Role of Laparoscopy in Penetrating Anterior Abdominal Wal... | NCT05826262

Studies
Role of Laparoscopy in Penetrating Anterior Abdominal Wall Injuries

NCT05826262

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Apr 24, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Evaluate Laparoscopic Management in Patients With Penetrating Anterior Abdominal Wall Trauma

Interventions

diagnostic laparoscopy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2023Actual

Primary Completion Date

Mar 10, 2024Estimated

Completion Date

Mar 10, 2024Estimated

First Submitted Date

Mar 20, 2023

First Submission Date that Met QC Criteria

Apr 20, 2023

First Posted Date

Apr 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2023

Last Update Posted Date

Apr 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Omar Ragheb, resident at general surgery department, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The current study is aiming to evaluate the diagnostic and therapeutic role of laparoscopy in patients with penetrating anterior abdominal wall trauma as regard the accuracy of diagnosis and efficacy in management and avoidance of unnecessary laparotomy

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with penetrating anterior abdominal wall injuries	Experimental		Procedure: diagnostic laparoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
diagnostic laparoscopy	Procedure	diagnosis and management of patients with penetrating anterior abdominal wall injuries	patients with penetrating anterior abdominal wall injuries

Measure	Description	Time Frame
Morbidity		1 month

Measure	Description	Time Frame
Mortality		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with penetrating anterior abdominal wall injuries Age will be between 5 - 65 years old

Exclusion Criteria:

Vitally unstable patients Patients with associated injuries

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed omar Ragheb, master	Contact	01066663969		ahmedoragheb@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University	Recruiting	Sohag			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jan 8, 2024
Reset	Jun 28, 2024

Submission Tracking

Estimated Results First Submitted Date

Jan 8, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 8, 2024			Jun 28, 2024

Intervention Browse Module

MeSH Terms

ID	Term
D010535	Laparoscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided