Robotic vs Open Surgery for Ventral Hernia

(ROVHR Trial)

Recruiting at 3 trial locations

Overseen By Alvaro Carvalho

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Age under 18, Pregnancy, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Hospital stay up to 30 days

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two types of surgeries for fixing abdominal wall hernias: traditional open surgery and robotic-assisted surgery. It aims to see if robotic surgery can shorten the hospital stay compared to open surgery. Patients with ventral hernias will undergo one of the two methods, and their recovery will be evaluated. Robotic-assisted surgery has been increasingly used in recent years for ventral hernia repair, combining minimally invasive techniques with retromuscular mesh placement.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for ventral hernia repair?

Research shows that combining the Rives-Stoppa procedure with minimally invasive techniques, like the eTEP approach, results in fewer recurrences and complications, making it a promising method for ventral hernia repair. ^{1 2 3 4 5}

Is the Rives-Stoppa technique for ventral hernia repair safe?

The Rives-Stoppa technique, including its minimally invasive eTEP approach, is generally considered safe for ventral hernia repair. Studies show low complication rates, with some cases of minor issues like seroma (fluid buildup) and rare instances of more serious complications like intestinal obstruction. ^{3 4 5 6 7}

How does the robotic retromuscular ventral hernia repair treatment differ from other treatments for ventral hernia?

The robotic retromuscular ventral hernia repair treatment is unique because it combines the benefits of minimally invasive surgery with the effective principles of the Rives-Stoppa procedure, which involves placing a mesh between muscle layers to reduce hernia recurrence. This approach allows for smaller incisions, potentially less pain, and quicker recovery compared to traditional open surgery. ^{2 5 8 9 10}

Research Team

Lucas Beffa, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for adults with a body mass index (BMI) of 45 or less who have ventral hernias measuring between 7 and 15 cm wide. Candidates must be suitable for both open and robotic surgery as determined by the surgeon. It excludes prisoners, emergency cases, individuals with BMI over 45, hernia sizes outside the specified range, those under age 18, and pregnant women.

Inclusion Criteria

My surgeon says I can have surgery either by hand or with a robot.

BMI less than or equal to 45

My hernia is between 7 cm and 15 cm wide.

Exclusion Criteria

Pregnant patients

I am 17 years old or younger.

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either open or robotic retromuscular ventral hernia repair

Hospital stay up to 30 days

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after surgery

1 year

Treatment Details

Interventions

• Open Retromuscular Ventral Hernia Repair
• Robotic Retromuscular Ventral Hernia Repair

Trial Overview The study is examining two methods of repairing ventral hernias: traditional open retromuscular repair versus a robotic-assisted approach. Participants will be randomly assigned to one of these surgical techniques to compare outcomes.

Participant Groups

Group I: Open Ventral Hernia Repair Active Control 1 Intervention

These patients will undergo open retromuscular ventral hernia repairs

Group II: Robotic Ventral Hernia Repair Active Control 1 Intervention

These patients will undergo robotic retromuscular ventral hernia repairs.

Open Retromuscular Ventral Hernia Repair is already approved in United States, European Union for the following indications:

Approved in United States as Open Retromuscular Ventral Hernia Repair for:

• Ventral hernia
• Incisional hernia

Approved in European Union as Open Retromuscular Ventral Hernia Repair for:

• Ventral hernia
• Incisional hernia

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Lucas Beffa

Lead Sponsor

Trials

1

Recruited

200+

Findings from Research

A novel method using the rectus width to hernia width ratio (RDR) can accurately predict the need for additional myofascial release (AMR) during open Rives-Stoppa hernia repair, achieving 77.6% accuracy.

An RDR greater than 2 indicates a high likelihood (90%) of being able to close the hernia defect without requiring AMR, suggesting that this measurement can help guide surgical decisions preoperatively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed tomography imaging in ventral hernia repair: can we predict the need for myofascial release? Love, MW., Warren, JA., Davis, S., et al.[2021]

A new laparoscopic technique for midline incisional hernia repair in 15 post-bariatric surgery patients demonstrated successful outcomes with no major complications, combining the benefits of minimally invasive and open surgical approaches.

CT scans confirmed total closure of the hernia defect post-surgery, and patient satisfaction was high, indicating that this method is both effective and well-accepted by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transabdominal midline reconstruction by minimally invasive surgery: technique and results. Costa, TN., Abdalla, RZ., Santo, MA., et al.[2022]

The extended total extraperitoneal (eTEP) approach for ventral hernia repair, applied in 63 cases, demonstrated a low complication rate with only one case of chronic pain and no recurrences reported during follow-up periods of up to 12 months.

This technique combines the benefits of the Rives-Stoppa procedure with minimally invasive surgery, allowing for effective repair of hernias while minimizing hospital stay, with a median hospitalization of just 1 day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retromuscular Approach in Ventral Hernia Repair - Endoscopic Rives-Stoppa Procedure. Radu, VG.[2019]

The retro-muscular Rives-Stoppa repair, enhanced by the endoscopic eTEP approach, offers significant advantages such as increased infection tolerance and reduced need for mesh fixation, making it a promising alternative to traditional laparoscopic repairs.

