A comparative study on effects of defect closure versus non-closure in laparoscopic totally extraperitoneal repair of direct inguinal hernia

Introduction: Totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) repair are the principal techniques in laparoscopic hernia repair. Seroma formation and pain are frequent complications of moderate-large size laparoscopic direct inguinal hernia mesh repair. This study was conducted to evaluate the feasibility of defect closure in moderate-large direct inguinal hernias and its effect on various outcomes. Method: This is a prospective cohort study from September 2020 to August 2021, where a total of 88 patients with uncomplicated direct inguinal hernia (M3 or more) were enrolled in the study and divided into two equal groups of TEP defect closure and non-closure, and various outcome measures were noted. Results: The majority of patients were male (94.31%), with a mean age range of 18–85 years, and had right-sided inguinal hernia (46.5%). Seroma formation at 10th POD in the defect closure and non-closure were 24% and 33% (p value: 0.225), which reduced to 11% and 18%, respectively, at 1 month (p value: 1.000). All seromas resolved within 6 months. Pain in VAS at 10th POD in the defect closure and non-closure were 1.55±0.571 and 1.38±0.527, respectively (p value: 0.121), which gradually decreased to 1.20±0.524 and 1.16±0.420 at a 6-month interval (p value: 0.689). The mean operative time in the bilateral and unilateral defect closure groups was 72.3±4.1 and 56.5±4.3 min, respectively, whereas that in the bilateral and unilateral defect non-closure groups was 62.3±3.7 and 45.7±3.6 min, respectively. Conclusion: The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested.


Introduction
Inguinal hernia is a common and widespread condition from which millions of people suffer.Repair of an inguinal hernia is one of the most frequently performed operations in general surgery [1] .European Hernia Society (EHS) has classified groin hernia in the following ways: The size of the hernia orifice is registered as 1 = less than 1.5 cm (1 finger), 2 = less than 3 cm (2 fingers), and 3 = greater than or equal to 3 cm (more than 2 fingers).For the anatomic localization, L = lateral, M = medial, and F = femoral [2] .Totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) repair are the principal techniques in laparoscopic hernia repair [3] .Laparoscopic hernia repair is recommended for bilateral and recurrent inguinal hernias.It has also been recommended for patients with primary unilateral inguinal hernia, contingent on the availability of surgical expertise and resources, due to a lower incidence of postoperative pain and chronic pain [4,5] .
Seroma formation is a frequent complication of laparoscopic mesh repair of moderate-large direct inguinal hernia defects.While rates of seroma formation have been reported to be as high as 10-30% [6] .Several attempts have been made to reduce the incidence of seroma formation, such as tacking the transversalis fascia (TF) to the ramus of the pubis, closing the direct inguinal hernia defect via the endoloop technique, and filling the potential dead space with fibrin glue.However, there is a potential increase in the risk of infection and also a risk of chronic pubic bone pain from the tack staples or vasculo-nervous injury if fixing the TF to

HIGHLIGHTS
• The defect closure in totally extraperitoneal (TEP) repair for moderate-large direct inguinal hernia has less seroma formation.• The pain was slightly higher in defect closure but statistically insignificant.• The difference in operative time between the defect closure and non-closure group is statistically insignificant.• Laparoscopic hernia repair is recommended for bilateral and recurrent inguinal hernias.
the abdominal wall, which would lead to extra discomfort for the patient [7] .The closure of a direct hernia defect with a barbed suture not only closes the defect superficially but also exterminates the defect cavity; consequently, the incidence of seroma formation has been greatly reduced [5,8,9] .However, there is still controversial evidence regarding the choice of the two procedures in terms of reducing the rate of seroma formation and pain.Thus, it is ambiguous which surgical technique should be considered best to repair an inguinal hernia.In this study, we tried to evaluate the technical aspect of direct defect closure in laparoscopic TEP inguinal hernia repair and its effect on the primary outcomes in terms of seroma formation and pain at different time intervals, along with the secondary outcomes such as operative time, length of postoperative hospital stay, days to resume normal activities, recurrence, and intraoperative complications like injury to the vas deference, vessel, and visceral injury or peritoneal tear.

