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The Impact of Abdominal Wall Reconstruction on Abdominal Wall Tension and Intra-Abdominal Pressure

NCT06575166 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2025-09-19

No results posted yet for this study

Summary

This is a prospective cohort study. Patients have an incisional or parastomal hernia with \>20 cm fascial defect on pre-operative imaging who will undergo an anticipated open bilateral transversus abdominis release with retromuscular synthetic mesh will have their abdominal wall tension measured using a tension scale and their intra-abdominal pressure measured using a urinary catheter containing pressure sensors. The investigators aim to quantify the changes, as well as explore and describe the physiologic shifts that may be associated with these changes.

Conditions

  • Ventral Hernia
  • Incisional Hernia
  • Parastomal Hernia

Interventions

DEVICE

Abdominal wall tension

Abdominal wall tension measurement All patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer."

DEVICE

Intra-abdominal pressure

Intra-abdominal pressure All patients will have their intra-abdominal pressure continuously monitored using Sentinel's FDA approved TraumaGuard catheter, a pressure-sensing urinary catheter.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Benjamin T Miller, MD · The Cleveland Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-16
Primary Completion
2025-09-12
Completion
2025-09-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06575166 on ClinicalTrials.gov