|Year : 2020 | Volume
| Issue : 3 | Page : 125-130
Prophylactic ilio-inguinal neurectomy in open inguinal hernia repair: A randomized controlled study
Piyush Bamnodkar1, Ramesh Dumbre1, Arun Fernandese1, Deepak Phalgune2
1 Department of Surgery, Poona Hospital and Research Centre, Pune, Maharashtra, India
2 Department of Research, Poona Hospital and Research Centre, Pune, Maharashtra, India
|Date of Submission||12-Feb-2021|
|Date of Acceptance||22-Jun-2021|
|Date of Web Publication||19-Jul-2021|
Dr. Deepak Phalgune
18/27, Bharat Kunj -1, Erandawane, Pune 411 038, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Controversies persist regarding excision of ilioinguinal nerve after inguinal hernia repair and the procedure is not widely accepted. The present study was aimed to compare outcomes and its impact on the quality of life between routine ilioinguinal nerve excision, and nerve preservation following Lichtenstein inguinal hernia repair.
Materials and Methods: Eighty-six patients scheduled for Lichtenstein inguinal hernia repair were randomly divided into two equal groups of 43 patients each. Group A patients underwent prophylactic neurectomy, whereas, in Group B patients, the nerve was preserved. Follow-up was done on day one, 3 months, 6 months, and 9 months after surgery. The primary outcome measure was the incidence of chronic groin pain, whereas secondary outcome measures were an impact on the quality of life and time to return to work. Inter-group comparison of categorical and continuous variables was done using Fisher's exact test and unpaired t-test respectively.
Results: The incidence of postoperative pain at 3 months was 13/43 (30.2%) and 5/43 (11.6%) in Group B and Group A, respectively (P = 0.034). The incidence of postoperative pain at 6 months was 11/43 (25.6%) and 3/43 (7.0%) in Group B and Group A, respectively (P = 0.038). The RAND 36-Item Short-Form Health Survey parameters such as mean social functioning scores at 6 months postoperatively were 88.4 and 82.9 in Group A as Group B, respectively (P = 0.037) and mean pain score was 98.7 and 95.3 in Group A as Group B, respectively (P = 0.047). The mean time to return to work was 4.5 days and 5.7 days in Group A as Group B, respectively (P = 0.002).
Conclusion: A routine ilioinguinal neurectomy is a reasonable option for preventing neuralgia when performing Lichtenstein inguinal hernia repair.
Keywords: Ilioinguinal nerve excision, incidence of pain, inguinal hernia, Lichtenstein inguinal hernia repair, quality of life, return to work
|How to cite this article:|
Bamnodkar P, Dumbre R, Fernandese A, Phalgune D. Prophylactic ilio-inguinal neurectomy in open inguinal hernia repair: A randomized controlled study. Saudi Surg J 2020;8:125-30
|How to cite this URL:|
Bamnodkar P, Dumbre R, Fernandese A, Phalgune D. Prophylactic ilio-inguinal neurectomy in open inguinal hernia repair: A randomized controlled study. Saudi Surg J [serial online] 2020 [cited 2021 Jul 30];8:125-30. Available from: https://www.saudisurgj.org/text.asp?2020/8/3/125/321726
| Introduction|| |
An inguinal hernia is a protrusion of the parietal peritoneum, “the peritoneal sac,” through a preformed or secondarily established defect in the inguinal area of the abdominal wall. The risk of inguinal hernia is highest in males and increases with age reaching 22.8% in people aged 60–74 years. The only treatment for inguinal hernia is surgical repair, which is one of the most commonly performed surgical procedures in the world. Lichtenstein et al. described tension-free hernioplasty in 1989 and it is still considered the gold standard in the management of inguinal hernia by open technique.