Key anatomical landmarks, identified by specific signs like the 'lamppost sign' and 'volcano sign', are crucial for safely navigating the surgical field and minimizing the risk of injury during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Signs and landmarks in eTEP Rives-Stoppa repair of ventral hernias. Ramana, B., Arora, E., Belyansky, I.[2023]

The Rives-Stoppa procedure for ventral incisional hernia repair demonstrated a very low recurrence rate of 1.1% over a mean follow-up of 96 months in a study of 176 patients, indicating its long-term efficacy.

The procedure was found to be safe, with no postoperative mortality and a morbidity rate of only 10.2%, suggesting it is a reliable option for patients, even those with complex hernia histories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of Rives-Stoppa technique in complex ventral incisional hernia repair. Mehrabi, M., Jangjoo, A., Tavoosi, H., et al.[2021]

The enhanced-view extended totally extraperitoneal (eTEP) approach for ventral hernia repair was performed on 19 patients, showing it to be a feasible and safe surgical technique with a low complication rate of 10.5%.

No hernia recurrences were reported during a median follow-up of 16 months, indicating promising short-term efficacy of the eTEP-RS method in treating ventral hernias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended totally extraperitoneal Rives-Stoppa (eTEP-RS) technique for ventral hernia: initial experience of The Wall Hernia Group and a surgical technique update. Andreuccetti, J., Sartori, A., Lauro, E., et al.[2021]

The Rives-Stoppa technique for retromuscular mesh hernia repair was successfully applied in a 9-year-old boy, demonstrating its potential effectiveness in pediatric cases, especially for large midline hernias.

After a 2-year follow-up, there were no recurrences of the hernia, suggesting that this technique not only provides a strong repair but also restores the anatomical integrity of the abdominal wall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal hernia repair using the Rives-Stoppa technique: an abdominal reconstruction. Molina Caballero, AY., Pérez Martínez, A., Goñi Orayen, C.[2022]

Robotic-assisted surgery for incisional hernias is gaining popularity due to its ability to perform minimally invasive procedures, which can lead to better perioperative outcomes compared to traditional open surgery.

The introduction of techniques like transversus abdominis muscle release allows for the effective treatment of larger and more complex hernias, showcasing the potential of robotic systems in enhancing surgical capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Roboticassisted incisional hernia surgery-Retromuscular techniques]. Vogel, R., Heinzelmann, F., Büchler, P., et al.[2023]

In a retrospective analysis of 21 patients who underwent the extended Totally Extraperitoneal (eTEP) procedure for ventral hernias, the technique showed a low rate of complications, with only two surgical site occurrences and one recurrence reported after a minimum follow-up of 2 months.

The eTEP technique appears to be a promising option for hernia repair, especially in centers with advanced laparoscopic skills, as it may offer advantages in terms of safety and reduced complications compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended totally extraperitoneal repair (eTEP) for ventral hernias: Short-term results from a single centre. Baig, SJ., Priya, P.[2022]

Laparoscopic repair of incisional hernia resulted in a shorter recovery time and lower pain medication requirements compared to open repair, with significant differences in time to solid food intake and postoperative stay.

Both surgical methods showed similar safety profiles, with no readmissions or recurrences within 6 months, suggesting that laparoscopic repair is a safe and effective alternative to open techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retromuscular sutured incisional hernia repair: a randomized controlled trial to compare open and laparoscopic approach. Navarra, G., Musolino, C., De Marco, ML., et al.[2014]

References

1. France pubmed.ncbi.nlm.nih.gov

Computed tomography imaging in ventral hernia repair: can we predict the need for myofascial release? [2021]

2. France pubmed.ncbi.nlm.nih.gov

Transabdominal midline reconstruction by minimally invasive surgery: technique and results. [2022]

3. Romania pubmed.ncbi.nlm.nih.gov

Retromuscular Approach in Ventral Hernia Repair - Endoscopic Rives-Stoppa Procedure. [2019]

4. France pubmed.ncbi.nlm.nih.gov

Signs and landmarks in eTEP Rives-Stoppa repair of ventral hernias. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term outcome of Rives-Stoppa technique in complex ventral incisional hernia repair. [2021]

6. Italy pubmed.ncbi.nlm.nih.gov

Extended totally extraperitoneal Rives-Stoppa (eTEP-RS) technique for ventral hernia: initial experience of The Wall Hernia Group and a surgical technique update. [2021]

7. Spain pubmed.ncbi.nlm.nih.gov

Abdominal hernia repair using the Rives-Stoppa technique: an abdominal reconstruction. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Roboticassisted incisional hernia surgery-Retromuscular techniques]. [2023]

9. India pubmed.ncbi.nlm.nih.gov

Extended totally extraperitoneal repair (eTEP) for ventral hernias: Short-term results from a single centre. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Retromuscular sutured incisional hernia repair: a randomized controlled trial to compare open and laparoscopic approach. [2014]