Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation
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ClinicalTrials.gov Identifier: NCT06051578 |
Recruitment Status :
Recruiting
First Posted : September 25, 2023
Last Update Posted : February 28, 2024
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The purpose of this study is to use a scale to learn more about the tension of the abdominal wall in hernia repairs without component separation.
- What is the abdominal wall tension for hernias repaired without a component separation?
- What patient factors contribute to greater abdominal wall tension?
- Is there an association between abdominal wall tension before primary closure or bridging repair and patient outcomes?
Participants will be asked to allow their surgeon to use a tension scale to measure the tension of the abdominal wall during surgery.
Condition or disease | Intervention/treatment |
---|---|
Hernia, Ventral Hernia, Abdominal Hernia Abdominal Wall | Other: Abdominal wall tension measurement |
Study Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation |
Actual Study Start Date : | September 8, 2023 |
Estimated Primary Completion Date : | September 8, 2025 |
Estimated Study Completion Date : | September 8, 2025 |
- Other: Abdominal wall tension measurement
All patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer."
- Abdominal wall tension in patients hernia repair without component separation [ Time Frame: 2 year ]The abdominal wall tension prior to closure will be measured
- Patient factors that contribute to greater abdominal wall tension [ Time Frame: 2 year ]Patient demographics, comorbidities, operative history, operative details, hernia size and width and abdominal wall tension will be collected and analyzed to determine what factors contribute to abdominal wall tension.
- Association between abdominal wall tension and patient outcomes [ Time Frame: 2 year ]Abdominal wall tension will be determined and patient outcomes will be analyzed including complications, wound morbidity, recurrence
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients who are planned to undergo ventral hernia repair without component separation
- Midline hernia
Exclusion Criteria:
- Mesh excision for reasons other than mesh infection
- Prior component separation
- Isolated flank hernia
- Patients under the age of 18 years
- Pregnant patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051578
Contact: Benjamin Miller, MD | 2164068573 | millerb35@ccf.org | |
Contact: Daphne Remulla, MD | 2163997047 | remulld@ccf.org |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Benjamin Miller, MD 216-406-8573 millerb35@ccf.org |
Principal Investigator: | Benjamin Miller, MD | The Cleveland Clinic |
Responsible Party: | Benjamin T. Miller, Principal Investigator, The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT06051578 |
Other Study ID Numbers: |
23-857 |
First Posted: | September 25, 2023 Key Record Dates |
Last Update Posted: | February 28, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hernia Hernia, Ventral Hernia, Abdominal Internal Hernia Pathological Conditions, Anatomical |