Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05888363
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2023-05-24
Brief Title:
Management and Removal of Foreign Bodies in the Emergency Department
Sponsor:
Arrowhead Regional Medical Center
Organization:
Arrowhead Regional Medical Center
Study Overview
Official Title:
Complications in the Management and Removal of Rectal and Vaginal Foreign Bodies
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None