An observational study in Rectal Foreign Body, Rectal Perforation and Colonic Perforation, sponsored by Arrowhead Regional Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by Arrowhead Regional Medical Center · Observational
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.
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.
29 studies on the registry are indexed under Foreign Bodies; 8 are open to participants now.
This study's enrollment of 78 is below the median of 100 across 19 observational studies indexed under Foreign Bodies.
Browse Foreign Bodies studies →Arrowhead Regional Medical Center is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
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To evaluate the safety of foreign body removals in the emergency department and in the operating room in patients older than 18 years of age.
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Exclusion Criteria:
All patients where the removal of the rectal foreign body was successful in the emergency department
Other: No Intervention
All patients where the removal of the rectal foreign body was not successful in the emergency department and required removal in the operating room
Other: No Intervention
Difference in outcomes in patients with rectal foreign bodies removed in the emergency department or in the operating room.
Surgical site infections within the first 30 days
Infection along surgical incision
Time frame: 30 days
Length of Hospital Stay
Length of total hospital stay from admission in the hospital
Time frame: 360 days
Hospital Mortality
Survival within the first 30 days
Time frame: 30 days
Plan to share: No
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Arrowhead Regional Medical Center