Cyanoacrylate vs tacker for mesh fixation in laparoendoscopic inguinal hernia repair-double blinded, randomized control study

Summary:

Cyanoacrylate vs. Tacker Mesh Fixation in Laparoendoscopic Inguinal Hernia Repair

Introduction: Inguinal hernia repair is one of the most common surgical procedures performed worldwide, with a prevalence ranging from 10 to 28 operations per 100,000 inhabitants. This type of hernia repair has undergone significant advancements over the years, with mesh fixation emerging as the gold standard due to its lower recurrence rates and overall better outcomes compared to non-mesh repairs. While both laparoscopic and open repair techniques have demonstrated reliability, laparoscopic approaches are gaining popularity due to their association with reduced postoperative pain and quicker recovery times. However, laparoscopic mesh fixation presents its own set of challenges, particularly with techniques involving tacks, which can lead to complications such as chronic pain, hematoma formation, and bowel fistula. To address these issues, glue has been developed, aiming to provide temporary fixation until the mesh integrates with the host tissue.

AIMS

1.     To study the cyanoacrylate glue vs tacker for mesh fixation in laparoendoscopic inguinal hernias repair.

OBJECTIVES

PRIMARY OUTCOME

2.     To compare the post operative pain at 6 weeks in cyanoacrylate glue and tackers used for mesh fixation in laparoendoscopic repair of inguinal hernias

SECONDARY OUTCOME

3.     To compare the incidence of seroma in cyanoacrylate glue and tackers used for mesh fixation in laparoendoscopic repair of inguinal hernias.

4.     To compare the incidence of recurrence in cyanoacrylate glue and tackers used for mesh fixation in laparoendoscopic repair of inguinal hernias.

MATERIAL AND METHODS

STUDY SETTING:

The study will be conducted in Department of General Surgery, King George’s Medical University, Lucknow, India

STUDY PERIOD:

2 YEARS

TYPE OF STUDY:

Prospective study

SAMPLE SIZE: Total 64 cases

The sample size formulae used are as follows: (Bernard, 5th edition)

Inclusion Criteria:

–     Patient giving written informed consent will be taken

–     Age 18-60 years

–     All adult patients diagnosed with inguinal hernias who were candidates for laparoendoscopic  repair .

–     Analysed only elective  repairs

•      Exclusion criteria:

–     Patient not giving consent

–     Patients with recurrent groin hernia or who had previous preperitoneal dissection or pelvic radiotherapy were excluded from the study.

–     Patients with ASA>2

–     Paediatric cases

METHODOLOGY

All Patients will be evaluated based on history,  general physical examination and clinicalexaminations. Consent will be taken for including the patients in study.

Information on age, education, occupation, SES,   income and history will be obtained from using a questionnaire.

A total of 64 patients with inguinal hernias who are eligible for laparoendoscopic repair will be included in this study.

All patients will be computer generated random number table divided into two groups:

Group A: Cyanoacrylate group (n=32)

Group B: Tacker mesh fixation (n-32).

Surgery will be carried out under aseptic conditions. Standard Laproendoscopic hernia repair will be done. At the time of mesh fixation

Randomization and Allocation Concealment

For allocation of patients into each group, random sequence generation was performed through the use of a study envelope for either glue or tack fixation in a 1:1 ratio. Randomization will be performed by selecting this envelope at the time of procedure after completing the Laparoendoscopic standard inguinal hernia area dissection. This will provide random allocation of the patient to 1 group of the trial. The envelope will be opaque, thus ensuring appropriate allocation concealment to the operating surgeon till the time of dissection. The study envelope was stored within a secured office. The sequence generation and allocation concealment processes will be undertaken by the chief investigator of the trial. Primary outcome will be observed by the junior doctor & nursing officer who is not part of operating team and research and will not be aware of which method of mesh fixation was used during the surgery. Mesh fixation method will not be disclosed on the discharge ticket also.

 Statistical analysis:

Collected data will be entered in Microsoft Excel 2018-19 and SPSS (Statistical package for the social sciences) software under the guidance of a statistician. Discrete (categorical) data will be summarized as in proportions and percentages (%) while quantitative data will be summarized as mean (SD), median or mode.  Chi sq and other appropriate tests will be used to check associations. Student t test will be used to compare two groups for normally distributed quantitative variables, whereas Mann–Whitney test will be used to compare two groups for not normally distributed quantitative variables. The significance of the obtained results will be 5% level.

 REVIEW OF LITERATURE

The review of the literature provides valuable insights into the evolution of laparoscopic inguinal hernia repair and the various mesh fixation techniques employed in clinical practice. Studies have highlighted the advantages and disadvantages of tissue glue, tacks, and sutures for mesh fixation, emphasizing the importance of selecting the most suitable method based on patient characteristics and surgical preferences. Recent research has focused on comparing the safety and efficacy of different fixation techniques, with cyanoacrylate glue emerging as a promising alternative to traditional tacker fixation. Studies have demonstrated comparable outcomes in terms of postoperative pain, recurrence rates, and complication rates between cyanoacrylate glue and tacker fixation, suggesting that glue fixation may offer certain advantages, such as reduced operative time and decreased risk of chronic pain.

Recent Relevant Studies:

Several recent studies have contributed to the understanding of mesh fixation techniques in laparoendoscopic inguinal hernia repair. Schwab et al. (2008) evaluated the biomechanical stability of mesh fixation using fibrin sealant compared to sutures in abdominal wall hernia repairs, demonstrating the efficacy of sealant fixation in preventing mesh dislocation and achieving optimal fixation stability. Kukleta et al. (2012) conducted in vitro and in vivo studies to evaluate the safety and biocompatibility of n-butyl cyanoacrylate glue for mesh fixation, reporting favourable clinical outcomes, including reduced postoperative pain and infection rates. Similarly, studies by Kaul et al. (2013), Berney et al. (2016), Liew et al. (2017), Choi et al. (2018), Nizam et al. (2021), Shukla et al. (2022), and Haroon et al. (2023) have compared the efficacy and safety of cyanoacrylate glue fixation with traditional tacker fixation, consistently demonstrating comparable outcomes with potentially fewer complications associated with glue fixation.

Conclusion:

In conclusion, this study will outline a comprehensive study protocol aimed at comparing cyanoacrylate glue and tacker mesh fixation in laparoendoscopic inguinal hernia repair. By investigating key outcome measures such as postoperative pain, seroma incidence, and hernia recurrence, the study aims to provide valuable insights into the optimal mesh fixation technique for improving patient outcomes and minimizing complications associated with inguinal hernia repair. The review of the literature and recent relevant studies highlight the growing interest in cyanoacrylate glue fixation as a promising alternative to traditional tacker fixation, paving the way for further research and clinical implementation of this technique in hernia repair surgeries.