1. End Colostomy With or Without Mesh to Prevent a Parastomal Hernia (GRECCAR 7): A Prospective, Randomized, Double Blinded, Multicentre Trial
- Author
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Guillaume Meurette, Zaher Lakkis, Bernard Meunier, Pascale Fabbro-Peray, Anne Dubois, Mehrdad Jafari, Christophe Demattei, Yves Panis, Philippe Rouanet, Mehdi Karoui, Eric Rullier, Eddy Cotte, Guillaume Piessen, Igor Sielezneff, Michel Prudhomme, Jean-Jacques Tuech, Bernard Lelong, Jean-Luc Faucheron, M. Bertrand, Guillaume Portier, Yann Parc, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), The French Research Group of Rectal Cancer Surgery = Groupe de Recherche en Chirurgie du Rectum (GRECCAR), Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Hôpital JeanMinjoz, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Service de Gastroentérologie [Hôpital Beaujon], Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Pontchaillou, CRLCC Val d'Aurelle - Paul Lamarque, Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Chirurgie Générale et Digestive [Rangueil], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU Clermont-Ferrand, Centre Hospitalier Vichy, Service d'oncologie digestive et hépato-gastro-entérologie [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Cancérologie-Radiothérapie Hôpital Albert MICHALLON (CHU de Grenoble), Université Joseph Fourier - Grenoble 1 (UJF), Centre hospitalier universitaire de Nantes (CHU Nantes), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Hôpital Claude Huriez [Lille], CHU Lille, CHU Pitié-Salpêtrière [AP-HP], Laboratoire de Biostatistique, Epidémiologie clinique, Santé Publique Innovation et Méthodologie [CHU Nîmes] (BESPIM), Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), and Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Population ,MESH: Colostomy ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,[SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery ,MESH: Surgical Mesh ,Parastomal hernia ,Group B ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Randomized controlled trial ,law ,Colostomy ,medicine ,Clinical endpoint ,Humans ,MESH: Double-Blind Method ,Prospective Studies ,MESH: Hernia, Abdominal ,education ,Aged ,MESH: Aged ,education.field_of_study ,MESH: Humans ,business.industry ,[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,Odds ratio ,Surgical Mesh ,Confidence interval ,MESH: Male ,MESH: Prospective Studies ,Hernia, Abdominal ,Surgery ,MESH: France ,030220 oncology & carcinogenesis ,Female ,030211 gastroenterology & hepatology ,France ,business ,MESH: Female - Abstract
International audience; 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.
- Published
- 2021