General SurgeryNCT05227911
Incidental Findings in Abdominal Surgery
An observational study of General Surgery, run by University of Aleppo at 1 site in Syria.
Trial summary
Despite the recent advancement in diagnostic modalities, many surgeons experience till this day unexpected findings during the course of surgery. Very few information is available in the medical literature in order to assist the surgeon with the anticipation and preparation to deal with Incidental Findings (IFs). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- General Surgery
- What is being tested?
- Abdominal Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 543 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jan 2018to 31 Dec 2019
- How long will I take part?
- 1 Day
- 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 13 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients undergoing abdominal surgery whether performed by laparotomy or laparoscopy for any indication, however, the procedure must include proper inspection of the abdominal cavity
Who may be able to join
- patients older than 13 y/o
- patients undergoing laparoscopy or laparotomy that must include a proper inspection of the abdominal cavity
Who cannot join
- patients aged 13 y/o or less
- patients with incomplete data
- gynecological procedures even if it involves laparotomy or laparoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence of Incidental Findings in All Abdominal Surgeries
Despite the recent advancement in diagnostic modalities, many surgeons experience till this day unexpected findings during the course of surgery. Very few information is available in the medical literature in order to assist the surgeon with the anticipation and preparation to deal with Incidental Findings (IFs). Such valuable information can be of great benefit to the surgeon, as the surgical team can prepare himself better -technically and scientifically- to deal with the common expected IFs. The authors aim to examine the incidence of all IFs in abdominal surgery -laparoscopy or laparotomy- and identify possible associations through a cross-sectional designed study conducted in Aleppo University Hospital - Department of Surgery. The authors collected patients' data who underwent abdominal surgery during the period of the two-consecutive years 2018-2019.
- Conditions
- General Surgery
- Being tested
- Abdominal Surgery
- Keywords
- Surgery, General surgery, Incidental findings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal SurgeryProcedure or surgery
Abdominal surgery (laparotomy or laparoscopy) ,which includes proper inspection of the abdominal cavity.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Surgery Group | Participant undergoing abdominal surgery for any indication Receives: Procedure: Abdominal Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of IFs detection
Examine the incidence of the detection of Incidental and unexpected findings in abdominal surgery patients.
Measured: Detection during the time of the procedure itself
IFs identification
The identification of the specific IFs encountered in abdominal surgery patients
Measured: Detection during the time of the procedure itself
Secondary outcomes (3)
The incidence of misdiagnosis events
Examine the incidence of misdiagnosis events in abdominal surgeries
Measured: Detection during the time of the procedure itself
The association between procedure type in IF detection
Examine the association between the type of surgery (laparoscopy or laparotomy) and the detection of IFs.
Measured: Detection during the time of the procedure itself
The association between gender in IF detection
Examine the association between the gender of the patient and the detection of IFs.
Measured: Detection during the time of the procedure itself
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General SurgeryStudies 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
- Cross-sectional
- Enrolment
- 543 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Aleppo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baraa Shebli, University of Aleppo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227911
- Sponsor's protocol ID
- 14761
- Status last verified
- Jan 2022
- First submitted
- 22 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Descriptive information about all sample will be provided with the specific characteristics of patients with encountered IFs
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Incidental Findings in All Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT05227911
- Acronym / sponsor ID
- 14761
- Conditions
- General Surgery
- Keywords
- Surgery, General surgery, Incidental findings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- University of AleppoUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Feb 2022 (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.
Despite the recent advancement in diagnostic modalities, many surgeons experience till this day unexpected findings during the course of surgery. Very few information is available in the medical literature in order to assist the surgeon with the anticipation and preparation to deal with Incidental Findings (IFs). Such valuable information can be of great benefit to the surgeon, as the surgical team can prepare himself better -technically and scientifically- to deal with the common expected IFs. The authors aim to examine the incidence of all IFs in abdominal surgery -laparoscopy or laparotomy- and identify possible associations through a cross-sectional designed study conducted in Aleppo University Hospital - Department of Surgery. The authors collected patients' data who underwent abdominal surgery during the period of the two-consecutive years 2018-2019.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal Surgery Group | – | Procedure: Abdominal SurgeryParticipant undergoing abdominal surgery for any indication |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing abdominal surgery whether performed by laparotomy or laparoscopy for any indication, however, the procedure must include proper inspection of the abdominal cavity
Key inclusion criteria (2 listed)
- patients older than 13 y/o
- patients undergoing laparoscopy or laparotomy that must include a proper inspection of the abdominal cavity
Key exclusion criteria (3 listed)
- patients aged 13 y/o or less
- patients with incomplete data
- gynecological procedures even if it involves laparotomy or laparoscopy.
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 |
|---|---|---|
| Abdominal SurgeryAbdominal surgery (laparotomy or laparoscopy) ,which includes proper inspection of the abdominal cavity. | Procedure or surgery | Abdominal Surgery Group |
Primary outcome
The Incidence of IFs detection
Time frame: Detection during the time of the procedure itself
Examine the incidence of the detection of Incidental and unexpected findings in abdominal surgery patients.
IFs identification
Time frame: Detection during the time of the procedure itself
The identification of the specific IFs encountered in abdominal surgery patients
3 secondary outcomes
The incidence of misdiagnosis events
Time frame: Detection during the time of the procedure itself
The association between procedure type in IF detection
Time frame: Detection during the time of the procedure itself
The association between gender in IF detection
Time frame: Detection during the time of the procedure itself
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 8 Feb 2022.
- Individual participant dataSharing planned: No. Descriptive information about all sample will be provided with the specific characteristics of patients with encountered IFs
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 General Surgery, run by University of Aleppo at 1 site in Syria.
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 2 inclusion and 3 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 8 Feb 2022. 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 Syria. 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?
The Incidence of IFs detection (time frame: Detection during the time of the procedure itself). The study lists 2 primary outcomes in all. 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 8 Feb 2022.