Hernia, InguinalNCT01825187
Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias
A study testing ULTRAPRO Mesh, 3DMAX and Evaluation in people with Hernia, Inguinal, run by South East Area Health Education Center, Wilmington, NC at 1 site in United States.
Trial summary
The purpose of this research study is to measure the clinical effectiveness of two different polypropylene meshes used for laparoscopic inguinal hernias by evaluating subjects' length of hospital stay, perioperative complications, recurrence rate, pain score, comfort level and postoperative quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- ULTRAPRO Mesh, 3DMAX and Evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects undergoing laparoscopic repair for the treatment of either single or bilateral inguinal hernias
- All surgical residents at New Hanover Regional Medical Center
Who cannot join
- Subjects requiring emergency surgery
- Pregnant subjects
- Subjects under the age of 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
About this study
Official title: Prospective Randomized Controlled Trial Comparing Resident Performance and Clinical Outcomes With Two Different Polypropylene Meshes for Laparoscopic Inguinal Hernias
The purpose of this research study is to measure the clinical effectiveness of two different polypropylene meshes used for laparoscopic inguinal hernias by evaluating subjects' length of hospital stay, perioperative complications, recurrence rate, pain score, comfort level and postoperative quality of life. A secondary goal of the study is to evaluate the ease of use and time it takes surgical residents to place the mesh and perform the surgery using these two different meshes.
Read the detailed description
Inguinal hernia repair is one of the most common operations performed by general surgeons in the world. There are two main ways to repair an inguinal hernia, open or laparoscopic. Open compared to laparoscopic, is more invasive and leads to more scarring and longer recovery periods. Laparoscopic repair is done by making a small cut in or just below the umbilicus and has become an accepted standard for inguinal hernia repair and has become the technique of choice for recurrent inguinal hernias.
During laparoscopic repair, the placement of a prosthetic mesh aids in reinforcing the abdominal wall and allowing for tension free repair. Meshes also helps to lower the recurrence rate. The most safe and effective type of mesh prosthesis currently being used in laparoscopic inguinal hernia repairs are polypropylene meshes. There is some emerging evidence that "lighter weight" forms of polypropylene meshes may improve quality of life outcomes following surgery for inguinal hernias. Further evaluation is needed to support this evidence.
- Conditions
- Hernia, Inguinal
- Being tested
- ULTRAPRO Mesh, 3DMAX, Evaluation
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRAPRO MeshDevice
Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair
3DMAXDevice
Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair
EvaluationOther
To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Active comparator | Patients in this group will be randomized to receive the ULTRAPRO mesh Receives: Device: ULTRAPRO Mesh |
| Treatment Group 2 | Active comparator | Patients in this group will be randomized to receive the 3DMAX Mesh Receives: Device: 3DMAX |
| Evaluation of Surgical Residents | Other | Surgical residents will be evaluated on the ease of use and the amount of time it takes for them to perform the surgery using these two different meshes. Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inguinal Hernia Mesh Insertion Times
The primary outcome measure was a comparison of mesh insertion times and were tested using a 2 × 2 ANOVA on the ranked times. Timing of the mesh placement was documented, which included time from mesh insertion in the trocar until completion of mesh fixation. Laparoscopic fixation was performed by placing four tacks; two in the pubic bone, one medial, and one lateral on the upper portion of the mesh. The types of tacks used were AbsorbaTack™ (Medtronics), sutures, CapSure™ (CR Bard) and OptiFix™ (CR Bard). Timing of mesh placement in robotic repairs included mesh placement and the time to place three suture fixation points; one at the pubis, one at the anterior, and 1 at the lateral abdominal wall at the top of the mesh.
Measured: During the procedure an average of an hour
Secondary outcomes (1)
NASA TLX Survey Index Scores
Following surgery, the Hart and Staveland's NASA Task Load Index (TLX) survey was completed by the surgeon to evaluate the surgeon's perceived difficulty and success of the operation. Scale ranges from very low (0) to very high (20) on a 20 point scale (0-20 points). For all outcome measures except performance, 0 indicates the worst outcome and 20 indicates the best outcome. For performance, 0 indicates perfect and 20 indicates failure.
Measured: During procedure an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startJun 2014
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies 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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- South East Area Health Education Center, Wilmington, NC
- Sponsor type
- University, hospital or other
- Collaborators
- New Hanover Regional Medical Center
- Responsible party
- Principal investigator, William Hope, South East Area Health Education Center, Wilmington, NC
- Investigators
- William W Hope, MD, Principal investigator, South East Area Health Education Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825187
- Sponsor's protocol ID
- 1302-1
- Status last verified
- Jun 2022
- First submitted
- 8 Mar 2013
- Last updated
- 14 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bilezikian JA, Tenzel PL, Johnson RG, Powers WF 4th, Hope WW. A preliminary evaluation of two different meshes in minimally invasive inguinal hernia surgery. Surg Endosc. 2021 Mar;35(3):1342-1347. doi: 10.1007/s00464-020-07512-9. Epub 2020 Mar 30.
PubMed 32232645
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Comparing Resident Performance and Clinical Outcomes With Two Different Polypropylene Meshes for Laparoscopic Inguinal Hernias
- ClinicalTrials.gov ID
- NCT01825187
- Acronym / sponsor ID
- 1302-1
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- South East Area Health Education Center, Wilmington, NCUniversity, hospital or other
- Collaborators
- New Hanover Regional Medical Center
- Study start
- Jun 2014
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Posted 14 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to measure the clinical effectiveness of two different polypropylene meshes used for laparoscopic inguinal hernias by evaluating subjects' length of hospital stay, perioperative complications, recurrence rate, pain score, comfort level and postoperative quality of life. A secondary goal of the study is to evaluate the ease of use and time it takes surgical residents to place the mesh and perform the surgery using these two different meshes.
Detailed description
Inguinal hernia repair is one of the most common operations performed by general surgeons in the world. There are two main ways to repair an inguinal hernia, open or laparoscopic. Open compared to laparoscopic, is more invasive and leads to more scarring and longer recovery periods. Laparoscopic repair is done by making a small cut in or just below the umbilicus and has become an accepted standard for inguinal hernia repair and has become the technique of choice for recurrent inguinal hernias.
During laparoscopic repair, the placement of a prosthetic mesh aids in reinforcing the abdominal wall and allowing for tension free repair. Meshes also helps to lower the recurrence rate. The most safe and effective type of mesh prosthesis currently being used in laparoscopic inguinal hernia repairs are polypropylene meshes. There is some emerging evidence that "lighter weight" forms of polypropylene meshes may improve quality of life outcomes following surgery for inguinal hernias. Further evaluation is needed to support this evidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Active comparator | Device: ULTRAPRO MeshPatients in this group will be randomized to receive the ULTRAPRO mesh |
| Treatment Group 2 | Active comparator | Device: 3DMAXPatients in this group will be randomized to receive the 3DMAX Mesh |
| Evaluation of Surgical Residents | Other | Other: EvaluationSurgical residents will be evaluated on the ease of use and the amount of time it takes for them to perform the surgery using these two different meshes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects undergoing laparoscopic repair for the treatment of either single or bilateral inguinal hernias
- All surgical residents at New Hanover Regional Medical Center
Key exclusion criteria (3 listed)
- Subjects requiring emergency surgery
- Pregnant subjects
- Subjects under the age of 18 years of age
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 |
|---|---|---|
| ULTRAPRO MeshPatients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair | Device | Treatment Group 1 |
| 3DMAXPatients who are randomized to this group will receive 3DMAX mesh for their hernia repair | Device | Treatment Group 2 |
| EvaluationTo evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes. | Other | Evaluation of Surgical Residents |
Primary outcome
Inguinal Hernia Mesh Insertion Times
Time frame: During the procedure an average of an hour
The primary outcome measure was a comparison of mesh insertion times and were tested using a 2 × 2 ANOVA on the ranked times. Timing of the mesh placement was documented, which included time from mesh insertion in the trocar until completion of mesh fixation. Laparoscopic fixation was performed by placing four tacks; two in the pubic bone, one medial, and one lateral on the upper portion of the mesh. The types of tacks used were AbsorbaTack™ (Medtronics), sutures, CapSure™ (CR Bard) and OptiFix™ (CR Bard). Timing of mesh placement in robotic repairs included mesh placement and the time to place three suture fixation points; one at the pubis, one at the anterior, and 1 at the lateral abdominal wall at the top of the mesh.
1 secondary outcome
NASA TLX Survey Index Scores
Time frame: During procedure an average of 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32232645Bilezikian JA, Tenzel PL, Johnson RG, Powers WF 4th, Hope WW. A preliminary evaluation of two different meshes in minimally invasive inguinal hernia surgery. Surg Endosc. 2021 Mar;35(3):1342-1347. doi: 10.1007/s00464-020-07512-9. Epub 2020 Mar 30.
- 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.
William W Hope, MD principal investigator
South East Area Health Education Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ULTRAPRO Mesh, 3DMAX and Evaluation in people with Hernia, Inguinal, run by South East Area Health Education Center, Wilmington, NC at 1 site 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 2 inclusion and 3 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 14 Jun 2022. 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 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?
Yes. Results are posted in the registry (first posted 14 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Inguinal Hernia Mesh Insertion Times (time frame: During the procedure an average of an hour). 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 NCT01825187, 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 14 Jun 2022.