Reduced Chronic Pain Following Laparoscopic Totally Extra-peritoneal Inguinal Hernia Repair Using Glue: A Randomized Clinical Trial

doi:10.21203/rs.3.rs-2317002/v1

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Reduced Chronic Pain Following Laparoscopic Totally Extra-peritoneal Inguinal Hernia Repair Using Glue: A Randomized Clinical Trial

https://doi.org/10.21203/rs.3.rs-2317002/v1

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Journal Publication

published 12 May, 2023

Read the published version in Langenbeck's Archives of Surgery →

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Purpose

Chronic pain following laparoscopic inguinal hernia repair occurs in up to 20% of the patients. We aim to compare glue and absorbable tackers on the rate of chronic pain after surgery in patients undergoing laparoscopic inguinal hernia repair.

Methods

Patients undergoing laparoscopic totally extraperitoneal inguinal hernia repair were enrolled in a single-blind randomized clinical trial and were randomized for mesh fixation with glue or absorbable tackers. Pain was assessed using a validated 4-point verbal-rank scale at 1 week, 1 month, 6 months and 1-year postoperatively. Chronic pain was defined as pain persisting beyond three months.

Results

Overall, 208 patients were analyzed. Chronic pain of any intensity was reported in 31.7% (66/208) after 6 months and in 13% (29/208) after12 months. No differences in postoperative pain were observed between the two forms of mesh fixation. Mesh fixation with glue resulted in less severe pain compared to fixation by tackers (logrank p = 0.025).

Conclusions

No differences in chronic pain rate were identified between tacker and glue fixation. Severe pain, however, was less common following glue fixation.

Laparoscopic hernia repair

TEP

glue fixation

tacker fixation

Inguinal hernia is one of the most common surgical pathologies. Postoperative chronic inguinal pain has been reported in 16–62% of patients who undergo inguinal hernia repair [1]. Prevalence of groin pain has been significantly decreased with the adoption of the laparoscopic approach, but up to 20% of the patients undergoing laparoscopic repair may still suffer from chronic pain [2, 3]. Although postoperative groin pain is usually mild in nature, quality of life studies have shown that chronic pain may significantly interfere with normal daily activity.[1, 4]

The underlying pathogenesis of postoperative groin pain is not completely clear, may be multifactorial, and in many cases may be impossible to define. One possible explanation relates to nerve damage during surgery, but this seems not to be the only factor, as many patients have postoperative sensory diminution without pain [1]. Another commonly cited reason may be associated with chronic foreign body inflammatory response due to the use of mesh [2]. The synthetic mesh is secured to the abdominal wall by tackers or glue [3], which may also potentially influence postoperative pain. The assumption is that tackers that are encored into the tissue such as pubic bone or abdominal wall muscles may result in a higher rate of local response and in higher rate of postoperative chronic pain compared to fixation methods that are not encored into the tissue. A recent network meta-analysis suggests that absorbable tacks and glue cause less local tissue response and may be associated with the lowest rate of chronic pain and recurrence [5].

The main aim of this study was to assess the effect of two methods for mesh fixation in laparoscopic totally extraperitoneal (TEP) inguinal hernia repair, absorbable tackers vs. glue, on postoperative chronic pain.

Design

We performed a single-blind randomized clinical trial comparing mesh fixation using glue to mesh fixation using absorbable tack staples in patients undergoing TEP hernia repair. The sample size was calculated to be 200 participants, by a power of 0.8 and significance of 0.5 with a presumed pain report incidence of 10% in the glue group compared to the previously reported 25% in the general inguinal hernia patients.

Participants

Patients at an age of 18 to 80 years who were admitted for elective inguinal hernia repair between March 1, 2017 and March 30, 2020 were eligible to participate in the study. Patients with recurrent, irreducible or incarcerated hernia, large inguino-scrotal hernia, pregnant women, patients presenting with co-morbid conditions that might interfere with pain assessment (impaired cognitive status, limited mobility, daily use of pain medicine), and patients with previous surgery in the groin were excluded from the study. Patient's flowchart is shown in Fig. 1.

Randomization

Randomization was made using sealed envelopes which were opened in the operating room, just before mesh fixation.

