Hernia, VentralNCT03490266
Robotic Versus Laparoscopic Ventral Hernia Repair
A study testing Robotic Repair and Laparoscopic Repair in people with Hernia, Ventral, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
Ventral hernias are a common disease and one half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias may be associated with significant morbidity, including surgical site infection, hernia recurrence and reoperation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- Robotic Repair and Laparoscopic Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Apr 2018to 12 May 2022
- 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
- -All patients undergoing elective ventral hernia repair deemed appropriate for minimally invasive repair.
Who cannot join
- Patients unlikely to survive beyond 2 years based upon surgeon judgment (e.g. advanced cirrhosis or metastatic cancer)
- Patients unlikely to follow-up (e.g. lives out of state or no phone)
- Advanced COPD or CHF
- History of open abdomen or extensive lysis of adhesions for bowel obstruction
- Ascites due to cirrhosis or malignancy
- Active infection such as infected mesh
- Ventral hernia size greater than 12 cm
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT Health-Memorial Hermann
Houston, Texas, 77024
UTHealth-Lyndon B. Johnson (LBJ) Hospital
Houston, Texas, 77026
About this study
Official title: Robotic Versus Laparoscopic Ventral Hernia Repair: A Multicenter Randomized Controlled Trial
Ventral hernias are a common disease and one half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias may be associated with significant morbidity, including surgical site infection, hernia recurrence and reoperation. Minimally invasive ventral hernia repair decreases rates of surgical site infection and hospital length of stay, without affecting recurrence, however the laparoscopic approach to ventral hernia repair accounts for only about 1/3 of all total hernia repairs performed in the US. Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair.
Read the detailed description
Ventral hernias are a common disease and one-half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias are associated with substantial morbidity including surgical site infection, hernia recurrence, and reoperation. Randomized controlled trials and nationwide databases have shown that minimally invasive ventral hernia repair (i.e. laparoscopic ventral hernia repair) as opposed to open ventral hernia repair is associated with decreased rates of surgical site infection and hospital length of stay with no impact on long-term outcomes of hernia recurrence.
Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair.
The growth of the robotic platform in surgery is growing exponentially. Despite this, the evidence supporting robotics remains limited. Studies demonstrating benefit such as improved outcomes or decreased hospital length of stay, are largely cohort studies subject to substantial bias. Among randomized controlled trials, none have demonstrated benefit with robotic surgery.
Recently, the America's Hernia Society (AHS) has endorsed robotic ventral hernia surgery. A series of studies published under the AHS Quality Collaborative (AHSQC) database have demonstrated improved outcomes with robotic ventral hernia repair when compared to open and laparoscopic surgery. However, the results of these studies remain hypothesis generating and randomized controlled trials are needed.
This study would represent among the first randomized controlled trials assessing the effect of robotic versus laparoscopic ventral hernia repair.
- Conditions
- Hernia, Ventral
- Being tested
- Robotic Repair, Laparoscopic Repair
- Keywords
- Ventral Hernia, Hernia 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
Also called da Vinci Si Surgical System, Endoscopic Instrument Control System, Model IS3000
The surgeon will be utilizing a robotic system to repair the hernia.
Laparoscopic RepairProcedure or surgery
The surgeon will be repairing the hernia laparoscopically.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Repair | Active comparator | The abdomen will be entered and insufflated utilizing a 5 mm optical port. Only 5 mm ports will be utilized laterally to take down all anterior abdominal wall adhesions. A mid-density polypropylene mesh with a one-sided adhesion barrier that provides at least 5 cm of overlap in all directions will be inserted through a 11 or 12 mm port placed through the defect. Excision of hernia sac and preperitoneal fat and defect closure will be performed per current practice. The mesh will be secured in four points with 0-PDS sutures and/or tacked with a double crown of tacks per our current practice. Receives: Procedure: Laparoscopic Repair |
| Robotic Repair | Experimental | Three lateral ports will be placed including a 12 port for the camera. Adhesions will be taken down from the anterior abdominal wall. Hernia sac and preperitoneal fat will be excised per current practice and defect will be closed using a running locking barbed suture. A mid-density polypropylene mesh with a one-sided adhesion barrier that provides at least 5 cm of overlap in all directions will be inserted through the 12 mm port. The mesh will be secured circumferentially with a running barbed suture. Receives: Procedure: Robotic Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of days in the hospital
Total number of days spent in the hospital. This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery. This information will be collected up to 90 days after the surgery.
