Background: Post operative pain following a hernioplasty is a common problem which can hinder in early return to normal activities in a patient. Lichtenstein repair is considered the preferred approach for open inguinal hernia repairs . From early 1990s ,laparoscopic approach to hernia gained popularity. Laparoscopic surgeons advocate less postoperative pain and early return to normal activities . This prospective randomised study was done to compare the postoperative pain and chronic pain in open Lichtenstien repair and Laparoscopic hernia repairs for uncomplicated inguinal hernias. Objective: To compare the open Lichtenstein repair and laparoscopic mesh repair for uncomplicated inguinal hernias in terms of early post operative pain and chronic pain. Methods: This is a prospective randomised study of total 80 patients having uncomplicated inguinal hernia . Patients were randomly divided into two groups. 40 patients underwent open Lichtenstein’s repair (group A) while 40 patients underwent totally extraperitoneal repair (TEP) (group B) who had presented to Surgery Department Civil Hospital Ahmedabad between January 22 to January 2024. Post operative pain intensity was assessed by VAS score .Follow up for 1year was done for assessment of chronic pain. Permission of ethics committee was taken. Results: A total 80 patients of inguinal hernia were studied. Results of our study showed that from post operative day 1 to day 14 ,pain was statistically more in open Lichtenstein group. However there was no difference in pain scores after 14 days upto 1 year follow up . Conclusion: Laparoscopic repair has less pain in early postoperative period but chronic pain is similar in both groups . This suggested that laparoscopic hernia repair may be better for early return of work due to less pain in early postoperative period
Repair of inguinal hernia is one of the most frequently performed surgeries worldwide. Treatment methods have evolved from traditional tissue repairs to prosthetic repairs and, more recently, laparoscopic techniques. The preferred approach for open inguinal hernia repair is Lichtenstein's tension-free inguinal hernioplasty using a prosthetic mesh .On the other hand Laparoscopic hernioplasty is usually done either by trans-abdominal preperitoneal repair (TAPP) or totally extraperitoneal repair (TEP). Postoperative pain is now recognized as one of the major problems related to inguinal hernia repair, as it affects directly the quality of life of patients . In current scenario of fast life less post operative pain and early return to work is a major concern for patients .hence there is an increasing trend to opt for laproscopic surgery. Many studies have shown that laparoscopic inguinal hernia repair results in a lower incidence of postoperative pain, edema formation and an earlier return to normal activities as compared to the Lichtenstein technique . However some studies claim lichtenstien repair to be better than laparoscopic repairs . We have conducted this study to specifically compare the open technique and the laparoscopic approach concerning post operative pain and hospital stay in uncomplicated inguinal hernia.
Eighty patients with uncomplicated inguinal hernia were randomly assigned of which 40 underwent open Lichenstein repair (Group A) and 40 TEP(Group B) . The hospital ethics committee approved this study, and all patients gave informed consent to participate.
Inclusion criteria
Exclusions included:
All selected subjects were approached and personally met & briefed about the study. After taking informed consent, a detailed questionnaire was administered to the selected patients. Strict confidentiality was employed in carrying out the survey and use of information provided by each respondent.
selected FP decline, next FP from the list frame will be contected for the same purpose.trument will be subjected to famPatients divided in two groups based on method of randomization by odd and even method. 1st group is operated by Open Lichtenstein Repair (Group A) and 2nd group is operated by Laparoscopic Totally Extra Peritoneal Repair ( Group B) .
Patients were admitted one day prior to surgery. All the procedures were performed by a single selected team of surgeons and assistants of the same surgical Unit. The antibiotic protocol consisting of one intravenous dose of injection Ceftriaxone 1-gram pre operatively, followed by Tablet Cefixime 200 milligram orally 12 hourly for 3 days. Polypropylene mesh of size 6x3 inches was used in Open Lichenstein group while 15x 15 cm size mesh cut to 15x12 cm was used per side in TEP group.
Injection diclofenac was given twelve hourly intravenously to all patients postoperatively after the surgery.
On first post operative day, first VAS score was noted in all patients and then Tablet Diclofenac was started 12 hourly for 3 days.
After completion of 3 days of tab diclofenac again VAS score was noted on post-operative day 4 by telephonic call as all the patients had been discharged on postoperative day one or day two. Those patients with moderate to severe pain (VAS score ≥ 4) were called in hospital, their wounds were assessed to rule out local complications as the probable cause of pain and then given Tablet Diclofenac sodium 12 hourly for another 3 days.
Patients were again assessed for the pain (VAS score noted) on day 7. Those patients with moderate to severe VAS score were given Tablet Diclofenac sodium twice daily for next 7 days.(upto 14th post operative day)
No additional treatment was given for mild pain.
On day 14 patients having (VAS score ≥ 4) were again given tablet diclofenac and were advised to take the tablet and when required.
Similarly, VAS score was noted VAS score 1st month, 3rd months & 6th months and 1 year for presence of post operative pain on follow up.
Chronic wound pain (pain persisting at 3 months follow up) was noted and compared between the two groups.
The collected data was compared using the student unpaired t-test and two tailed P-value. A p value of < 0.05 was considered as significant.
Data was collected to compare and contrast open Lichtenstein hernia repair with TEP repairs for inguinal hernias. The end points of study were:
Table 1: Age distribution of study participants [N=80]
Age Group (in years) |
Group A (n=40) Open Lichtenstein repair |
Group B (n=40) TEP repair |
||
N |
% |
N |
% |
|
18-30 |
1 |
2.5 |
3 |
7.5 |
31-45 |
10 |
25.0 |
15 |
37.5 |
46-60 |
15 |
37.5 |
13 |
32.5 |
60-75 |
12 |
30.0 |
9 |
22.5 |
>75 |
2 |
5.0 |
0 |
0.0 |
Mean ± SD |
52.2 ± 12.1 |
48.4 ± 13.3 |
Table 2: Side of hernia among study participants [N=80]
Side |
Group A(n=40) Open Lichtenstein repair |
Group B (n=40) TEP repair |
P value |
||
N |
% |
N |
% |
||
Right |
18 |
45.0 |
16 |
40.0 |
0.1* |
Left |
13 |
32.5 |
12 |
30.0 |
|
Bilateral |
9 |
22.5 |
12 |
30.0 |
* - Chi-square Test
Table 3: Type of hernia among study participants [N=80]
Type |
Group A(n=40) Open Lichtenstein repair |
Group B (n=40) TEP repair |
P value |
||
N |
% |
N |
% |
||
Direct |
14 |
35.0 |
17 |
42.5 |
0.06* |
Indirect |
24 |
60.0 |
22 |
55.0 |
|
Direct + Indirect |
2 |
5.0 |
1 |
2.5 |
* - Chi-square Test
Table 4: Intensity of post-operative pain on VAS [N=80]
Post-operative Duration and Pain scale |
Group A(n=40) Open Lichtenstein repair |
Group B (n=40) TEP repair |
P value |
||
N |
% |
N |
% |
||
Day 1
|
|||||
No pain: 0 |
0 |
0.0% |
0 |
0.0% |
0.02699* (<0.005) |
Mild: 1-3 |
6 |
15.0% |
24 |
60.0% |
|
Moderate: 4-6 |
28 |
70.0% |
12 |
30.0% |
|
Severe: 7-10 |
6 |
15.0% |
4 |
10.0% |
|
Day 4
|
|||||
No pain: 0 |
0 |
0.0% |
0 |
0.0% |
0.00072* (<0.005) |
Mild: 1-3 |
11 |
27.5% |
28 |
70% |
|
Moderate: 4-6 |
24 |
60% |
10 |
25% |
|
Severe: 7-10 |
5 |
12.5% |
2 |
5% |
|
Day 7
|
|||||
No pain: 0 |
0 |
0.0% |
1 |
2.5% |
0.00944* (<0.005) |
Mild: 1-3 |
23 |
57.5% |
31 |
77.5% |
|
Moderate: 4-6 |
14 |
35.0% |
7 |
17.5% |
|
Severe: 7-10 |
3 |
7.5% |
1 |
2.5% |
|
Day 14
|
|||||
No pain: 0 |
4 |
10.0% |
20 |
50.0% |
0.00412* (<0.005) |
Mild: 1-3 |
34 |
85.0% |
18 |
45.0% |
|
Moderate: 4-6 |
2 |
5.0% |
2 |
5.0% |
|
Severe: 7-10 |
0 |
0.0% |
0 |
0.0% |
|
1 month
|
|||||
No pain: 0 |
29 |
72.5% |
33 |
82.5% |
0.53* |
Mild: 1-3 |
10 |
25.0% |
6 |
15.0% |
|
Moderate: 4-6 |
1 |
2.5% |
1 |
2.5% |
|
Severe: 7-10 |
0 |
0.0% |
0 |
0.0% |
|
3 months
|
|||||
No pain: 0 |
37 |
92.5% |
39 |
97.5% |
0.3* |
Mild: 1-3 |
3 |
7.5% |
1 |
2.5% |
|
Moderate: 4-6 |
0 |
0.0% |
0 |
0.0% |
|
Severe: 7-10 |
0 |
0.0% |
0 |
0.0% |
|
6months
|
|||||
No pain:0 |
38 |
95% |
39 |
97.5% |
0.55* |
Mild:1-3 |
2 |
5% |
1 |
2.5% |
|
Moderate 4-6 |
0 |
0.0% |
0 |
0.0% |
|
Severe 7-10 |
0 |
0.0% |
0 |
0.0% |
1 year |
|||||
Mild pain :1-3 |
2 |
5% |
1 |
2.5% |
0.55* |
* - Chi-square Test
Table 5: Mean post-operative pain score (VAS) [N=80]
Post-operative Duration |
Mean post-operative pain score (Mean ± SD) |
P value* |
|
Group A(n=40) Open Lichtenstein repair |
Group B (n=40) TEP repair |
||
Day 1 |
6.3 ± 1.8 |
4.9 ± 2.4 |
<0.05 |
Day 4 |
5.5± 1.5 |
4.3± 1.7 |
<0.05 |
Day 7 |
4.9 ± 2.6 |
3.1 ± 1.2 |
<0.05 |
Day 14 |
2.9 ± 1.3 |
1.7 ± 1.5 |
<0.05 |
1 month |
0.5 ± 0.9 |
0.4 ± 0.8 |
>0.05 |
3 months |
0.08 ± 0.2 |
0.03 ± 0.1 |
>0.05 |
6month |
0.075 ±0.2 |
0.025 |
>0.05 |
1year |
0.075±0.2 |
0.025 |
>0.05 |
* - Student ‘t’ Test
Table 6: Mean duration of ‘return to normal activity’ [N=80]
Duration (in day) |
Group A(n=40) Open Lichtenstein repair |
Group B (n=40) TEP repair |
P value |
Mean ± SD |
7.2 ± 1.1 |
4.2 ± 0.9 |
0.001* |
* - Student ‘t’ Test
Table 7: Chronic pain [N=80]
Post-op Complication |
Group A(n=40) Open Lichtenstein repair |
Group B (n=40) TEP repair |
P value |
||
N |
% |
N |
% |
||
Chronic wound pain (after 3 months to 1 year) |
2 |
7.5 |
1 |
2.5 |
0.17* |
Table 8: Comparison of observations of present study with other similar study
Parameter |
Present study |
Rathod CM et al[5] |
Pereira C et al[6] |
|||
Group A |
Group B |
Group A |
Group B |
Group A |
Group B |
|
Mean Age |
52.2 yrs |
48.4 yrs |
42.16 yrs |
44.44 yrs |
48.7 yrs |
42.17 yrs |
Gender: Male |
95.0% |
100.0% |
- |
- |
86.7% |
93.3% |
