Different Clinicopathological Features of Non-Elderly Sig... | NCT04360525

Studies
Different Clinicopathological Features of Non-Elderly Sigmoid Volvulus Patients

NCT04360525

Sponsor

Dr. Ersin Arslan Education and Training Hospital

Status

Completed

Last Update Posted

Apr 24, 2020Actual

Enrollment

134Actual

Phase

Not provided

Conditions

Pathology

Interventions

Reasons

Countries

Turkey (Türkiye)

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

Apr 2020

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

Jan 1, 2020Actual

Primary Completion Date

Apr 1, 2020Actual

Completion Date

Apr 18, 2020Actual

First Submitted Date

Apr 18, 2020

First Submission Date that Met QC Criteria

Apr 21, 2020

First Posted Date

Apr 24, 2020Actual

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 21, 2020

Last Update Posted Date

Apr 24, 2020Actual

Name	Class
Inonu University	OTHER

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

Sigmoid volvulus is frequently seen in male patients over 60 years old. In the sigmoid volvulus <60 age groups, the male/female ratio is close to each other. If sigmoid volvulus develops in <60 age groups, it is more likely to be another underlying organic pathology.

Detailed Description

Sigmoid volvulus is frequently seen in male patients over 60 years old. Here, the investigators aimed to investigate the causes of sigmoid volvulus developing in patients under 60 years of age. Patients diagnosed with sigmoid volvulus between 2009 and 2018 were retrospectively screened. The patients were divided into two as under 60 years old and above. The co-morbidity, mortality, morbidity, complications, age and gender data of the patients were analyzed. In the sigmoid volvulus <60 age groups, the male/female ratio is close to each other. If sigmoid volvulus develops in <60 age groups, it is more likely to be another underlying organic pathology.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elderly patients		Elderly patients (60≤ age) with sigmoid volvulus	Other: Reasons
Young patients		Young patients (<60 age) with sigmoid volvulus	Other: Reasons

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reasons	Other	Causes of sigmoid volvulus	Elderly patients Young patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Elderly and young patients mortality	up to three months
Morbidity	Elderly and young patients morbidity	up to three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sigmoid volvulus patients under the age of 60
Sigmoid volvulus patients at the age of ≥60

Exclusion Criteria:

Lack of data

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

Patients who were treated for the sigmoid volvulus between 2009 and 2018 at Inonu University General Surgery Clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ufuk uylas, Specialist	Dr. Ersin Arslan Training and Resource Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Ersin Arslan Training and Resource Hospital		Gaziantep			Turkey (Türkiye)

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

Condition Browse Module

MeSH Terms

ID	Term
D045822	Intestinal Volvulus
D008607	Intellectual Disability
D006627	Hirschsprung Disease

Ancestor Terms

ID	Term
D007415	Intestinal Obstruction
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided