (treatment group) in which mesh fixation was done using N-butyl 2-cyanoacrylate tissue glue and Group II (control group) in which mesh fixation was done with polypropylene sutures.

Randomization was conducted by online software (www.randomization.com). The assignment of patients to each group was concealed by the sealed envelope method in which computer-generated numbers were put in opaque closed envelopes which were opened by a nurse in the operation theater immediately before the fixation of the mesh. The operating surgeons were aware of the nature of the study and method of fixation. Patients gave consent to be included in the study but were unaware of the method of mesh fixation and group allocation.

Preoperative assessment

Patients were interviewed about the present complaint, associated medical comorbidities, previous surgeries, previous treatments for the current condition, presence of any predisposing factors such as chronic cough, chronic constipation, and benign prostatic hyperplasia.

Patients were clinically examined to determine the side and type of inguinal hernia and to exclude complications. Anesthetic fitness was assessed using the American Society of Anesthesiologists (ASA) classification.

Surgical procedure

After explaining the nature of the study and the potential benefits and harms, informed consent was obtained from all patients. All patients underwent Lichtenstein tension-free repair under spinal anesthesia. A single dose of intravenous ampicillin-sulbactam 1.5 g was administered before the operation.

An oblique inguinal incision was made 3 cm above and parallel to medial 2/3 of the inguinal ligament. The external oblique aponeurosis was incised, and the ilioinguinal nerve was identified and protected. Dissection of the spermatic cord from the posterior wall of the inguinal canal was performed, followed by the division of cremasteric muscle and fascia. Afterward, the hernia sac was identified and dissected up to the neck, the fundus was opened with scissors, and the contents were reduced back to the peritoneal cavity. The hernia sac was transfixed and ligated at its neck using polyglactin 2/0 suture, then the sac was excised. A 6 × 12 heavy-weight microporous polypropylene mesh (Prolene® Ethicon, Johnson and Johnson) was placed on the posterior wall of the inguinal canal. The method of fixation of the mesh in each group varied as follows:

  • Group I (treatment group): The mesh was fixated with dots of N-butyl 2-cyanoacrylate tissue glue (Histoacryl®)
  • Group II (control group): The mesh was fixated with polypropylene 2/0 sutures. The mesh was affixed to the aponeurosis over the public tubercle then fixated with a running suture to the inguinal ligament. Then, the mesh was anchored to the internal oblique muscle with interrupted sutures. The mesh was divided lateral to the internal inguinal ring and the overlying cranial part of the mesh was affixed with interrupted sutures to its lower part and to the inguinal ligament.


The external oblique aponeurosis was closed over the spermatic cord with running polypropylene 0 sutures, then the subcutaneous tissue and skin were closed.

Patients were monitored in the regular ward and fluid intake was resumed 4 h after surgery. Pain control was achieved by paracetamol infusion using analgesia on-demand protocol. Patients were instructed to ambulate freely but to avoid lifting heavy weights for 6 months postoperatively.

Endpoints and follow-up

The outcome was assessed by a resident and an attendant of general surgery, both were unaware about the nature of the study. Patients were followed in the outpatient clinic at 1 week and at 1, 6, and 12 months postoperatively.

Groin pain was assessed at every visit using the visual analog scale (VAS) from 0 to 10 where 0 implied absence of pain and 10 indicated the worst severe pain. Recurrence of hernia and complications were assessed and recorded on follow-up. Complications included surgical site infection (SSI), wound hematoma, seroma, dehiscence, testicular edema, or pain.

Recurrence was defined as persistence or reappearance of a groin swelling at the anatomical site of inguinal hernia with characteristic features of hernia such as reducibility and expansible impulse on cough. Complications were defined as any undesirable and unintended result of the operation affecting the patient that occurred as a direct result of the operation. SSI was defined according to the standard criteria devised by the center for disease and control. Seroma was defined as a pocket of sterile clear serous fluid at the site of the incision, and hematoma was defined as a collection of blood or clots in the surgical wound.

The primary endpoint of the study was CGP in both the groups at 12 months postoperatively. Secondary endpoints were hernia recurrence, complications, and operation time.

Sample size calculation

The sample size of this study was based on the primary endpoint of the study (VAS of CGP at 12 months after surgery). In the light of the previous studies[15],[16] that assessed CGP after Lichtenstein tension-free repair of inguinal hernia, we hypothesized that the average CGP score at 12 months in Group I will be 1.5 versus 2.5 ± 1 in Group II.

Sample size and study power calculation software (www.clinicalc.com) was used, and a total of 32 patients (16 patients in each group) were needed to attain a study power of 80% with a significance level set at 5%. Estimating a dropout rate and loss to follow-up of 20%, a total of 40 patients were ultimately included.

Statistical analysis

We used SPSS version 21 (IBM Corp; Bristol, UK) for the data analysis. Parametric data were expressed in the form of mean ± standard deviation or median and range. Nonparametric data were expressed in the form of proportions. Continuous data were analyzed using Student's t-test, whereas Fisher exact test or Chi-square test was used for processing categorical variables. Multiple linear regression analysis was performed to determine the significant independent predictors of higher pain VAS after Lichtenstein tension-free repair. Significant results of the comparison between the two groups were determined by P < 0.05.


  Results Top


Patients' characteristics

Overall, 78 patients with inguinal hernia were assessed in the study period and 35 patients did not meet the study criteria and were excluded. Forty-three patients were enrolled in the study and were assigned to one of the study groups. Three patients were lost to follow-up and were excluded, and thus, 40 patients were included in the final analysis [Figure 1].
Figure 1: CONOSRT flowchart illustrating the process of patient selection and exclusion

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Patients were 39 (97.5%) male and one (2.5%) female of a mean age of 48.2 ± 12.1 years and mean BMI of 27.9 ± 2.2 kg/m2. All patients presented with indirect inguinal hernia, among whom 36 (90%) had bubonocele or funicular type of hernia and four (10%) had a scrotal type. The mean duration of complaint was 26.9 ± 17.8 months. Ten (25%) patients had type 2 diabetes mellitus, eight (20%) had hypertension, and 19 (47.5%) were smokers.

Both the groups were comparable in regard to age, sex distribution, duration of symptoms, type of hernia, body mass index (BMI), medical comorbidities, ASA grade, and smoking history, as illustrated in [Table 1].
Table 1: Baseline characteristics of patients in the two groups

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Postoperative pain

Patients in Group I had significantly lower pain scores at 1 week and 6 and 12 months after surgery, as compared to Group II. The pain VAS in the two groups was similar at 1 month postoperatively [Table 2]. Fifteen percent of Group I patients required analgesia versus 45% of Group II patients; however, this difference was not statistically significant [Table 3].
Table 2: Pain score of patients in the two groups

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Table 3: Outcome of patients in the two groups

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Recurrence and complications

The operation time in Group I was significantly shorter than Group II (51.7 ± 8.15 vs. 58.7 ± 7.6, P = 0.007). No recurrence of hernia was recorded in either group at 12 months of follow-up. Four patients in Group I experienced complications as compared to two patients in Group II with no significant difference (P = 0.66). Complications included SSI (n = 1) and wound seroma (n = 5). There were no recorded cases of hematoma, testicular pain or atrophy, ilioinguinal entrapment syndrome, or wound dehiscence. The mean time required to return to work and daily activities was comparable in the two groups (21.3 ± 5.6 vs. 18.3 ± 3.9 days; P = 0.056) [Table 3].

Predictors of higher pain visual analog scale at 12 months after Lichtenstein repair

Multiple regression analysis of the pain VAS at 12 months revealed that the predictive factors of higher pain scores were increased BMI (coefficient = 0.27, standard error [SE] = 0.11, P = 0.023) and suture mesh fixation (coefficient = 2.2, SE = 0.37, P = 0.0001) [Figure 2].
Figure 2: Histogram illustrating pain score at 12 months according to the method of mesh fixation

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On the other hand, age (coefficient = 0.035, SE = 0.02, P = 0.09), sex (coefficient = -1.84, SE = 1.62, P = 0.26), smoking (coefficient = -0.18, SE = 0.51, P = 0.73), diabetes mellitus (coefficient = 0.06, SE = 0.64, P = 0.92), and duration of symptoms (coefficient = -0.001, SE = 0.01, P = 0.95) were not associated with higher pain VAS at 12 months.


  Discussion Top


Lichtenstein technique is the most widely performed procedure for the management of inguinal hernia, as it has been found superior to other anatomic suture repairs. However, CGP or inguinodynia is recorded after Lichtenstein repair at variable rates ranging from 0.5% to 6%[17],[18] depending on different factors such as the method of mesh fixation, type of mesh used, and the subjective threshold of pain.[19]

CGP after Lichtenstein's repair is a challenging problem since chronic pain can significantly compromise the quality of life of the patients. Pain experienced after inguinal hernia repair can be classified as neuropathic and nonneuropathic, with neuropathic pain being caused by injury of ilioinguinal, iliohypogastric, or genitofemoral nerves during surgery.[20] Nerve injury may be attributed to nerve entrapment within the fixating sutures or within the developing scar over the mesh. Furthermore, accidental transection of these nerves may lead to the formation of neuroma at the divided ends of the nerves and subsequently chronic pain.

It has been suggested that CGP can be avoided by meticulous recognition and preservation of the nerves during dissection, atraumatic fixation of the mesh with glues to prevent the entrapment of nerves in sutures, and using lightweight meshes which cause less fibrous reaction hence avoid nerve entrapment.[21]

This randomized controlled trial aimed at comparing suture mesh fixation with sutureless fixation using cyanoacrylate tissue glue in Lichtenstein tension-free repair. The majority of patients in our study were male, in concordance with the male predominance of inguinal hernia reported by the previous studies.[14],[22],[23] The mean age of patients was about 48 years, lower than what other investigators have reported in the literature.[22],[24] Approximately half of the patients were smokers which emphasizes the role of active smoking as a predisposing factor for the development of groin hernia. It has been reported that up to 70% of patients with groin hernia have a history of cigarette smoking.[23]

We randomly allocated patients to one of two groups; in the first group, mesh fixation was carried out by cyanoacrylate tissue glue, whereas it was done using sutures in the second group. There were no significant differences in age, sex distribution, smoking status, and medical comorbidities between the two groups which may indicate minimal risk of selection bias owing to the adequate randomization method.

We opted to use cyanoacrylate as tissue adhesive because it fulfills the criteria of the ideal adhesive material being biocompatible, cheap, and easy to store and use.[25] Fibrin glue is another tissue adhesive that has been associated with very good results,[26],[27],[28] yet it is more costly and not commercially available in our community. We used the butyl-octyl variant of cyanoacrylate as it has demonstrated very good tissue compatibility and has been used extensively in medicine and surgery.

The primary outcome of this study was the degree of postoperative pain after the two methods of fixation. Patients who had their meshes fixated by cyanoacrylate had significantly lower pain scores at 1 week and at 6 and 12 months after surgery, as compared to patients with suture mesh fixation. This finding was in concordance with a meta-analysis of nine trials[29] that compared fibrin glue as tissue adhesive with sutures for mesh fixation and concluded lower incidence of CGP in the fibrin glue group (relative risk (RR) = 0.42). On the contrary, a long-term randomized trial concluded[30] that cyanoacrylate glue and suture mesh fixation were equal in terms of CGP at up to 7 years after surgery. The comparable pain scores in the latter study might be attributed to the use of absorbable sutures, unlike our study that used nonabsorbable polypropylene sutures for mesh fixation.