Measured: 90 days post-operative
Secondary outcomes (6)
Surgical Site Infection (SSI)
CDC definition
Measured: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Surgical Site Occurrence (SSO)
Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam.
Measured: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Hernia Reoccurence
A hernia that was repaired in the past but has returned
Measured: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Patient centered outcomes
Collected using HerQLes
Measured: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Patient centered outcomes
Collected using EQ5D
Measured: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Cost from a healthcare perspective
Looking at differences in what is spent for robotic repair and laparoscopic repair of ventral hernias
Measured: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start3 Apr 2018
- Primary completion9 Apr 2020
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shinil Shah, The University of Texas Health Science Center, Houston
- Investigators
- Shinil Shah, DO, Principal investigator, UTHealth-Memorial HermannMike K Liang, MD, Principal investigator, UTHealth-Lyndon B. Johnson (LBJ) Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490266
- Sponsor's protocol ID
- HSC-MS-18-0137
- Status last verified
- May 2022
- First submitted
- 21 Mar 2018
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cherla DV, Moses ML, Viso CP, Holihan JL, Flores-Gonzalez JR, Kao LS, Ko TC, Liang MK. Impact of Abdominal Wall Hernias and Repair on Patient Quality of Life. World J Surg. 2018 Jan;42(1):19-25. doi: 10.1007/s00268-017-4173-6.
PubMed 28828517Liang MK, Holihan JL, Itani K, Alawadi ZM, Gonzalez JR, Askenasy EP, Ballecer C, Chong HS, Goldblatt MI, Greenberg JA, Harvin JA, Keith JN, Martindale RG, Orenstein S, Richmond B, Roth JS, Szotek P, Towfigh S, Tsuda S, Vaziri K, Berger DH. Ventral Hernia Management: Expert Consensus Guided by Systematic Review. Ann Surg. 2017 Jan;265(1):80-89. doi: 10.1097/SLA.0000000000001701.
PubMed 28009730Holihan 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 26206646Holihan JL, Hannon C, Goodenough C, Flores-Gonzalez JR, Itani KM, Olavarria O, Mo J, Ko TC, Kao LS, Liang MK. Ventral Hernia Repair: A Meta-Analysis of Randomized Controlled Trials. Surg Infect (Larchmt). 2017 Aug/Sep;18(6):647-658. doi: 10.1089/sur.2017.029. Epub 2017 May 30.
PubMed 28557648Holihan JL, Alawadi ZM, Harris JW, Harvin J, Shah SK, Goodenough CJ, Kao LS, Liang MK, Roth JS, Walker PA, Ko TC. Ventral hernia: Patient selection, treatment, and management. Curr Probl Surg. 2016 Jul;53(7):307-54. doi: 10.1067/j.cpsurg.2016.06.003. Epub 2016 Jun 18. No abstract available.
PubMed 27569431Carbonell AM, Warren JA, Prabhu AS, Ballecer CD, Janczyk RJ, Herrera J, Huang LC, Phillips S, Rosen MJ, Poulose BK. Reducing Length of Stay Using a Robotic-assisted Approach for Retromuscular Ventral Hernia Repair: A Comparative Analysis From the Americas Hernia Society Quality Collaborative. Ann Surg. 2018 Feb;267(2):210-217. doi: 10.1097/SLA.0000000000002244.
PubMed 28350568Prabhu AS, Dickens EO, Copper CM, Mann JW, Yunis JP, Phillips S, Huang LC, Poulose BK, Rosen MJ. Laparoscopic vs Robotic Intraperitoneal Mesh Repair for Incisional Hernia: An Americas Hernia Society Quality Collaborative Analysis. J Am Coll Surg. 2017 Aug;225(2):285-293. doi: 10.1016/j.jamcollsurg.2017.04.011. Epub 2017 Apr 24.
