Physiologic Tension of the Abdominal Wall | NCT05163184

Studies
Physiologic Tension of the Abdominal Wall

NCT05163184

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

Feb 1, 2023Actual

Enrollment

86Actual

Phase

Not provided

Conditions

Abdominal Wall Hernia

Interventions

Not provided

Countries

United States

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

Jan 2023

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 10, 2022Actual

Primary Completion Date

Sep 14, 2022Actual

Completion Date

Sep 14, 2022Actual

First Submitted Date

Dec 6, 2021

First Submission Date that Met QC Criteria

Dec 6, 2021

First Posted Date

Dec 20, 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

Jan 30, 2023

Last Update Posted Date

Feb 1, 2023Actual

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

Restoring the physiologic tension of the abdominal wall is a key concept in abdominal wall reconstruction. Yet little is known quantitatively about the normal tension of the abdominal wall. To better understand the ideal tension for abdominal wall reconstruction, the physiologic tension of the abdominal wall needs to be measured. This study aims to measure the tension of the abdominal wall during laparotomy closure.

Detailed Description

Not provided

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

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Label	Type	Description	Intervention Names
Laparotomy		Patients undergoing laparotomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abdominal wall tension at laparotomy	The tension necessary to bring the abdominal wall to the midline during laparotomy will be measured.	Tension measurements will be recorded immediately. No further data collection or patient follow-up will occur postoperatively.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing laparotomy
Patient able to provide informed consent

Exclusion Criteria:

Presence of a ventral hernia
Patients unable to provide informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients undergoing laparotomy without a ventral hernia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic Main Campus		Cleveland	Ohio	44195	United States

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

Condition Browse Module

MeSH Terms

ID	Term
D046449	Hernia, Abdominal

Ancestor Terms

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided