Abdominal Wall HerniaEUROTARNCT05195957
Outcomes of Open Versus Robotic-assisted Laparoscopic Posterior Component Separation in Complex Abdominal Wall Repair
An observational study of Abdominal Wall Hernia, run by University of Oulu at 2 sites in 2 countries.
Trial summary
This is a retrospective European multicenter study evaluating surgical treatment of patients with a complex ventral incisional hernia using robotic-assisted laparoscopic transversus abdominis release (rTAR) or open transversus abdominis release (oTAR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Wall Hernia
- What is being tested?
- Robotic tranversus abdominis release operation and Open transversus abdominis release operation
- Type of treatment
- Surgery or procedure
- How many people
- 169 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Jan 2021to 21 Dec 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients undergoing bilateral either open of robotic-assisted transversus abdominis release in the treatment of their ventral incisional hernia.
Who may be able to join
- All consecutive patients undergoing bilateral either open of robotic-assisted transversus abdominis release in the treatment of their ventral incisional hernia.
Who cannot join
- unilateral transversus abdominis release
- patients with a stoma or parastomal hernia
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Outcomes of Open Versus Robotic-assisted Laparoscopic Posterior Component Separation in Complex Abdominal Wall Repair A Retrospective Multicenter Case-control Study
This is a retrospective European multicenter study evaluating surgical treatment of patients with a complex ventral incisional hernia using robotic-assisted laparoscopic transversus abdominis release (rTAR) or open transversus abdominis release (oTAR).
Read the detailed description
Consecutive patients who undergo bilateral TAR in the treatment of their ventral incisional hernia in two European hernia centers are included in the study. A retrospective analysis of a prospectively maintained database and electronic patient files will be performed. Primary endpoint of the study was length of postoperative hospital stay. Secondary endpoints are intraoperative complications, in-hospital complications, overall and surgical site related complications during the first 30 postoperative days, overall and surgical site related complications during the reported follow-up period, and hernia recurrence during the reported follow-up period.
Data on the following variables wlll be collected.
- Patient characteristics: age, sex, body-mass index (BMI), comorbidities, smoking habits, previous hernia repair and hernia dimensions
- Intraoperatively: skin-to-skin operative time, wound contamination class (according to the center for disease control and prevention (CDC) classification)15, administration of antibiotics, mesh type used, mesh size, closure of the hernia defect, combined surgical procedures and intraoperative complications.
- Postoperatively at discharge: length of postoperative hospital stay and in-hospital complications.
- Postoperatively at 30 days after surgery: overall (according to the Clavien-Dindo classification)16 and surgical site related complications17, readmission rates during the first 30 days after surgery.
- During follow-up: duration of reported follow-up, reoperation rates and hernia recurrences during the reported follow-up period.
- Conditions
- Abdominal Wall Hernia
- Being tested
- Robotic tranversus abdominis release operation, Open transversus abdominis release operation
- Keywords
- Abdominal wall surgery, Open surgery, Robotic surgery, Transversus abdominis release, Posterior component separation technique
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic tranversus abdominis release operationProcedure or surgery
Mini-invasive robotic-assisted TAR using either DaVinci Xi or Si systems and 6 laparoscopic ports.
Open transversus abdominis release operationProcedure or surgery
Original open TAR using midline incision.
| Study group | Role | What they receive |
|---|---|---|
| rTAR | All consecutive patients undergoing bilateral robotic transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion. Receives: Procedure: Robotic tranversus abdominis release operation | |
| oTAR | All consecutive patients undergoing bilateral open transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion. Receives: Procedure: Open transversus abdominis release operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of postoperative hospital stay
Postoperative treatment and follow-up period in hospital
Measured: immediately after the surgery
Secondary outcomes (2)
Complication rates
Postoperative complications during 30 days after surgery and longer follow-up
Measured: through study completion, an average of 1 year
Recurrence and reoperation rates
Postoperative recurrence of hernia and possible reoperations for recurrence
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start17 Jan 2021
- Primary completion30 Oct 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Wall HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 169 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Algemeen Ziekenhuis Maria Middelares
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195957
- Sponsor's protocol ID
- 12/2021
- Acronym
- EUROTAR
- Status last verified
- Jan 2022
- First submitted
- 29 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data is available for European Hernia Society researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Open Versus Robotic-assisted Laparoscopic Posterior Component Separation in Complex Abdominal Wall Repair A Retrospective Multicenter Case-control Study
- ClinicalTrials.gov ID
- NCT05195957
- Acronym / sponsor ID
- EUROTAR / 12/2021
- Conditions
- Abdominal Wall Hernia
- Keywords
- Abdominal wall surgery, Open surgery, Robotic surgery, Transversus abdominis release, Posterior component separation technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Algemeen Ziekenhuis Maria Middelares
- Study start
- 17 Jan 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective European multicenter study evaluating surgical treatment of patients with a complex ventral incisional hernia using robotic-assisted laparoscopic transversus abdominis release (rTAR) or open transversus abdominis release (oTAR).
Detailed description
Consecutive patients who undergo bilateral TAR in the treatment of their ventral incisional hernia in two European hernia centers are included in the study. A retrospective analysis of a prospectively maintained database and electronic patient files will be performed. Primary endpoint of the study was length of postoperative hospital stay. Secondary endpoints are intraoperative complications, in-hospital complications, overall and surgical site related complications during the first 30 postoperative days, overall and surgical site related complications during the reported follow-up period, and hernia recurrence during the reported follow-up period.
Data on the following variables wlll be collected.
- Patient characteristics: age, sex, body-mass index (BMI), comorbidities, smoking habits, previous hernia repair and hernia dimensions
- Intraoperatively: skin-to-skin operative time, wound contamination class (according to the center for disease control and prevention (CDC) classification)15, administration of antibiotics, mesh type used, mesh size, closure of the hernia defect, combined surgical procedures and intraoperative complications.
- Postoperatively at discharge: length of postoperative hospital stay and in-hospital complications.
- Postoperatively at 30 days after surgery: overall (according to the Clavien-Dindo classification)16 and surgical site related complications17, readmission rates during the first 30 days after surgery.
- During follow-up: duration of reported follow-up, reoperation rates and hernia recurrences during the reported follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTAR | – | Procedure: Robotic tranversus abdominis release operationAll consecutive patients undergoing bilateral robotic transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion. |
| oTAR | – | Procedure: Open transversus abdominis release operationAll consecutive patients undergoing bilateral open transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients undergoing bilateral either open of robotic-assisted transversus abdominis release in the treatment of their ventral incisional hernia.
Key inclusion criteria (1 listed)
- All consecutive patients undergoing bilateral either open of robotic-assisted transversus abdominis release in the treatment of their ventral incisional hernia.
Key exclusion criteria (2 listed)
- unilateral transversus abdominis release
- patients with a stoma or parastomal hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic tranversus abdominis release operationMini-invasive robotic-assisted TAR using either DaVinci Xi or Si systems and 6 laparoscopic ports. | Procedure or surgery | rTAR |
| Open transversus abdominis release operationOriginal open TAR using midline incision. | Procedure or surgery | oTAR |
Primary outcome
Length of postoperative hospital stay
Time frame: immediately after the surgery
Postoperative treatment and follow-up period in hospital
2 secondary outcomes
Complication rates
Time frame: through study completion, an average of 1 year
Recurrence and reoperation rates
Time frame: through study completion, an average of 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: Yes. All data is available for European Hernia Society researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Wall Hernia, run by University of Oulu at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of postoperative hospital stay (time frame: immediately after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.