UmbilicoplastyNCT02723409
Trial of Techniques for Umbilical Reconstruction
A study testing Round Procedure Umbilicoplasty, Scarless" round procedure and "Inverted U" Procedure in people with Umbilicoplasty, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Umbilicoplasty
- What is being tested?
- Round Procedure Umbilicoplasty, Scarless" round procedure and "Inverted U" Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Aug 2023
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Female patients undergoing abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps)
Who cannot join
- Patients with prior history of umbilicoplasty
- History of keloid formation
- Active smokers
- Body Mass Index (BMI) over 40
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Umbilicoplasty: A Randomized Controlled Trial of Techniques for Umbilical Reconstruction Following Abdominoplasty and Abdominally-based Free Tissue Transfer
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.
Read the detailed description
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:
- Round procedure
- "Scarless" round procedure
- "Inverted u" procedure
- "Inverted v" procedure, and
- "Y deepithelialized" procedure
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.
- Conditions
- Umbilicoplasty
- Being tested
- Round Procedure Umbilicoplasty, Scarless" round procedure, "Inverted U" Procedure, "Inverted V"Procedure, "Y deepithelialized" Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Round Procedure UmbilicoplastyProcedure or surgery
Umbilicoplasty surgery (belly button reshaping) is performed using the "Round Procedure"
Scarless" round procedureProcedure or surgery
Umbilicoplasty surgery (belly button reshaping) is performed using the "Scarless" round procedure
"Inverted U" ProcedureProcedure or surgery
Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted U" Procedure
"Inverted V"ProcedureProcedure or surgery
Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted V" Procedure
"Y deepithelialized" ProcedureProcedure or surgery
Umbilicoplasty surgery (belly button reshaping) is performed using the "Y deepithelialized" procedure
| Study group | Role | What they receive |
|---|---|---|
| Round Procedure | Active comparator | umbilicoplasty technique Receives: Procedure: Round Procedure Umbilicoplasty |
| "Scarless" round procedure | Active comparator | umbilicoplasty technique Receives: Procedure: Scarless" round procedure |
| "Inverted U" procedure | Active comparator | umbilicoplasty technique Receives: Procedure: "Inverted U" Procedure |
| "Inverted V" procedure | Active comparator | umbilicoplasty technique Receives: Procedure: "Inverted V"Procedure |
| Y deepithelialized" procedure | Active comparator | umbilicoplasty technique Receives: Procedure: "Y deepithelialized" Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measurement of patient assessment post-operative and pre-operative, using a VAS survey results with a positive result indicating a favorable outcome
Measured: Baseline, 12 Weeks
Assessment of inter-rater reliability among physicians in the assessment of the aesthetic outcomes of umbilical reconstruction.
Measured: 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).
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2023
- Study completionAug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UmbilicoplastyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VIshal Thanik, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723409
- Sponsor's protocol ID
- 15-00480
- Status last verified
- Sep 2023
- First submitted
- 8 Mar 2016
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilicoplasty: A Randomized Controlled Trial of Techniques for Umbilical Reconstruction Following Abdominoplasty and Abdominally-based Free Tissue Transfer
- ClinicalTrials.gov ID
- NCT02723409
- Acronym / sponsor ID
- 15-00480
- Conditions
- Umbilicoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2023 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 30 Mar 2016 (estimated)
- 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.
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.
Detailed description
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:
- Round procedure
- "Scarless" round procedure
- "Inverted u" procedure
- "Inverted v" procedure, and
- "Y deepithelialized" procedure
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Round Procedure | Active comparator | Procedure: Round Procedure Umbilicoplastyumbilicoplasty technique |
| "Scarless" round procedure | Active comparator | Procedure: Scarless" round procedureumbilicoplasty technique |
| "Inverted U" procedure | Active comparator | Procedure: "Inverted U" Procedureumbilicoplasty technique |
| "Inverted V" procedure | Active comparator | Procedure: "Inverted V"Procedureumbilicoplasty technique |
| Y deepithelialized" procedure | Active comparator | Procedure: "Y deepithelialized" Procedureumbilicoplasty technique |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed Informed Consent Form
- Female patients undergoing abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps)
Key exclusion criteria (4 listed)
- Patients with prior history of umbilicoplasty
- History of keloid formation
- Active smokers
- Body Mass Index (BMI) over 40
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 |
|---|---|---|
| Round Procedure UmbilicoplastyUmbilicoplasty surgery (belly button reshaping) is performed using the "Round Procedure" | Procedure or surgery | Round Procedure |
| Scarless" round procedureUmbilicoplasty surgery (belly button reshaping) is performed using the "Scarless" round procedure | Procedure or surgery | "Scarless" round procedure |
| "Inverted U" ProcedureUmbilicoplasty surgery (belly button reshaping) is performed using the "Inverted U" Procedure | Procedure or surgery | "Inverted U" procedure |
| "Inverted V"ProcedureUmbilicoplasty surgery (belly button reshaping) is performed using the "Inverted V" Procedure | Procedure or surgery | "Inverted V" procedure |
| "Y deepithelialized" ProcedureUmbilicoplasty surgery (belly button reshaping) is performed using the "Y deepithelialized" procedure | Procedure or surgery | Y deepithelialized" procedure |
Primary outcome
Change in measurement of patient assessment post-operative and pre-operative, using a VAS survey results with a positive result indicating a favorable outcome
Time frame: Baseline, 12 Weeks
Assessment of inter-rater reliability among physicians in the assessment of the aesthetic outcomes of umbilical reconstruction.
Time frame: 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).
Time frame: 12 Weeks
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 13 Sep 2023.
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.
VIshal Thanik, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Round Procedure Umbilicoplasty, Scarless" round procedure and "Inverted U" Procedure in people with Umbilicoplasty, run by NYU Langone Health 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 4 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 13 Sep 2023. 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?
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?
Change in measurement of patient assessment post-operative and pre-operative, using a VAS survey results with a positive result indicating a favorable outcome (time frame: Baseline, 12 Weeks). The study lists 3 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 13 Sep 2023.