Inguinal HerniaRAPrTAPPNCT04718597
Repair of Groin Hernias After Abdominal Prostatectomy With Robotic TAPP
An observational study of Inguinal Hernia, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial summary
This retrospective study investigates if robotic assisted groin hernia repair in patients who previously underwent abdominal prostatectomy has an equal or more favorable clinical outcome, compared to open repair in those patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Robotic assisted inguinal hernia repair and Open inguinal hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2020to 1 Dec 2020
- 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 18 years and older
- Men only
- Adult, Older adult
Study population: Patients who underwent robotic assisted or open inguinal hernia repair in the period March 2015 - March 2020 and previously underwent an abdominal prostatectomy.
Who may be able to join
- Adult patients
- Underwent uni-or bilateral groin hernia repair in the period March 2015 - March 2020
- Groin hernia repair via robotic assisted laparoscopy or open surgery
- History of abdominal prostatectomy before the groin hernia repair
Who cannot join
- Age below 18
- Groin hernia repair via conventional laparoscopy
- Groin hernia repair via open surgery other than Liechtenstein method
- Groin hernia repair without mesh placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lichtenstein or Robotic TAPP Repair of Groin Hernias After Abdominal Prostatectomy: a Single Centre Retrospective Comparative Study
This retrospective study investigates if robotic assisted groin hernia repair in patients who previously underwent abdominal prostatectomy has an equal or more favorable clinical outcome, compared to open repair in those patients.
Read the detailed description
In the personal practice of the investigators, there has been a decrease in open groin hernia repair from 17% to 6% since the introduction of robotic assisted surgery. This reflects a change in indication for complex hernias from an open to a minimal invasive approach. One of the typical indications for open approach before adopting the robotic platform were groin hernias after previous abdominal prostatectomy. Since prostatectomy results in scarring of the retropubic area where we need to dissect during MIS groin hernia repair, an open anterior approach is often suggested. With the enhanced view and instrument dexterity of the robotic platform, the investigators have now changed to a minimal invasive approach in these patients.
Therefore, this study will evaluate the clinical outcome after robotic assisted repair of groin hernias in patients who previously underwent an abdominal prostatectomy in comparison to open groin hernia repair.
- Conditions
- Inguinal Hernia
- Being tested
- Robotic assisted inguinal hernia repair, Open inguinal hernia repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted inguinal hernia repairProcedure or surgery
Robotic assisted inguinal hernia repair with DaVinci Xi system instead of open repair
Open inguinal hernia repairProcedure or surgery
Classical approach (open repair)
| Study group | Role | What they receive |
|---|---|---|
| Open hernia repair | Patients who underwent inguinal hernia repair via an open Liechtenstein procedure Receives: Procedure: Open inguinal hernia repair | |
| Robotic assisted hernia repair | Patients who underwent inguinal hernia repair via robotic assisted laparoscopy Receives: Procedure: Robotic assisted inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-hospital complications
Complications during hospital stay according to Clavien-Dindo
Measured: From admission until hospital discharge, on average 12-24 hours
Operative time and per-operative complications
Skin-to-skin operating time and complications during the procedure
Measured: During the hernia repair procedure
Secondary outcomes (1)
Early complications at home
Complications at 1 month follow-up (readmission, seroma, infection) according to Clavien-Dindo
Measured: Immediately post hospital discharge until 1 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Aug 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Muysoms, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Filip Muysoms, PhD, Principal investigator, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718597
- Sponsor's protocol ID
- MMS.2020.067
- Acronym
- RAPrTAPP
- Status last verified
- Jan 2021
- First submitted
- 26 Aug 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lichtenstein or Robotic TAPP Repair of Groin Hernias After Abdominal Prostatectomy: a Single Centre Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT04718597
- Acronym / sponsor ID
- RAPrTAPP / MMS.2020.067
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 22 Jan 2021 (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 retrospective study investigates if robotic assisted groin hernia repair in patients who previously underwent abdominal prostatectomy has an equal or more favorable clinical outcome, compared to open repair in those patients.
Detailed description
In the personal practice of the investigators, there has been a decrease in open groin hernia repair from 17% to 6% since the introduction of robotic assisted surgery. This reflects a change in indication for complex hernias from an open to a minimal invasive approach. One of the typical indications for open approach before adopting the robotic platform were groin hernias after previous abdominal prostatectomy. Since prostatectomy results in scarring of the retropubic area where we need to dissect during MIS groin hernia repair, an open anterior approach is often suggested. With the enhanced view and instrument dexterity of the robotic platform, the investigators have now changed to a minimal invasive approach in these patients.
Therefore, this study will evaluate the clinical outcome after robotic assisted repair of groin hernias in patients who previously underwent an abdominal prostatectomy in comparison to open groin hernia repair.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open hernia repair | – | Procedure: Open inguinal hernia repairPatients who underwent inguinal hernia repair via an open Liechtenstein procedure |
| Robotic assisted hernia repair | – | Procedure: Robotic assisted inguinal hernia repairPatients who underwent inguinal hernia repair via robotic assisted laparoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent robotic assisted or open inguinal hernia repair in the period March 2015 - March 2020 and previously underwent an abdominal prostatectomy.
Key inclusion criteria (4 listed)
- Adult patients
- Underwent uni-or bilateral groin hernia repair in the period March 2015 - March 2020
- Groin hernia repair via robotic assisted laparoscopy or open surgery
- History of abdominal prostatectomy before the groin hernia repair
Key exclusion criteria (4 listed)
- Age below 18
- Groin hernia repair via conventional laparoscopy
- Groin hernia repair via open surgery other than Liechtenstein method
- Groin hernia repair without mesh placement
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 assisted inguinal hernia repairRobotic assisted inguinal hernia repair with DaVinci Xi system instead of open repair | Procedure or surgery | Robotic assisted hernia repair |
| Open inguinal hernia repairClassical approach (open repair) | Procedure or surgery | Open hernia repair |
Primary outcome
Intra-hospital complications
Time frame: From admission until hospital discharge, on average 12-24 hours
Complications during hospital stay according to Clavien-Dindo
Operative time and per-operative complications
Time frame: During the hernia repair procedure
Skin-to-skin operating time and complications during the procedure
1 secondary outcome
Early complications at home
Time frame: Immediately post hospital discharge until 1 month postoperative
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 22 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Filip Muysoms, PhD principal investigator
Algemeen Ziekenhuis Maria Middelares
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
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 4 inclusion and 4 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Intra-hospital complications (time frame: From admission until hospital discharge, on average 12-24 hours). The study lists 2 primary outcomes in all. 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 22 Jan 2021.