Abdomen EnlargedNCT05361525
Lipoabdominoplasty With Anatomic Definition Versus Traditional Abdominoplasty
A study testing modified saldhana's technique and Traditional abdominoplasty in people with Abdomen Enlarged, run by Assiut University at 1 site in Egypt.
Trial summary
A tummy tuck also known as abdominoplasty is a cosmetic surgical procedure to improve the shape and appearance of the abdomen. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdomen Enlarged
- What is being tested?
- modified saldhana's technique and Traditional abdominoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 May 2024
- 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 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients between 25 to 60 with redundant abdominal wall.
- BMI less than 35.
Who cannot join
- Patients younger than 25 or older than 60.
- BMI more than 35.
- Hernias and scars interfering with abdominal vascularity.
- Patients smoking or with comorbidities (DM, HTN, ...etc).
- Patients seeking for another pregnancies.
- Any causes that may interfere with general anaesthesia. Refusal for any part of the written conset
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Asyut university hospital
Asyut, 75555
Mohamed Salah, 01028284928
About this study
A tummy tuck also known as abdominoplasty is a cosmetic surgical procedure to improve the shape and appearance of the abdomen.
Read the detailed description
Lipoabdominoplasty guarantees a safe combination of abdominoplasty and liposuction while minimizing the risk of ischemic flap complications. This is because of the limited undermining performed and the liposuction adjunct, both of which minimize perforator injury. In the last several years, the integration of anatomic definition through the use of liposuction has further refined the procedure, led to improved results, and increased patient satisfaction. The more natural results of the anatomic abdominal definition is a next step in abdominal contour refinement.
- Conditions
- Abdomen Enlarged
- Being tested
- modified saldhana's technique, Traditional abdominoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified saldhana's techniqueProcedure or surgery
tummy tuck with anatomic definition using liposuction
Traditional abdominoplastyProcedure or surgery
uses the traditional technique of abdominoplasty with liposuction with v-shaped dissection till the coastal margin
| Study group | Role | What they receive |
|---|---|---|
| Lipoabdominoplasty with anatomic definition | Active comparator | Lipoabdominoplasty with anatomic definition without over dissection on the lateral recti region Receives: Procedure: modified saldhana's technique |
| traditional abdominoplasty | Sham comparator | abdominoplasty with dissection in v- shaped pattern till coastal margin Receives: Procedure: Traditional abdominoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetically
natural look, patient satisfaction on scale (Rosenberg self esteem scale, it uses scale 0-30, where score less than 15 indicate low self esteem problem) with 10 items 6 months post operative and compare it with the preoperative results of the same patient, patient sexual satisfaction after 6 months in comparison with the preoperative results, doctors opinion and natural curves at the muscle insertion sites
Measured: 6 months post op
Secondary outcomes (1)
complications
the usual complications of abdominoplasty
Measured: up to 2 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 May 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdomen EnlargedStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah El Din Mohamed Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361525
- Sponsor's protocol ID
- Lipoabdominoplasty
- Status last verified
- Sep 2022
- First submitted
- 18 Apr 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Lipoadominoplasty with anatomin definition versus traditional abdominoplasty
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipoabdominoplasty With Anatomic Definition Versus Traditional Abdominoplasty
- ClinicalTrials.gov ID
- NCT05361525
- Acronym / sponsor ID
- Lipoabdominoplasty
- Conditions
- Abdomen Enlarged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 4 May 2022 (actual)
- 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.
A tummy tuck also known as abdominoplasty is a cosmetic surgical procedure to improve the shape and appearance of the abdomen.
Detailed description
Lipoabdominoplasty guarantees a safe combination of abdominoplasty and liposuction while minimizing the risk of ischemic flap complications. This is because of the limited undermining performed and the liposuction adjunct, both of which minimize perforator injury. In the last several years, the integration of anatomic definition through the use of liposuction has further refined the procedure, led to improved results, and increased patient satisfaction. The more natural results of the anatomic abdominal definition is a next step in abdominal contour refinement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipoabdominoplasty with anatomic definition | Active comparator | Procedure: modified saldhana's techniqueLipoabdominoplasty with anatomic definition without over dissection on the lateral recti region |
| traditional abdominoplasty | Sham comparator | Procedure: Traditional abdominoplastyabdominoplasty with dissection in v- shaped pattern till coastal margin |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female patients between 25 to 60 with redundant abdominal wall.
- BMI less than 35.
Key exclusion criteria (6 listed)
- Patients younger than 25 or older than 60.
- BMI more than 35.
- Hernias and scars interfering with abdominal vascularity.
- Patients smoking or with comorbidities (DM, HTN, ...etc).
- Patients seeking for another pregnancies.
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 |
|---|---|---|
| modified saldhana's techniquetummy tuck with anatomic definition using liposuction | Procedure or surgery | Lipoabdominoplasty with anatomic definition |
| Traditional abdominoplastyuses the traditional technique of abdominoplasty with liposuction with v-shaped dissection till the coastal margin | Procedure or surgery | traditional abdominoplasty |
Primary outcome
Aesthetically
Time frame: 6 months post op
natural look, patient satisfaction on scale (Rosenberg self esteem scale, it uses scale 0-30, where score less than 15 indicate low self esteem problem) with 10 items 6 months post operative and compare it with the preoperative results of the same patient, patient sexual satisfaction after 6 months in comparison with the preoperative results, doctors opinion and natural curves at the muscle insertion sites
1 secondary outcome
complications
Time frame: up to 2 weeks post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: Yes. Lipoadominoplasty with anatomin definition versus traditional abdominoplasty
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RecruitingObservational study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified saldhana's technique and Traditional abdominoplasty in people with Abdomen Enlarged, run by Assiut University at 1 site in Egypt.
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 6 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: status not confirmed, as of the sponsor's last update on 8 Sep 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Hassan (01028284928, mohamed_salah2012@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aesthetically (time frame: 6 months post op). 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 8 Sep 2022.