Clinical trial NCT05888363: Management and Removal of Foreign Bodies in the Emergency Department
Official title: Complications in the Management and Removal of Rectal and Vaginal Foreign Bodies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Foreign Body
Rectal Perforation
Colonic Perforation
Lead sponsor: Arrowhead Regional Medical Center
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* All individuals under the age of 18

Primary outcomes:
measure: Surgical site infections within the first 30 days
timeFrame: 30 days
measure: Length of Hospital Stay
timeFrame: 360 days
measure: Hospital Mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
Study officials:
affiliation: Arrowhead Regional Medical Center
name: Michael M Neeki, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ooi BS, Ho YH, Eu KW, Nyam D, Leong A, Seow-Choen F. Management of anorectal foreign bodies: a cause of obscure anal pain. Aust N Z J Surg. 1998 Dec;68(12):852-5. doi: 10.1046/j.1440-1622.1998.01463.x.
citation: Sei H, Tomita T, Nakai K, Nakamura K, Tamura A, Ohda Y, Oshima T, Fukui H, Watari J, Miwa H. Rectal Foreign Body of Eggplant Treated Successfully by Endoscopic Transanal Removal. Case Rep Gastroenterol. 2018 Apr 26;12(1):189-193. doi: 10.1159/000488974. eCollection 2018 Jan-Apr.
citation: Traub SJ, Hoffman RS, Nelson LS. Body packing--the internal concealment of illicit drugs. N Engl J Med. 2003 Dec 25;349(26):2519-26. doi: 10.1056/NEJMra022719. No abstract available.
citation: Rodriguez-Hermosa JI, Codina-Cazador A, Ruiz B, Sirvent JM, Roig J, Farres R. Management of foreign bodies in the rectum. Colorectal Dis. 2007 Jul;9(6):543-8. doi: 10.1111/j.1463-1318.2006.01184.x.