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Completed

NCT Number: NCT06409091

Short Term Outcomes of Heavy-weight Versus Medium-weight Synthetic Mesh

This study compares short term outcomes of patients undergoing a hernia repair with heavy weight mesh vs medium weight mesh in clean-contaminated and contaminated cases.

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Key information

Conditions

HERNIA, VENTRAL Hernia Hernia Incisional Hernia, Abdominal Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

The Abdominal Core Health Quality Collaborative was queried for patients undergoing open retromuscular hernia repairs with both heavy weight polypropylene (PP) mesh and medium weight PP mesh in cases where there was clean-contaminated and contaminated surgeries. The short term outcomes were then evaluated including wound infections, readmissions, recurrences of the hernia, and quality of life scores.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing open ventral hernia repairs with synthetic mesh in contaminated and clean contaminated surgery

Exclusion criteria

  • Laparoscopic or robotic surgery
  • clean cases or dirty cases
  • pregnancy
  • under age of 18

Treatment and study plan

Medium weight or Heavy weight mesh

Device

Patients received a hernia repair with one of the two groups

Primary outcomes

  1. Wound complications

    Time frame: 30 days post op

    Wound complcations

Secondary outcomes

  1. Mesh removal

    Time frame: 30 days post op

    mesh removal after surgery

  2. Readmissions

    Time frame: 30 days post op

    readmission or ER visit after surgery

  3. Reoperations

    Time frame: 30 days post op

    Reoperation after surgery

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Short Term Outcomes of Heavy-weight Versus Medium-weight Synthetic Mesh in a Retrospective Cohort of Clean-Contaminated and Contaminated Retromuscular Ventral Hernia Repairs

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
May 10, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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