Intervention

In group I, mesh was secured by glue (LIQUIBAND FIX 8, Liquiband, Advanced Medical Solutions, UK), and group II included patients with mesh secured to the tissue by absorbable tackers (SECURE STRAP, Johnson & Johnson, USA). Surgery was performed under general anesthesia by 5 attending surgeons with individual experience of more than 200 laparoscopic inguinal hernia repairs. A standard uniform surgical technique of TEP inguinal hernia repair was applied in all cases. All patients received prophylactic antibiotics with 2 grams of intravenous Cefazolin before surgery. The TEP inguinal hernia repair were routinely done using 3 trocars with the camera 11 mm port at the umbilical boarder and two 5 mm ports along the midline about 4 cm and 8 cm above the pubis. Pre-peritoneal balloons were not used to dissect the pre-peritoneal space in this study. An appropriately sized knitted polypropylene mesh (Bard 3Dmax, BD, USA) was used in all patients. The mesh fixation points were standardized for all participants. The mesh was secured medially to the Cooper ligament and to the back of transversalis fascia laterally (maximum of 4 tackers or glue applications).

Patients were discharged from the hospital within 24 hours following surgery. Standard postoperative care instructions were given by staff nurses, who were blinded to the randomization.

Outcomes

All patients were examined in the outpatient clinic at 7 days and 1 year after surgery. A telephone interview was also performed at 1 month and 6 months after surgery. The examinations and telephone interviews were performed by an attending surgeon blinded to the form of mesh fixation. All the interview questions were standardized. Pain was assessed using a 4-point verbal-rank scale [6]. Briefly, patients were asked about the degree of pain, use of pain medications, restriction of daily activity and use of medical resources such as medical consult for inguinal pain. Mild pain was defined as occasional pain or discomfort that did not limit daily activity and did not require pain medications, moderate pain interfered with normal daily activity with rare analgesic requirement, and severe pain was incapacitating, at frequent intervals, or interfering with daily activities with a frequent need for painkillers. Daily activity included both physical and sport activities such as walking, lifting a bag, or jogging. Chronic pain was defined as a pain persisting beyond 3 months after surgery [6].

Statistical Analysis

Statistical analysis was performed with R version 4.1.0 (R Foundation for Statistical Computing) and GraphPad Prism (version 6.00 for Windows, GraphPad Software, La Jolla California USA). Descriptive statistics were presented with mean (standard deviation) or number (percentage) for continuous and categorical covariates, respectively. Comparisons between the two groups were analyzed with independent t-test and χ² tests for continuous and categorical variables, respectively. Time-to-event curves were constructed for each of the groups for residual pain. The log-rank test was used to test the differences between the time-to-event curves. Means, standard deviation, and percentages were approximated to the nearest decimals and P values to the nearest thousandth.

Recruitment data

Three hundred and seventy-two patients who underwent laparoscopic TEP inguinal hernia repair at the Shamir Medical Center during the study period were screened for this study. Eighty-nine did not meet the inclusion criteria and 68 patients refused to participate. Two hundred fifteen patients (199 male and 16 female) were randomly assigned to the 2 study groups. Seven patients were lost for follow-up and were excluded from the final analysis. Figure 1 summarizes the study flowchart from eligibility assessment to final analysis.

Seventeen patients were unable to visit the outpatient clinic for examination 1 year after surgery due to COVID 19 pandemic restrictions. These patients were interviewed by telephone regarding pain, and were considered as minor protocol deviation.

Baseline characteristics

Two-hundred and eight patients participated in the study and underwent 346 laparoscopic TEP repair, including 70 patients who underwent unilateral and 138 bilateral hernia repairs. No significant differences were observed in age and gender distribution between the groups. Table 1 summarizes intraoperative findings that also did not show difference between the groups. Overall, 17 patients were unable to visit the outpatient clinic for physical examination 1 year after surgery (8 from group 1 and 9 from group 2).

Table 1

Baseline characteristics
		Group I	Group II	P value
Age	Mean (SD)	54.5 (16.3)	54.5 (16.0)	0.972
Gender	male	96 (94.1%)	99 (93.4%)	1.000
	female	6 (5.9%)	7 (6.6%)	1.000
Sides	unilateral	34 (33.3%)	36 (34.3%)	1.000
	bilateral	68 (66.7%)	70(65.7%)	1.000
Hernia type	Direct	43 (25.1%)	49 (27.8%)	0.34
	Indirect	120 (70.2%)	113 (64.2%)
	Pantaloon	8 (4.7%)	14 (8.0%)
Large hernia		10 (5.8%)	13 (7.4%)	0.67
Lipoma		31 (18.1%)	36 (20.5%)	0.59

Postoperative pain assessment

Residual pain following surgery of any intensity was reported in 54.8% (114/208) after 1 month, 31.7% (66/208) after 6 months, and in 13% (29/208) after12 months (Fig. 2). When the patients were stratified according to the technique of mesh fixation no difference in moderate to severe residual pain were observed (Fig. 3). Severe pain after surgery was infrequent, and declined from 11% of the patients one week after surgery to 1% one year later. At each time point, there were less patients suffering from severe pain when mesh fixation was made with the glue compared to tacks fixation (Logrank p = 0.025) (Fig. 4).

Postoperative complications and hernia recurrences

Two patients from group 1 developed urinary retention and one patient from group 2 was readmitted due to large inguinoscrotal hematoma.

Following one year, four (1.2%) symptomatic recurrences were identified. All four had undergone mesh-fixation with absorbable tackers. Recurrent asymptomatic unilateral hernia was diagnosed in six more patients at 1 year by physical examination at the outpatient clinic and confirmed by ultrasonography. These patients were unaware of their hernia recurrence. Of these, one patient had undergone mesh-fixation with glue and 5 others had undergone tacker-fixation.

Laparoscopic TEP inguinal hernia repair is a standard practice today. In a large cohort study based on Swedish national hernia registry, Lindstrem et al. showed significant decrease in chronic groin pain after TEP repair compared with open repair, at the cost of increased risk of recurrence requiring surgery [7].

Mesh is traditionally used to cover hernia defects. Some authors recommend proper mesh placement in preperitoneal space with no fixation in order to avoid additional tissue damage and decrease the rate of chronic pain [8]. Moreno-Egea et al., in randomized control trial (RCT), showed no difference in the rate of chronic pain when comparing mechanical mesh fixation with non-fixation technique [9]. Nevertheless, many surgeons routinely fix the mesh to the tissue to avoid it displacement. Different types of mesh fixation have been proposed, varying from mechanical staples, tacks, glue, and simple sutures. Still, high-quality evidence for differences between the different techniques and their influence on chronic pain is lacking. Most RCTs were either based on small number of patients or included a mix of TEP and transabdominal preperitoneal repair. Techapongsatorn et al., recently evaluated 11 RCTs and found no significant difference between various types of mesh fixation for laparoscopic hernia repair, but ranked glue as the best method for less chronic pain [5]. Chin-Chin Yu et al. retrospectively studied single institution data of 583 patients after TEP repair [10] and found higher rate of acute groin pain in patients with mechanical fixation compared to the glue. However, chronic groin pain rates were similar between the groups.

Chronic pain defined as a pain persisting for more than 3 months. This definition is probably inaccurate since most patients suffering from inguinal pain 3 months after surgery will not have pain at 1 year after surgery. In our study persisting pain was noted in 32% of patients 6 months after surgery and decreased to 13% at1 year.

The main aim of this study was to evaluate whether the form of mesh fixation may affect chronic pain. Overall, no differences in chronic pain were found between patients who underwent mesh fixation with glue and those who underwent fixation with tackers. Our results do show that patients in whom mesh was secured by glue had lower rates of severe chronic pain. These results suggest that mesh fixation with glue may be of benefit in patients undergoing TEP hernia repair.

Recurrent inguinal hernia after laparoscopic repair appears in 1 to 13% of the patients [3, 11]. These figures are probably underestimated the real recurrence rate as many studies did not actively follow their patients on the long term and patients were actively examined only if they experienced symptoms of recurrent hernia. All, but 17 patients in our study were examined by attending surgeon blinded to study randomization 1 year after surgery. Indeed, only 4 patients had a symptomatic recurrence. In addition, recurrence was diagnosed during physical examination and confirmed by ultrasonography in six asymptomatic patients who were examined at 1 year from surgery. Most of the recurrences were diagnosed in patients whose mesh was secured using absorbable trackers, suggesting an additional benefit for the glue. The reason for this difference is not completely clear, as both methods should secure the mesh in place in the pre-peritoneal space during the initial healing phase, to allow fibrosis. The use of tackers may require more precise application at the pubic bone to ensure appropriate anchoring. We standardized the technique of mesh securing and all the attending surgeons participating in the study were highly experienced in the use of tackers for laparoscopic hernia repair, and it seems unlikely that misuse of the tackers can explain this difference.

The study is an investigator initiated trial, which was not supported by any of the industrial companies, and both products were readily available for the use of surgeons in our Institute. This limits potential publication bias and other potential biases that may be associated with sponsored studies.

Certain strengths and limitations should be taken into account when interpreting the results of this study. Though a single center study, the mesh fixation technique was determined following randomization. Pain is a subjective sensation and pain severity may fluctuate with time. Still, we used a functional scale for pain which takes into account impediment of daily routines. Severe pain followed a similar pattern as lesser intensities of pain even if differences for different pain severity thresholds did not reach statistical significance. Some would argue that a larger number of subjects could in theory prove that different rates of pain observed following glue fixation were indeed smaller compared pain following fixation with tackers. Still, we did not seek clinically insignificant differences that would become statistically significant just because larger groups of patients were compared.

In conclusion, this study shows no differences in chronic pain prevalence between the glue and mesh fixation with absorbable tackers in patients undergoing laparoscopic TEP hernia repairs. Severe pain, however, was less common following glue fixation.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Ethical committee approval

The study was approved by the local Institutional Review Board (193-16-ASF), and all patients gave their written informed consent.

The authors have no conflicts of interest.

Author Contributions

Study conception and design: Jeroukhimov, Dykman

Acquisition of data: Nesterenko, Poluksht, Ben Yehuda, Stephansky, Jeroukhimov.

Analysis and interpretation of data: Jeroukhimov, Hershkovitz

Drafting of the manuscript: Jeroukhimov, Hershkovitz

Critical revision: Jeroukhimov, Zmora

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Stina Öberg, Kristoffer Andresen, Jacob Rosenberg. Decreasing prevalence of chronic pain after laparoscopic groin hernia repair: a nationwide cross-sectional questionnaire study. Surg Today. 2018 Aug;48(8):796-803.
Alabi, A., Haladu, N., Scott, N.W. et al. Mesh fixation techniques for inguinal hernia repair: an overview of systematic reviews of randomized controlled trials. Hernia 2021 Dec 14.
E Aasvang , H Kehlet. Surgical management of chronic pain after inguinal hernia repair. Br J Surg . 2005 Jul;92(7):795-801
Techapongsatorn S, Tansawet A, Kasetsermwiriya W, et al. Mesh fixation technique in totally extraperitoneal inguinal hernia repair - a network meta-analysis. Surgeon 2019; 17(4):215–224.
Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl 1986;3:S1-S226.
K-J Lundström, H Holmberg, A Montgomery, P Nordin. Patient-reported rates of chronic pain and recurrence after groin hernia repair. Br J Surg. 2018 Jan;105(1):106-12.
Taylor C., Layani L., Liew V., Ghusn M., Crampton N., White S. Laparoscopic inguinal hernia repair without mesh fixation, early results of a large randomised clinical trial. Surg Endosc 2008; 22: pp. 757-62.
Moreno-Egea A., Torralba Martinez J.A., Morales Cuenca G., Aguayo Albasini J.L.: Randomized clinical trial of fixation vs nonfixation of mesh in TEP inguinal hernioplasty. Arch Surg 2004; 139: pp. 1376-9.
Chih-Chin Yu, Yung-Tai Chen, Ching-Shui Huang A comprehensive study comparing tack and glue mesh fixation in laparoscopic total extraperitoneal repair for adult groin hernias. Surg Endosc. 2020 Oct;34(10):4486-93.
Manjunath Siddaiah-Subramanya, Darius Ashrafi, Breda Memon,. Causes of recurrence in laparoscopic inguinal hernia repair. Hernia (2018) 22:975–86

No competing interests reported.

Download PDF

Journal Publication

published 12 May, 2023

Read the published version in Langenbeck's Archives of Surgery →

Editorial decision: Major revision
30 Mar, 2023
Reviews received at journal
22 Dec, 2022
Reviewers agreed at journal
18 Dec, 2022
Reviewers invited by journal
18 Dec, 2022
Editor assigned by journal
28 Nov, 2022
Submission checks completed at journal
27 Nov, 2022
First submitted to journal
27 Nov, 2022

You are reading this latest preprint version

Reduced Chronic Pain Following Laparoscopic Totally Extra-peritoneal Inguinal Hernia Repair Using Glue: A Randomized Clinical Trial

Status:

Journal Publication

Version 1

Abstract

Purpose

Methods

Results

Conclusions

Figures

Background

Methods

Design

Participants

Randomization

Intervention

Outcomes

Statistical Analysis

Results

Recruitment data

Baseline characteristics

Postoperative pain assessment

Postoperative complications and hernia recurrences

Discussion

Declarations

References

Additional Declarations

Status:

Journal Publication

Version 1