Role of protective stoma after primary anastomosis for generalized peritonitis due to perforated diverticulitis—DIVERTI 2 (a prospective multicenter randomized trial): rationale and design (nct04604730)

Jean Pinson (1) , Jean-Jacques Tuech (2) , Mehdi Ouaissi (3) , Murielle Mathonnet (4) , François Mauvais (5, 6) , Estelle Houivet (7, 8) , Elie Lacroix (7) , Julie Rondeaux (9, 10) , Charles Sabbagh (6) , Valérie Bridoux (11, 12, 13, 14)

1 ITODYS (UMR_7086) - Interfaces, Traitements, Organisation et Dynamique des Systèmes
2 GPMCND - Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques
3 T2i - Transplantation, Immunologie, Inflammation [Tours]
4 UNILIM - Université de Limoges
5 Chirurgie digestive [CHU Amiens]
6 SSPC - Simplification des soins chez les patients complexes - UR UPJV 7518
7 Unité de Biostatistiques [CHU Rouen]
8 CESP - Centre de recherche en épidémiologie et santé des populations
9 EnVI - Endothélium, valvulopathies et insuffisance cardiaque
10 EnVI - Nouvelles Cibles Pharmacologiques de la Protection Endothéliale et de l'Insuffisance Cardiaque
11 ADEN - Nutrition, Inflammation et axe Microbiote-Intestin-Cerveau
12 IRIB - Institute for Research and Innovation in Biomedicine
13 UNIROUEN UFR Santé - UNIROUEN - UFR Santé
14 Service de Chirurgie Digestive [CHU Rouen]

Abstract Background Traditionally, patients with peritonitis Hinchey III and IV due to perforated diverticulitis were treated with Hartmann’s procedure. In the past decade, resection and primary anastomosis have gained popularity over Hartmann’s procedure and recent guidelines recommend Hartmann’s procedure in two situations only: critically ill patients and in selected patients with multiple comorbidity (at high risk of complications). The protective stoma (PS) is recommended after resection with primary anastomosis, however its interest has never been studied. The aim of this trial is to define the role of systematic PS after resection and primary anastomosis for peritonitis Hinchey III and IV due to perforated diverticulitis. Methods/design This DIVERTI 2 trial is a multicenter, randomized, controlled, superiority trial comparing resection and primary anastomosis with (control group) or without (experimental group) PS in patients with peritonitis Hinchey III and IV due to perforated diverticulitis. Primary endpoint is the overall 1 year morbidity according to the Clavien–Dindo classification of surgical complications. All complications occurring during hospitalization will be collected. Late complications occurring after hospitalization will be collected during follow-up. In order to obtain 80% power for a difference given by respective main probabilities of 67% and 47% in the protective stoma and no protective stoma groups respectively, with a two-sided type I error of 5%, 96 patients will have to be included in each group, hence 192 patients overall. Expecting a 5% rate of patients not assessable for the primary end point (lost to follow-up), 204 patients will be enrolled. Secondary endpoints are postoperative mortality, unplanned reinterventions, incisional surgical site infection (SSI), organ/space SSI, wound disruption, anastomotic leak, operating time, length of hospital stay, stoma at 1 year after initial surgery, quality of life, costs and quality-adjusted life years (QALYs). Discussion The DIVERTI 2 trial is a prospective, multicenter, randomized, study to define the best strategy between PS and no PS in resection and primary anastomosis for patients presenting with peritonitis due to perforated diverticulitis. Trial registration ClinicalTrial.gov: NCT04604730 date of registration October 27, 2020. https://clinicaltrials.gov/ct2/show/NCT04604730?recrs=a&cond=Diverticulitis&draw=2&rank=12 .

Domaines: Chirurgie

Jean Pinson, Jean-Jacques Tuech, Mehdi Ouaissi, Murielle Mathonnet, François Mauvais, et al.. Role of protective stoma after primary anastomosis for generalized peritonitis due to perforated diverticulitis—DIVERTI 2 (a prospective multicenter randomized trial): rationale and design (nct04604730). BMC Surgery, 2022, 22 (1), pp.191. ⟨10.1186/s12893-022-01589-w⟩. ⟨hal-03673254⟩