Methods
It is a prospective cohort study and the work has been reported in line with the STROCSS criteria [10] , which was conducted over a period of 12 months, from September 2020 to August 2021.Ethical approval was obtained from the Institutional Review Committee (IRC /1971/020).
Patients with inguinal hernia presenting to surgery OPD with the inclusion criteria of age greater than 18 years and uncomplicated direct inguinal hernia ( ≥ M3) were enrolled in the study.The exclusion criteria were defect size less than or equal to M2, complicated hernia (irreducible, obstructed, or recurrent hernia), patients unfit for general anesthesia, and patients not giving consent.After obtaining informed written consent a total of 88 patients were enrolled in the study using the purposive alternate number sampling technique.They were divided into 2 groups: 44 patients each in the defect closure and non-closure groups.Postoperative seroma formation and pain are the primary outcomes.All patients were explained and familiarized with the visual analog score (VAS) pain chart preoperatively.

Sample size calculation
They consider 95% CI and 80% power to estimate the sample size.According to study by Usmani et al.[ [5] ] it was found that the prevalence of seroma formation is 12.6% in defect closure and 6.4% in non-defect closure groups, respectively.Now using the formula- Where, n = sample size in each group And, Zα/2 = 1.96 at 95% CI Zβ = 0.842 at 80% power

Based on last year's medical records
Total number of laparoscopic inguinal hernia repair at Surgery Department: 100.Now the study needs corrected sample size formula for finite population (100).
Analyses were performed using SPSS statistical software, version 11.5.Continuous variables were presented as mean and standard deviation and categorical variables as a percentage.Continuous variables were compared between the two groups by Student's t-test and presented as mean standard deviation.Categorical variables were compared between two groups by Fischer's exact test and presented as absolute numbers (percentage).

Preoperative care
Relevant investigations as per the pre-anesthesia check-up protocol were performed.An informed written consent was obtained.Premedication with benzodiazepine (diazepam 10 mg or lorazepam 2 mg) was done.Patients were kept nil per oral from midnight and were instructed to void just before surgery.

Intraoperative care
After general anesthesia, the patient was kept in a supine position with both hands tucked.Prophylactic antibiotic (inj.ceftriaxone 1 gram) at the time of induction.

Operative procedure
TEP repair was performed according to Guidelines for Laparoscopic (TAPP) and Endoscopic (TEP) Treatment of Inguinal Hernia [11] .The operation was performed by the same surgeon throughout the study period using a standard 3-port technique.
All connective tissue was dissected bluntly with a telescope and sharply with a grasper to identify Retzius and Bogros spaces.In direct hernia, content was reduced, and the fascia transversalis (pseudo sac) was pulled and incorporated into closure with a nonabsorbable polypropylene barbed monofilament size-0 suture.Then the Parietalisation of the cord structure was done until the peritoneum was reflected to the point at which the vas deference turns medially.Anteriorly, the peritoneum was reflected up to the arcuate line.In patients whose arcuate line was very low, the arcuate ligament was cut 1-2 cm so that an adequate space was created to place the mesh without any wrinkles.
For unilateral inguinal hernia, one polypropylene mesh of standard size 15 × 10 cm was inserted, and for bilateral hernia, two meshes of the same size were inserted, overlapping in the midline in preperitoneal space through the 10-mm port.The two 5-mm port trocars were frequently used for the proper placement and positioning of the mesh.The lower 2-3 cm of the mesh was tucked into the space of Retzius.The mesh was placed without wrinkles to cover all the myopectineal orifices.The space was deflated carefully so as not to displace the mesh.

Postoperative care
Patient was kept nil per oral and on maintenance intravenous fluid till patient recovers from effects of general anesthesia.The analgesic, ketorolac (30 mg IV), was given at the end of surgery and continued at 8-h intervals postoperatively.Additional requirements for the analgesics (inj.tramadol 50 mg IV with inj.ondansetron 4 mg IV) were given when required.All uncomplicated patients were discharged the next day, as per departmental policy, and encouraged to follow-up in the outpatient department on the 10th day, 1 month, 3 months, and 6 months.At each follow-up pain assessment, seroma formation and hernia recurrence (if any occurred) were noted.

Intraoperative characteristics
Operative time in the defect closure group was slightly higher than that of the non-closure group in unilateral and bilateral TEP repair, but the difference was not statistically significant.Also, there was no significant difference in the intraoperative complication rate in terms of vas deference, vessel and visceral injury, or peritoneal tear between the two groups, as shown in (Table 2).

Postoperative outcome
In our study, there was no significant difference in hospital stay or resume of normal activity.Pain was slightly more common in the defect closure group but was statistically insignificant.Seroma formation was less in the defect closure group but was statistically insignificant.In the 6 months of follow-up, no one had seroma formation.Also, there was no hernia recurrence within 6 months of the interval, as shown in (Table 3).

Discussion
This study was conducted to evaluate the effect of laparoscopic defect closure in moderate-large ( ≥ M3) direct inguinal hernias.IEHS/EHS Bittner et al. [11] . also recommend defect closure in cases of large direct inguinal hernia (M3), as it prevents seroma formation, infection, recurrence, and chronic pain, altogether reducing discomfort and postoperative complications.

Age distribution
In our study, most of the patients were in the middle age group, with a mean age of 40.13 19 and 45.35 18.33 years in the defect closure and non-closure groups, respectively.Similarly, in studies by Parshad et al. [12] .and Garg et al. [13] . the mean age was 46.40 and 47.16 years, and 56.8 and 45.27 years in the defect closure and non-closure groups, respectively.The results showed consistency of mean age in studies done at various geographical locations, suggesting that the incidence of direct hernia occurs mostly after the 4th decade of life, as with increasing age, the weakness in the abdominal wall musculature increases.

Operative time
The reasons behind more operative time in defect closure are due to the time taken during suturing the defect (~4-5 bites).The operative time in our study was consistent with other studies (Table 4).

Vessel injury
Our study found bleeding from the inferior epigastric artery (IEA) in 5.5% of cases, which is almost double that mentioned by Bittner et al. [10] .The higher incidence may be due to the operating surgeon's initial phase of learning.The bleeding was controlled by either clip, monopolar, or ligature energy devices.

Peritoneal tear
The incidence of peritoneal tear was higher, that is 47%, in the study by Lau et al. [16] . in relation to our study.The techniques for the closure of a peritoneal tear include pretied suture, loop ligation, endoscopic stapling, and endoscopic suturing.Careful dissection in close proximity to the vas deferens, in addition to cautious use of traction and countertraction, associated with prudent application of sharp dissection with endo-scissors to divide adhesions, can help to prevent peritoneal laceration.

Seroma formation
The incidence of seroma formation was slightly higher in the nonclosure group as compared to the defect closure group, although it was statistically non-significant.Similar findings were reported by various studies, as shown in (Table 5), except for a study by Koch et al. [17] .In closing the wall of the direct defect, the pulled fascia transversalis was also incorporated.This led to obliteration of the empty cavity of the defect, hence less seroma formation.Thus, a large defect size with huge dead space, a wider dissection area, inguinoscrotal hernia, and a residual hernia sac result in more seroma formation.All the seromas were managed conservatively, except in 2 patients at 1 month of their presentation, as patients were experiencing discomfort, so the seroma was aspirated under aseptic precautions.

Postoperative hospital stay
In our study, there was no significant difference in postoperative hospital stay between both groups.It was similar to the study conducted by Garg et al. [13] .which showed 1.12 0.3 days in the defect closure group and 1.12 0.4 days in the non-closure group.There are many studies, such as those by Usmani et al. [5] ., Li et al. [8] ., Zhu et al. [14] , Parshad et al. [12] , Koch et al. [17] , Reddy et al. [18] .mentioning no differences between the two groups for postoperative hospital stays.

Days to return to normal activities
As in any laparoscopic surgery, our study reports an early return to work, similar to the study by Garg et al. [13] .

Pain
Although the finding is statistically not significant, our study showed slightly higher pain in the defect closure group at 10th POD, 1 month, 3 months, and 6 months POD in comparison to the non-defect closure group.A similar finding has been reported in a study by Koch et al. [17] , where the pain in VAS was 0.8 1.7 and 0.3 0.8 in defect closure and non-closure groups, respectively, with a p value of 0.15, which was statistically not significant.The reasons for pain may be due to deep suited bite of the suture or the nerve entrapment by the suture, such as osteitis pubic.

Limitation
There are a few limitations to this study, the first being the small sample size of 88.The reliability of the measured complications would be improved with a larger sample size.Our follow-up of both groups was limited to 6 months, where assessment of only early recurrence was feasible.Surgery was performed by a single surgeon whose experience may limit the ability to generalize the result of an entire population undergoing TEP repair.There was no preoperative pain assessment.

Conclusion
The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia.Although these findings were statistically insignificant, they may be clinically significant.And there was no statistical difference in the secondary outcome of defect closure or non-closure in terms of operative time, length of postoperative hospital stays, days to resume normal activities and work, recurrence, or intraoperative complications like Vas deference, vessel, visceral injury, or peritoneal tear.

Table 4
Operative time Sah et al.Annals of Medicine & Surgery (2024)