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The primary objective of the study will be to determine which of five traditionally used umbilical reconstructive techniques offers superior aesthetic results. Additionally, secondary objectives of post-operative complications such as hypertrophic scar formation will also be measured.
This is a five arm, prospective, randomized, trial. Patients undergoing abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps) at NYU Medical Center will be randomly assigned to receive one of five conventionally used umbilicoplasty techniques during the course of their surgery:
As there has not yet been a superiority or inferiority comparison of these five methods, no patient will be receiving substandard care by randomization to one of the five procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Round Procedure | Active Comparator | umbilicoplasty technique |
|
| "Scarless" round procedure | Active Comparator | umbilicoplasty technique |
|
| "Inverted U" procedure | Active Comparator | umbilicoplasty technique |
|
| "Inverted V" procedure | Active Comparator | umbilicoplasty technique |
|
| Y deepithelialized" procedure | Active Comparator | umbilicoplasty technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Round Procedure Umbilicoplasty | Procedure | Umbilicoplasty surgery (belly button reshaping) is performed using the "Round Procedure" |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in measurement of patient assessment post-operative and pre-operative, using a VAS survey results with a positive result indicating a favorable outcome | Baseline, 12 Weeks | |
| Assessment of inter-rater reliability among physicians in the assessment of the aesthetic outcomes of umbilical reconstruction. | 12 Weeks | |
| Comparison of aesthetic outcomes of umbilical reconstruction using five accepted techniques for umbilicoplasty following abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps). | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| VIshal Thanik, MD | New York University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| Scarless" round procedure | Procedure | Umbilicoplasty surgery (belly button reshaping) is performed using the "Scarless" round procedure |
|
| "Inverted U" Procedure | Procedure | Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted U" Procedure |
|
| "Inverted V"Procedure | Procedure | Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted V" Procedure |
|
| "Y deepithelialized" Procedure | Procedure | Umbilicoplasty surgery (belly button reshaping) is performed using the "Y deepithelialized" procedure |
|