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临床试验/NCT05888363
NCT05888363已完成不适用

Complications in the Management and Removal of Rectal and Vaginal Foreign Bodies

Arrowhead Regional Medical Center1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2020年12月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Hospital Mortality

研究概览

简要总结

Management of rectal foreign bodies presents unique challenges in the emergency department. Rectal foreign bodies may consist of various compositional materials and ergonomics which include but are not limited to vegetables, light bulbs, everyday household items, and body packing of illicit drugs. Patients presenting to the emergency department with rectal foreign bodies range widely in age from prepubertal patients to older adults. Insertion of rectal foreign bodies have been classified as voluntary or involuntary, as well as sexual or non-sexual. The definition of rectal foreign bodies can be blurry, as many objects inserted via the rectum are large enough to enter the sigmoid colon. Although detailed epidemiologic data are scant, recent studies reported a progressive rise in complications related to rectal foreign bodies with incidence disproportionately higher in men and an average age in the mid 40s.

详细描述

rectal foreign bodies have been reported to result in a varying range of complications. According to the Rectal Organ Injury Scale (ROIS) proposed by the American Association for the Surgery of Trauma, injuries caused by rectal foreign bodies range from Grade I to Grade V. Grade I injury is defined as hematoma without devascularization. Grade II injury includes partial thickness laceration less than 50% of circumference while Grade III injury demonstrates partial thickness laceration greater than 50% of circumference. Grade IV injury is noted as a full-thickness laceration extending into the perineum. Grade V injury demonstrates devascularized segment. Colonic organ injury scale grading is very similar to the ROIS with differences consisting of transection of the colon in grade IV and transection of the colon with devascularized segment and tissue loss in grade V. Prior studies suggest that most injuries resulting from inserted objects are classified as Grade I injuries.

Investigators from two separate studies suggested a nearly 10% complication rate in cases of attempted transanal bedside removals in the ED. The most commonly reported complications of bedside procedures were perforation of the rectum, followed by the rectal mucosal injury. One particular study noted that 17% of patients sustained perforation of colon. The underlying cause for such high rates of complications may be multifactorial, including the status of the patients, the presence of comorbidities, and delays in presentation to the hospital. To reduce the rate of complication various extraction methods such as the use of sigmoidoscopy. With the increased incidence of rectal foreign bodies and the associated complications, it is imperative to explore and determine a set of standards for the safe and effective removal of rectal foreign bodies. However, current literature is not clear as to the ideal setting. This study aims to further explore various methods of extraction, outcomes and complications associated with bedside attempts at removal of rectal foreign bodies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Rectal foreign body removal
  • Colonic foreign body removal
  • Vaginal foreign body removal
  • Foreign body removals performed in the emergency department

排除标准

  • All individuals under the age of 18

结局指标

主要结局

Hospital Mortality

时间窗: 30 days

Survival within the first 30 days

Surgical site infections within the first 30 days

时间窗: 30 days

Infection along surgical incision

Length of Hospital Stay

时间窗: 360 days

Length of total hospital stay from admission in the hospital

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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