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A case-controlled pilot study assessing the safety and efficacy of the Stapled Mesh stomA Reinforcement Technique (SMART) in reducing the incidence of parastomal herniation

Abstract

Background

Parastomal hernias (PH) are frequent with a high morbidity. Three randomised controlled trials have shown that prophylactic mesh stoma reinforcement significantly reduces their incidence. Implantation and fixation of mesh can be time-consuming, difficult to perform laparoscopically and does not deal with the excessive stretching of the trephine and the creation of an oversized defect. The Stapled Mesh stomA Reinforcement Technique (SMART) obviates these technical problems. The aim of this study was to assess the safety and efficacy of a novel surgical technique called SMART in preventing parastomal herniation.

Method

SMART uses a purpose designed circular stapling gun (Compact™, Frankenman International Limited) of various diameters to create a precise trephine and simultaneously fixes a mesh sub-peritoneally and circumferentially to the trephine. Recruited patients were deemed to be high risk for parastomal herniation and randomisation in a controlled trial was contraindicated. Incidence of parastomal related symptoms and recurrences were documented at clinic visits and radiological confirmation of recurrences, when available, was used for final analysis. A control group of patients who underwent stoma resiting without mesh reinforcement for parastomal herniation was used for comparative purposes.

Results

22 patients (16 F:6 M, mean age 49 ± 16 years, BMI 33.0 ± 7.0) underwent SMART (18 open, 4 laparoscopic). There were no intra-operative or early stoma complications. During a median FU of 21 months (range 12–24), four patients (19 %) were diagnosed with recurrent parastomal herniation, one of which required re-operation. The parastomal herniation rate (73 %) in the control group (6 F:5 M) was significantly higher (p = 0.003) although patients had similar age (59 ± 15 years, p = 0.1) and body-mass index (29.0 ± 3.0, p = 0.1).

Conclusion

SMART is a new and simple technique of precisely creating a reinforced stoma trephine at both open and laparoscopic surgery. It obviates the technical disadvantages of traditional stoma formation. This pilot study, in a selected group of patients at high risk for parastomal herniation, indicates that the procedure is clinically safe but randomised controlled trials are required to determine its efficacy in reducing parastomal herniation in all patients undergoing elective stoma formation.

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Conflict of interest

NSW is a consultant to Frankenman International who have a licensing agreement with QMUL, his employer, to manufacture stapling instrumentation for SMART. NSW has designed a circular stapling instrument specifically for use in the SMART procedure. The instrument is subject to a licensing agreement between his employer and the manufacturer. AH, CB, JM and CLC declare no conflicts of interest.

Author information

Correspondence to A. Hotouras.

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Williams, N.S., Hotouras, A., Bhan, C. et al. A case-controlled pilot study assessing the safety and efficacy of the Stapled Mesh stomA Reinforcement Technique (SMART) in reducing the incidence of parastomal herniation. Hernia 19, 949–954 (2015). https://doi.org/10.1007/s10029-015-1346-9

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Keywords

  • Parastomal hernia
  • Prevention
  • Prophylaxis
  • Mesh reinforcement