Michel Prudhomme1, Eric Rullier2, Zaher Lakkis3, Eddy Cotte4, Yves Panis5, Bernard Meunier6, Philippe Rouanet7, Jean-Jacques Tuech8, Mehrdad Jafari9, Guillaume Portier10, Anne Dubois11, Igor Sielezneff12, Yann Parc13, Jean-Luc Faucheron14, Guillaume Meurette15, Bernard Lelong16, Guillaume Piessen17, Mehdi Karoui18, Pascale Fabbro-Peray19, Christophe Demattei19, Martin M Bertrand1. 1. Department of Digestive Surgery, CHU Nimes, Univ Montpellier, Nimes, France. 2. Department of Digestive Surgery, GH Sud Haut-Lévêque - CHU de Bordeaux, Pessac, France. 3. Department of Digestive Surgery, L'Hôpital Jean Minjoz, CHRU de Besançon, Besançon, France. 4. Department of Digestive Surgery, Center Hospitalier Lyon-Sud, Lyon, France. 5. Department of Colorectal Surgery, AP-HP Hôpital Beaujon, Clichy, France. 6. Department of Digestive Surgery, Hôpital Pontchaillou, Rennes, France. 7. Department of Oncologic Surgery, Center Régional de Lutte Contre le Cancer CRLC Val d'Aurelle - Paul Lamarque, Montpellier, France. 8. Department of Digestive Surgery, Hôpital Charles-Nicolle, CHU de Rouen, Rouen, France. 9. Department of Oncologic Surgery, Center Oscar Lambret, Lille, France. 10. Department of Digestive Surgery, Hôpital Rangueil - CHU de Toulouse, Toulouse, France. 11. Department of Digestive Surgery, CHRU Clermont- Ferrand Hôtel - Dieu, Clermont-Ferrand, France and Department of Digestive Surgery, CH de Vichy, Vichy, France. 12. Department of Digestive Surgery, AP-HM Hôpital de la Timone, Marseille, France. 13. Department of Digestive Surgery, AP-HP Hôpital Saint Antoine, Paris, France. 14. Department of Digestive Surgery, Hôpital Albert Michallon, CHU de Grenoble, Grenoble, France. 15. Department of Digestive Surgery, Center Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes, Nantes, France. 16. Department of Oncologic Surgery, Center Régional de Lutte contre le Cancer Institut Paoli-Calmettes, Marseille, France. 17. Department of Digestive Surgery, Hôpital Claude Huriez, Center Hospitalier Régional Universitaire, (CHRU) de Lille, Lille, France. 18. Department of Digestive Surgery, Hôpital La Pitié Salpetrière, (AP-HP), Paris, France. 19. Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology, CHU Nimes, Univ Montpellier, Nimes, France.
Abstract
OBJECTIVE: To evaluate whether systematic mesh implantation upon primary colostomy creation was effective to prevent PSH. SUMMARY OF BACKGROUND DATA: Previous randomized trials on prevention of PSH by mesh placement have shown contradictory results. METHODS: This was a prospective, randomized controlled trial in 18 hospitals in France on patients aged ≥18 receiving a first colostomy for an indication other than infection. Participants were randomized by blocks of random size, stratified by center in a 1:1 ratio to colostomy with or without a synthetic, lightweight monofilament mesh. Patients and outcome assessors were blinded to patient group. The primary endpoint was clinically diagnosed PSH rate at 24 months of the intention-to-treat population. This trial was registered at ClinicalTrials.gov, number NCT01380860. RESULTS: From November 2012 to October 2016, 200 patients were enrolled. Finally, 65 patients remained in the no mesh group (Group A) and 70 in the mesh group (Group B) at 24 months with the most common reason for drop-out being death (n = 41). At 24 months, PSH was clinically detected in 28 patients (28%) in Group A and 30 (31%) in Group B [P = 0.77, odds ratio = 1.15 95% confidence interval = (0.62;2.13)]. Stoma-related complications were reported in 32 Group A patients and 37 Group B patients, but no mesh infections. There were no deaths related to mesh insertion. CONCLUSION: We failed to show efficiency of a prophylactic mesh on PSH rate. Placement of a mesh in a retro-muscular position with a central incision to allow colon passage cannot be recommended to prevent PSH. Optimization of mesh location and reinforcement material should be performed.
OBJECTIVE: To evaluate whether systematic mesh implantation upon primary colostomy creation was effective to prevent PSH. SUMMARY OF BACKGROUND DATA: Previous randomized trials on prevention of PSH by mesh placement have shown contradictory results. METHODS: This was a prospective, randomized controlled trial in 18 hospitals in France on patients aged ≥18 receiving a first colostomy for an indication other than infection. Participants were randomized by blocks of random size, stratified by center in a 1:1 ratio to colostomy with or without a synthetic, lightweight monofilament mesh. Patients and outcome assessors were blinded to patient group. The primary endpoint was clinically diagnosed PSH rate at 24 months of the intention-to-treat population. This trial was registered at ClinicalTrials.gov, number NCT01380860. RESULTS: From November 2012 to October 2016, 200 patients were enrolled. Finally, 65 patients remained in the no mesh group (Group A) and 70 in the mesh group (Group B) at 24 months with the most common reason for drop-out being death (n = 41). At 24 months, PSH was clinically detected in 28 patients (28%) in Group A and 30 (31%) in Group B [P = 0.77, odds ratio = 1.15 95% confidence interval = (0.62;2.13)]. Stoma-related complications were reported in 32 Group A patients and 37 Group B patients, but no mesh infections. There were no deaths related to mesh insertion. CONCLUSION: We failed to show efficiency of a prophylactic mesh on PSH rate. Placement of a mesh in a retro-muscular position with a central incision to allow colon passage cannot be recommended to prevent PSH. Optimization of mesh location and reinforcement material should be performed.