Rectal Foreign BodyNCT05888363
Management and Removal of Foreign Bodies in the Emergency Department
An observational study of Rectal Foreign Body and Rectal Perforation, run by Arrowhead Regional Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Rectal Foreign Body, Rectal Perforation, Colonic Perforation
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2020to 8 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Rectal foreign body removal
- Colonic foreign body removal
- Vaginal foreign body removal
- Foreign body removals performed in the emergency department
Who cannot join
- All individuals under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Arrowhead Regional Medical Center
Colton, California, 92324
About this study
Official title: Complications in the Management and Removal of Rectal and Vaginal Foreign Bodies
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.
Read the 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.
- Conditions
- Rectal Foreign Body, Rectal Perforation, Colonic Perforation
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Difference in outcomes in patients with rectal foreign bodies removed in the emergency department or in the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Rectal foreign body removed in emergency department | All patients where the removal of the rectal foreign body was successful in the emergency department Receives: 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 Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infections within the first 30 days
Infection along surgical incision
Measured: 30 days
Length of Hospital Stay
Length of total hospital stay from admission in the hospital
Measured: 360 days
Hospital Mortality
Survival within the first 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start8 Dec 2020
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rectal Foreign BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael M Neeki, DO, Principal investigator, Arrowhead Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888363
- Sponsor's protocol ID
- 20-46a
- Status last verified
- Dec 2021
- First submitted
- 24 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9885867Sei 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.
PubMed 29805365Traub 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.
PubMed 14695412Rodriguez-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.
PubMed 17573750
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications in the Management and Removal of Rectal and Vaginal Foreign Bodies
- ClinicalTrials.gov ID
- NCT05888363
- Acronym / sponsor ID
- 20-46a
- Conditions
- Rectal Foreign Body, Rectal Perforation, Colonic Perforation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Arrowhead Regional Medical CenterUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal foreign body removed in emergency department | – | Other: No InterventionAll patients where the removal of the rectal foreign body was successful in the emergency department |
| Rectal foreign body removed in operating room | – | Other: No InterventionAll patients where the removal of the rectal foreign body was not successful in the emergency department and required removal in the operating room |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Rectal foreign body removal
- Colonic foreign body removal
- Vaginal foreign body removal
- Foreign body removals performed in the emergency department
Key exclusion criteria (1 listed)
- All individuals under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionDifference in outcomes in patients with rectal foreign bodies removed in the emergency department or in the operating room. | Other | Rectal foreign body removed in emergency department, Rectal foreign body removed in operating room |
Primary outcome
Surgical site infections within the first 30 days
Time frame: 30 days
Infection along surgical incision
Length of Hospital Stay
Time frame: 360 days
Length of total hospital stay from admission in the hospital
Hospital Mortality
Time frame: 30 days
Survival within the first 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Background: PubMed 9885867Ooi 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.
- Background: PubMed 29805365Sei 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.
- Background: PubMed 14695412Traub 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.
- Background: PubMed 17573750Rodriguez-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael M Neeki, DO principal investigator
Arrowhead Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Foreign Body and Rectal Perforation, run by Arrowhead Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infections within the first 30 days (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05888363, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.