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NCT01355939 · ClinicalTrials.gov registry record

Comparative Effectiveness Multicenter Trial for Adhesion Characteristics of Ventral Hernia Repair Mesh

A clinical trial, sponsored by Washington University School of Medicine.

Completed
Registry status
173
Enrollment target

NCT01355939 is a clinical trial that has completed, run by Washington University School of Medicine. The registered enrollment target is 173 participants.

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The verdict

NCT01355939 has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
173 participants
Enrollment target

Study Summary

The proposed study will compare the benefits, harms, and comparative effectiveness of intraperitoneal barrier-coated and non-barrier coated ventral hernia repair (VHR) mesh in reducing adhesions, adhesion-related complications, and adhesiolysis sequelae in actual patient subpopulations and clinical circumstances. A subset of the data will be analyzed to compare the benefits, harms, and comparative effectiveness of the laparoscopic and open approaches to adhesiolysis. A comprehensive array of health-related risk factors and patient-centered outcomes will be assessed in the investigators diverse patient population for proper multivariate data analysis. Specific Aim I: To evaluate and compare the adhesion characteristics of intraperitoneal barrier-coated versus non-barrier-coated mesh during abdominal re-exploration after prior ventral hernia repair. Specific Aim II: To evaluate and compare the adhesion-related complications and adhesiolysis-related complications of intraperitoneal barrier-coated versus non-barrier-coated mesh during abdominal re-exploration after prior ventral hernia repair. Specific Aim III: To determine the comparative effectiveness of intraperitoneal barrier-coated versus non-barrier-coated ventral hernia repair mesh in reducing adhesions, adhesion-related complications, and adhesiolysis sequelae in actual patient subpopulations and clinical circumstances. Specific Aim IV: To evaluate and compare the adhesiolysis-related complications of the laparoscopic and open approaches to adhesiolysis during abdominal re-exploration after prior ventral hernia repair. Specific Aim V: To determine the comparative effectiveness of the laparoscopic and open approaches to adhesiolysis during abdominal re-exploration after prior ventral hernia repair.

Interventions

  • PROCEDURE Clinically-Indicated Abdominal Re-Exploration Surgery

Trial Details

FieldValue
Enrollment Target 173 participants
Start Date 2011-05
Est. Completion 2015-01

What the Registry Record Tells You About NCT01355939

The ClinicalTrials.gov registry entry for NCT01355939 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Clinically-Indicated Abdominal Re-Exploration Surgery is the first listed.

NCT01355939 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01355939 about?

NCT01355939 is a clinical study titled "Comparative Effectiveness Multicenter Trial for Adhesion Characteristics of Ventral Hernia Repair Mesh". The proposed study will compare the benefits, harms, and comparative effectiveness of intraperitoneal barrier-coated and non-barrier coated ventral hernia repair (VHR) mesh in reducing adhesions, adhesion-related complications, and adhesiolysis sequelae in actual patient subpopulations and clinical ...

What is the current status of trial NCT01355939?

This trial is currently completed. The enrollment target is 173 participants. The study started on 2011-05. Estimated completion is 2015-01.

What interventions are being tested in trial NCT01355939?

The interventions under investigation include: Clinically-Indicated Abdominal Re-Exploration Surgery (PROCEDURE).

Who is sponsoring clinical trial NCT01355939?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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