Clinical trial NCT03007758: Open Versus Robotic Retromuscular Ventral Hernia Repair
Official title: Prospective Randomized Control Trial of Open Versus Robotic REtrOmuscular Ventral Hernia Repair (ORREO Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Keywords: Hernia repair
Robotic hernia repair
Open hernia repair
Incisional hernia
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite outcome of diagnosis of surgical site occurrence or infection, hospital readmission, or hernia recurrence
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: All surgical site occurrences
timeFrame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
measure: Surgical site occurrences requiring procedural intervention
timeFrame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
measure: All surgical site infections
timeFrame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
measure: Surgical site infections requiring procedural intervention
timeFrame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
measure: Length of stay at hospital measured in days
timeFrame: Time from procedure until discharge, an expected range of 2 to10 days
measure: Operative time (procedure start to procedure finish measured in minutes)
timeFrame: Day of surgery
measure: Quality of Life via questionnaire
timeFrame: Baseline and Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
measure: Cost for hospital charges from billing office
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Prisma Health-Upstate
name: Jeremy A Warren, MD
role: PRINCIPAL_INVESTIGATOR
References: