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

NCT06575166 | Terminated

• 1 other identifier: 24-655
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Correlation between intra-abdominal pressure (mmHg) and rate of post-operative complications

  Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Post-operative complications measured in proportion of events

  1 year

Secondary Outcomes (4)

• Correlation between intra-abdominal pressure (mmHg) to abdominal wall tension (lbs)

  1 year

• Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to hernia defect size (cm)

  1 year

• Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to airway pressure (cmH2O)

  1 year

• Temporal changes in renal function (serum Creatinine)

  1 year

Interventions

Abdominal wall tension DEVICE

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

Also known as: Tensiometry

Intra-abdominal pressure DEVICE

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.

Also known as: IAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with an incisional or parastomal hernia with a \>20 cm fascial defect on pre-operative imaging who undergo an anticipated open bilateral transversus abdominis release with retro-muscular synthetic mesh placement will be included. The investigators anticipate that patients with very large defects will experience the greatest changes in abdominal wall tension and intra-abdominal pressure.

You may qualify if:

• Patients ≥ 18 years of age
• Incisional or parastomal hernia with \>20 cm fascial defect on pre-operative imaging
• Anticipated open bilateral transversus abdominis release with retro-muscular synthetic mesh placement

You may not qualify if:

• Pregnant patients
• Require a Legally Authorized Representative (LAR) to sign the informed consent form

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hernia, Ventral; Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Benjamin T Miller, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 28, 2024
• Study Start: August 16, 2024
• Primary Completion: September 12, 2025
• Study Completion: September 12, 2025
• Last Updated: September 19, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)