|Year : 2021 | Volume
| Issue : 1 | Page : 13-19
Case–control comparison of separation of component retrorectus urinary bladder extracellular surgical device hernia repair with acellular dermal matrix underlay and prosthetic mesh overlay hernia repair
Candace Gonzalez, Nicholas Russo, John P Hanna, Thanh Tran, Beth Montera, Khattiya Chharath, Adham R Saad, Vic Velanovich
Division of General Surgery, Morsani College of Medicine, The University of South Florida, Tampa, FL, USA
|Date of Submission||15-Nov-2020|
|Date of Acceptance||04-Dec-2020|
|Date of Web Publication||22-Feb-2021|
Dr. Vic Velanovich
Division of General Surgery, Morsani College of Medicine, The University of South Florida, 5 Tampa General Circle, Suite 740, Tampa, FL 33606
Source of Support: None, Conflict of Interest: None
PURPOSE: The purpose of this study is to compare the complication rates and recurrence rates of two types of incisional hernia repairs by a single surgeon.
MATERIALS AND METHODS: The medical records of all patients undergoing incisional hernia repair by the senior author were reviewed. Patients who underwent the biologic mesh underlay/synthetic mesh overlay (BUSO) “sandwich” repair and separation of components with retrorectus mesh (SOCRM) repair were assessed. Only Grades I, II, and III incisional hernias were included. The two groups were matched for age, sex, hernia size, and body mass index. The groups were compared for any 30-day complication, any adverse event in the follow-up period, and any recurrence as determined by physical examination or imaging.
RESULTS: Fifty-six patients were successfully matched. There were no differences in the type of suture used, skin closure, dressing, or drain use. There was no difference in 30-day postoperative complications or discharge status. The BUSO group had a 29% recurrence rate, compared to 4% in the SOCRM group (P = 0.0248). However, the follow-up was longer in the BUSO group.
CONCLUSIONS: The results of this study suggest that for incisional hernias not amenable to primary closure, SOCRM repair may be superior to even a two-mesh layer bridging repair.
Keywords: Bridging hernia repair, incisional hernia repair, separation of components hernia repair
|How to cite this article:|
Gonzalez C, Russo N, Hanna JP, Tran T, Montera B, Chharath K, Saad AR, Velanovich V. Case–control comparison of separation of component retrorectus urinary bladder extracellular surgical device hernia repair with acellular dermal matrix underlay and prosthetic mesh overlay hernia repair. Int J Abdom Wall Hernia Surg 2021;4:13-9
|How to cite this URL:|
Gonzalez C, Russo N, Hanna JP, Tran T, Montera B, Chharath K, Saad AR, Velanovich V. Case–control comparison of separation of component retrorectus urinary bladder extracellular surgical device hernia repair with acellular dermal matrix underlay and prosthetic mesh overlay hernia repair. Int J Abdom Wall Hernia Surg [serial online] 2021 [cited 2021 May 10];4:13-9. Available from: http://www.herniasurgeryjournal.org/text.asp?2021/4/1/13/309984
| Introduction|| |
Incisional hernias are frequent postsurgical outcomes, with the incidence exceeding 20%., The complications from an incisional hernia vary widely and include incarceration, strangulation, pain, cosmetic defects, and limitations in mobility. These hernias may lead to significant distress to patients, limiting their quality of life.
Incisional hernias and their operative repair are a significant burden on the health-care system with approximately 400,000 ventral hernias repaired every year. The goal for any hernia repair is to restore the integrity and function of the abdominal wall with as little morbidity as possible. Despite the large number of ventral hernia repairs, there is variation in repair techniques. The basis for this variation includes, but certainly not limited to, the size and location of the hernia, the biomechanical properties of the abdominal wall, and the preferences and training of the surgeon.
A long-standing technique commonly used for incisional hernia repair is the two-layer underlay/overlay mesh repair, colloquially referred to as the “sandwich” repair, which is a type of bridging repair. The senior author (VV), who has been in the independent practice of general surgery since 1992, has modified this technique to replace the synthetic underlay mesh with a biologic mesh to reduce the incidence of synthetic-mesh-related bowel complications. This has been his operation of choice for incisional hernias of >4 cm or recurrent incisional hernias, based on the results of the study of Hesselink et al. from 1993. Although this has been a relatively satisfactory technique, recurrences and mesh-related complications are still problematic., With the development of the separation of components repair initially described by Ramirez et al., then later modified to include retrorectus (sublay) mesh placement and a transversus abdominis release as an alternative to an external oblique release, the senior author began to incorporate these techniques into his practice.
To our knowledge, there has been no direct comparison of the sandwich repair to the separation of components repair with retrorectus biologic mesh. Furthermore, the transition of abandoning one technique for another has not been well documented. Our goal is to compare the two techniques with primary endpoints being recurrence rates and postoperative complications.
| Materials and Methods|| |
This study has been approved by the Institutional Review Boards of Tampa General Hospital and the University of South Florida.
We retrospectively identified patients at a single institution who underwent repair by the senior author of large hernias using either the sandwich biologic mesh underlay/synthetic mesh overlay (BUSO) repair technique or separation of components with retrorectus mesh (SOCRM) between May 1, 2012 and May 31, 2019, inclusive. The medical records were reviewed for patient age, sex, body mass index (BMI), hernia size, first-time or recurrent hernia, grade of hernia, method of repair, complications, and recurrences. Patients undergoing primary repair or repairs of other ventral hernias, such as umbilical, epigastric, and Spigelia More Detailsn hernias, were excluded.
Description of the repair techniques
The patient was supine and general anesthesia was used in all cases. Urinary catheters were used if the operation was anticipated to be longer than 2 h. Body warming devices, venothrombotic prophylaxis with subcutaneous heparin and sequential compression stockings, and preoperative antibiotics were used in all cases. Skin preparation was with a chlorhexidine/alcohol solution or an iodine-based solution. The BUSO repair entailed an excision of or incision through the existing scar, the majority of which were midline incisions, but some were transverse or flank incisions, dissection, and excision of the hernia sac to allow for adequate exposure of the facial edges. Skin flaps were developed around the fascial defect to allow for at least 4 cm of overlap from the edge of the fascia to the edge of the planned synthetic mesh overlay with the fascia lying in its “tension-free” position. The hernia defect was always measured in two dimensions with a ruler and recorded. The size of the mesh used was chosen to allow for at least 4 cm of overlap between the edge of the fascial defect and the edge of the mesh. The mesh used was either porcine acellular dermis (Permacol,™ Medtronic, Minneapolis, MN, USA) or bovine fetal/calf acellular dermis (Surgimend,™ Integra Life Sciences Corp, Princeton, NJ, USA) mesh. Intra-abdominal adhesions were lysed as necessary to achieve sufficient anterior abdominal wall space for mesh placement with as wide of overlap as possible. This mesh was placed in the underlay position with as much overlap as possible, but at least 4 cm. Transfascial sutures of usually of a permanent polypropylene monofilament or occasionally absorbable polyglyconate monofilament sutures are placed in a U-stitch fashion at least 2 cm from the edge of the mesh and edge of the fascia with no gaps remaining in between the sutures. The midline fascia was almost never closed, as closing the fascia was not feasible due to the tension this would cause. A synthetic, permanent mesh overlay with either macroporous polypropylene mesh (Prolene® mesh, Johnson and Johnson, New Brunswick, NJ, USA) or macroporous polyester mesh (Parietex™ mesh, Medtronic, Minneapolis, MN, USA) was chosen and fashioned to allow for as much overlap from the edge of the mesh to the edge of the fascia, but at least 4 cm. The previously placed transfascial sutures were passed through the mesh, at least 2 cm from the edge of the mesh, and secured. The wound was irrigated with normal saline solution. If deemed appropriate, one or two flat, 10 mm Jackson-Pratt drains were placed in the subcutaneous space and brought out through separate skin incisions. The subcutaneous tissue was closed with absorbable glycolide/lactide copolymer suture (Polysorb™ suture, Medtronic, Minneapolis, MN, USA). The skin was closed with either staples, external nylon suture, or intradermal, 4-0 absorbable monofilament suture. Wounds were dressed with silver-impregnated gauze (Silverlon™, Argentum Medical, Geneva, IL, USA) or gauze and tape. All patients were placed in an abdominal binder upon extubation.
