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A newer method of seroma reduction by fenestration of pseudo-sac during laparoscopic repair of direct inguinal hernia: A randomised, controlled pilot study
Mahendra Lodha, Satya Prakash Meena, Yash K Parihar, Mayank Badkur, Ashok K Puranik, Prathyusha V Kompally
Department of General Surgery, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India
|Date of Submission||22-Dec-2021|
|Date of Decision||25-Jan-2022|
|Date of Acceptance||04-Apr-2022|
|Date of Web Publication||06-Jul-2022|
Satya Prakash Meena,
Department of General Surgery, All India Institute of Medical Sciences, Jodhpur, Rajasthan
Source of Support: None, Conflict of Interest: None
Background: Minimally invasive surgeries for inguinal hernia repair have been reduced post-operative morbidity. However, certain complications such as seroma formation are unavoidable. In this study, we introduce a newer technique of reducing seroma formation by fenestration of the pseudo-sac (thickened transversalis fascia) in patients undergoing laparoscopic hernia repair for uncomplicated direct inguinal hernia.
Patients and Methods: A randomised, controlled pilot study was conducted from January 2019 to December 2020 for the patients undergoing laparoscopic hernia repair for uncomplicated direct inguinal hernia. Study participants were randomised into interventional group and control groups. Demographics, operative duration and complications including post-operative pain and seroma on days 1, 10 and 30 were analysed between both the groups.
Results: A total of 20 cases with 30 hernias were included in the study. Demographic data were comparable between the two groups. The intervention group showed a statistically significant decrease in the incidence of seroma formation on the post-operative day 10 (13.3% vs. 46.6%, P = 0.046). The mean volume of seroma on day 10 was also less compared to the non-fenestration group (2.5 vs. 6.58 ml, P = 0.048). After the 30th day, no patient had a presence of seroma. There were no statistically significant differences in terms of mean operative duration, post-operative pain and other complications.
Conclusion: Fenestration of pseudo-sac in laparoscopic hernia repair for uncomplicated direct inguinal hernia is a simple and effective technique. It has reduced the incidence and volume of seroma formation without any increased risk of infection, acute or chronic pain and recurrence.
Keywords: Direct hernia, fascia transversalis, fenestration, fenestration, laparoscopic technique, pseudo-sac, seroma, transabdominal pre-peritoneal, total extraperitoneal
|How to cite this URL:|
Lodha M, Meena SP, Parihar YK, Badkur M, Puranik AK, Kompally PV. A newer method of seroma reduction by fenestration of pseudo-sac during laparoscopic repair of direct inguinal hernia: A randomised, controlled pilot study. J Min Access Surg [Epub ahead of print] [cited 2022 Aug 14]. Available from: https://www.journalofmas.com/preprintarticle.asp?id=350047
| ¤ Introduction|| |
A minimally invasive approach is preferred for inguinal hernia if resources and expertise are available due to quicker post-operative recovery, lower risk of chronic pain and cost-effectiveness., An incidence of seroma formation following inguinal hernia repair ranges from 0.5% to 22.9% and tends to be more pronounced in direct inguinal hernias, large inguinoscrotal hernias and significantly higher in endoscopic techniques.,
Several adjunctive techniques have been used by surgeons to reduce seroma formation, which include endoloop technique, use of tacks, barbed sutures, drains, fibrin glue and distal sac fixation.,,,,,,,,,
In the study, we aimed to introduce a simple yet innovative approach to reduce seroma formation following laparoscopic direct inguinal hernia repair, by fenestration of thickened transversalis fascia (TF) (pseudo-sac).
| ¤ Patients and Methods|| |
Study design and participants
A randomised, controlled pilot study was performed in the department of general surgery in a tertiary health-care institute of Rajasthan, India. The study was conducted from January 2019 to December 2020 for the patients undergoing laparoscopic hernia repair for uncomplicated direct inguinal hernia. To date, no previous studies have been done on the effectiveness of pseudo-sac fenestration in reducing seroma formation. Therefore, we conducted a randomised, controlled pilot study with a sample size of 20 cases. Study participants were randomised into interventional and control groups with 10 patients in each group.
