Surgical Port Site HerniaNCT02589171
The neoClose Abdominal Closure vs Carter-Thomason Trial
A study testing Neo Close Abdominal Closure and Carter Thomason Device in people with Surgical Port Site Hernia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare the neoClose abdominal closure to the standard Carter-Thomason closure in a bariatric surgery gastric bypass population. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgical Port Site Hernia
- What is being tested?
- Neo Close Abdominal Closure and Carter Thomason Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2016to 25 Apr 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Morbid obesity (BMI > 35).
- Completed multimodality pre operative evaluation (Psychology, Nutrition, Support Groups).
- Approved for robotic assisted laparoscopic gastric bypass.
Who cannot join
- Previous midline laparotomy or weight loss procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Randomized Trial Evaluating Effectiveness of neoClose Abdominal Closure Device Versus Carter-Thomason Needle Passer
The purpose of this study is to compare the neoClose abdominal closure to the standard Carter-Thomason closure in a bariatric surgery gastric bypass population.
Read the detailed description
Both the neoClose abdominal closure to the standard Carter-Thomason closure will be used to close 12 mm camera port sites and 12 mm stapler port sites upon completion of a robotic assisted laparoscopic gastric bypass. The procedure requires a 12 mm port site be placed in the midline approximately 3 cm cephalad to the umbilicus and a second 12mm port site in the right mid abdomen. Port sites will be closed as defined as the inability to palpate a fascial defect and the incision being air tight upon carbon dioxide insufflation.
- Conditions
- Surgical Port Site Hernia
- Being tested
- Neo Close Abdominal Closure, Carter Thomason Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo Close Abdominal ClosureDevice
Neo Close Abdominal Closure
Carter Thomason DeviceDevice
Carter Thomason Device
| Study group | Role | What they receive |
|---|---|---|
| Neo Close Abdominal Closure | Experimental | Not described Receives: Device: Neo Close Abdominal Closure |
| Carter Thomason Device | Active comparator | Not described Receives: Device: Carter Thomason Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site
Measured: at the time of surgery
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site
Measured: at the time of surgery
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site
Measured: at the time of surgery
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site
Measured: at the time of surgery
Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site
Measured: at the time of surgery
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Measured: immediately post op
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Measured: 1 week
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Measured: 6 weeks
Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively
Abdominal ultrasound will be used to detect port site hernia.
Measured: 6 weeks
Secondary outcomes (9)
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Measured: day 1
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Measured: 1 week
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Measured: 6 weeks
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Measured: day 1
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Measured: 1 week
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Measured: 6 weeks
Pain as Assessed by Number of Participants Who Took Pain Medications
Measured: week 1
Pain as Assessed by Number of Participants Who Took Pain Medications
Measured: week 6
Hospital Stay Duration
Measured: from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start12 Feb 2016
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
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.
- Other trials for Surgical Port Site HerniaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- NeoSurgical Limited
- Responsible party
- Principal investigator, Shinil Shah, The University of Texas Health Science Center, Houston
- Investigators
- Shinil Shah, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589171
- Sponsor's protocol ID
- HSC-MS-15-0668
- Status last verified
- Aug 2019
- First submitted
- 20 Oct 2015
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Evaluating Effectiveness of neoClose Abdominal Closure Device Versus Carter-Thomason Needle Passer
- ClinicalTrials.gov ID
- NCT02589171
- Acronym / sponsor ID
- HSC-MS-15-0668
- Conditions
- Surgical Port Site Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- NeoSurgical Limited
- Study start
- 12 Feb 2016 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Posted 15 Aug 2019
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 study is to compare the neoClose abdominal closure to the standard Carter-Thomason closure in a bariatric surgery gastric bypass population.
Detailed description
Both the neoClose abdominal closure to the standard Carter-Thomason closure will be used to close 12 mm camera port sites and 12 mm stapler port sites upon completion of a robotic assisted laparoscopic gastric bypass. The procedure requires a 12 mm port site be placed in the midline approximately 3 cm cephalad to the umbilicus and a second 12mm port site in the right mid abdomen. Port sites will be closed as defined as the inability to palpate a fascial defect and the incision being air tight upon carbon dioxide insufflation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neo Close Abdominal Closure | Experimental | Device: Neo Close Abdominal Closure |
| Carter Thomason Device | Active comparator | Device: Carter Thomason Device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Morbid obesity (BMI > 35).
- Completed multimodality pre operative evaluation (Psychology, Nutrition, Support Groups).
- Approved for robotic assisted laparoscopic gastric bypass.
Key exclusion criteria (1 listed)
- Previous midline laparotomy or weight loss procedure.
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 |
|---|---|---|
| Neo Close Abdominal ClosureNeo Close Abdominal Closure | Device | Neo Close Abdominal Closure |
| Carter Thomason DeviceCarter Thomason Device | Device | Carter Thomason Device |
Primary outcome
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site
Time frame: at the time of surgery
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site
Time frame: at the time of surgery
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site
Time frame: at the time of surgery
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site
Time frame: at the time of surgery
Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site
Time frame: at the time of surgery
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Time frame: immediately post op
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Time frame: 1 week
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Time frame: 6 weeks
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively
Time frame: 6 weeks
Abdominal ultrasound will be used to detect port site hernia.
9 secondary outcomes
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Time frame: day 1
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Time frame: 1 week
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Time frame: 6 weeks
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Time frame: day 1
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Time frame: 1 week
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Time frame: 6 weeks
Pain as Assessed by Number of Participants Who Took Pain Medications
Time frame: week 1
Pain as Assessed by Number of Participants Who Took Pain Medications
Time frame: week 6
Hospital Stay Duration
Time frame: from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
Related trials for Surgical Port Site Hernia
Recruiting
Robotic Single Port Ventral Hernia Repair
Ventral Hernia Repair
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, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neo Close Abdominal Closure and Carter Thomason Device in people with Surgical Port Site Hernia, run by The University of Texas Health Science Center, Houston 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 3 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 28 Aug 2019. 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 15 Aug 2019). 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?
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site (time frame: at the time of surgery). The study lists 9 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 28 Aug 2019.