Preventing Parastomal Hernia Using a Modified Sugarbaker Technique With Composite Mesh During Laparoscopic Abdominoperineal Resection

A Randomized Controlled Trial

Manuel López-Cano, MD; Xavier Serra-Aracil, MD; Laura Mora, MD; José Luis Sánchez-García, MD; Luis Miguel Jiménez-Gómez, MD; Marc Martí, MD; Francesc Vallribera, MD; Domenico Fraccalvieri, MD; Anna Serracant, MD; Esther Kreisler, MD; Sebastiano Biondo, MD; Eloy Espín, MD; Salvador Navarro-Soto, MD; Manuel Armengol-Carrasco, MD

Disclosures

Annals of Surgery. 2016;264(6):923-928. 

In This Article

Discussion

This study shows that placement of a large-pore lightweight composite mesh through the laparoscopic route following the modified Sugarbaker technique at the time when a permanent colostomy is performed after laparoscopic APR has a significant preventive effect on the development of PH, after a median follow-up of 26 months (IQR 12 mnths, range 13 to 38 mnths).

The study groups were homogeneous, without statistically significant differences in all epidemiological characteristics and risk factors most frequently related to the appearance of PH. Differences in morbidity and mortality, significant stoma-related problems, and mesh infection were not found. These findings are consistent with previous studies using the laparoscopic approach[6,7] or open surgery,[1–5] in which safety of insertion of a mesh prosthesis for preventing PH in relation to complications associated with the stoma or the prosthesis have been consistently demonstrated.

A different aspect relates to the potential failure of prevention and therefore development of a PH. In this regard, the keyhole technique used in all randomized studies published in the literature (independently of the open or laparoscopic approach) has been shown to be effective to prevent PH. It has been suggested that stabilization of the fascial orifice size by the mesh in the keyhole procedure may be possibly a crucial factor for the prevention of PH.[3] However, studies using a synthetic prosthesis with a minimum follow-up of 1 year have shown inconsistent results, varying from effective prevention of PH,[1,3] effective, but not so much as the previous studies,[2,19] or surprising/poor results with a high incidence of PH in the mesh group assessed radiologically.[6,7] On the contrary, in the single study of implantation of biologic material with a minimum follow-up of 1 year, significant differences between the groups were not observed, although both the population and the surgical procedure were heterogeneous, including ileostomies and colostomies as well as laparoscopy and open surgery.[5] Also, the use of a biologic prosthesis may explain the differences.[8] In addition and interestingly, in a very recent observational study with more than 200 patients receiving a prophylactic keyhole synthetic mesh, the authors conclude that a prophylactic stoma mesh did not reduce the rate of clinically or CT-verified PHs.[20]

To our knowledge, specific recommendations regarding the rationale of the material or the surgical technique for prosthetic reinforcement of stomas are lacking. Biologic mesh cannot be currently considered a gold standard in PH prevention or repair.[21] Accordingly, focusing on randomized controlled studies in which synthetic material has been used for prevention of PH associated with an end-colostomy, with a minimum follow-up of 1 year, and independently of the surgical approach,[1,3,6,7] it seems that there is no relationship between development of PH and the main risk factors associated with PH formation. In this context, if we assume that the technique of making the hole in the center of the mesh and in the abdominal wall has been quite homogeneous among surgeons of the different studies, then it is possible that inconsistent data reported may be related to the keyhole technique itself and the need to create a central gap in the prosthesis with variable changes in the hole resulting from contraction of the mesh with time.[6–8] In the modified Sugarbaker technique, the synthetic prosthesis covers completely the ostomy site and no trephine opening in the mesh is required, avoiding potential variability of the technique and making the procedure more generalizable. Interestingly, this strategy for PH prevention has been already advocated for PH repair,[11,22,23] where the keyhole procedure has been recommended to be abandoned due to the high recurrence rates[24] and substituted by the modified Sugarbaker technique.

However, the modified Sugarbaker technique proposed in our study was also associated with a significantly lower rate of PH than the nonmesh group. Although surgical techniques were homogenized among the participating centers, the occurrence of PH in the mesh group may be probably associated with a misplacement of the prosthetic material combined with mesh contraction with time, because the reoperated patient showed a defect in 1 of the lateral edges of the mesh with a reduction in the size of the mesh as compared with the original size, but integrated in the abdominal wall without adhesions. Moreover, the occurrence of PH in the mesh group could show the difficulty of solving the conundrum of "closing" a gap through which emerges the stoma without, in fact, "closing" it as is the case of PH prevention (or treatment). On the contrary, PHYSIOMESH was chosen in our study because it represents a new generation of composite meshes with a wide pore and low weight, very easy to handle in the abdominal cavity, allowing transparent view of the other side of the mesh, with marks that allow orientation, and that both sides of the mesh can be placed in contact with the viscera. In addition, the modified Sugarbaker technique did not significantly prolong the surgical time. Although the present study was performed in patients undergoing laparoscopic surgery, the modified Sugarbaker technique for PH prevention can be also extrapolated to open surgery without substantial changes.

Limitations of the study include the relative small number of patients, the lack of comparison of different mesh types, and the fact that CT studies were not performed in the prone position so that the proportion of PH may be underestimated.[25] Also, this was not an expertise-based randomized trial,[26] and despite expertise in laparoscopic surgery of the surgical teams and homogenization of the technique, which may favor the external validity of the study, the specialized groups that performed the surgical technique were different. On the contrary, the randomized design, the prolonged follow-up period, and the use of radiological criterion to determine the presence of PH increase the strength of the results obtained. In addition, the treatment-specific effect assessed by the NNT of 2.5 indicates that prevention of PH using the technique proposed in the study is effective, independently of the statistically significant result in favor of the mesh group.

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