Ventral HerniaRoboventNCT04171921
Robotic Versus Open Primary Ventral Hernia Repair
A study testing Robotic ventral hernia repair and Open ventral hernia repair in people with Ventral Hernia, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
Umbilical and epigastric hernia repair, whether considering primary or incisional hernias, are associated with a high risk of local complications, with global rate of surgical complications at one month up to 25%. To date three techniques are used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Robotic ventral hernia repair and Open ventral hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2019to 1 Sep 2023
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature
- Aged 18 years or older
- Undergoing primary umbilical or epigastric hernia repair of size between 1cm and 5cm +/-5mm, with mesh reinforcement, in the Visceral Surgery Department of the University Geneva Hospital
Who cannot join
- Patients under corticosteroids or other immunosuppressive treatment
- Pregnancy or breastfeeding
- Intention to become pregnant during the course of the study
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential
- Incisional hernia and/or substantial history of intra-abdominal surgery
- Upon anesthesiologist evaluation, clinically significant concomitant disease states which require to shorten operative time at maximum
Show all 11Show fewer
- Upon anesthesiologist evaluation, clinically significant concomitant disease states being a contra-indication to laparoscopic approach and/or general anesthesia
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia of the participant
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Visceral surgery department - Geneva University Hospital
Geneva, 1211
About this study
Official title: Robotic Versus Open Primary Ventral Hernia Repair: a Randomized Controlled Trial
Umbilical and epigastric hernia repair, whether considering primary or incisional hernias, are associated with a high risk of local complications, with global rate of surgical complications at one month up to 25%. To date three techniques are used.
Open ventral hernia repair (OVHR) is associated with a high risk of surgical site infection, wound dehiscence, and hematoma, but is the main technique due to advantages such as cost-effectiveness, short operative time and totally extra-peritoneal repair.
Read more
Laparoscopic hernia repair (LHR) reduces these complications but implies to place a mesh in intra-peritoneal position which is known to lead to adhesions, requires advanced laparoscopic skills, does not allow the closure of the defect due to limited range of motion, and can lead to excessive pain and pain-killers consumption due to the use of "tackers" to hold the mesh in place.
Robotic ventral hernia repair (RVHR) uses the same laparoscopic access as LHR but thanks to the extended range of motion given by the robotic system allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills.
LHR is of very low adoption in Geneva University Hospital for the aforementioned inconvenient. Moreover, the final result of the procedure is not the same than with OVHR or RVHR, since the defect is not primarily closed and the mesh is in intra-peritoneal position. OVHR and RVHR , however, lead to the same final result and only defer by the access type (direct vs. laparoscopic). RVHR is gaining rapid popularity and adoption in the United States but remains a costly solution. It is unclear whether the supposed benefits for the patients of RVHR overwhelm the extra costs and time, especially by reducing the complication rate and consecutive in-hospital and out-hospital costs. Moreover, increasing experience of the robotic system in Geneva University Hospital has led to a significant costs and time reduction in other robotic procedures and could eventually make RVHR cost effective if its clinical benefits were to be proven.
This study aims at demonstrating that robotic trans-abdominal pre-peritoneal (rTAPP) primary ventral hernia repair leads to lower surgical site complication rate than the same procedure performed through standard open approach (OVHR), while being an acceptable solution from an economic, operative time and functional standpoint.
- Conditions
- Ventral Hernia
- Being tested
- Robotic ventral hernia repair, Open ventral hernia repair
- Keywords
- Open ventral hernia repair, Robotic ventral hernia repair, Surgical site complications, Esthetic satisfaction, Pain, Pain-killers consumption, Costs, Operative time, Early hernia recurrence, General complications
- Medical subject headings
- Hernia, Ventral, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic ventral hernia repairProcedure or surgery
Laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement
Open ventral hernia repairProcedure or surgery
Standard open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement
| Study group | Role | What they receive |
|---|---|---|
| Robotic ventral hernia repair | Active comparator | Not described Receives: Procedure: Robotic ventral hernia repair |
| Open ventral hernia repair | Active comparator | Not described Receives: Procedure: Open ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site complication
Yes or no
Measured: At 31 days after surgery
Secondary outcomes (11)
Detailed surgical site complications
Classified according to aforementioned Clavien-Dindo's scoring system (scale from 1 to 5, higher score mean a worse outcome)
Measured: At 31 days after surgery
General complications, not directly related to surgical site
Classified according to aforementioned Clavien-Dindo's scoring system (scale from 1 to 5, higher score mean a worse outcome)
Measured: At 31 days after surgery
General pain: Visual Analogue Scale
Evaluated using Visual Analogue Scale (VAS, scale from 0 to 10, higher score mean a worse outcome))
Measured: At 31 days after surgery
Painkillers consumption
Recorded from patient's medical record for in-hospital stay for out-hospital period will be evaluated with consumption recall at each visit
Measured: At 31 days after surgery
Esthetic satisfaction: European Hernia Society Quality of Life (EuraHS-QoL)
Using European Hernia Society Quality of Life (EuraHS-QoL) ( scale from 0-90, with the lower scores being the most favorable outcome)
Measured: At 31 days after surgery
Quality of life score
Using European Hernia Society Quality of Life (EuraHS-QoL) form (scale from 0-90, with the lower scores being the most favorable outcome)
Measured: At 31 days after surgery
In-hospital costs
Hospitalization costs including medications, care and labs, cost of the procedure, diagnosis related group class, total amount billed to the insurance.
