Hernia, VentralNCT05320055
Pain and Readmission After Lap IPOM vs. Robotic Ventral Hernia Repair
An observational study of Hernia, Ventral, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Comparison of results after rTARUP and lap IPOM in patients with small- and medium-sized ventral hernia. Retrospective cohort study of consecutive patients undergoing rTARUP or IPOM repair for small or medium-sized primary ventral and incisional hernias. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- robotic repair
- Type of treatment
- Surgery or procedure
- How many people
- 59 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 1 Oct 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population is all patients referred from primary sector and eligible for laparoscopic primary ventral or incisional hernia repair
Who may be able to join
- all patients undergoing elective minimally invasive repair for small or medium-sized primary ventral or incisional hernia repairs at one academic hernia center with an unrestricted patient referral.
- Consecutive patients undergoing IPOM (December 1st, 2017 - December 1st, 2018) and rTARUPrRetrorectus (March 1st, 2021 - June 1st, 2021).
Who cannot join
- open repairs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Less Postoperative Pain and Length of Stay After Robotic-assisted Laparoscopic Transabdominal Repair With Retro Rectus Mesh Placement (rTARUP) Compared With Laparoscopic Intraperitoneal Onlay Mesh Repair (IPOM) for Small and Medium-sized Ventral Hernias
Comparison of results after rTARUP and lap IPOM in patients with small- and medium-sized ventral hernia. Retrospective cohort study of consecutive patients undergoing rTARUP or IPOM repair for small or medium-sized primary ventral and incisional hernias. The primary outcome was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter, secondary outcomes were 30-day complications, and length of stay. All patients underwent elective surgery and were followed for 30 days postoperatively.
Read the detailed description
Single-center retrospective cohort study of consecutive patients undergoing rTARUP or IPOM repair for small or medium-sized primary ventral and incisional hernias. The primary outcome was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter, secondary outcomes were 30-day complications, and length of stay. All patients underwent elective surgery and were followed for 30 days postoperatively.
- Conditions
- Hernia, Ventral
- Being tested
- robotic repair
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic repairProcedure or surgery
robotic assisted retromuscular hernia repair
| Study group | Role | What they receive |
|---|---|---|
| IPOM | receiving laparoscopic intraperitoneal onlay mesh repair Receives: Procedure: robotic repair | |
| rTARUP | recieving robotic assited retromuscular repair Receives: Procedure: robotic repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
epidural blockade or TAP block
postoperative pain requiring epidural or TAP block
Measured: 0-1 postoperative day
Secondary outcomes (2)
readmissison
if the patients get readmitted during the follow-up
Measured: 30 days
complications
if the patients get any medical or surgical complication during the follow-up
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Mar 2021
- Primary completion1 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hernia, VentralStudies 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
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Willaume, Bispebjerg Hospital
- Investigators
- Mette Willaume, phd, Principal investigator, University of Copenhagen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320055
- Sponsor's protocol ID
- IPOM vs TARUP
- Status last verified
- Aug 2023
- First submitted
- 1 Apr 2022
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christoffersen MW, Jorgensen LN, Jensen KK. Less postoperative pain and shorter length of stay after robot-assisted retrorectus hernia repair (rRetrorectus) compared with laparoscopic intraperitoneal onlay mesh repair (IPOM) for small or medium-sized ventral hernias. Surg Endosc. 2023 Feb;37(2):1053-1059. doi: 10.1007/s00464-022-09608-w. Epub 2022 Sep 15.
PubMed 36109358
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Less Postoperative Pain and Length of Stay After Robotic-assisted Laparoscopic Transabdominal Repair With Retro Rectus Mesh Placement (rTARUP) Compared With Laparoscopic Intraperitoneal Onlay Mesh Repair (IPOM) for Small and Medium-sized Ventral Hernias
- ClinicalTrials.gov ID
- NCT05320055
- Acronym / sponsor ID
- IPOM vs TARUP
- Conditions
- Hernia, Ventral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 11 Apr 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.
Comparison of results after rTARUP and lap IPOM in patients with small- and medium-sized ventral hernia. Retrospective cohort study of consecutive patients undergoing rTARUP or IPOM repair for small or medium-sized primary ventral and incisional hernias. The primary outcome was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter, secondary outcomes were 30-day complications, and length of stay. All patients underwent elective surgery and were followed for 30 days postoperatively.
Detailed description
Single-center retrospective cohort study of consecutive patients undergoing rTARUP or IPOM repair for small or medium-sized primary ventral and incisional hernias. The primary outcome was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter, secondary outcomes were 30-day complications, and length of stay. All patients underwent elective surgery and were followed for 30 days postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPOM | – | Procedure: robotic repairreceiving laparoscopic intraperitoneal onlay mesh repair |
| rTARUP | – | Procedure: robotic repairrecieving robotic assited retromuscular repair |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is all patients referred from primary sector and eligible for laparoscopic primary ventral or incisional hernia repair
Key inclusion criteria (2 listed)
- all patients undergoing elective minimally invasive repair for small or medium-sized primary ventral or incisional hernia repairs at one academic hernia center with an unrestricted patient referral.
- Consecutive patients undergoing IPOM (December 1st, 2017 - December 1st, 2018) and rTARUPrRetrorectus (March 1st, 2021 - June 1st, 2021).
Key exclusion criteria (1 listed)
- open repairs
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 repairrobotic assisted retromuscular hernia repair | Procedure or surgery | IPOM, rTARUP |
Primary outcome
epidural blockade or TAP block
Time frame: 0-1 postoperative day
postoperative pain requiring epidural or TAP block
2 secondary outcomes
readmissison
Time frame: 30 days
complications
Time frame: 30 days
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 7 Aug 2023.
- Derived from this study: PubMed 36109358Christoffersen MW, Jorgensen LN, Jensen KK. Less postoperative pain and shorter length of stay after robot-assisted retrorectus hernia repair (rRetrorectus) compared with laparoscopic intraperitoneal onlay mesh repair (IPOM) for small or medium-sized ventral hernias. Surg Endosc. 2023 Feb;37(2):1053-1059. doi: 10.1007/s00464-022-09608-w. Epub 2022 Sep 15.
- Individual participant dataSharing planned: No
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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.
Mette Willaume, phd principal investigator
University of Copenhagen, Bispebjerg Hospital
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 Hernia, Ventral, run by Bispebjerg Hospital at 1 site in Denmark.
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 2 inclusion and 1 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 7 Aug 2023. 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 Denmark. 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?
epidural blockade or TAP block (time frame: 0-1 postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05320055, which also lists 1 linked publication.
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 7 Aug 2023.