背景:传统上,穿孔憩室炎引起的HincheyIII和IV型腹膜炎患者接受Hartmann手术治疗。在过去的十年里,与Hartmann的手术相比,切除和原发性吻合术越来越受欢迎,最近的指南推荐Hartmann的手术仅适用于两种情况:危重病患者和有多种合并症(并发症高危)的部分患者.保护性造口(PS)是建议切除后的主要吻合,然而,它的兴趣从未被研究过。该试验的目的是确定系统性PS在切除和原发性吻合后对穿孔憩室炎引起的腹膜炎HincheyIII和IV的作用。
方法:这项DIVERTI2试验是一项多中心试验,随机化,控制,在穿孔憩室炎HincheyIII和IV型腹膜炎患者中,比较切除和初次吻合(对照组)或不使用PS(实验组)的优越性试验。主要终点是根据Clavien-Dindo手术并发症分类的1年总发病率。将收集住院期间发生的所有并发症。住院后发生的晚期并发症将在随访期间收集。为了在保护性造口和无保护性造口组中分别获得67%和47%的主要概率给出的差异的80%功率,具有5%的双面I型误差,每组必须包括96名患者,因此总共192名患者。预计主要终点不可评估的患者比例为5%(未随访),将招募204名患者。次要终点是术后死亡率,计划外的再干预,手术切口感染(SSI),器官/空间SSI,伤口破裂,吻合口漏,操作时间,住院时间,初次手术后1年的造口,生活质量,成本和质量调整寿命年(QALYs)。
结论:DIVERTI2试验是一项前瞻性试验,多中心,随机化,本研究旨在确定穿孔憩室炎引起的腹膜炎患者在切除和一期吻合中PS和无PS之间的最佳策略。
背景:ClinicalTrial.gov:NCT04604730注册日期2020年10月27日。https://clinicaltrials.gov/ct2/show/NCT04604730?recrs=a&cond=憩室炎&draw=2&rank=12.
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: 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).
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrial.gov: NCT04604730 date of registration October 27, 2020. https://clinicaltrials.gov/ct2/show/NCT04604730?recrs=a&cond=Diverticulitis&draw=2&rank=12 .