Derived using REKOLE® method.
Measured: At day 31 after surgery
Out-hospital costs
Consults and drugs Estimated based on hospital's billing data.
Measured: At day 31 after surgery
Early recurrence at 1 month
Evaluated by physical evaluation
Measured: At day 31 after surgery
Defect size
Measured with ruler
Measured: During surgery
Number of device related adverse events by the operating surgeon
Surgical complications which are identified by the operating surgeon as directly related to malfunction of the robotic system
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Nov 2019
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Ventral 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jonathan Douissard, University of Geneva, Switzerland
- Investigators
- Jonathan Douissard, MD, Principal investigator, University of Geneva, Geneva University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171921
- Sponsor's protocol ID
- 2019-00113
- Other IDs
- 2019
- Acronym
- Robovent
- Status last verified
- May 2023
- First submitted
- 14 Nov 2019
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9.
PubMed 21904861Holihan JL, Alawadi Z, Martindale RG, Roth JS, Wray CJ, Ko TC, Kao LS, Liang MK. Adverse Events after Ventral Hernia Repair: The Vicious Cycle of Complications. J Am Coll Surg. 2015 Aug;221(2):478-85. doi: 10.1016/j.jamcollsurg.2015.04.026. Epub 2015 May 9.
PubMed 26206646Bisgaard T, Kehlet H, Bay-Nielsen M, Iversen MG, Rosenberg J, Jorgensen LN. A nationwide study on readmission, morbidity, and mortality after umbilical and epigastric hernia repair. Hernia. 2011 Oct;15(5):541-6. doi: 10.1007/s10029-011-0823-z. Epub 2011 May 3.
PubMed 21538150Helgstrand F. National results after ventral hernia repair. Dan Med J. 2016 Jul;63(7):B5258.
PubMed 27399983Reynolds D, Davenport DL, Korosec RL, Roth JS. Financial implications of ventral hernia repair: a hospital cost analysis. J Gastrointest Surg. 2013 Jan;17(1):159-66; discussion p.166-7. doi: 10.1007/s11605-012-1999-y. Epub 2012 Sep 11.
PubMed 22965649Hajibandeh S, Hajibandeh S, Sreh A, Khan A, Subar D, Jones L. Laparoscopic versus open umbilical or paraumbilical hernia repair: a systematic review and meta-analysis. Hernia. 2017 Dec;21(6):905-916. doi: 10.1007/s10029-017-1683-y. Epub 2017 Oct 14.
PubMed 29032495Froylich D, Segal M, Weinstein A, Hatib K, Shiloni E, Hazzan D. Laparoscopic versus open ventral hernia repair in obese patients: a long-term follow-up. Surg Endosc. 2016 Feb;30(2):670-675. doi: 10.1007/s00464-015-4258-y. Epub 2015 Jun 20.
PubMed 26091995Muysoms FE, Bontinck J, Pletinckx P. Complications of mesh devices for intraperitoneal umbilical hernia repair: a word of caution. Hernia. 2011 Aug;15(4):463-8. doi: 10.1007/s10029-010-0692-x. Epub 2010 Jun 17.
PubMed 20556448Liang MK, Berger RL, Li LT, Davila JA, Hicks SC, Kao LS. Outcomes of laparoscopic vs open repair of primary ventral hernias. JAMA Surg. 2013 Nov;148(11):1043-8. doi: 10.1001/jamasurg.2013.3587.
PubMed 24005537Tandon A, Pathak S, Lyons NJ, Nunes QM, Daniels IR, Smart NJ. Meta-analysis of closure of the fascial defect during laparoscopic incisional and ventral hernia repair. Br J Surg. 2016 Nov;103(12):1598-1607. doi: 10.1002/bjs.10268. Epub 2016 Aug 22.
