NCT05227911

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

January 22, 2022

Last Update Submit

January 22, 2022

Conditions

Keywords

Surgery, General surgery, Incidental findings

Outcome Measures

Primary Outcomes (2)

  • The Incidence of IFs detection

    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

    The identification of the specific IFs encountered in abdominal surgery patients

    Detection during the time of the procedure itself

Secondary Outcomes (3)

  • The incidence of misdiagnosis events

    Detection during the time of the procedure itself

  • The association between procedure type in IF detection

    Detection during the time of the procedure itself

  • The association between gender in IF detection

    Detection during the time of the procedure itself

Study Arms (1)

Abdominal Surgery Group

Participant undergoing abdominal surgery for any indication

Procedure: Abdominal Surgery

Interventions

Abdominal surgery (laparotomy or laparoscopy) ,which includes proper inspection of the abdominal cavity.

Abdominal Surgery Group

Eligibility Criteria

Age13 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • patients older than 13 y/o
  • patients undergoing laparoscopy or laparotomy that must include a proper inspection of the abdominal cavity

You may not qualify if:

  • patients aged 13 y/o or less
  • patients with incomplete data
  • gynecological procedures even if it involves laparotomy or laparoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aleppo University Hospital

Aleppo, Aleppo Provice, 22743, Syria

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiology Resident

Study Record Dates

First Submitted

January 22, 2022

First Posted

February 8, 2022

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 8, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Descriptive information about all sample will be provided with the specific characteristics of patients with encountered IFs

Locations