The study included all male patients with age more than 18 years, undergoing laparoscopic hernia repair for uncomplicated inguinal hernia. The study excluded all the patients diagnosed with chronic liver disease, kidney disease, heart failure, drug allergy, active skin infection and recurrent hernia. After an intraoperative diagnosis of direct inguinal hernia, cases were randomly allocated into groups. Both the groups underwent a laparoscopic inguinal hernia repair either by transabdominal pre-peritoneal or total extraperitoneal (TEP). The interventional group underwent fenestration of pseudo-sac in addition to the standard laparoscopic hernia repair. Pre-operative demographics, intra-operative data, post-operative pain, seroma and other complications were analysed.
The primary outcome of the study was to compare the presence of seroma on post-operative days 1, 10 and 30 by clinical and radiological assessment between the two groups. Total operative duration, immediate post-operative pain, chronic pain (pain lasting over 3 months) and complications were the secondary outcomes of the study.
Definition of seroma
Seroma is defined as a collection of fluid in a scrotal dead space or over the surgical site post-operatively, detected either clinically or radiologically. It has no cough impulse or tenderness over the inguinoscrotal area.
Technique and follow-up
In the intervention group, the pseudo-sac (thickened fascia transversals) was pulled inside the cavity and a 0.5 cm × 0.5 cm size single fenestration was made at the apex of the pseudo-sac with the help of scissor with or without monopolar cautery [as shown by a yellow arrow in [Figure 1]]. A polypropylene mesh of 12 cm × 15 cm size was used in all patients. Seroma formation was documented clinically on day 1 before discharge. In the follow-up period, ultrasonography was performed on the post-operative day 10 to measure and compare the volume of the seroma, followed by clinical examination on day 30.
Statistical analysis was done using SPSS software (IBM SPSS for windows version 25.0, 2017, Armonk, NY, USA: IBM corp.). Nominal data were described using frequency and percentages and compared using the Chi-square test or Fisher's exact test. Ordinal data were described using median and compared using the Mann–Whitney U test. Continuous data were described using mean ± standard deviation and compared using unpaired t-test. P < 0.05 was considered statistically significant.
Institutional ethics committee clearance (AIIMS/IEC/2018/762) was obtained before the study. Informed consent was taken from the study participants.
| ¤ Results|| |
A total of 20 cases were included in this study, with 10 cases in each group: intervention group and control group. A total of 30 hernias with 15 in each arm were included. All patients were male; demographic profiles between the two groups were comparable [Table 1].
On the post-operative day 1, 10 and 30, all patients were clinically examined. There was no statistically significant difference on day 1 (P = 0.143) and day 30 (P = 0.309). However, on the post-operative day 10, a statistically significant difference was found (P = 0.046) in both the groups clinically as well as radiologically [Table 2].
|Table 2: Post-operative seroma in the terms of frequency and volume in the intervention (fenestration) and control group|
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No patient in the intervention group had a seroma after the 30th day, whereas one patient in the control group had seroma, which resolved on its own by 6 weeks. None of them required an intervention for seroma. There were no intraoperative complications, and the difference in post-operative pain between the two groups was not significant. One case in the control group had a recurrence at a follow-up of 3 months.
| ¤ Discussion|| |
A seroma is a big concern for patients, as they may notice a swelling in the groin similar to what they had before surgery. It is an early post-operative phenomenon with a proposed aetiopathogenesis of retained hernial sac, dead space created by tissue dissection and elevating flaps, presence of a foreign prosthetic mesh, disruption of vascular or lymphatic channels despite adequate haemostasis and inflammatory mediators such as prostaglandins, histamine and adenosine. The risk factors for seroma formation include large hernial defects especially direct, large sac size (>4 cm), inguinoscrotal hernias and old age. There is also evidence suggesting a lower rate of seroma formation with biological mesh rather than a synthetic mesh.,
There have been several methods described in the literature for seroma reduction. Reddy et al. have conducted a prospective non-randomised trial where they have inverted the lax TF and tacked it to the pubic ramus in direct inguinal hernia repair, which showed a significant reduction in seroma formation (4.15% vs. 14.29%, P < 0.05). Berney's prospective study has shown endoloop plication of weakened TF in 76 patients with direct inguinal hernia undergoing TEP and found a low incidence of seroma formation (3.9%) at the 2nd week. Several studies have been conducted on the closure of direct defects that have reported a decreased incidence and volume of seroma formation; however, there was an increase in the mean operative time., Placement of a closed suction drain in the pre-peritoneal space has also had a significant reduction in seroma formation.,, Fibrin sealant application into the potentially dead space behind the mesh reported a lower volume (P < 0.001) and lower incidence (5% vs. 15%) of seroma formation in a prospective study of 40 large indirect inguinal hernias. One patient developed a seroma eight days after distal sac fixation in a prospective observational study on six patients with large inguinoscrotal hernias. Li et al.'s study has conducted a systematic review on the seroma reduction in laparoscopic inguinal hernia repair, describing six adjunctive techniques., No studies have been done comparing these techniques.
The study has shown a decreased incidence of seroma formation in the intervention group on post-operative day 1, 10 and 30 (33% vs. 60%), (13.3% vs. 46.6%; P = 0.046) and (0% vs. 6.6%), respectively. Furthermore, a significant reduction in the volume of the seroma was measured radiographically (P = 0.048) on the post-operative day 10. There were many techniques used to reduce seroma formation in the direct hernia, including tacking of TF, Endoloop techniques, and barbed suture closure of TF. The principle behind every one of these techniques was to reduce dead space. These methods require surgical expertise like intracorporeal suturing, which might be time-consuming and procurement of additional resources, which would be challenging in a low-resource setting. We have hypothesised that fenestration of the TF would lead to an alternative pathway for fluid absorption, i.e., it provides an additional surface area for the absorption of trapped fluid and reduces the formation of seroma. So far, there are no studies on the efficacy of fenestration of the pseudo-sac on seroma formation.
The purpose of our study was to evaluate the efficacy of pseudo-sac fenestration on post-operative seroma formation. The incidence of seroma formation in our study group (13.3%) appears higher than that of the other techniques. This difference in incidence should not be compared as the definition and method of detection of seroma are different.
A seroma should be called a sequela rather than a complication unless it persists beyond 6 weeks, increases in size, becomes symptomatic or gets infected requiring intervention., Aspiration of the seroma is done only when it is long-standing, else it would introduce infection and possible recurrence. Hence, it is of concern as the infection might lead to a probability of recurrence. As it is a physiological process, its formation cannot be prevented. Almost all hernias would show some amount of seroma formation in the immediate post-operative period when measured radiographically, but would not be large enough to cause a clinical swelling. We can only strive to invent ways to reduce its volume and its clinical appearance.
Our pilot study has highlighted a simple, feasible and effective technique to reduce the incidence and amount of seroma in uncomplicated direct hernia repair. The results have been appreciable in spite of their limitations. It neither requires any additional equipment such as tacks, glue, endoloops nor an extra effort of intracorporeal suturing.
Limitation of our study
Although our study has shown results in favour of pseudo-sac fenestration, our sample size is small with an adequate follow-up period. Further studies with a large sample size are to be conducted to assess its efficacy, considering a multifactorial aetiology. Furthermore, studies comparing various adjunctive techniques should also be done to evaluate the superiority of one technique over the other.
| ¤ Conclusion|| |
This novice technique of fenestration of pseudo-sac for laparoscopic repair of uncomplicated direct inguinal hernia has shown some hope in reduction of seroma incidence and its volume without adding to operative duration or perioperative complications. It requires multicentre randomised, controlled trials at high-volume centres and might turn out to be a promising technique in the future.
Our sincere thanks to Dr. Mahaveer Rodha, Dr. Ramkaran Chaudhary and Dr. Binit Sureka to guide us for this research.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]