Post-op VAS score |
Group A > Group B |
Group A > Group B |
Group A > Group B |
|||
Return to normal activity |
6.2 days |
4.2 days |
5.76 days |
4.56 days |
13.2 days |
7.21 days |
In our study the mean age was 52.2 years and 48.4 years for the Open Lichtenstein group (Group A) & TEP (Group B) respectively. There was no statistical difference in the laterality of hernia as well as type of hernia in both groups as shown in Table 2 and Table 3 respectively.
VAS score was noted in all patients at post operative day1, day4, day7 ,day 14, 1month, 3 month and 6 month and 1 year as shown in Table 4. It was observed that pain was statistically significant (p<0.05) on day 1 ,7 and 14 in Open Lichtenstein group (group A) as compared to TEP group (group B) however there was no statistical difference in pain in both groups after 14 day upto 1 year follow up. The mean post operative pain on day 1, 7 ,14 were statistically significant while not significant at 1 month 3 months and 6 months and 1 year when compared between Lichtenstein group and TEP group. We have compared our study with study of Rathod CM et al and Pereira C et al )which showed similar results as shown in Table 8. The study done by Pereira C et al which compared Open Lichtenstein reapir versus TAPP noted that the mean post-operative pain score after 24 hours was 4.01 & 2.73 & after seven days it was 2.98 & 1.09 for the Open Lichtenstein Group & Laparoscopic Group respectively .This was also comparable with present study. The less pain in early post operative period may be attributed to small size of incision, no need of extra or bilateral incisions in case of bilateral hernias and less handling of cord structures and nerves. Another reason may be that Laparoscopic technique involves a posterior approach, hence significantly reduces the chances of sensory nerve entrapment. Another study by Eddie Myers et al which studied the quality of life suggested that TEP repair results in less postoperative pain, a quicker return to normal functional status, and improved quality-of-life outcomes with equivalent recurrence rates when compared to the Lichtenstein repair.
In our study the mean duration of return of normal activity was 7.2 days with 1.1 SD and 4.2 days with 0.9 SD for the Lichtenstein Group A & TEP Group B respectively (Table 6). The difference in mean duration of return of normal activity among both the groups was statistically significant (p<0.05). This could be attributed to significantly less pain in TEP group and hence early mobilization in the first 14 days of surgery. These observations were correlate with the similar study done by Rathod CM et al5, Pereira C et al6, McCormack K et al, Neumayer et al , Lal P et al .
Chronic pain is defined as pain which lasts for more than three months after a surgical procedure and is described by patients as an ongoing awareness of pain. In our study wound pain at 3 months was noted in 3 patients ( 7.5%) Lichtenstein Group & 1 patient (2.5%) in the Laparoscopic group. At 6 months and 1 year follow up 2 patients from Lichtenstein group and 1 patient from laparoscopic group had mild occasional pain Although chronic pain was not statistically significant in our study however it was more common in the open Lichtenstein group.
One of the reasons for chronic pain following hernia surgeries is entrapment of the sensory nerves. Dividing or preserving these nerves during surgery has been debatable with no clear advantage of one over the other.noted byDouek et al . Another reason for Chronic pain may be caused by nerve damage during surgery. It may also be related to the positioning of the mesh in the inguinal canal . in open repairs.
There is definitely less pain in early postoperative period (within 2 weeks) and hence early return to normal activities in laparoscopic hernia repair . However there seems to be no difference in pain after 2 weeks in both groups. However a larger sample size and longer follow up may be required to substantiate the above results..