PubMed 28450062Prete FP, Pezzolla A, Prete F, Testini M, Marzaioli R, Patriti A, Jimenez-Rodriguez RM, Gurrado A, Strippoli GFM. Robotic Versus Laparoscopic Minimally Invasive Surgery for Rectal Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Ann Surg. 2018 Jun;267(6):1034-1046. doi: 10.1097/SLA.0000000000002523.
PubMed 28984644Tasiopoulou VS, Svokos AA, Svokos KA, Zacharoulis D, Magouliotis DE. Robotic versus laparoscopic sleeve gastrectomy: a review of the current evidence. Minerva Chir. 2018 Feb;73(1):55-63. doi: 10.23736/S0026-4733.17.07583-6. Epub 2017 Dec 14.
PubMed 29243456Ilic D, Evans SM, Allan CA, Jung JH, Murphy D, Frydenberg M. Laparoscopic and robotic-assisted versus open radical prostatectomy for the treatment of localised prostate cancer. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD009625. doi: 10.1002/14651858.CD009625.pub2.
PubMed 28895658Coakley KM, Sims SM, Prasad T, Lincourt AE, Augenstein VA, Sing RF, Heniford BT, Colavita PD. A nationwide evaluation of robotic ventral hernia surgery. Am J Surg. 2017 Dec;214(6):1158-1163. doi: 10.1016/j.amjsurg.2017.08.022. Epub 2017 Sep 20.
PubMed 29017732Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, Dietz UA, Eker HH, El Nakadi I, Hauters P, Hidalgo Pascual M, Hoeferlin A, Klinge U, Montgomery A, Simmermacher RK, Simons MP, Smietanski M, Sommeling C, Tollens T, Vierendeels T, Kingsnorth A. Classification of primary and incisional abdominal wall hernias. Hernia. 2009 Aug;13(4):407-14. doi: 10.1007/s10029-009-0518-x. Epub 2009 Jun 3.
PubMed 19495920Dhanani NH, Lyons NB, Olavarria OA, Bernardi K, Holihan JL, Shah SK, Wilson TD, Loor MM, Kao LS, Liang MK. Robotic Versus Laparoscopic Ventral Hernia Repair: Two-Year Results From a Prospective, Multicenter, Blinded Randomized Clinical Trial. Ann Surg. 2023 Aug 1;278(2):161-165. doi: 10.1097/SLA.0000000000005903. Epub 2023 May 19.
PubMed 37203558Dhanani NH, Olavarria OA, Holihan JL, Shah SK, Wilson TD, Loor MM, Ko TC, Kao LS, Liang MK. Robotic Versus Laparoscopic Ventral Hernia Repair: One-year Results From a Prospective, Multicenter, Blinded Randomized Controlled Trial. Ann Surg. 2021 Jun 1;273(6):1076-1080. doi: 10.1097/SLA.0000000000004795.
PubMed 33630447Olavarria OA, Bernardi K, Shah SK, Wilson TD, Wei S, Pedroza C, Avritscher EB, Loor MM, Ko TC, Kao LS, Liang MK. Robotic versus laparoscopic ventral hernia repair: multicenter, blinded randomized controlled trial. BMJ. 2020 Jul 14;370:m2457. doi: 10.1136/bmj.m2457.
PubMed 32665218
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Laparoscopic Ventral Hernia Repair: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03490266
- Acronym / sponsor ID
- HSC-MS-18-0137
- Conditions
- Hernia, Ventral
- Keywords
- Ventral Hernia, Hernia Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 9 Apr 2020 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 6 Apr 2018 (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.
Ventral hernias are a common disease and one half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias may be associated with significant morbidity, including surgical site infection, hernia recurrence and reoperation. Minimally invasive ventral hernia repair decreases rates of surgical site infection and hospital length of stay, without affecting recurrence, however the laparoscopic approach to ventral hernia repair accounts for only about 1/3 of all total hernia repairs performed in the US. Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair.
Detailed description
Ventral hernias are a common disease and one-half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias are associated with substantial morbidity including surgical site infection, hernia recurrence, and reoperation. Randomized controlled trials and nationwide databases have shown that minimally invasive ventral hernia repair (i.e. laparoscopic ventral hernia repair) as opposed to open ventral hernia repair is associated with decreased rates of surgical site infection and hospital length of stay with no impact on long-term outcomes of hernia recurrence.
Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair.
The growth of the robotic platform in surgery is growing exponentially. Despite this, the evidence supporting robotics remains limited. Studies demonstrating benefit such as improved outcomes or decreased hospital length of stay, are largely cohort studies subject to substantial bias. Among randomized controlled trials, none have demonstrated benefit with robotic surgery.
Recently, the America's Hernia Society (AHS) has endorsed robotic ventral hernia surgery. A series of studies published under the AHS Quality Collaborative (AHSQC) database have demonstrated improved outcomes with robotic ventral hernia repair when compared to open and laparoscopic surgery. However, the results of these studies remain hypothesis generating and randomized controlled trials are needed.
This study would represent among the first randomized controlled trials assessing the effect of robotic versus laparoscopic ventral hernia repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Repair | Active comparator | Procedure: Laparoscopic RepairThe abdomen will be entered and insufflated utilizing a 5 mm optical port. Only 5 mm ports will be utilized laterally to take down all anterior abdominal wall adhesions. A mid-density polypropylene mesh with a one-sided adhesion barrier that provides at least 5 cm of overlap in all directions will be inserted through a 11 or 12 mm port placed through the defect. Excision of hernia sac and preperitoneal fat and defect closure will be performed per current practice. The mesh will be secured in four points with 0-PDS sutures and/or tacked with a double crown of tacks per our current practice. |
| Robotic Repair | Experimental | Procedure: Robotic RepairThree lateral ports will be placed including a 12 port for the camera. Adhesions will be taken down from the anterior abdominal wall. Hernia sac and preperitoneal fat will be excised per current practice and defect will be closed using a running locking barbed suture. A mid-density polypropylene mesh with a one-sided adhesion barrier that provides at least 5 cm of overlap in all directions will be inserted through the 12 mm port. The mesh will be secured circumferentially with a running barbed suture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -All patients undergoing elective ventral hernia repair deemed appropriate for minimally invasive repair.
Key exclusion criteria (7 listed)
- Patients unlikely to survive beyond 2 years based upon surgeon judgment (e.g. advanced cirrhosis or metastatic cancer)
- Patients unlikely to follow-up (e.g. lives out of state or no phone)
- Advanced COPD or CHF
- History of open abdomen or extensive lysis of adhesions for bowel obstruction
- Ascites due to cirrhosis or malignancy
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 RepairAlso: da Vinci Si Surgical System, Endoscopic Instrument Control System, Model IS3000The surgeon will be utilizing a robotic system to repair the hernia. | Procedure or surgery | Robotic Repair |
| Laparoscopic RepairThe surgeon will be repairing the hernia laparoscopically. | Procedure or surgery | Laparoscopic Repair |
Primary outcome
Total number of days in the hospital
Time frame: 90 days post-operative
Total number of days spent in the hospital. This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery. This information will be collected up to 90 days after the surgery.
6 secondary outcomes
Surgical Site Infection (SSI)
Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Surgical Site Occurrence (SSO)
Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Hernia Reoccurence
Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Patient centered outcomes
Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Patient centered outcomes
Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Cost from a healthcare perspective
Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
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 25 May 2022.
- Background: PubMed 28828517Cherla DV, Moses ML, Viso CP, Holihan JL, Flores-Gonzalez JR, Kao LS, Ko TC, Liang MK. Impact of Abdominal Wall Hernias and Repair on Patient Quality of Life. World J Surg. 2018 Jan;42(1):19-25. doi: 10.1007/s00268-017-4173-6.
- Background: PubMed 28009730Liang MK, Holihan JL, Itani K, Alawadi ZM, Gonzalez JR, Askenasy EP, Ballecer C, Chong HS, Goldblatt MI, Greenberg JA, Harvin JA, Keith JN, Martindale RG, Orenstein S, Richmond B, Roth JS, Szotek P, Towfigh S, Tsuda S, Vaziri K, Berger DH. Ventral Hernia Management: Expert Consensus Guided by Systematic Review. Ann Surg. 2017 Jan;265(1):80-89. doi: 10.1097/SLA.0000000000001701.
- 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 28557648Holihan JL, Hannon C, Goodenough C, Flores-Gonzalez JR, Itani KM, Olavarria O, Mo J, Ko TC, Kao LS, Liang MK. Ventral Hernia Repair: A Meta-Analysis of Randomized Controlled Trials. Surg Infect (Larchmt). 2017 Aug/Sep;18(6):647-658. doi: 10.1089/sur.2017.029. Epub 2017 May 30.
- Background: PubMed 27569431Holihan JL, Alawadi ZM, Harris JW, Harvin J, Shah SK, Goodenough CJ, Kao LS, Liang MK, Roth JS, Walker PA, Ko TC. Ventral hernia: Patient selection, treatment, and management. Curr Probl Surg. 2016 Jul;53(7):307-54. doi: 10.1067/j.cpsurg.2016.06.003. Epub 2016 Jun 18. No abstract available.
- Background: PubMed 28350568Carbonell AM, Warren JA, Prabhu AS, Ballecer CD, Janczyk RJ, Herrera J, Huang LC, Phillips S, Rosen MJ, Poulose BK. Reducing Length of Stay Using a Robotic-assisted Approach for Retromuscular Ventral Hernia Repair: A Comparative Analysis From the Americas Hernia Society Quality Collaborative. Ann Surg. 2018 Feb;267(2):210-217. doi: 10.1097/SLA.0000000000002244.
- Background: PubMed 28450062Prabhu AS, Dickens EO, Copper CM, Mann JW, Yunis JP, Phillips S, Huang LC, Poulose BK, Rosen MJ. Laparoscopic vs Robotic Intraperitoneal Mesh Repair for Incisional Hernia: An Americas Hernia Society Quality Collaborative Analysis. J Am Coll Surg. 2017 Aug;225(2):285-293. doi: 10.1016/j.jamcollsurg.2017.04.011. Epub 2017 Apr 24.
- Background: PubMed 28984644Prete FP, Pezzolla A, Prete F, Testini M, Marzaioli R, Patriti A, Jimenez-Rodriguez RM, Gurrado A, Strippoli GFM. Robotic Versus Laparoscopic Minimally Invasive Surgery for Rectal Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Ann Surg. 2018 Jun;267(6):1034-1046. doi: 10.1097/SLA.0000000000002523.
- Background: PubMed 29243456Tasiopoulou VS, Svokos AA, Svokos KA, Zacharoulis D, Magouliotis DE. Robotic versus laparoscopic sleeve gastrectomy: a review of the current evidence. Minerva Chir. 2018 Feb;73(1):55-63. doi: 10.23736/S0026-4733.17.07583-6. Epub 2017 Dec 14.
- Background: PubMed 28895658Ilic D, Evans SM, Allan CA, Jung JH, Murphy D, Frydenberg M. Laparoscopic and robotic-assisted versus open radical prostatectomy for the treatment of localised prostate cancer. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD009625. doi: 10.1002/14651858.CD009625.pub2.
- Background: PubMed 29017732Coakley KM, Sims SM, Prasad T, Lincourt AE, Augenstein VA, Sing RF, Heniford BT, Colavita PD. A nationwide evaluation of robotic ventral hernia surgery. Am J Surg. 2017 Dec;214(6):1158-1163. doi: 10.1016/j.amjsurg.2017.08.022. Epub 2017 Sep 20.
- Background: PubMed 19495920Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, Dietz UA, Eker HH, El Nakadi I, Hauters P, Hidalgo Pascual M, Hoeferlin A, Klinge U, Montgomery A, Simmermacher RK, Simons MP, Smietanski M, Sommeling C, Tollens T, Vierendeels T, Kingsnorth A. Classification of primary and incisional abdominal wall hernias. Hernia. 2009 Aug;13(4):407-14. doi: 10.1007/s10029-009-0518-x. Epub 2009 Jun 3.
- 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.
Shinil Shah, DO principal investigator
UTHealth-Memorial Hermann
Mike K Liang, MD principal investigator
UTHealth-Lyndon B. Johnson (LBJ) Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Repair and Laparoscopic Repair in people with Hernia, Ventral, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
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 7 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 25 May 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 United States. 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?
Total number of days in the hospital (time frame: 90 days post-operative). 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 NCT03490266, which also lists 15 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 25 May 2022.