Open Versus Robotic Retromuscular Ventral Hernia Repair

Ventral Hernia Clinical Trial

— ORREO  

Official title:

Prospective Randomized Control Trial of Open Versus Robotic REtrOmuscular Ventral Hernia Repair (ORREO Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03007758
• Other study ID #: Pro00062464
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

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