- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05227911
Incidental Findings in Abdominal Surgery
January 22, 2022 updated by: Baraa Shebli, University of Aleppo
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
543
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Aleppo Provice
-
Aleppo, Aleppo Provice, Syrian Arab Republic, 22743
- Aleppo University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- patients older than 13 y/o
- patients undergoing laparoscopy or laparotomy that must include a proper inspection of the abdominal cavity
Exclusion Criteria:
- patients aged 13 y/o or less
- patients with incomplete data
- gynecological procedures even if it involves laparotomy or laparoscopy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Abdominal Surgery Group
Participant undergoing abdominal surgery for any indication
|
Abdominal surgery (laparotomy or laparoscopy) ,which includes proper inspection of the abdominal cavity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Detection during the time of the procedure itself
|
|
IFs identification
Time Frame: Detection during the time of the procedure itself
|
The identification of the specific IFs encountered in abdominal surgery patients
|
Detection during the time of the procedure itself
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence of misdiagnosis events
Time Frame: Detection during the time of the procedure itself
|
Examine the incidence of misdiagnosis events in abdominal surgeries
|
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
|
Examine the association between the type of surgery (laparoscopy or laparotomy) and the detection of IFs.
|
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
|
Examine the association between the gender of the patient and the detection of IFs.
|
Detection during the time of the procedure itself
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
January 22, 2022
First Submitted That Met QC Criteria
January 22, 2022
First Posted (Actual)
February 8, 2022
Study Record Updates
Last Update Posted (Actual)
February 8, 2022
Last Update Submitted That Met QC Criteria
January 22, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 14761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Descriptive information about all sample will be provided with the specific characteristics of patients with encountered IFs
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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