|Year : 2023 | Volume
| Issue : 1 | Page : 4-9
Intraperitoneal onlay mesh versus laparoscopy-assisted ventral hernia patch mesh repair in small primary ventral hernias: A randomised control trial
Harish Kanuri, Ashish Dey, Tarun Mittal, Shikhar Tripathi, Vinod K Malik
Department of General and Laparoscopic Surgery, Sir Ganga Ram Hospital, New Delhi, India
|Date of Submission||13-Nov-2022|
|Date of Decision||09-Jan-2023|
|Date of Acceptance||16-Jan-2023|
|Date of Web Publication||24-Feb-2023|
Dr. Vinod K Malik
Department of General and Laparoscopic Surgery, Sir Ganga Ram Hospital, New Delhi - 110 060
Source of Support: None, Conflict of Interest: None
Aims: The aim of this study is to compare and evaluate short-term outcomes of laparoscopy-assisted composite patch mesh repair versus laparoscopic intraperitoneal onlay mesh in small primary midline ventral hernias.
Materials and Methods: Eighty consecutive patients with small (<2 cm) midline ventral hernia admitted to the Department of General and Laparoscopic surgery at Sir Ganga Ram Hospital, New Delhi, from January 2017 to May 2019 were included in the study and randomised into two groups. Group A included patients who underwent laparoscopic intraperitoneal onlay mesh repair with the classical barrier flat mesh and Group B patients underwent laparoscopy-assisted ventral hernia patch-mesh repair. Parameters assessed at the follow-up were early post-operative pain by Visual Analogue Scale score, wound complications, early recurrence and hospital stay.
Results: Early post-operative pain was more in the laparoscopic intraperitoneal onlay mesh group and the difference was statistically significant. Usage of additional analgesia in the post-operative period was required only in the laparoscopic intraperitoneal onlay mesh group. There was a statistically significant difference between the two groups in terms of hospital stay.
Conclusion: For primary midline ventral hernia, with defect size <2 cm, laparoscopy-assisted composite patch mesh repair is feasible and safe. It causes less pain and necessitates less usage of additional analgesia enabling patients to be discharged earlier.
Keywords: Intraperitoneal onlay mesh, laparoscopy, patch mesh, small ventral hernia
|How to cite this article:|
Kanuri H, Dey A, Mittal T, Tripathi S, Malik VK. Intraperitoneal onlay mesh versus laparoscopy-assisted ventral hernia patch mesh repair in small primary ventral hernias: A randomised control trial. Curr Med Res Pract 2023;13:4-9
|How to cite this URL:|
Kanuri H, Dey A, Mittal T, Tripathi S, Malik VK. Intraperitoneal onlay mesh versus laparoscopy-assisted ventral hernia patch mesh repair in small primary ventral hernias: A randomised control trial. Curr Med Res Pract [serial online] 2023 [cited 2023 Apr 2];13:4-9. Available from: http://www.cmrpjournal.org/text.asp?2023/13/1/4/370512
| Introduction|| |
Mesh hernioplasty for ventral hernia outperforms primary suture repair not only in large hernias but also in primary small midline hernias with defect sizes ranging from 1 to 3 cm.,, With the introduction of laparoscopic surgery and its demonstrated benefits, there have been many modifications in the types and sizes of meshes utilised for ventral hernia repair. Along with good clinical results, laparoscopic intraperitoneal onlay mesh (IPOM) repair reduces surgical time, hospital stay, and post-operative convalescence. However, they are not without drawbacks, such as accompanying post-operative pain, especially for large hernias. Therefore, it needs to be seen whether smaller meshes with less fixation in smaller ventral hernias are feasible, thereby lessening the drawbacks associated with them needs to be studied.
Patient-reported outcomes, such as pain, are crucial indices for quantifying efficiency while analysing the success of a hernia surgery. The laparoscopic approach employs an 'onlay' technique, in which the mesh is put intraperitoneally and secured with 'tacks' and transfascial sutures. This results in significant post-operative pain, which is a significant drawback in such repairs. Following IPOM repairs, patients have experienced severe pain that interferes with fundamental activities of daily living such as walking, or creates major occupational challenges, some times prompting them to seek care from pain specialists. Although, using a lower number of tacks and transfascial sutures in such ventral hernia repairs has been suggested to decrease post-operative pain, it must be weighed against the effectiveness of the decreased number of tacks and sutures in maintaining the placement and position of the mesh.,
The Patch mesh, used for smaller ventral hernias in this study, uses a lesser number of fixation devices because of its smaller size, without compromising on the overlap. This also reduces the extent of lateral dissection that is generally necessary for pre-peritoneal implantation, hence reducing post-operative seromas. In addition, there is an overlap of roughly 3 cm that is taken while fixing the patch mesh, for small hernias, which reduces the possibility of recurrence. There are few studies in the literature that use these meshes in the laparoscopic repair of small midline ventral hernias. Ventralex™ Hernia Patch and Parietex™ Composite Ventral Patch are two such patch meshes on the market. These are third-generation meshes featuring an adhesion barrier on the undersurface in contact with intra-abdominal contents, similar to the standard 15 cm × 15 cm meshes used in conventional repair. Use of these meshes have been shown to give good results in studies from around the world.,,,,,,,,,
For the purposes of this study, we used the conventional definition of a small hernia, described as a primary abdominal wall (ventral) hernia which is <2 cm in size. In this study, we compared and evaluated short-term outcomes of laparoscopy-assisted composite patch mesh repair versus laparoscopic IPOM in small primary midline ventral hernias, using 15 cm × 15 cm third-generation meshes in small ventral midline hernias. The aforementioned mesh is non-absorbable and made of knitted polypropylene monofilament that resists tissue enzyme breakdown and permanently retains strength in clinical usage. Its bidirectional elastic feature permits adaptation to diverse stresses experienced in the body.
| Materials and Methods|| |
This was a prospective single-blinded randomised controlled study. The study pool consisted of patients admitted to the Department of General and Laparoscopic Surgery, at Sir Ganga Ram Hospital with small primary midline ventral hernias measuring <2 cm.
Our estimated sample size was based on pain scores of previous studies using a similar protocol, showed the assumed mean pain score being 7 with a standard deviation of 1.5., Assuming that the laparoscopy-assisted ventral hernia patch repair approach is superior, 40 patients per group gave 80% one-sided power for identifying a 20% difference in pain levels between groups at an alpha level of 0.05. Starting from January 2017, a total of 105 patients were recruited for the study, out of which 80 patients, who fulfilled the inclusion criteria – aged between 18 and 60 years with primary midline ventral/umbilical/epigastric hernias with size <2 cm in the largest diameter, (defect was assessed by pre-operative ultrasound and/or intraoperative findings), were included in the study. Exclusion criteria included patients with body mass index (BMI) >35 kg/m2, larger (>2 cm) and complicated ventral hernias. Patients with known collagen or connective tissue disorder, psychiatric illnesses, chronic steroids or drug abusers, pregnancy and American Society of Anaesthesiologists Grade 3 and above were also excluded from the study. All the participants in the study were explained about the surgical procedure along with its risks, complications and anticipated pain. They were made aware about the Visual Analogue Scale score, seroma and recurrence and a written informed consent was obtained. The patients had the right to opt out of the study if she/he desired so.
Randomisation was done by a computer-generated sequence (www.randomization.com) and into two groups. Group A consisted of participants who underwent IPOM with flat mesh repair and Group B consisted of participants who underwent laparoscopy-assisted composite patch mesh repair. For the purposes of this study, in Group B, a ventral hernia patch mesh [Figure 1], which is a self-expanding polypropylene + ePTFE patch that enables for a tension-free repair within the abdomen, was used. Primary outcome parameters assessed were Visual Analogue Scale (VAS) score, usage of additional analgesia, duration of hospital stay, time taken to return to normal activity, seroma formation and wound complications. Early recurrence was clinically examined and in case of doubtful recurrence, ultrasound was done for confirmation. Study allocation is shown in [Figure 2].
Patients in Group A underwent IPOM with flat mesh repair, where the mesh used was 15 cm × 15 cm in size, with a 5 cm or more overlap in each direction, and was secured with midline transfascial sutures and non-absorbable titanium 'Protack' fixation device (Covidien, Midline USA). Group B patients underwent a laparoscopy-assisted composite patch mesh repair. Laparoscopic adhesiolysis and content reduction were first performed if necessary. A 2 cm incision was then made on the skin over the defect site. The largest 'patch' mesh available, 8 cm in diameter, was subsequently put through the defect, with the bio-resorbable side towards the abdominal contents [Figure 3]. The free or unattached end of the positioning strap remained outside of the abdomen during placement and was manipulated to facilitate proper positioning of the patch. Gently pulling up on the positioning strap flattened the mesh against the underside of the abdominal wall. To secure the patch, the straps were secured to the margins of the defect so as not to allow abdominal contents to enter the space between the mesh and the abdominal wall, which may result in recurrence. The 'patch' mesh placement normally does not need laparoscopic guidance. However, we used the benefits of laparoscopy to allow adhesiolysis, if required, to visually ensure proper deployment overlap and fixation of the mesh. Fixation has not been conventionally recommended in this technique. However, we used 4–6 tackers at the edges of the mesh equidistant to each other [Figure 4], although the numbers were far less than the number of tacks needed in IPOM.
Post-operatively, all patients in the study group received analgesia with diclofenac sodium 75 mg intravenously eight hourly. All patients were evaluated for pain using a VAS at six hourly intervals for 24 h and at 48 h. Rescue analgesia was given when the VAS score was more than 6. The medication for rescue analgesia was injection paracetamol 1 g intravenously twelve hourly. The patient was discharged when his VAS score in the previous 6 h was ≤4. Follow-up was done at 1 week, 1 month and 6 months. If patients were not able to follow-up in outpatient department, telephonic inquiry was made regarding outcomes.
| Results|| |
Patients in Group A had a mean age of 46.70 ± 10.31 years, whereas patients in Group B had a mean age of 50.00 ± 12.78 years. There were 26 men and 54 women among the 80 hernias corrected. The mean BMI of patients in Groups A and B was 24.30 ± 2.87 kg/m2 and 25.48 ± 3.09 kg/m2, respectively [Table 1]. There were 56 umbilical hernias, 12 supra umbilical hernias, two infraumbilical hernias and ten epigastric hernias. There were no serious intraoperative problems, such as a hollow viscus or significant vascular damage.
Group A experienced more early post-operative discomfort than Group B. At 6 h following surgery, the mean VAS scores in Group A and Group B were 7.25 ± 0.97 and 4.90 ± 0.64, respectively and the difference was statistically significant, with a 'P' = 0.001. On post-operative day 2, the mean VAS scores in Group A and Group B were 2.80 ± 0.77 and 0.7 ± 0.66, respectively and the difference was statistically significant, with a 'P' = 0.001 [Table 2].
[Figure 5] depicts a graphical comparison of mean VAS scores between the two groups. Group A required additional analgesics for 28 patients, while Group B required no additional analgesics. The mean hospital stay in Group A was 2.30 ± 0.57 days and 1.10 ± 0.31 days in Group B, with a P = 0.001. The mean time taken to resume regular daily activities in Groups A and B was 2.25 ± 0.55 days and 1.10 ± 0.31 days, respectively, with a P = 0.001 [Table 3]. There were no recurrences in either group. Small asymptomatic seromas were discovered in four individuals, two from each group. There were no recurrences in either of the groups. Within 2 months, all seromas spontaneously resolved. There were no wound infections in any of the groups.
|Figure 5: Graphic comparison of mean VAS scores between the two groups. VAS: Visual Analogue Scale|
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|Table 3: Comparison of Mean Hospital stay and Time to return to normal activity|
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| Discussion|| |
Recurrence and post-operative discomfort are the two most significant outcomes following ventral hernia surgery. The frequency of hernia recurrence, in ventral hernia, has lately decreased worldwide due to strict adherence to current standards regarding fixation, overlap and size of defect amenable to laparoscopic procedures. Post-operative pain, therefore, remains an essential index for gauging outcomes in hernia repair surgery and is becoming increasingly relevant in surgical practice. Studies using these patch meshes have yielded promising results. However, there have been very few comparison studies in IPOM repairs between patch meshes and regular flat meshes for small primary midline ventral hernias.,,,
Transabdominal sutures and tacks are commonly used in IPOM mesh fixation and are the cause of post-operative pain. More such fixation devices can be assumed to be the cause of increased post-operative pain and decreasing the number of tacks should result in decreased post-operative pain. It has also been proposed that transfixation sutures used in large conventional meshes cause local muscle ischaemia, resulting in significant post-operative discomfort. In studies of ventral hernia repairs employing transfascial sutures, 1% to 6% of patients reported lasting pain and discomfort.,,,, To maintain appropriate mesh fixation, many sutures of this type are usually required around the periphery of the hernia defect. This is where smaller meshes can suffice, maintaining overlap as recommended and utilising fewer tacks and no transfascial sutures, which may be assumed to cause less pain., In our study, the mean post-operative VAS scores at time intervals, periodically, every 6 h, post-surgery, were relatively more in Group A, where large conventional meshes were used, as compared to Group B, where smaller patch meshes were used, and the difference was statistically significant ('P' < 0.001).
Recurrence is another negative outcome of any hernia operation. A study that looked at the usefulness and safety of hernia 'patch' meshes in the treatment of umbilical hernias found a recurrence rate of 4.1% which is comparable to studies in hernia repairs where conventional meshes are used. Lowham et al. performed a meta-analysis that attempted to offer an assessment of the mechanisms that lead to hernia recurrence following laparoscopic and conventional pre-peritoneal herniorrhaphy. The results revealed that among the studies that were analysed for the different techniques of hernia repair, open peritoneal herniorrhaphy had a mean recurrence rate of 10.57%, laparoscopic peritoneal herniorrhaphy had a mean recurrence rate of 1.55% and laparoscopic extraperitoneal herniorrhaphy had a mean recurrence rate of 0.64%. The recurrence rate in another retrospective study of 152 individuals, in which the patch was secured by positioning straps sutured to fascial edges using two interrupted sutures, was 2.6%. The recurrence rate was 2.0% in another prospective analysis of 51 patients in which the patch was secured by positioning straps sutured to fascial edges using four interrupted sutures. Similarly, the recurrence rate in another prospective study in which the patch was fixed by positioning straps sutured to fascial margins using six interrupted sutures was 2.0%. All of which shows acceptable recurrence rates compared to other meshes used to repair ventral hernias.
Another adverse result of ventral hernia surgeries is post-operative seroma. Seroma occurred in 4% of 135 individuals treated with the ventralex patch mesh for minor abdominal hernias in a retrospective study. In a retrospective study that reviewed and analysed 55 cases of laparoscopic ventral hernia repair and utilised conventional meshes, the incidence of seroma was found to be at 14.5%. Only one patient had a seroma in another prospective analysis of 51 individuals who utilised the patch. In this study, seromas were seen in 5% of the patients in both groups in our investigation. In both groups, we also analysed the number of days spent in the hospital and the time it took to return to normal daily activities. Both were shown to be higher in the IPOM group compared to the patch mesh repair group, most likely due to higher post-operative discomfort in the former. Overall, there were no major intraoperative complications in either of the groups, which showed that the patch mesh repair was safe in such defects.
| Conclusion|| |
For midline ventral hernias, equal to or smaller than 2 cm in diameter, laparoscopic-assisted ventral hernia patch repair is safe and viable. Better pain scores and comparable recurrences rates make it an appropriate treatment for the repair of small hernias, with added advantages. However, long-term follow-up is required to study long-term recurrences and outcomes.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
[Table 1], [Table 2], [Table 3]