PubMed 27546188Hilling DE, Koppert LB, Keijzer R, Stassen LP, Oei IH. Laparoscopic correction of umbilical hernias using a transabdominal preperitoneal approach: results of a pilot study. Surg Endosc. 2009 Aug;23(8):1740-4. doi: 10.1007/s00464-008-0177-5. Epub 2008 Nov 18.
PubMed 19015918Colavita PD, Tsirline VB, Belyansky I, Walters AL, Lincourt AE, Sing RF, Heniford BT. Prospective, long-term comparison of quality of life in laparoscopic versus open ventral hernia repair. Ann Surg. 2012 Nov;256(5):714-22; discussion 722-3. doi: 10.1097/SLA.0b013e3182734130.
PubMed 23095614Douissard J, Meyer J, Dupuis A, Peloso A, Mareschal J, Toso C, Hagen M. Robotic versus open primary ventral hernia repair: A randomized controlled trial (Robovent Trial). Int J Surg Protoc. 2020 Apr 4;21:27-31. doi: 10.1016/j.isjp.2020.03.004. eCollection 2020.
PubMed 32368702
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Open Primary Ventral Hernia Repair: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04171921
- Acronym / sponsor ID
- Robovent / 2019-00113
- Conditions
- Ventral Hernia
- Keywords
- Open ventral hernia repair, Robotic ventral hernia repair, Surgical site complications, Esthetic satisfaction, Pain, Pain-killers consumption, Costs, Operative time
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 21 Nov 2019 (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.
Umbilical and epigastric hernia repair, whether considering primary or incisional hernias, are associated with a high risk of local complications, with global rate of surgical complications at one month up to 25%. To date three techniques are used.
Open ventral hernia repair (OVHR) is associated with a high risk of surgical site infection, wound dehiscence, and hematoma, but is the main technique due to advantages such as cost-effectiveness, short operative time and totally extra-peritoneal repair.
Laparoscopic hernia repair (LHR) reduces these complications but implies to place a mesh in intra-peritoneal position which is known to lead to adhesions, requires advanced laparoscopic skills, does not allow the closure of the defect due to limited range of motion, and can lead to excessive pain and pain-killers consumption due to the use of "tackers" to hold the mesh in place.
Robotic ventral hernia repair (RVHR) uses the same laparoscopic access as LHR but thanks to the extended range of motion given by the robotic system allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills.
LHR is of very low adoption in Geneva University Hospital for the aforementioned inconvenient. Moreover, the final result of the procedure is not the same than with OVHR or RVHR, since the defect is not primarily closed and the mesh is in intra-peritoneal position. OVHR and RVHR , however, lead to the same final result and only defer by the access type (direct vs. laparoscopic). RVHR is gaining rapid popularity and adoption in the United States but remains a costly solution. It is unclear whether the supposed benefits for the patients of RVHR overwhelm the extra costs and time, especially by reducing the complication rate and consecutive in-hospital and out-hospital costs. Moreover, increasing experience of the robotic system in Geneva University Hospital has led to a significant costs and time reduction in other robotic procedures and could eventually make RVHR cost effective if its clinical benefits were to be proven.
This study aims at demonstrating that robotic trans-abdominal pre-peritoneal (rTAPP) primary ventral hernia repair leads to lower surgical site complication rate than the same procedure performed through standard open approach (OVHR), while being an acceptable solution from an economic, operative time and functional standpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic ventral hernia repair | Active comparator | Procedure: Robotic ventral hernia repair |
| Open ventral hernia repair | Active comparator | Procedure: Open ventral hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed Consent as documented by signature
- Aged 18 years or older
- Undergoing primary umbilical or epigastric hernia repair of size between 1cm and 5cm +/-5mm, with mesh reinforcement, in the Visceral Surgery Department of the University Geneva Hospital
Key exclusion criteria (11 listed)
- Patients under corticosteroids or other immunosuppressive treatment
- Pregnancy or breastfeeding
- Intention to become pregnant during the course of the study
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential
- Incisional hernia and/or substantial history of intra-abdominal surgery
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 ventral hernia repairLaparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement | Procedure or surgery | Robotic ventral hernia repair |
| Open ventral hernia repairStandard open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement | Procedure or surgery | Open ventral hernia repair |
Primary outcome
Surgical site complication
Time frame: At 31 days after surgery
Yes or no
11 secondary outcomes
Detailed surgical site complications
Time frame: At 31 days after surgery
General complications, not directly related to surgical site
Time frame: At 31 days after surgery
General pain: Visual Analogue Scale
Time frame: At 31 days after surgery
Painkillers consumption
Time frame: At 31 days after surgery
Esthetic satisfaction: European Hernia Society Quality of Life (EuraHS-QoL)
Time frame: At 31 days after surgery
Quality of life score
Time frame: At 31 days after surgery
In-hospital costs
Time frame: At day 31 after surgery
Out-hospital costs
Time frame: At day 31 after surgery
Early recurrence at 1 month
Time frame: At day 31 after surgery
Defect size
Time frame: During surgery
Number of device related adverse events by the operating surgeon
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 21904861Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9.
