NCT05163184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2022

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

December 6, 2021

Last Update Submit

January 30, 2023

Conditions

Abdominal Wall Hernia

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Laparotomy

Patients undergoing laparotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing laparotomy without a ventral hernia.

You may qualify if:

  • Patients undergoing laparotomy
  • Patient able to provide informed consent

You may not qualify if:

  • Presence of a ventral hernia
  • Patients unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

December 6, 2021

First Posted

December 20, 2021

Study Start

January 10, 2022

Primary Completion

September 14, 2022

Study Completion

September 14, 2022

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)