While cyanoacrylate mesh fixation conferred lower pain scores at 1 week and at 6 and 12 months postoperatively than suture repair, both the groups had similar pain scores at 1 month. This finding may be explained that pain after inguinal hernia repair is classified into early and late (chronic) pain. Early pain which occurs in the 1st week after surgery is mostly attributed to surgical trauma and incision-related pain. Chronic pain which persists more than 3 months after surgery is mostly related to excess fibrosis causing nerve entrapment. The cyanoacrylate glue group was associated with less surgical trauma and thus with less pain at 1 week than the suture repair group. At 1 month, both the groups had similar pain scores since the impact of surgical trauma has already resolved, and at the same time, fibrosis has not fully established to induce groin pain. This is why pain scores in the cyanoacrylate glue group were significantly lower than suture repair at 6 and 12 months postoperatively because by that time, fibrosis has developed and contributed to the development of CGP.

The method of fixation of the mesh has been suggested to be one of the chief reasons for CGP after inguinal hernia repair. Different methods of mesh fixation have been studied including self-gripping meshes which have higher costs than that of the regular meshes.[31] However, a recent regression analysis of 625 patients found that new recurrent hernias and high pain scores at 7 days postoperatively were the only predictive factors for CGP after Lichtenstein repair, whereas the type of mesh or the method of its fixation did not predict CGP.[32] In contradiction, the linear regression analysis conducted in the present trial identified suture mesh fixation to be associated with higher pain scores at 12 months postoperatively.

Mesh fixation with cyanoacrylate required shorter operation time than the classical suture mesh fixation which may be reasonable as the application of tissue glue managed to save about 5–10 min of time needed for fixating the mesh with interrupted sutures.

Both the groups were comparable in regard to postoperative complications which were in discordance with another study[23] that found the rate of postoperative morbidities after cyanoacrylate fixation significantly lower than after suture fixation. The rates of seroma and hematoma formation in the two groups were quite similar. Conversely, Liu et al.[29] found the pooled rate of hematoma/seroma formation after mesh fixation with fibrin glue significantly lower than that after suture fixation. The small numbers of patients included to the present trial may explain the comparable rates of complications in the two groups.

No recurrence of hernia was recorded in either group on short-term follow-up. The efficacy of tissue adhesive glue to provide sufficient fixation of the mesh and prevention of hernia recurrence in the long-term has been questioned. Regardless of the short follow-up in our study, other studies[25],[30],[32],[33] with longer follow-up already provided similar results which affirms the effectiveness of tissue adhesive glue in the prevention of hernia recurrence.

Limitations of the present study include being a single-institution study that comprised small numbers of patients with short follow-up. Larger, multicenter trials with longer follow-up are needed to confirm the findings of the present trial.


  Conclusions Top


Fixation of the mesh in Lichtenstein repair with cyanoacrylate tissue adhesive conferred significantly lower pain scores in the early postoperative period and at 6 and 12 months of follow-up than the classical suture fixation. No difference in the hernia recurrence and postoperative complication rates between cyanoacrylate and suture mesh fixation groups was observed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Campanelli G, Champault G, Hidalgo Paschal M. Randomised controlled blinded trial of Tissucol/Tisseel for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: Rationale and study design of TIMELI trial. Hernia 2008;12:159-65.  Back to cited text no. 14
    
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de Goede B, Klitsie PJ, van Kempen BJ, Timmermans L, Jeekel J, Kazemier G, et al. Meta-analysis of glue versus sutured mesh fixation for Lichtenstein inguinal hernia repair. Br J Surg 2013;100:735-42.  Back to cited text no. 15
    
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Losi P, Burchielli S, Spiller D, Finotti V, Kull S, Briganti E, et al. Cyanoacrylate surgical glue as an alternative to suture threads for mesh fixation in hernia repair. J Surg Res 2010;163:e53-8.  Back to cited text no. 17
    
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    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]


This article has been cited by
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Hernia. 2022;
[Pubmed] | [DOI]



 

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