SnapSBO - An International Non-randomized Time-bound Prospective Observational Cohort Study Addressing the Epidemiology and Management of Small Bowel Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of Small Bowel Obstruction, by etiology
研究概览
简要总结
Small bowel obstruction (SBO) and its complications are frequently seen in patients admitted through the Emergency Departments of all acute care hospitals2.
There is variation in the optimal use of imaging, the appropriate timing and duration of non-operative management attempts, anti-microbial therapies, and the criteria for surgical management, which results in heterogeneity in approaches and outcomes across international clinical centers. The expected number of SBO cases in most clinical centers is predictable, enabling a suitably-sized cohort of patients to be gathered in the snapshot audit.
This 'ESTES snapshot audit' -a prospective observational cohort study- has a dual purpose. Firstly, as an epidemiological study, it aims to uncover the burden of disease. Secondly, it aims to demonstrate current strategies employed to diagnose and treat these patients. These twin aims will serve to provide a 'snapshot' of current practice, but will also be hypothesis-generating while providing a rich source of patient-level data to allow further analysis of the particular clinical questions.
详细描述
Prospective audit of consecutive patients admitted in Emergency Department for mechanical small bowel obstruction over a 3-month period. The audit shall include unscheduled patient admissions from November 2023 until May 2024 as outlined in 'Key Study Dates'.
As this is an observational cohort audit, no change to normal patient management is required.
Primary Objective
To explore differences in patients, management and outcomes across the entire cohort to identify areas of practice variability resulting in apparent differences in outcome warranting further study. The outcomes that the study will examine are:
- Incidence of small bowel obstruction by etiology.
- Differences in clinical presentation.
- Diagnostic work-up.
- Non-operative management strategies.
- Time to surgery and outcomes.
- Complications related to disease and/or therapies within 60 post-operative days.
- Length of Emergency Department and Hospital stay.
- Re-admission within 6 months for related conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥16 years of age) admitted for mechanical small bowel obstruction. Example etiologies which should be included:
- •Hernias with bowel compromise (incisional/parastomal, ventral, inguinal, femoral, obturator, internal).
- •Malignancy (primary: lymphoma, carcinoid, GIST, adenocarcinoma/metastatic disease: colon, ovarian, gastric, pancreatic, melanoma and others).
- •Enteroliths/gallstones/bezoars/foreign bodies
- •Inflammation (Crohn's disease, mesenteric adenitis, appendicitis, diverticulitis, tuberculosis, actinomycosis, ascariasis).
- •Congenital (malrotation, duplication cysts).
- •Trauma (hematomas, ischemic strictures).
排除标准
- •Functional small bowel obstruction (dysmotility or adynamic ileus secondary to abdominal operations, peritonitis, trauma or medications).
结局指标
主要结局
Incidence of Small Bowel Obstruction, by etiology
时间窗: 6 months
This study aims to quantify (as an integer, n) the etiologies of small bowel obstruction (adhesions, hernias, malignancy and other causes)
Time to Surgical Treatment of Small Bowel Obstruction vs Outcomes
时间窗: 6 months
Time (hours) from hospital admission to Surgical Treatment of Small Bowel Obstruction vs Outcomes
次要结局
- Adherence to evidence-based guidelines vs outcomes(6 months from hospital admission)
- Complications related to operative or non-operative management of small bowel obstruction(6 months from hospital admission)
- Patient-related Outcome Metrics for Surgical vs Non-operative management(At first post-discharge clinic visit, anticipated within 6 months of admission)
研究者
Isidro Martinez Casas, MD PhD
Chair, SnapSBO Steering Group
European Society for Trauma and Emergency Surgery