Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias

Ventral Incisional Hernia Clinical Trial

— ROCSTAR  

Official title:

Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias: an Open-label Multicenter International Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05575141
• Other study ID #: ROCSTAR
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: March 1, 2029

Study information

• Verified date: October 2022
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: Maaike Vierstraete, MD
• Phone: +3292467400
• Email: maaikevierstraete[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 1, 2029
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with a ventral incisional hernia of more than 8 centimeters in width

Exclusion Criteria:

• Emergency surgery

• Pregnancy

• Age<18

• Incisional hernia repair after open abdomen or enterocutaneous fistula

• Active wound infection

• Previous anterior or posterior component separation

• Absence of a signed informed consent

• Patients unable to give informed consent or complete the quality-of-life assessment (due to language barriers or intellectual capacity)

• Primary ventral hernias

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal
• Hernia, Ventral
• Incisional Hernia
• Internal Hernia
• Ventral Incisional Hernia

Intervention

Procedure:
• Component separation (transversus abdominis release)
Component separation by transversus abdominis release, to allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of postoperative hospital stay	Length of postoperative hospital stay	From date of operation until the date of discharge, assessed up to 20 days
Secondary	Skin-to-skin operative time	Skin-to-skin operative time	Per-operative (minutes)
Secondary	Conversion rate	Conversion rate	Per-operative
Secondary	Postoperative complication rate	Surgical site infection - surgical site occurrence - surgical site occurrence requiring procedural interventions	30 days
Secondary	Readmission and reoperation rate	Readmission and reoperation rate	30 Days
Secondary	Post-anesthetic discharge scoring system	Minimum score is 0, maximum score is 12. The higher the score, the better the outcome.	Immediately after the surgery
Secondary	Postoperative visual analogue scale pain score	Minimum score is 0, maximum score is 10. The higher the score, the worse the outcome.	Immediately after the surgery
Secondary	Quality of Life Scoring	Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome.	Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
Secondary	Body image score	Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome).	Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
Secondary	Hernia recurrence	Hernia recurrence	3 Months, 12 months, 24 months, 60 months
Secondary	Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence	Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence	3 Months, 12 months, 24 months, 60 months