Abstract
Background:
The incidence of seroma formation is high following laparoscopic surgery for an inguinal hernia. Literature has shown many intraoperative techniques to reduce post-operative seroma formation. The hypothesis was made that scrotal support may reduce seroma formation following laparoscopic or robotic hernia surgery. This study aimed to compare the post-operative outcome of uncomplicated inguinal hernia patients with or without scrotal support application.
Patients and Methods:
A randomised controlled trial was conducted on 266 male patients with inguinal hernias. A block randomisation was done, and accordingly, a scrotal support was applied after mobilisation of study patients following laparoscopic or robotic surgery. After discharge, all patients were followed up for 30 days and their outcomes were compared.
Results:
Post-operative numbness after hernia surgery was significantly reduced with the application of scrotal support (P = 0.03). However, there were no significant differences in the early post-operative period for seroma formation, scrotal oedema, scrotal haematoma, surgical site infections, epididymo-orchitis or groin pain between the groups.
Conclusion:
A scrotal support application is not effective at reducing the formation of seroma after laparoscopic or robotic inguinal hernia repairs. Early post-operative groin numbness may be reduced by including scrotal support in post-operative care protocols.
Keywords: Haematoma, inguinal hernia, minimal access surgery, scrotal support, seroma
INTRODUCTION
Inguinal hernia surgery is being done by various techniques like laparoscopic hernioplasty in terms of transabdominal preperitoneal (TAPP), totally extraperitoneal (TEP) and robotic TAPP. In the literature, postoperative swelling and pain in the groin following laparoscopic inguinal hernia repair have been reported due to scrotal oedema, seroma, haematoma, and epididymo-orchitis.[1,2,3,4] Most of the patients are returning to a normal functional life after 1 week of surgery; however, post-operative complications may affect the quality of life.[5]
This study aimed to compare the post-operative outcome of uncomplicated inguinal hernia patients with or without scrotal support application. The hypothesis behind the study was that the scrotal support may reduce post-operative scrotal oedema or seroma and groin pain by 50% or may not be effective.
PATIENTS AND METHODS
Definition of scrotal seroma
Scrotal seroma is defined as any volume of post-operative fluid accumulation in the scrotum readily visible on physical examination and of concern to the patient.[6]
Objectives of the study
The primary objective was to compare post-operative groin swelling in terms of seroma during 30-day follow-up. The assessment of time to resume normal physical activity, hospital stay, postoperative pain as well as scrotal haematoma, ecchymosis, epididymo-orchitis and return to work or driving during 30 days followup, were the secondary objectives.
Study design, setting and duration
A prospective randomised controlled trial (RCT) was conducted in the department of general surgery at a tertiary care health institute in North India during 2022–2023.
Sample size
Based on Krishna et al.’s study with 28% seroma formation, 80% power, 95% confidence interval and 20% or 50% attrition, the study included 266 patients. A total of 133 patients were included in each group as with or without scrotal support [Figure 1].[7]
Figure 1.
Consort flow diagram
Study participants and selection criteria
All male patients of age between 18 and 70 years and with a diagnosis of uncomplicated (reducible and irreducible) inguinal hernia were included in the study after consent. The patients with a history of ascites due to congestive heart failure, liver disease, renal disease, immobility due to neurological deficit and lower limb prosthesis were excluded from the study.
Randomisation
All patients were randomly allocated to the classic group or the scrotal support group by block randomisation using the randomly permuted block technique on the day of surgery. Blocks of random allocation have been established in order to maintain similar treatment group sizes. An independent statistician, who was not involved in patient care, generated the randomisation sequence using the website www.randomization.com. The opaque sealed envelopes were used for randomisation. A resident, who was not involved in outcome measurements, opened the envelopes. The patients were also aware of the assigned group of treatment (no blinding). The procedure and intervention were explained to each patient by the operating team, and informed consent was obtained before transfer to the operating room.
