Department of Surgery, Alingsås Hospital, Södra Ringatan, Sweden.
Trials. 2011 Aug 1;12:186. doi: 10.1186/1745-6215-12-186.
Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results.
DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL) to the traditional Hartmann's Procedure (HP). Primary endpoint is the number of re-operations within 12 months. Secondary endpoints consist of mortality, quality of life (QoL), re-admission, health economy assessment and permanent stoma. Patients are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally, placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months. A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40).
HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life.
British registry (ISRCTN) for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287.
穿孔性憩室炎与大量发病率有关。最近发表的报告表明，腹腔镜灌洗具有更少的并发症和更短的住院时间。到目前为止，还没有随机研究发表任何结果。
DILALA 是一项斯堪的纳维亚的随机试验，比较了腹腔镜灌洗（LL）与传统的 Hartmann 手术（HP）。主要终点是 12 个月内再次手术的数量。次要终点包括死亡率、生活质量（QoL）、再入院、健康经济学评估和永久性造口。当需要手术时纳入患者。进行腹腔镜检查，如果诊断为 Hinchey Ⅲ级，则将患者纳入并按 1:1 随机分为 LL 或 HP 组。接受 LL 的患者接受 >3L 生理盐水腹腔内灌洗、盆腔引流管放置和持续使用抗生素。随访计划为 6-12 周、6 个月和 12 个月。出院时、6 个月和 12 个月填写 QoL 表。纳入 80 例患者（40+40）。
HP 与高并发症发生率相关。不仅主要手术会产生并发症，而且后续手术也与高发病率相关。因此，患者的综合治疗风险很高。DILALA 试验的目的是评估腹腔镜灌洗是否是 Hinchey Ⅲ级穿孔性憩室炎患者安全、微创的方法，从而减少再次手术、降低发病率、死亡率、成本和提高生活质量。
英国临床试验注册处（ISRCTN）ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287。
