Surgical Outcome at HFSUH | NCT04772716

Studies
Surgical Outcome at HFSUH

NCT04772716

Sponsor

Haramaya Unversity

Status

Completed

Last Update Posted

Feb 26, 2021Actual

Enrollment

352Actual

Phase

Not provided

Conditions

Surgical Outcome

Interventions

operation

Countries

Ethiopia

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Jan 31, 2020Actual

Completion Date

Feb 28, 2020Actual

First Submitted Date

Feb 24, 2021

First Submission Date that Met QC Criteria

Feb 25, 2021

First Posted Date

Feb 26, 2021Actual

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

Feb 25, 2021

Last Update Posted Date

Feb 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 study was conducted on already intervened hospital patients with surgical management and their final outcome was followed from the chart of the patients.

Detailed Description

It was a prospective chart review of operated patient at Hiwot fana specialized hospital for different emergency as well elective surgeries. The study subjects signed informed written consent and their data collected anonymously. the follow up protocol was until discharge from hospital the longest date as 30 days.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

7 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

352Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
operation	Procedure	The intervention was not decided by the investigator but studied following emergency or elective surgeries undergoing in the system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
post operative complications	the outcome variable is adichotomous on with no complication and has complictions	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all operated patients at surgical ward

Exclusion Criteria:

patients operated at other facilities and transferred here. readmission within a month of discharge

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

all patient admitted surgical ward and underwent surgical intervention

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
HFSUH		Harar	Harari NS	251	Ethiopia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided