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Procedure

Ventral Hernia Repair for Ventral Hernia

N/A
Waitlist Available
Led By Clayton C Petro, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year (9-15 month) follow-up
Awards & highlights

Study Summary

This trial will help to determine if the eTEP approach is superior to the standard IPOM approach for repair of small to medium-sized ventral hernias with respect to postoperative pain, cost, recurrence, and intraoperative surgeon workload.

Eligible Conditions
  • Ventral Hernia
  • Epigastric Hernia
  • Umbilical Hernia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year (9-15 month) follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year (9-15 month) follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain on postoperative day 1
Secondary outcome measures
Abdominal wall-specific quality of life
Direct costs
Hernia recurrence rates
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced-view Totally Extraperitoneal (eTEP) Hernia RepairExperimental Treatment1 Intervention
Initial access into the retromuscular space is achieved using an optical trocar. Insufflation of CO2 is performed under direct visualization. Multiple assistant ports will be placed medial to the semilunar line to continue developing the retromuscular space. The medial insertion of the posterior rectus sheath will be incised to enter the preperitoneal plane and facilitate reduction of hernia contents. The contralateral posterior rectus sheath will be incised and the contralateral retrorectus space will be matured. Suture will be used to close any defect in the hernia sac. The defect will be measured, as will be the retrorectus space. The fascial defect will be closed with suture. Non-barrier coated mesh will be placed in the retrorectus space and flat positioning will be confirmed. Ports will be removed under direct visualization, and the abdomen desufflated. Anterior fascia of any larger ports (8mm or greater) will be closed.
Group II: Intraperitoneal Onlay Mesh (IPOM) Hernia RepairActive Control1 Intervention
Access is achieved using an optical trocar. Insufflation of CO2 is performed. Two additional trocars are placed on the left side along the anterior axillary line. If necessary, auxiliary ports may be placed on the right side. When present, hernia contents are reduced using graspers. Adhesions between abdominal contents and the abdominal wall are lysed. The hernia defect is identified and measured internally with a sterile plastic ruler with the abdomen insufflated. Defect closure is performed using nonabsorbable suture. Mesh repair is performed using polypropylene mesh with an absorbable hydrogel barrier. Mesh is chosen to achieve a minimum 3 to 5-centimeter overlap from the edges of the closed defect. Inside the abdomen, the mesh is unrolled and positioning against the anterior abdominal wall is confirmed. Mesh edges are fixed circumferentially with permanent fixation. Ports are removed and the abdomen is desufflated. The anterior fascia of the 12mm port is closed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ventral Hernia Repair
2019
N/A
~100

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,025 Previous Clinical Trials
1,365,776 Total Patients Enrolled
Clayton C Petro, MDPrincipal InvestigatorAssistant Professor of Surgery
3 Previous Clinical Trials
1,090 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for enrolment in this experiment?

"The records provided by clinicaltrials.gov show that this medical trial is not currently recruiting participants, although it was first made available on November 4th 2019. Fortunately, there are 160 other trials actively looking for patients at the present time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernias
Clayton Petro 2019. "Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernias". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04150796.
~18 spots leftby Apr 2025
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