Length of Small Bowel. How Can Standardise Measurement an... | NCT02560064

Studies
Length of Small Bowel. How Can Standardise Measurement and Why?

NCT02560064

Sponsor

Inonu University

Status

Unknown status

Last Update Posted

Oct 5, 2015Estimated

Enrollment

45Estimated

Phase

Not provided

Conditions

Small/Large Bowel

Interventions

Laparotomy

Countries

Not provided

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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Jan 2016Estimated

Completion Date

Feb 2016Estimated

First Submitted Date

Sep 16, 2015

First Submission Date that Met QC Criteria

Sep 23, 2015

First Posted Date

Sep 25, 2015Estimated

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

Oct 2, 2015

Last Update Posted Date

Oct 5, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Measurement of the small bowel length studied by anatomists, surgeons and radiologists. Results were highly different among these series. Technical and mechanical factors have major effects on measures. Investigators decided to reach a standardization for the measurement of small bowel length.

Detailed Description

Small bowel length will be measure in patients undergoing intraabdominal surgery. This will be establish by two surgeon from Treitz ligament to ileocecal valve two, consecutively. For measurement, a tape will place to antimesenteric, mesenteric border and the midline between these two sides.

Exclusion criteria include patients with inflammatory bowel disease, peritonitis, prior abdominal surgery.

Demographic data, patients clinical details and small bowel length will be recorded.

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

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laparotomy and small bowel length		measurement of small bowel length in laparotomies	Procedure: Laparotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparotomy	Procedure	Small bowel length will measure in laparotomy, regardless of indication.	laparotomy and small bowel length

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of Small Bowel. How Can Standardise Measurement and Why?		postop 1 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Candidate for abdominal surgery

Exclusion Criteria:

Inflammatory bowel disease
History of intraabdominal surgery
peritonitis

Accepts Healthy Volunteers

Yes

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

Power analyse was done. Study include at least 44 patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Servet Karagul	Contact	905334779255		servetkaragul@hotmail.com

Overall Officials

Name	Affiliation	Role
Cuneyt Kayaalp	Inonu University, Faculty of Medicine	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007813	Laparotomy

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided