NCT05142761

Brief Summary

The purpose of this study is to measure the changes in tension after each release in a standard posterior component separation during abdominal wall reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

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

November 17, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

December 2, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2022

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

November 17, 2021

Last Update Submit

March 28, 2023

Conditions

Ventral Incisional Hernia

Keywords

ventral hernia repairtension

Outcome Measures

Primary Outcomes (1)

  • Tension changes in posterior component separation

    The tension required to bring the anterior and posterior elements of the abdominal wall to the midline after each step of the posterior component separation will be measured with a scale designed by Cleveland Clinic Mechanical Prototype machinists. The scale, hooked to a clamp on the edge of the abdominal wall, will measure tension in pounds.

    Tension measurements will be recorded immediately during surgery

Secondary Outcomes (6)

  • Wound Morbidity

    30 days after surgery

  • Readmission

    30 days after surgery

  • Reoperation

    30 days after surgery

  • Ileus

    30 days after surgery

  • Pulmonary complications

    30 days after surgery

  • +1 more secondary outcomes

Study Arms (1)

Posterior component separation

Patients undergoing posterior component separation

Eligibility Criteria

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

All patients undergoing abdominal wall reconstruction with posterior component separation.

You may qualify if:

  • Candidates for abdominal wall reconstruction
  • Patients able to provide informed consent

You may not qualify if:

  • Patients unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Comprehensive Hernia Center

Cleveland, Ohio, 44195, United States

Location

Study Officials

  • Michael J Rosen, M.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 3, 2021

Study Start

December 2, 2021

Primary Completion

August 2, 2022

Study Completion

September 2, 2022

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)