Recently, with more attention to patient outcomes, chronic groin pain has replaced recurrence as the primary complication after open inguinal hernia repair. The incidence of chronic groin pain varies between 6% and 29% for Lichtenstein repair. Pain is often mild in nature. Quality of life studies have shown that chronic pain, irrespective of severity, can significantly interfere with normal daily activities.,,
Theoretically, excision of the ilioinguinal nerve would eliminate the possibility of inflammatory neuralgia arising from entrapment, neuroma, and fibrotic reactions. Yet, controversies persist, and the procedure is not widely accepted., Routine ilioinguinal nerve excision has been proposed as a means to avoid the troubling complication of long-term post herniorrhaphy neuralgia., The present study was aimed at comparing outcomes and its impact on the quality of life between routine ilioinguinal nerve excision and nerve preservation following Lichtenstein inguinal hernia repair.
| Materials and Methods|| |
This single-blind randomized study was conducted between October 2018 and November 2019. After approval from the institutional ethics committee (Letter No. RECH/EC/2018-19/460), written informed consent was obtained from all the patients before enrollment explaining the risks and benefits of the procedure. Patients between 25 and 75 years who had a unilateral inguinal hernia (direct or indirect) were included. Patients who had complicated (strangulated, incarcerated, obstructed, etc.) inguinal hernia, recurrent inguinal hernia, bilateral hernia, peripheral neuropathy, or history of previous lower abdominal surgeries were excluded.
Data were collected in a pretested study pro forma. It included general information, clinical details of the patient, and investigations. Out of 100 patients assessed for eligibility, 14 were excluded. Eighty-six patients were randomly divided into two equal groups of 43 each with the help of www.randomizer.org [Figure 1]. Group A patients underwent prophylactic neurectomy, whereas, in Group B patients, the nerve was preserved. Postoperative follow-up was done on day 1, at 3 months, 6 months, and 9 months.
An oblique incision was taken in the groin over the inguinal canal. Two layers of superficial fascia, outer Camper, and inner Scarpa were incised. External oblique aponeurosis was identified and an incision was made in the external oblique aponeurosis in the direction of the aponeurosis fibers. The cord was opened. The ilioinguinal nerve was identified. In Group A patients, the ilioinguinal nerve was cut with a sharp cut with a blade, 1–2 cm medial to deep inguinal ring. Three to four cm of the nerve was excised. In Group B patients, the nerve was preserved. In indirect hernias, the hernial sac was identified and transfixed at the neck after reducing all contents. The redundant hernial sac was excised and herniotomy was completed. In direct hernias, the sac was inverted by plication. A 15 cm × 8 cm sized polypropylene mesh was placed over the posterior wall. The lateral portion of the mesh was split such that the superior tail comprised two-thirds of its width and the inferior tail comprised the remaining one-third. This mesh was placed beyond the pubic tubercle medially and laterally, beyond the deep ring. The inferior border was sutured to the upturned inguinal ligament and medially, to the pubic tubercle taking care to avoid placing sutures directly into the periosteum of the pubic tubercle. The superior border of the mesh was sutured to the internal oblique as it lay and the medial border to the conjoint tendon using 3-0 prolene. The wound was closed in layers and a sterile dressing was applied.
A broad-spectrum antibiotic was administered intravenously, one dose preoperatively and another, the next day postoperatively. Injection diclofenac was given postoperatively for 1 day, followed by oral diclofenac thereafter for 5 days. After surgery, all the patients were monitored carefully for pain and other complications. The pain was assessed using the visual analog scale (VAS) score. The quality of life assessment was made via RAND 36-Item Short-Form Health Survey.
Patients were discharged when ambulant and on an oral diet. They were asked to come for regular follow-up at 3 months, 6 months, and 9 months. Patients were advised to return to prehernia lifestyle. Lifting heavyweights was forbidden. All patients were followed to observe postoperative pain, time to return to work, and quality of life assessment. The incidence of chronic groin pain, time to return to work, and quality of life were all evaluated.
Patients were taught about the VAS score preoperatively and were asked to mark the pain they perceived on the horizontal 10 cm line with word descriptions during follow-up. Using a ruler, the score was determined by measuring the distance (mm) on the 10 cm line between the “no pain” mark and the patient's mark, providing a range of scores from 0 to 100. The pain severity was classified according to the recommended cut points on the VAS score: No pain (0–4 mm), mild pain (5–44 mm), moderate pain (45–74 mm), and severe pain (75–100 mm).
RAND 36-Item Short-Form Health Survey was used to measure the quality of life. It is a set of generic, coherent, and easily administered quality of life measures. It includes eight health domains: Physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Patients were asked to answer the RAND 36-Item Short-Form Health Survey questionnaire on follow-up. The questionnaire was processed according to scoring rules for the RAND 36-Item Health Survey (Version 1.0). Higher values in each domain denote a better outcome.
The primary outcome measure was the incidence of chronic groin pain, whereas secondary outcome measures were an impact on the quality of life and time to return to work. Based on a previously published study, a sample size of 43 patients was calculated for each group by the formula with 80% power and 5% probability of Type I error to reject the null hypothesis.
Data collected were entered in Excel 2007, and analysis was done using Statistical Package for Social Sciences for Windows, Version 20.0 from IBM Corporation, Armonk, NY, USA. The data on categorical variables are shown as n (% of cases) and the data on continuous variables are presented as mean and standard deviation (SD). The comparison of quantitative variables and qualitative variables between the groups was done using unpaired student's t-test and Chi-square test or Fisher's exact test, respectively. The confidence limit for significance was fixed at a 95% level with a P < 0.05.
| Results|| |
The present research was a randomized controlled study between prophylactic ilioinguinal neurectomy and nerve preservation in open inguinal hernia repair. Out of 100 patients assessed for eligibility, 14 were excluded because of bilateral hernia (4), previous lower abdominal surgery (3), and refusal to participate (7). Two patients in Group A and three patients in Group B were lost to follow-up at 9 months [Figure 1]. The study included 86 patients between 25 and 75 years who presented with unilateral inguinal hernia (direct or indirect). These patients were divided into two groups of 43 patients. Group A patients underwent prophylactic ilioinguinal neurectomy, whereas Group B patients had the nerve preserved.
There was no statistically significant difference in relation to mean age, gender, hernia type, and duration of hernia between the two groups [Table 1]. As evident from [Table 2], the incidence of pain at 3 months and 6 months postoperatively was significantly higher in Group B as compared to Group A. The mean of RAND 36-Item Short-Form Health Survey parameters at three and 9 months postoperatively such as physical functioning, role limitations due to emotional problems, role limitations due to physical health, energy/fatigue, emotional well-being, social functioning, pain, general health, and Total RAND 36-Item Short-Form Health Survey score did not differ significantly between the two study groups. The mean of RAND 36-Item Short-Form Health Survey parameters such as social functioning and the pain was significantly higher in Group A as compared to Group B at 6 months postoperatively, whereas there was no statistically significant difference in other parameters at 6 months postoperatively [Table 3]. The mean ± SD of time to return to work in Group A and Group B was 4.5 ± 1.1 days and 5.7 ± 2.1 days, respectively (P = 0.002).
|Table 2: Incidence of pain at postoperative day 1, 3 months, 6 months, and 9 months|
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|Table 3: Comparison of mean RAND 36-item short-form health survey parameters at postoperative 3 months, 6 months and 9 months|
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| Discussion|| |
Inguinal hernia repair is one of the most common surgeries performed worldwide. New technologies and techniques are evolving in hernia surgery to restrict complications to the minimum. The emergence of chronic groin pain, although with a varied incidence as the primary complication of open inguinal hernia repair has led various curious surgeons to investigate this aspect to minimize its burden. The present study was conducted to compare the outcome and its impact on the quality of life between routine ilioinguinal nerve excision and nerve preservation following Lichtenstein inguinal hernia repair. We found out that in the nerve preservation group, the incidence of chronic groin pain at 3 months and 6 months and time to return to work was significantly higher, but with no significant difference in the quality of life. Despite controversies in the management of the ilioinguinal nerve during hernioplasty, our results revealed that elective resection was better with respect to chronic postoperative pain.
In the present study, the mean ± SD of age in Group A, and Group B was 54.4 ± 15.0 years and 52.2 ± 14.7 years, respectively. This was comparable with the randomized controlled study by Malekpour et al. wherein mean age was 45.0 ± 18.0 years, and by Picchio et al. wherein mean age in nerve preservation group and elective transection group was 58.7 ± 19 years and 57.0 ± 17.0 years respectively. In the present study, 85 (99.0%) were males. This is comparable with the study conducted by Malekpour et al., and Picchio et al. in which 115/121 (95.0%), and 736/813 (91.0%) of the study group were males, respectively. Picchio et al. and Malekpour et al. reported 542/813 (66.7%) and 102/121 (84.3%) patients had indirect hernia, respectively. In the present study, 64/86 (74.4%) had an indirect hernia.
The current definition of chronic groin pain as per the International Association for the Study of Pain requires evaluation of pain at 3 months. Our study has evaluated pain at 3 months and beyond to find out the incidence of chronic groin pain. There is an increasing consensus on modifying the definition of chronic pain after hernia repair as pain lasting for at least 6 months after surgery. In this study, pain at 3 months postsurgery and beyond was considered as chronic groin pain. Malekpour et al. reported that the incidence of pain 3 months postoperatively was 3/50 (6.0%) and 10/50 (20.0%) in patients who underwent nerve excision and nerve preservation, respectively. Amuthan et al. reported that the incidence of pain 3 months postoperatively was 2/24 (8.3%) and 10/26 (38.4%) in patients who underwent nerve excision and nerve preservation, respectively. In the present study, the incidence of pain 3 months postoperatively was 5/43 (11.6%) and 12/43 (30.2%) in patients who underwent nerve excision and nerve preservation, respectively (P = 0.034).
As evident from [Table 4], the incidence of postoperative pain in the nerve excision group at six months was comparable to studies conducted by Malekpour et al., Amuthan et al., Ravichandran et al., Dittric et al., Mui et al., and Omar et al. The incidence of pain was higher in the study conducted by Picchio et al., whereas Bansal et al. reported no pain in any patients postoperatively. In the nerve preserved group, the incidence of postoperative pain at 6 months was comparable to studies conducted by Malekpour et al., Dittric et al. and Mui et al. The incidence of pain was higher in studies conducted by Picchio et al., and Amuthan et al., whereas the incidence of pain was less in studies conducted by Ravichandran et al., Omar et al., and Bansal et al.
|Table 4: Comparison of incidence of pain of various studies after ilioinguinal nerve division or preservation at 6 months follow up|
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The mean time to return to work was 4.5 ± 1.1 days and 5.7 ± 2.1 days in Group A and Group B patients, respectively, which was statistically significant (P = 0.002). This is comparable with the randomized controlled trial conducted by Khoshmohabat et al. wherein the mean time to return to work was 4.6 ± 0.8 days and 5.7 ± 0.9 days in the nerve excision group and nerve preserved group, respectively
In the present study, there was no significant difference in health-related quality of life of individual eight domains between the two study groups at 6 months and 9 months follow up. At 6 months follow up, there was a significant difference between the groups related to social functioning (P = 0.037) and pain (P = 0.047) domains with favorable scores in Group A compared to Group B, whereas there was no significant difference in health-related quality of life in remaining six domains. These results are not consistent with Mui et al. wherein they reported that there was no significant difference in health-related quality of life at 1 month and 6 months of follow-up. These results denote a significant impact on the quality of life pertaining to social functioning and pain at 6 months postoperatively indicating favorable outcomes in the neurectomy group, although with time, all of them seem to normalize.
There are few limitations to our study which include small sample size, relatively short duration of follow up and the highly subjective nature of the studied pain, which makes its evaluation vulnerable to bias. Other implications of neurectomy like local cutaneous neurosensory disturbances and pain incidence during various bodily activities were not evaluated. Larger clinical trials with more patients and longer follow-up are warranted to study the long-term effect of prophylactic neurectomy in patients undergoing Lichtenstein repair.
| Conclusion|| |
The incidence of pain 3 months postoperatively was significantly higher in Group B (nerve preserved group) 12/43 (30.2%) as compared to Group A (neurectomy group) 5/43 (11.6%). The incidence of pain at 6 months postoperatively was significantly higher in Group B (nerve preserved group) 11/43 (25.6%) as compared to Group A (neurectomy group) 3/43 (7.0%). The mean of RAND 36-Item Short-Form Health Survey parameters such as social functioning (88.4 vs. 82.9) and pain (98.7 vs. 95.3) was significantly higher in Group A as compared to Group B at 6 months postoperatively. The mean time to return to work was significantly less in patients who underwent prophylactic excision of the ilioinguinal nerve (4.5 days) as compared to the nerve preserved group (5.7 days).
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]