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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05163184
Other study ID # 21-1036
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2022
Est. completion date September 14, 2022

Study information

Verified date January 2023
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date September 14, 2022
Est. primary completion date September 14, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing laparotomy - Patient able to provide informed consent Exclusion Criteria: - Presence of a ventral hernia - Patients unable to provide informed consent

Study Design


Locations

Country Name City State
United States Cleveland Clinic Main Campus Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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