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Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation

NCT03938688 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2023-06-22

No results posted yet for this study

Summary

This will be a single blinded, registry based, non-inferiority, randomized control trial comparing transfacial sutures for mesh fixation to no mesh fixation in open retromuscular repairs. The primary outcome of interest is recurrence measured one year postoperatively as per standard of care at Cleveland Clinic Center for Abdominal Core Health. Hence, recurrence will be measured using either physical examination, CT scan, or the Ventral Hernia Recurrence Inventory (VHRI). Study population will include all adult patients (18 years or older) undergoing elective open ventral hernia repair of a clean (Wound class I) defect, where the midline fascia can be approximated and mesh will be placed in the retromuscular position. Only a midline approach to hernia repair and hernia widths equal to or less than 20cm measured intraoperatively will be included

Conditions

  • Ventral Hernia
  • Incisional Hernia

Interventions

PROCEDURE

Mesh placement with Transfascial Sutures

Sutures that pass through the full thickness of the abdominal wall, which are used routinely for mesh fixation

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Ajita S Prabhu · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2022-12-18
Completion
2022-12-18

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 NCT03938688 on ClinicalTrials.gov