Procedure
In the pre-operative area, a single prophylactic dose of injection ceftriaxone 1 g intravenously was administered after the skin test. Before making an incision, all patients underwent catheterisation. All patients had general anaesthesia and underwent laparoscopic three-port or robotic four-port technique of hernia surgery in supine and Trendelenburg position. Based on randomisation, the patients were divided into two groups: the traditional group and the scrotal support or study group (who received scrotal support during the post-operative phase). Following the procedure, Foley’s catheter was taken out.
Postoperatively, injection paracetamol 1 g intravenous eight hourly was administered to all patients. The additional analgesic requirement may be fulfilled by injection diclofenac 75 mg by the intravenous route, as needed. A similar type of scrotal support was advised to the study patients during mobilisation in the hospital as well as at home after discharge [Figure 2]. The patients were released from the hospital after being observed for 24 h and instructed to keep their groin area clean. They underwent follow-up for 30 days following surgery to analyse the results.
Figure 2.
Post-operative scrotal support application
Data collection and statistical analysis
The data were collected in the paper-based case record form before, during and after operations and transferred to Microsoft Office Excel. A statistician, who was not involved in patient care, performed the statistical analysis. Statistical analysis was performed using the SPSS software (IBM SPSS for Windows version 23.0, 2015, Armonk, NY: IBM Corp.). Nominal data such as complications present or absent were described using frequency and percentages and compared using the Chi-square test or Fisher’s exact test. Ordinal data like Visual Analogue Scale scores were described using median and interquartile range and compared using the Mann–Whitney U test. P <0.05 was considered statistically significant.
RESULTS
Baseline details
The difference in baseline demographics such as age, BMI and clinical characteristics, including ASA grade, duration of symptoms, type of hernia, laterality, extent of hernia and number of recurrent hernias included in the study were not significant between the two groups (P > 0.05). The difference of serum level of albumin in both the groups also was not significant (P = 0.18) [Table 1].
Table 1.
Demography of the inguinal hernia patients
| Factors | Scrotal support group | Classic group | P |
|---|---|---|---|
| Age (mean±SD) | 45.23±17.60 | 48.62±17.71 | 0.11 |
| BMI, n (%) | |||
| Underweight | 3 (2.21) | 5 (3.68) | 0.50 |
| Normal | 126 (92.65) | 119 (87.5) | |
| Overweight | 5 (3.68) | 10 (7.35) | |
| Obese | 2 (1.47) | 2 (1.47) | |
| Duration of symptoms | 10.84±9.39 | 9.06±7.25 | 0.08 |
| ASA grade | |||
| 1 | 117 (86.03) | 111 (81.62) | 0.57 |
| 2 | 18 (13.24) | 23 (16.91) | |
| 3 | 1 (0.74) | 2 (1.47) | |
| Serum albumin | 4.35±0.69 | 4.25±0.51 | 0.18 |
| Laterality | |||
| Bilateral | 38 (27.94) | 98 (72.06) | 1.00 |
| Unilateral | 98 (72.06) | 38 (27.94) | |
| Type | |||
| Direct | 36 (26.47) | 27 (19.85) | 0.19 |
| Indirect | 100 (73.53) | 109 (80.15) | |
| Extent | |||
| Complete | 94 (69.12) | 95 (69.85) | 0.89 |
| Incomplete | 42 (30.88) | 41 (30.15) | |
| Recurrent inguinal hernia | 4 (2.94) | 5 (3.68) | 0.73 |
SD: Standard deviation, BMI: Body mass index, ASA: American Society of Anesthesiologists
Peri-operative outcomes
The study group employed robotic TAPP and laparoscopic TEP procedures more frequently than laparoscopic TAPP, although statistically, there was no difference between the groups (P = 0.29). According to intraoperative observations, neither group had any kind of femoral hernia. Intraoperative bleeding from the cord structures and vas deference injury during dissection were not statistically significant.