- Background: PubMed 26206646Holihan JL, Alawadi Z, Martindale RG, Roth JS, Wray CJ, Ko TC, Kao LS, Liang MK. Adverse Events after Ventral Hernia Repair: The Vicious Cycle of Complications. J Am Coll Surg. 2015 Aug;221(2):478-85. doi: 10.1016/j.jamcollsurg.2015.04.026. Epub 2015 May 9.
- Background: PubMed 21538150Bisgaard T, Kehlet H, Bay-Nielsen M, Iversen MG, Rosenberg J, Jorgensen LN. A nationwide study on readmission, morbidity, and mortality after umbilical and epigastric hernia repair. Hernia. 2011 Oct;15(5):541-6. doi: 10.1007/s10029-011-0823-z. Epub 2011 May 3.
- Background: PubMed 27399983Helgstrand F. National results after ventral hernia repair. Dan Med J. 2016 Jul;63(7):B5258.
- Background: PubMed 22965649Reynolds D, Davenport DL, Korosec RL, Roth JS. Financial implications of ventral hernia repair: a hospital cost analysis. J Gastrointest Surg. 2013 Jan;17(1):159-66; discussion p.166-7. doi: 10.1007/s11605-012-1999-y. Epub 2012 Sep 11.
- Background: PubMed 29032495Hajibandeh S, Hajibandeh S, Sreh A, Khan A, Subar D, Jones L. Laparoscopic versus open umbilical or paraumbilical hernia repair: a systematic review and meta-analysis. Hernia. 2017 Dec;21(6):905-916. doi: 10.1007/s10029-017-1683-y. Epub 2017 Oct 14.
- Background: PubMed 26091995Froylich D, Segal M, Weinstein A, Hatib K, Shiloni E, Hazzan D. Laparoscopic versus open ventral hernia repair in obese patients: a long-term follow-up. Surg Endosc. 2016 Feb;30(2):670-675. doi: 10.1007/s00464-015-4258-y. Epub 2015 Jun 20.
- Background: PubMed 20556448Muysoms FE, Bontinck J, Pletinckx P. Complications of mesh devices for intraperitoneal umbilical hernia repair: a word of caution. Hernia. 2011 Aug;15(4):463-8. doi: 10.1007/s10029-010-0692-x. Epub 2010 Jun 17.
- Background: PubMed 24005537Liang MK, Berger RL, Li LT, Davila JA, Hicks SC, Kao LS. Outcomes of laparoscopic vs open repair of primary ventral hernias. JAMA Surg. 2013 Nov;148(11):1043-8. doi: 10.1001/jamasurg.2013.3587.
- Background: PubMed 27546188Tandon A, Pathak S, Lyons NJ, Nunes QM, Daniels IR, Smart NJ. Meta-analysis of closure of the fascial defect during laparoscopic incisional and ventral hernia repair. Br J Surg. 2016 Nov;103(12):1598-1607. doi: 10.1002/bjs.10268. Epub 2016 Aug 22.
- Background: PubMed 19015918Hilling DE, Koppert LB, Keijzer R, Stassen LP, Oei IH. Laparoscopic correction of umbilical hernias using a transabdominal preperitoneal approach: results of a pilot study. Surg Endosc. 2009 Aug;23(8):1740-4. doi: 10.1007/s00464-008-0177-5. Epub 2008 Nov 18.
- Results publication: PubMed 23095614Colavita PD, Tsirline VB, Belyansky I, Walters AL, Lincourt AE, Sing RF, Heniford BT. Prospective, long-term comparison of quality of life in laparoscopic versus open ventral hernia repair. Ann Surg. 2012 Nov;256(5):714-22; discussion 722-3. doi: 10.1097/SLA.0b013e3182734130.
- 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.
Jonathan Douissard, MD principal investigator
University of Geneva, Geneva University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic ventral hernia repair and Open ventral hernia repair in people with Ventral Hernia, run by University of Geneva, Switzerland at 1 site in Switzerland.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 3 May 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 Switzerland. 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?
Results are not available in the source record.
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?
Surgical site complication (time frame: At 31 days after surgery). 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 NCT04171921, which also lists 13 linked publications.
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 3 May 2023.