|Year : 2021 | Volume
| Issue : 2 | Page : 51-57
Long-term parastomal hernia occurrence rate following Stapled Mesh stomA Reinforcement Technique
Zi Qin Ng1, Patrick Tan1, Jih Huei Tan2, Mary Theophilus3
1 Department of General Surgery, Royal Perth Hospital, Perth, Western, Australia
2 Department of General Surgery, Hospital Sultanah Aminah, Johor Bahru, Johor, Malaysia
3 Department of General Surgery, Royal Perth Hospital, Perth; Curtin Medical School, Curtin University, Bentley, Western, Australia
|Date of Submission||08-Dec-2020|
|Date of Decision||13-Jan-2021|
|Date of Acceptance||21-Jan-2021|
|Date of Web Publication||31-May-2021|
Dr. Zi Qin Ng
Department of General Surgery, Royal Perth Hospital, Wellington Street, Perth, WA 6000
Source of Support: None, Conflict of Interest: None
PURPOSE: Our initial publication on Stapled Mesh stomA Reinforcement Technique (SMART) for the prevention of parastomal hernias (PSH) demonstrated promising results. The aim of this study is to evaluate the long-term PSH occurrence rate with SMART and its associated complications and to radiologically measure the progression of trephine diameters.
MATERIALS AND METHODS: All SMART cases from November 2013 to July 2016 were reviewed. Demographics, peri-operative details, and long-term mesh-related complications were collected. Serial computed tomography (CT) scans during follow-up were used to identify PSH and measure the progression of axial and sagittal trephine diameters and trephine area.
RESULTS: 15 patients (M:F = 10:5) underwent an elective stoma formation with SMART. Nine died during the study period. Two patients died before any CT scan with no clinical evidence of PSH. All except one of the remaining 13 patients developed radiological PSH. There were no long-term mesh-related complications. Only one patient required the relocation of stoma due to the incarceration of small bowel in the PSH in an emergency setting. The median follow-up was 28 months (3–77 months).
CONCLUSION: Prophylactic mesh placement by SMART did not prevent the occurrence of PSH in the long-term despite only a minority of patients required surgical intervention for PSH.
Keywords: Hernia, outcomes, parastomal, prevention, Stapled Mesh stomA Reinforcement Technique
|How to cite this article:|
Ng ZQ, Tan P, Tan JH, Theophilus M. Long-term parastomal hernia occurrence rate following Stapled Mesh stomA Reinforcement Technique. Int J Abdom Wall Hernia Surg 2021;4:51-7
| Introduction|| |
The recent interest in parastomal hernias (PSH) has been focused on a preventative strategy using prophylactic mesh placement. Several trials have shown conflicting evidence of PSH occurrence rates, owing to differences in diagnosis modality (clinical or radiological) and duration of follow-up.,,,, The Dutch PREVENT trial in 2017 reported a significant reduction of PSH occurrence with prophylactic augmentation of the abdominal wall in patients with stoma creation. The most recent randomized controlled trial (RCT), STOMAMESH, showed no difference in PSH occurrence rate, regardless of prophylactic mesh use. Earlier meta-analyses and systematic reviews did not include the two aforementioned RCTs and concluded that prophylactic placement of mesh during the index operation reduced PSH occurrence., Interestingly, a recent review of bias of these meta-analyses and systematic reviews showed a considerable mixture of high- and low-quality reviews on this topic.
The multicentre trial assessing the efficacy of Stapled Mesh stomA Reinforcement Technique (SMART) in Europe is still ongoing. We published our initial outcomes on the novel approach introduced by Williams et al., the SMART, in 2016. The aim of our current study is to: (i) evaluate the long-term occurrence rate of PSH with SMART and its associated complications and (ii) perform radiological measures of the progression of trephine diameter and area.
| Materials and Methods|| |
This study is a follow-up of a previous publication that was approved by the hospital quality improvement committee (QI 11708). All the patients that underwent SMART between November 2013 and July 2016 were retrospectively reviewed. The operative technique has already been described in the previous publication. The authors have not modified their technique since and the mesh used was either partially absorbable lightweight (Ultrapro, Ethicon, USA) or nonabsorbable heavyweight polypropylene (Prolene, Ethicon, USA). Briefly, a circular disc of skin and subcutaneous tissue is excised to expose the anterior rectus sheath. A cruciate incision is then made in the anterior rectus sheath to expose the rectus muscle exposing the posterior rectus sheath. A CS Compact EA circular stapler (Frankenman International Ltd. Hong Kong) with knife diameter 25 mm or 28 mm is used to create the stoma aperture. The anvil shaft is introduced through the peritoneum and posterior rectus sheath with the aid of the Frankenman grasping forceps. A circular piece of mesh is prepared with a 1-mm incision at its center. The anvil shaft is introduced through this small defect with mesh placed onto the anvil shaft. The stapler gun is docked to the anvil shaft and tightened slowly. The stapler gun is fired, leaving behind a circular rim of staples anchoring the mesh to the posterior rectus sheath as the end result. The excess mesh is then stitched onto the anterior rectus sheath as an onlay component. A wound retractor is used for the exteriorization of the bowel and the stoma is matured in the conventional way.
One additional patient underwent SMART following our last report. During the same study period, the authors did not perform any other techniques for prophylactic mesh placement for end stomas.
Measurement of the trephine size and sac surface area
Based on the study by Ho et al., the size of the trephine was measured using computed tomography (CT) reconstruction. The maximum diameter of the defect in the abdominal wall across the visible staple at the musculofascial layers both in axial [Figure 1]a and sagittal views [Figure 1]b were taken. The maximum diameter was measured three times and the median value was used. Similarly, for the size of the hernia sac (if present), the maximum diameter in axial and sagittal views was measured and the median was utilized. The measurements were all done by a single investigator (ZN) to ensure uniformity.
|Figure 1: An example of the maximum diameter of the defect in the abdominal wall across the visible staple at the musculofascial layers (green arrows) both in axial (a) and sagittal (b) views; yellow arrows showing the maximum diameter of the sac and red asterisk showing small bowel content in the parastomal hernias|
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The area of the trephine was calculated using the formula: Area = π(A/2)(B/2) where A is the sagittal and B the axial diameter.
Any available post-operative and follow-up CT scans (supine position with no Valsalva protocol) were used for the radiological measurement. These CT scans were not performed for prospective evaluation of PSH. They were done for either malignancy surveillance or other clinical indications. At least three CT scans were required for any evaluation of the progression trend of the above parameters.
Identification and classification of parastomal hernias
In the previous publication, PSH was defined based on clinical examination. However, as a substantial number of patients have passed away before follow-up, radiological identification of PSH on CT was instead used. In addition, the remaining patients that were alive have survived beyond the 5-year follow-up period for the malignancy and therefore no longer being seen in the outpatient clinic routinely. The Moreno-Matias (MM) and European Hernia Society (EHS) classifications were selected for the grading of the PSH.
If the patient passed away before any CT scan, the last documented clinical review of the presence of PSH was considered the last follow-up.
| Results|| |
15 patients (10 males and 5 females) underwent elective stoma formation with SMART [Table 1]. Nine patients died during the study period. The median age was 76 years (54–89 years) and the median ASA was 3 (range 2–3). The median BMI was 29.8 kg/m2 (23.6–36 kg/m2). 12 patients underwent surgery for malignancy: Eight abdomino-perineal resections (APRs), four ultralow Hartmann's procedures; and three stoma relocations due to PSH (two initial primary surgeries were for malignancy and one for ulcerative colitis). The stapler size with knife diameter used were 25 mm in 11 patients and 28 mm in four patients. 14 patients received partially absorbable lightweight mesh (Ultrapro, Ethicon, USA). One patient received nonabsorbable heavyweight polypropylene (Prolene, Ethicon, USA) for the stoma relocation as the patient has had two previous local revisions for PSH.
|Table 1: Summary of the demographics of the patients and operative details|
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There were no mesh-related complications, such as mesh infection, stenosis, erosion or fistulation, on follow-up. The mean follow-up of this study was 28 months (3–77 months).
Two patients died before any follow-up CT scan due to unrelated causes (one due to pulmonary embolism 3 months postoperation and one due to a fall 3 years postoperation). These two patients did not have any clinical evidence of PSH occurrence. Of the remaining 13 patients, all except one patient developed radiological PSH at some stage during the follow-up. The only patient that did not develop any PSH died secondary to the progression of disease after 60 months. More than 50% of patients developed PSH by 1-year follow-up [Figure 2].
|Figure 2: Number of parastomal hernias occurrence with respect to patient survival|
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According to the EHS classification, there were eight type 1, nil type 2, three type 3, and one type 4 PSH; according to the MM classification, there were three type 0, nil type 1a, one type 1b, one type 2, and seven type 3 [Table 2]. The median time to earliest CT scans after surgery was 11.5 months.
|Table 2: The number of parastomal hernias according to the European Hernia Society and Moreno-Matias classifications|
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One male patient, who underwent SMART during stoma relocation, developed incarcerated small bowel obstruction in the PSH 24 months later. He required an emergency laparotomy with completion colectomy due to perforation, and simultaneous relocation of the stoma. None of the other patients required surgical intervention for a PSH.
Trephine diameter and area
Only six patients had at least three or more serial follow-up CT scans for the evaluation of progression of the axial and sagittal trephine diameter, the axial and sagittal sac diameter, and the area of the trephine.
Both axial and sagittal trephine diameters gradually increased in size, especially in the first 12–24 months, and then plateaued [Figure 3]a and [Figure 3]b. Both axial and sagittal sac diameters remained relatively stable on follow-up after the occurrence of PSH [Figure 3]c and [Figure 3]d. No trend was observed in the axial/sagittal ratio [Figure 4]. Similarly to the progression of axial and sagittal trephine diameters, the area of trephine increased gradually and then plateaued thereafter [Figure 5].
|Figure 3: Graphs showing (a) progression of axial trephine diameter (b) progression of sagittal trephine diameter (c) progression of axial sac diameter (d) progression of sagittal sac diameter|
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| Discussion|| |
This study demonstrated that despite the early promising results of prevention of PSH with SMART, PSH occurred in nearly all the patients on long-term follow-up. This is the longest follow-up study for SMART in the literature with a median of 28 months.
When Williams et al. introduced this novel technique in 2011, it was meant to address the long-standing issue of inevitable PSH facing most colorectal surgeons based on the earlier randomized trials that prophylactic mesh placement during the index operation reduces the PSH occurrence rates. A meta-analysis of 10 RCTs in 2016 confirmed that prophylactic placement of mesh during the index operation reduced the occurrence of PSH. However, the follow-up duration was variable among the studies. Of all, Janes et al. had the longest follow-up (mean 65.2 months) with PSH occurrence rate of 7.4%. It is also interesting to note that the recent STOMAMESH trial demonstrated 32% of PSH occurrence with prophylactic mesh placement at a mere 1-year follow-up. With longer follow-up, a higher rate of occurrence is very likely.
Previous studies have shown that the aperture size of ≥25 mm is associated with an increased risk of PSH occurrence where every millimeter increase in diameter size is associated with 10% increased risk of PSH development. Despite the use of staplers with knife diameter of 25 mm in 10 patients, only one patient has not had a PSH occurrence in our series. In our experience, we attempt to use a smaller stapler knife diameter if possible, but most patients were obese with bulky mesenteries and we did not want to compromise the blood supply of the conduit. As shown in this study, the axial and sagittal diameter of the trephine gradually increased with time and then plateaued. As demonstrated in the study by Ho et al., both the axial trephine diameters increased by a mean of 0.11 mm/month (male), 0.28 mm/month (female) and similarly in overall sagittal trephine diameter increased by a mean of 0.22 mm/month.
Another important observation of the occasional “dip” in the graphs representative of the axial and sagittal trephine and sac diameters and the area of trephine could be explained by the timing of the CT scan. For example, when the CT scan was performed for small bowel obstruction with a distended abdomen and the potential slight difference in positioning of the patient on the CT scan table.
From our review of the literature [Table 3], a total of four studies (inclusive of our previous report) were found (total of 72 patients).,,, The majority of the SMARTs were performed in conjunction with low rectal resection or APRs for malignancies. Open procedures (76.3%) were more commonly performed than laparoscopic (55:17). Different types of mesh were used, including porcine collagen implants (Permacol), partially absorbable lightweight polypropylene (Ultrapro), nonabsorbable heavyweight polypropylene (Prolene), and monofilament polypropylene (HexaPro). Three of the four studies reported the stapler knife diameter used which ranged from 24 mm to 33 mm.,, There were no cases of mesh-related complications reported in any of the studies. Only three of the four studies reported the PSH occurrence rate. In this review, only 10 cases of PSH were detected both clinical and radiologically (7.2%).,, Only one case of reoperation for PSH was reported in our current report. The duration of follow-up ranged from a median of 21–27 months.
|Table 3: A summary of the review of the literature of the studies reporting the outcomes of Stapled Mesh stomA Reinforcement Technique|
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The high PSH occurrence rate in this study could be explained by a few reasons. The inclusion criteria differed between studies and we included only high-risk patients (i.e., obesity, asthma/chronic airway disease, chronic liver disease, or a combination of these). In our previous report, the diagnosis of PSH was made based on clinical findings which are likely to miss small asymptomatic PSHs, especially in the obese group. However, the CT scan grading of PSH by both MM and EHS classifications are likely to detect even the subtle occurrence of PSH which may not be symptomatic for the patients. Both of these classifications have their limitations, but they provide an objective reporting system.
A study reported an overall 45.7% recurrence rate of PSH for all recurrent PSH repairs (median follow-up of 58 months) with various types of mesh location placement and mesh choice. None of our patients underwent elective repair of PSH due to either frailty or progression of the malignancy with clinical indication not to interrupt chemotherapy treatment. A few patients in our series were also counseled against reoperation due to the potential significant postoperative morbidity. This was evident in Harries et al.'s study where one in 10 patients return to theatre within 30 days postsurgery. In a meta-analysis of 10 RCTs, there were only 5 of 197 patients that underwent a repair of PSH following prophylactic mesh placement.
There is some evidence to suggest that the retro-rectus placement of mesh may be more durable for the repair of PSH. However, there are no direct comparative trials of different locations (onlay, preperitoneal, retro-rectus, or intraperitoneal) of prophylactic mesh placement for the prevention of PSH. Majumder et al. described a novel approach for the repair instead of prevention: Stapled Transabdominal Ostomy Reinforcement with retromuscular mesh (STORRM) where the retro-rectus plane is developed and it differs from the SMART which utilizes the onlay plane. Nevertheless, long-term results are not available (only mean 12.8 months of results reported). It is pertinent to bear in mind that STORRM may not be feasible during the index operation which could already be a relatively long cancer operation with a potentially contaminated operative field.
We acknowledge that this study is limited by the radiological diagnosis of PSH and the CT scans were performed in the supine position, which may affect the grading of PSH on MM classification as some contents of the PSH may spontaneously reduce and the CT scans were not done with Valsalva protocol. The limited number of serial CT scans also prevented further potential interpretation of the progression of trephine diameters and area. Given the increasing sphincter-preserving procedures being performed, the number of APRs has reduced over the years. Hence, due to small patient numbers, the authors have not attempted other techniques for prophylactic mesh placement for comparison with SMART. In patients that died before any CT scan, the clinical examination may not accurately detect very subtle PSHs. As the majority of the patients underwent the primary surgery for malignancy, the progression of disease with death precluded longer-term follow-up.
| Conclusion|| |
Despite the early promise of SMART for the prevention of PSH, it did not prevent the occurrence of PSH. The perfect technique and choice of mesh for the prevention of PSH is still awaited.
Financial support and sponsorship
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]