As with the sandwich repairs, the SOCRM repair was done under general anesthesia, with similar usages of urinary catheters, prophylactic antibiotics, venothrombotic prophylaxis, and skin preparation. A midline incision was made to allow for adequate exposure of the hernia defect. The hernia sac was dissected from the subcutaneous tissue to the fascia, then excised to expose the fascial edge. The fascial defect was measured with a ruler. Lateral skin flaps were developed to at least lateral to the linea semilunaris, but usually to the anterior axillary line. The external oblique aponeurosis lateral to the linea semilunaris was divided vertically from the costal margin to the pelvic brim. The plane between the external and internal oblique was further developed to increase the mobility of the resultant myofascial flap. From the edge of the midline fascia, the retrorectus space was entered and developed laterally to the lateral borders of the rectus abdominis muscles to develop space for the mesh. The posterior rectus sheath was closed primarily with running 0 looped absorbable polyglyconate monofilament sutures. An appropriate sized sheet of thick porcine urinary bladder extracellular matrix device (Gentrix® Surgical Matrix, ACell, Inc., Columbia, MD, USA) was placed in the retrorectus space with 3-0 absorbable suture fixation to the lateral borders of the rectus abdominis muscle. The anterior rectus sheath was then closed primarily with interrupted, #1 absorbable polyglyconate monofilament sutures in a figure-of-eight fashion. Two 10 mm flat Jackson-Pratt drains were placed in the subcutaneous space and brought out through separate stable incisions. The subcutaneous tissue was closed with absorbable glycolide/lactide copolymer suture (Polysorb™ suture, Medtronic, Minneapolis, MN, USA). The skin was closed with either staples, external nylon suture, or intradermal, 4-0 absorbable monofilament suture. Wounds were dressed with silver-impregnated gauze (Silverlon™, Argentum Medical, Geneva, IL, USA) or gauze and tape. All patients were placed in an abdominal binder on extubation.
Medical records of patients who underwent one of these two procedures by the senior author were reviewed for sex, age, hernia size, hernia grade using the Ventral Hernia Working Group definition and BMI. Only patients with Grade I, II, or III hernias were included (i.e., low risk for wound occurrences, or low risk with associated comorbidities). Patients were matched 1:1 based on sex, age (±6 years), hernia size (±110 cm2), and BMI (±5). Records were reviewed for any complications within 30 days and any adverse events at any time during follow-up. Patients were contacted by telephone if there was no recent follow-up to determine if any adverse events occurred or if the hernia recurred. If there were any concerns, the patients were offered follow-up with the surgeon. Recurrence was determined by either physical examination by the senior author or imaging documenting a recurrence. Symptomatic and asymptomatic recurrences were included.
All statistical analysis was done using SAS version 9.4. Data were analyzed using descriptive statistics, two-sided t-test/Wilcoxon rank-sum test for continuous variables, and Chi-square/Fisher exact test for categorical variables. P < 0.05 was considered statistically significant.
| Results|| |
A total of 56 patients from May 2012 to May 2019 who met inclusion criteria and could be matched were included in the study. The patients who underwent the SOCRM repair were the case group, whereas the patients who underwent the BUSO repair were the control group. Both the case and control groups were composed of 28 patients who were successfully matched for age, sex, BMI, and hernia size. The average ages for the two groups were 57 ± 9 years, with the majority of patients (68%) being females [Table 1].
With respect to materials used in the repairs, there was no statistically significant difference between the two groups. This held true for suture type used, which included 14% nonabsorbable monofilament sutures used in each group; 29% versus 25% used absorbable monofilament sutures from the SOCRM group and BUSO group, respectively; and 54% versus 61% use of absorbable braided sutures from the SOCRM and BUSO groups, respectively. In each group, 71% of patients had staples for skin closure. Silverlon™ dressing was used in 96% of patients in the SOCRM group versus 89% of patients in the BUSO group. Drains were used in 50% of each group. The average time of drain usage was 13 ± 3 days for the SOCRM group and 16 ± 8 days for the BUSO group, which was not statistically significant.
Postoperative complications were not statistically different between the two groups [Table 2]. One patient in the SOCRM group required a bedside debridement for superficial skin necrosis. One patient in the BUSO group required re-operation within 30 days for early hernia recurrence. Three patients in each group had superficial surgical site infection. In the SOCRM group, one patient was treated with antibiotics alone, a second patient was treated with opening of the wound for drainage, and the third patient was treated with antibiotics and drainage of the wound infection. In the BUSO group, all three patients were treated with antibiotics and bedside drainage of the infection with subsequent wound care. Based on their Clavien-Dindo classifications, there was no significant difference in the complication rates [Table 2]. Seroma formation occurred in five patients in the SOCRM group versus three patients in the BUSO group, one patient in each of the groups required aspiration of the seroma. This was not statistically significant. Based on their Clavien-Dindo classifications, there was no significant difference in the complication severity. In both the SOCRM group and the BUSO group, three patients required either “Home Health” assistance or placement at a skilled nursing facility.
Primary outcome assessment demonstrated that there were eight (29%) patients who reported hernia recurrence in the BUSO group versus one patient (4%) in the SOCRM group (P = 0.0248). Although this is a significant finding, we must note that the median time from index procedure to last follow-up is longer, although not statistically significant, in the BUSO group when compared to the SOCRM group (238 [interquartile range (IQR) = 46–431] vs. 81.5 [IQR = 53.5–187.5] days, respectively, P = 0.1108). The longer time from the index procedure to the last follow-up is because most of the BUSO repairs were performed in the years before the adoption of the SOCRM technique. Although there is a difference in follow-up length of time, there is no statistical difference in the median number of follow-ups visits for incisional hernia postoperative management between the two groups (3.0 in SOCRM [IQR = 2.0–5.5] vs. 3.0 in BUSO [IQR = 1.5–6.0], P = 0.9375) [Table 1]. The figure presents the recurrence-free survival curves. Although there is some separation of the curves, it did not reach statistical significance.
| Discussion|| |
Despite incisional and ventral hernias being a common problem, there is no consensus on surgical management. Several techniques and types of mesh have been developed in an attempt to create an ideal repair. Options for ventral hernias include primary closure, mesh underlay, mesh overlay, mesh sublay, mesh inlay, and combinations of these. Large ventral hernias are usually defined as ventral hernias larger than 10 cm in width. These hernias pose a unique challenge as they are not usually amenable to primary closure and they are often complex. The authors' experiences over 30 years of surgery have demonstrated that incisional hernias present in a variety of manners in a variety of patients and a “one-size fits all” approach is probably sophomoric in concept.
The main findings of our case–control study are that the separation of components repair with retrorectus biological mesh is associated with reduced rates of recurrence, with no increase in complications. We matched for age, sex, and hernia size in Grades I, II, and III incisional hernias. The same surgeon performed all the repairs with the assistance of residents; therefore, one can argue that the surgeon was matched for skill and judgment as well. We do acknowledge longer follow-up time in the BUSO group, and because there was only one recurrence in the SOCRM group, it is impossible to predict future recurrences.
The main issues in incisional hernia repair are recurrences and wound complications. We do not wish to diminish other potential severe complications, such as cardiopulmonary or hollow-organ injury, but these are fairly uncommon and would require a matched large sample size to adequately study. Numerous techniques have been introduced to either or both reduce recurrences and limit wound complications. We are reminded of the old surgical aphorism: “When there is more than one way to do something, they all work equally well or equally badly.” With respect to incisional hernias, the primary repair choice is primary repair versus mesh repair. The primary repair can involve simple suture approximation or a separation of components repair without mesh placement. However, for larger hernias (say, >4 cm), the literature does support the use of mesh in ventral hernia repairs, with the added benefit of a reduction in the number of hernia recurrences when mesh is used., Mesh is available as either permanent, synthetic, or biologic, both having their pros and cons for various reasons. Most notable, among the complications observed when using synthetic mesh, are infection, chronic nonhealing wounds, chronic pain, and formation of enterocutaneous fistulas and chronically infected wounds., It is certainly our experience that synthetic mesh placed in the subcutaneous space as an onlay appears to have more wound complications (seroma, infection, and skin separation) and prone to enterocutaneous fistula as an underlay. The disadvantage to using biologic mesh is its gradual attenuation over time, with subsequently developed of a “recurrence” when used as a facial replacement. Hence, the senior author's rationale for using the biologic mesh as an underlay (prevention of enterocutaneous fistula), and a permanent synthetic as an overlay (prevention of attenuation) as a tension-free repair. Nevertheless, as wound complications and recurrences still vexed the BUSO repair, the introduction of the SOCRM repair had theoretical appeal. However, we found that there was relatively little difference in wound complications between the groups. Our group previously found that mesh, recurrent ventral hernia, operation time, hernia size, and blood loss were contributing factors to wound complications. As this study was a matched comparison between these operations, the main risk factors for wound complications were evenly distributed between the groups. This may be a reason for the lack of difference in this relatively small sample size.
