Foreign BodiesNCT04921826
Potential Causes of Retained Items During Surgery
An observational study of Foreign Bodies and Surgical Sponge, Retained, run by Imam Mohammad ibn Saud Islamic University at 1 site in Saudi Arabia.
Trial summary
to understand and analyze the potential causes of retained items (sponge and instruments) during surgery, which include room preparations, initial count, adding sponges, removing sponges, first closing count, final closing count. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Foreign Bodies, Surgical Sponge, Retained
- What is being tested?
- online survey
- How many people
- 400 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Jun 2021to 25 Sep 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: an online survey will be send through cluster administration to operating room staff ,to answer voluntarily without compensation. informed consent was obtained. This study was exempt from review board approval at authors' institutions.
Who may be able to join
- operating room staff of hail hospital cluster
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
to understand and analyze the potential causes of retained items (sponge and instruments) during surgery, which include room preparations, initial count, adding sponges, removing sponges, first closing count, final closing count.
- Conditions
- Foreign Bodies, Surgical Sponge, Retained
- Being tested
- online survey
- Medical subject headings
- Foreign Bodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online surveyOther
online survey
What is being measured
The primary outcome is the main question the study is designed to answer.
study potential causes of retained item during surgery
to understand participant opinion about the potential causes of retained item which include :room preparation with needed operating room equipment according to the specialty, initial count of sponges and instruments, adding sponges by event recording in a chart, removing sponges by event recording in a chart, first closing count in a chart , final closing count in a chart.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start10 Jun 2021
- Primary completion15 Jun 2022 (estimated)
- Study completion25 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foreign BodiesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Mohammad ibn Saud Islamic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammad bukhetan alharbi, Imam Mohammad ibn Saud Islamic University
- Investigators
- mohammad alharbi, Principal investigator, imam mohamamd ibn saud islamic university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921826
- Sponsor's protocol ID
- RETAINED ITEM DURING SURGERY
- Status last verified
- Aug 2021
- First submitted
- 1 Jun 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Causes of Retained Items During Surgery
- ClinicalTrials.gov ID
- NCT04921826
- Acronym / sponsor ID
- RETAINED ITEM DURING SURGERY
- Conditions
- Foreign Bodies, Surgical Sponge, Retained
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Imam Mohammad ibn Saud Islamic UniversityUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 25 Sep 2022 (estimated)
- First posted
- 10 Jun 2021 (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.
to understand and analyze the potential causes of retained items (sponge and instruments) during surgery, which include room preparations, initial count, adding sponges, removing sponges, first closing count, final closing count.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- an online survey will be send through cluster administration to operating room staff ,to answer voluntarily without compensation. informed consent was obtained. This study was exempt from review board approval at authors' institutions.
Key inclusion criteria (1 listed)
- operating room staff of hail hospital cluster
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| online surveyonline survey | Other | – |
Primary outcome
study potential causes of retained item during surgery
Time frame: 20 days
to understand participant opinion about the potential causes of retained item which include :room preparation with needed operating room equipment according to the specialty, initial count of sponges and instruments, adding sponges by event recording in a chart, removing sponges by event recording in a chart, first closing count in a chart , final closing count in a chart.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
mohammad alharbi principal investigator
imam mohamamd ibn saud islamic university
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 Foreign Bodies and Surgical Sponge, Retained, run by Imam Mohammad ibn Saud Islamic University at 1 site in Saudi Arabia.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Sep 2021. 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 Saudi Arabia. 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?
Results are not available in the source record.
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?
study potential causes of retained item during surgery (time frame: 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2021.