N/A
N=70
The neoClose Abdominal Closure vs Carter-Thomason Trial
Surgical Port Site Hernia
Bottom Line
View on ClinicalTrials.gov: NCT02589171 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site — 2; 1.84 number of sutures
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neo Close Abdominal Closure (Device); Carter Thomason Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site |
2; 1.84 | — |
| PRIMARY Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site |
2; 1.83 | — |
| PRIMARY Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site |
20.95; 33.23 | — |
| PRIMARY Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site |
18.49; 28.63 | — |
| PRIMARY Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site |
3.2; 4.9 | — |
| PRIMARY Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively |
0; 0 | — |
| PRIMARY Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively |
0; 0 | — |
| PRIMARY Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively |
0; 0 | — |
| PRIMARY Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively |
0; 0 | — |
| SECONDARY Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale |
0; 0.07 | — |
| SECONDARY Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale |
0; 0.07 | — |
| SECONDARY Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale |
0; 0.07 | — |
| SECONDARY Pain at the Stapler Port Site as Assessed by a Visual Analog Scale |
0; 0 | — |
| SECONDARY Pain at the Stapler Port Site as Assessed by a Visual Analog Scale |
0; 0 | — |
| SECONDARY Pain at the Stapler Port Site as Assessed by a Visual Analog Scale |
0; 0 | — |
| SECONDARY Pain as Assessed by Number of Participants Who Took Pain Medications |
0; 1 | — |
| SECONDARY Pain as Assessed by Number of Participants Who Took Pain Medications |
0; 1 | — |
| SECONDARY Hospital Stay Duration |
2.12; 2.12 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Morbid obesity (BMI > 35).
- Completed multimodality pre operative evaluation (Psychology, Nutrition, Support Groups).
- Approved for robotic assisted laparoscopic gastric bypass.
Exclusion Criteria
- Previous midline laparotomy or weight loss procedure.
Data sourced from ClinicalTrials.gov (NCT02589171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.