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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-16

Study Completion Date

2025-09-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Ventral Hernia Incisional Hernia Parastomal Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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."

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Tensiometry IAP

Eligibility Criteria

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Inclusion Criteria

* 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