One of the reasons that the separation of components technique may be associated with fewer recurrences is that it allows for expansion of the intra-abdominal space, leading to a decrease in intra-abdominal pressure and reduced tension on the closure. The external oblique aponeurosis release produced a myofascial advancement flap of several centimeters, thus decreasing tension. Several studies have demonstrated excellent results using both the external oblique and transversus abdominis release.,,,,, Systematic reviews now demonstrate lower recurrence rates with this technique,, while also allowing patients to be eligible for surgery who previously would not be candidates.,
The placement of a retrorectus sublay mesh adds to the strength of the repair. Although there are several types of mesh available, we chose porcine urinary bladder extracellular matrix device (Gentrix™ Surgical Matrix, ACell, Inc., Columbia, MD, USA). This mesh allows for long-term tissue remodeling over several weeks, thereby increasing the tensile strength of the fascia. However, being a biological mesh, it lacks the disadvantages of permanent, synthetic mesh. Others have also shown that the long-term clinical results with Gentrix mesh™ results appear promising. In our study, we believe that our lower hernia recurrence rate in the SOCRM technique is partially due to the technique which lowers tension and therefore, short-term recurrences. In addition the Gentrix device promotes long-term recurrence reduction due to tissue remodeling.
There are several weaknesses of this study. First, it is a retrospective design; therefore, data collection is limited by documentation in the medical chart, and our results are contingent on the accuracy of the documentation. We tried to mitigate this weakness by directly contacting patients when there were gaps in the medical record for long-term adverse events and recurrences. Another weakness in our study is the time elapsed from the index procedure to the last postoperative follow-up is significantly longer in the BUSO group than in the SOCRM group. The freedom from recurrence plot [Figure 1] shows wide 95% confidence intervals, due to sample size and follow-up time. Finally, although our groups were matched by BMI, our study did not review other factors or comorbid conditions such as smoking, diabetes, chronic obstructive pulmonary disease, nutritional status, chronic steroid use, and immunosuppression. All of which have been shown to contribute to hernia infection rate and as a result, recurrence rate. In addition, we only compared two types of incisional hernia repairs. The fundamental difference between the two techniques is that in the SOCRM repair, the fascia is approximated, whereas in the BUSO repair, it is not. How much of the difference is related to the fascial approximation versus the type of mesh cannot be determined. We acknowledge that laparoscopic and robotic underlay repairs are gaining great interest, with the specific advantage of lower wound complications. Laparoscopic and robotic separation of component repairs has been reported with quite favorable results.,, However, we did not compare these other techniques.
|Figure 1: Recurrence-free survival in days. The control group is the BUSO repair and the case group is the SOCRM repair|
Click here to view
| Conclusions|| |
We demonstrate that when BUSO “sandwich” repair is transitioned to the SOCRM repair, there were fewer recurrences, but no difference in adverse event rates. The reasons for the improvement in the recurrence rate with SOCRM we believe is two fold: expanding the dimensions of the abdominal wall leading to less tension and tissue remodeling increasing the tensile strength of the fascia. Prospective studies are needed to confirm these results.
Declaration of patient consent
The institutional review boards waived the need for consent.
Financial support and sponsorship
This study was funded by Acell, Inc., Columbia, MD.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]