The Clavien–Dindo Scale did not show statistical significance for immediate post-operative complications (P > 0.05). Furthermore, the P value was not significant for hospital stay, day of normal activity and return to work or driving between the scrotal support and classic groups [Table 2].
Table 2.
Operative technique and perioperative outcome of the inguinal hernia patients
| Patient’s outcome and operative technique | Scrotal support group | Classic group | P |
|---|---|---|---|
| Surgical technique, n (%) | |||
| TAPP | 52 (38.24) | 64 (47.06) | 0.29 |
| TEP | 61 (44.85) | 55 (40.44) | |
| Robotic TAPP | 23 (16.91) | 17 (12.50) | |
| Cord structure bleed during surgery, n (%) | 18 (13.24) | 19 (13.97) | 0.85 |
| VAS deference injury during surgery, n (%) | 0 | 1 (0.74) | 0.35 |
| Clavien–Dindo Scale, n (%) | 0.94 | ||
| Grade 1 | 114 (83.82) | 112 (82.35) | |
| Grade 2 | 16 (11.76) | 17 (12.5) | |
| Grade 3a | 6 (4.41) | 7 (5.15) | |
| Hospital stay | 2.77±0.90 | 2.77±0.89 | 0.99 |
| Return to normal activity | 2.69±0.71 | 2.62±0.68 | 0.46 |
| Return to work or driving | 23.53±13.72 | 23.24±15.99 | 0.87 |
TAPP: Transabdominal preperitoneal, TEP: Totally extraperitoneal, VAS: Visual Analogue Scale
Follow-up
Analysis of peri-operative outcomes revealed that the patients who received scrotal support experienced significantly lower levels of numbness (P = 0.03) over the inguino-scrotal area. These patients have complaints of the sensation of tingling, burning, pin-pricking, itching or diminished sensation over the skin of the inguino-scrotal and upper medial thighs. Based on the history and the clinical evaluation, these findings were recorded. In the scrotal support group, 10% of patients had seroma compared to 14% in the classic group; however, statistically no significant difference was found (P = 0.35). Furthermore, the other post-operative complications such as scrotal haematoma, symptoms of urinary tract infection, groin pain and surgical site infection were not significantly different between the groups (P > 0.05). In addition, the sign of scrotal oedema or swelling due to epididymo-orchitis in the post-operative period was dramatically reduced in the scrotal support group, however statistically not significant (P = 0.18). Analgesic requirement was also lower in the scrotal support group, indicating better pain management as well as leading to improved patient comfort and satisfaction with the use of scrotal support. The average duration of return to functional work or driving was 23 days in both the groups, and no statistical difference was found (P = 0.87) [Table 3].
Table 3.
Early post-operative complications during 30-day follow-up of inguinal hernia patients
| Complications | Scrotal support group, n (%) | Classic group, n (%) | P |
|---|---|---|---|
| Seroma | 14 (10.29) | 19 (13.97) | 0.35 |
| Scrotal haematoma | 4 (2.95) | 5 (3.68) | 0.73 |
| Epididymo-orchitis | 3 (2.21) | 9 (6.62) | 0.18 |
| UTI with scrotal oedema | 4 (2.94) | 6 (4.41) | 0.52 |
| Surgical site infection | 3 (2.21) | 3 (2.21) | 1 |
| Numbness inguino-scrotal/thigh area | 1 (0.74) | 7 (5.15) | 0.03* |
| Groin pain | 15 (11.03) | 11 (8.09) | 0.18 |
*Statistical significant value. UTI: Urinary tract infection
DISCUSSION
The findings of this study highlight the potential benefits of scrotal support application following MAS for inguinal hernia. According to the hypothesis, scrotal support may reduce post-operative pain, scrotal oedema, epididymo-orchitis and scrotal haematoma and enhance patient comfort and satisfaction during the recovery period. The mechanism of action may involve providing additional support to the scrotum, reducing tissue tension and promoting lymphatic drainage, thereby minimising swelling and discomfort. These results are consistent with previous studies that have reported similar benefits of scrotal support in various surgical procedures.[8] Tamilselvan et al.’s study has shown routine use of scrotal support after inguino-scrotal surgery should be avoided due to no benefit to prevent scrotal oedema or seroma.[9]
Kalwania et al.’s study has shown 17% scrotal oedema and 6.6% scrotal haematoma in the study of 90 patients. Furthermore, these signs had been reduced following the 2nd week of surgery.[10] Guangbo et al.’s study on 122 patients has shown scrotal oedema at 7.5% and seroma at 5% in the closed suction group compared to the without drainage control group of 23% and 20%, respectively.[11] The study by Shao et al. reported the benefit of narrowing the internal orifice by suturing the divided distal hernia sac. The postoperative seroma rate decreased significantly from 80% to 32% in a week and 12% to 6% in a month.[12] Lodha et al.’s study has shown a newer method as fenestration of pseudo sac during inguinal hernia surgery and found a decrease in seroma formation from 46% to 13% to reduce seroma.[13] Junesheng et al.’s study has suggested the fixation of the distal sac with the posterior abdominal wall to prevent seroma formation.[14] However, in this study, no significant difference was found in seroma formation, haematoma and scrotal oedema after the application of scrotal support following minimal access hernia surgery.
Zao et al.’s study has shown a decrease in post-operative acute scrotal pain following the application of compression belt after TAPP or TEP. Furthermore, this method is effective for the patients who have moderate pain (VAS 4–7).[15] Choi et al.’s study on 160 patients concluded no difference of post-operative pain with the use of staples and fibrin glue to fix the mesh during laparoscopic hernia repair.[16] Messaris et al.’s study has shown a decrease in groin pain following mesh placement without fixation during laparoscopic inguinal hernia repair.[17] Similarly, in this study, no benefit was found with the use of scrotal support application on moderate groin pain during an immediate follow-up of 2 weeks. Kolte et al.’s study has shown a 14% incidence of nociceptive sensation or numbness in the groin area.[18] However, following application of scrotal support, 0.7% of the patients have appreciated numbness in the groin or thigh in this study. Surgical site infection (SSI) rate was minimum and similar in both the groups. Seroma formation is one of the causes of SSI or mesh infection, although unsterile environment during surgery and the patient factors may have other causes of SSI.[19]
Scrotal support application is a simple, easy and theoretically sound method to reduce seroma and associated SSI. Therefore, surgeons advise scrotal support during the discharge of patients. However, the study concluded clinically no benefit of scrotal support to reduce seroma, haematoma, SSI and groin pain following laparoscopic or robotic inguinal hernia repair. Scrotal support might be helpful to reduce groin or thigh numbness, probably due to decreased stretching or pulling over inguinal nerves and spermatic veins.
Strengths and limitations
The most effective part of the study was that it was performed with a large sample size compared to other studies that show methods to reduce seroma formation. However, it is essential to acknowledge the limitations of this study that the study was conducted at a single centre and the results may not be applicable to all patient populations. The choice of minimal access surgery and the results following surgery may be influenced by the size of the defect. To confirm the impact of scrotal support on post-operative outcomes, multicentre studies with larger sample sizes and inclusion of defect size according to EHS classification are required.
CONCLUSION
The results of this randomised controlled trial do not support the use of scrotal support application to reduce seroma formation following minimal access approach for inguinal hernia repair. Incorporating scrotal support into post-operative care protocols may lead to improved patient comfort and satisfaction, leading to improved groin numbness in the early post-operative period.
Ethical approval
The study was approved by the Institutional Ethics Committee (AIIMS/IEC/2022/3973) and registered in the Clinical Trials Registry-India as CTRI (REF/2022/04/053386[DE]).
Conflicts of interest
There are no conflicts of interest.
Funding Statement
Nil.
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