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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03007758
Other study ID # Pro00062464
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date December 2025

Study information

Verified date February 2024
Source Prisma Health-Upstate
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine how the robotic retromuscular hernia repair compares to the open retromuscular hernia repair for large hernia defects in patients at higher risk of wound complications.


Description:

All patients presenting to the Greenville Health System Hernia Center who meet the inclusion criteria will be considered for enrollment. Patients who qualify and agree to participate will be randomized 1:1 to robotic retromuscular ventral hernia repair or open retromuscular ventral hernia repair. Data to be collected includes the following: demographic information, medical characteristics, medications, medical and surgical history, operative details, hospital stay data, and patient-reported outcomes via a quality of life questionnaire. Post-operative follow-up will occur at 2 weeks, 6 weeks, 6 months, 1 year and 2 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ventral or incisional hernia measuring = 7 cm and = 15 cm. - At least one of the following risk factors: Body Mass Index > 30, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, current smoker (within 1 month) Exclusion Criteria: - Current abdominal wall infection - Presence of ileostomy, colostomy, or ileal conduit - Center for Disease Control wound class 3 or 4 - Hernia defect < 7 cm or >15 cm - Pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
open ventral hernia repair
An open retromuscular ventral hernia repair involves an incision through your abdominal wall, most often through a prior surgery scar. The contents of the hernia, which may include intestine or fatty tissue, are returned into the abdominal cavity. The posterior (inner-most) layer of the abdominal wall is separated from the muscle and closed, which closes the abdominal cavity. Mesh is then placed over that closed layer, which is outside of the abdominal cavity, but below the abdominal muscles. The anterior (outer-most) layer of the abdominal wall is then closed over the mesh, which closes the hernia.
robotic ventral hernia repair
A robotic retromuscular ventral hernia repair involves a similar separation of the layers of the abdominal wall, similar mesh placement, and similar closure of the hernia defect. The surgical robot is a tool that allows your surgeon to place long, narrow instruments through small incisions in order to perform surgery from the inside of your abdomen. Rather than one longer incision in the middle of your abdomen, four to six small incisions, about 1 inch, are made along the outer part of your abdomen between the rib cage and hip.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Prisma Health-Upstate

Outcome

Type Measure Description Time frame Safety issue
Primary Composite outcome of diagnosis of surgical site occurrence or infection, hospital readmission, or hernia recurrence A composite outcome of events which are clinically significant including but not limited to seroma requiring procedural intervention, skin dehiscence, cellulitis, hematoma, skin necrosis, and surgical site infections which may require interventions such as wound care or antibiotic therapy. Through study completion, an average of 2 years
Secondary All surgical site occurrences Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Secondary Surgical site occurrences requiring procedural intervention Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Secondary All surgical site infections Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Secondary Surgical site infections requiring procedural intervention Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Secondary Length of stay at hospital measured in days Time from procedure until discharge, an expected range of 2 to10 days
Secondary Operative time (procedure start to procedure finish measured in minutes) Day of surgery
Secondary Quality of Life via questionnaire Baseline and Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Secondary Cost for hospital charges from billing office Through study completion, an average of 2 years
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