Management and Removal of Foreign Bodies in the Emergency Department

NCT05888363 | Completed

• 1 other identifier: 20-46a
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Foreign Body; Rectal Perforation; Colonic Perforation

Outcome Measures

Primary Outcomes (3)

• Surgical site infections within the first 30 days

  Infection along surgical incision

  30 days

• Length of Hospital Stay

  Length of total hospital stay from admission in the hospital

  360 days

• Hospital Mortality

  Survival within the first 30 days

  30 days

Study Arms (2)

Rectal foreign body removed in emergency department

All patients where the removal of the rectal foreign body was successful in the emergency department

Other: No Intervention

Rectal foreign body removed in operating room

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

Interventions

No Intervention OTHER

Difference in outcomes in patients with rectal foreign bodies removed in the emergency department or in the operating room.

Rectal foreign body removed in emergency department; Rectal foreign body removed in operating room

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• All individuals under the age of 18

Sponsors & Collaborators

• Arrowhead Regional Medical Center: lead

Study Sites (1)

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

Related Publications (4)

• 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.

  PMID: 9885867 BACKGROUND

• 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.

  PMID: 29805365 BACKGROUND

• 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.

  PMID: 14695412 BACKGROUND

• 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.

  PMID: 17573750 BACKGROUND

Study Officials

• Michael M Neeki, DO

  Arrowhead Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: December 8, 2020
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: June 5, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)