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Completed

NCT Number: NCT03007758

Open Versus Robotic Retromuscular Ventral Hernia Repair

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.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Ventral Hernia Repair

Procedure

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

Procedure

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.

Primary outcomes

  1. Composite Outcome of Diagnosis of Surgical Site Occurrence or Infection, Hospital Readmission, or Hernia Recurrence

    Time frame: Through study completion, an average of 2 years

    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.

Secondary outcomes

  1. All Surgical Site Occurrences

    Time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years

    Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections.

  2. Surgical Site Occurrences Requiring Procedural Intervention

    Time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years

    Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections

  3. All Surgical Site Infections

    Time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years

    Surgical site occurrence is defined as all wound complications that occur after a surgical procedure but are not surgical site infections.

  4. Surgical Site Infections Requiring Procedural Intervention

    Time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years

  5. Length of Stay at Hospital Measured in Days

    Time frame: Time from procedure until discharge, an expected range of 2 to10 days

  6. Operative Time (Procedure Start to Procedure Finish Measured in Minutes)

    Time frame: Day of surgery

  7. Cost for Hospital Charges From Billing Office

    Time frame: Through study completion, an average of 2 years

  8. BMI

    Time frame: Measured at study enrollment

    Body Mass Index

  9. Hernia Width

    Time frame: measured at surgery

    Width of Hernia

  10. Hernia Length

    Time frame: measured at surgery

    Length of Hernia

  11. Quality of Life Via Questionnaire - 30 Days

    Time frame: assessed at Baseline and Post-operatively at 30 days

    Patient reported outcomes via the Hernia related quality of life score. The survey contains 12 statements about the patients abdominal wall and asks the patient to rate how strongly the disagree (1) or agree (6) with the statements on a scale 1-6. The score is calculated with the following formula: (120-[(20/12)*(sum of response on all 12 questions)]).The highest possible number, meaning the abdominal wall does not affect the patient, is 100, and the lowest, meaning the abdominal wall greatly affects the patient's quality of life, is a 0.

  12. Quality of Life Via Questionnaire - 6 Through 12 Months

    Time frame: assessed at Baseline and Post-operatively at 6 through 12 months. Data for the 6 and 12-month patient reported outcomes were combined for analysis.

    Patient reported outcomes via the Hernia related quality of life score. The survey contains 12 statements about the patients abdominal wall and asks the patient to rate how strongly the disagree (1) or agree (6) with the statements on a scale 1-6.The score is calculated with the following formula: (120-[(20/12)*(sum of response on all 12 questions)]).The highest possible number, meaning the abdominal wall does not affect the patient, is 100, and the lowest, meaning the abdominal wall greatly affects the patient's quality of life, is a 0.

  13. Quality of Life Via Questionnaire - 24 Months

    Time frame: assessed at Baseline and Post-operatively at 24 months

    Patient reported outcomes via the Hernia related quality of life score. The survey contains 12 statements about the patients abdominal wall and asks the patient to rate how strongly the disagree (1) or agree (6) with the statements on a scale 1-6. The score is calculated with the following formula: (120-[(20/12)*(sum of responses on all 12 questions)]).The highest possible number, meaning the abdominal wall does not affect the patient, is 100, and the lowest, meaning the abdominal wall greatly affects the patient's quality of life, is a 0.

  14. Pain Score - 30 Day Patient Reported Outcomes

    Time frame: assessed at Baseline and Post-operatively at 30 days.

    Patient is asked 3 different questions all in relation to their pain in the past 7 days: how intense was it as its worst, on average, and right now. They then rank their pain for each question on a scale of 1 - 5. 1 meaning no pain and 5 very severe pain. The pain scores were then averaged and used for this analysis.

  15. Pain Score - 6 or 12 Month Patient Reported Outcomes

    Time frame: assessed at Baseline and Post-operatively at 6-12 months; data for 6 and 12-month pain scores were combined for analysis.

    Patient is asked 3 different questions all in relation to their pain in the past 7 days: how intense was it as its worst, on average, and right now. They then rank their pain for each question on a scale of 1 - 5. 1 meaning no pain and 5 very severe pain. The pain scores were then averaged and used for this analysis.

  16. Pain Score - 24 Month Patient Reported Outcomes

    Time frame: assessed at Baseline and Post-operatively at 24 months

    Patient is asked 3 different questions all in relation to their pain in the past 7 days: how intense was it as its worst, on average, and right now. They then rank their pain for each question on a scale of 1 - 5. 1 meaning no pain and 5 very severe pain. The pain scores were then averaged and used for this analysis.

  17. Ventral Hernia Recurrence Inventory 1 Year

    Time frame: assessed at Baseline and Post-operatively at 12 months.

    Patients are asked 3 yes or no questions about their hernia operation: do you feel your hernia has come back, do you feel or see a bulge, and do you have physical pain or symptoms at the site.

  18. Ventral Hernia Recurrence Inventory 2 Years

    Time frame: assessed at Baseline and Post-operatively at 24 months

    Patients are asked 3 yes or no questions about their hernia operation: do you feel your hernia has come back, do you feel or see a bulge, and do you have physical pain or symptoms at the site.

  19. Hernia Recurrence

    Time frame: assessed Post-operatively as 24 months

    The ventral hernia recurrence inventory asked patients if they have had any additional surgery since the hernia operation. If they answer yes, they choose if the surgery was for a hernia or another reason. The answers from 1 year follow up and 2 year follow up to the last question were combined for this analysis. Composite recurrence was then determined by excluding patients with negative CT scan or physical exam but had answered the ventral hernia recurrence inventory indication the hernia recurrence.

  20. Conversion to Open

    Time frame: Assessed at index surgery.

    Robotic surgeries converted to open surgeries.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Official study title

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

Acronym: ORREO

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jan 2, 2017
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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