Disorder of AbdomenPhase 4NCT02674035
Plication of the Rectus Abdominis in Two Planes and in One Continuous Suture Plan
A Phase 4 study testing Correction of diastasis of the rectus abdominis muscles in people with Disorder of Abdomen, run by Luiz Jose Muaccad Gama at 1 site in Brazil.
Trial summary
Thirty women with similar abdominal deformities, who had had at least one pregnancy, were randomized into three groups to undergo abdominoplasty. Plication of the anterior rectus sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in a single layer with either a continuous 2-0… Read more about this study
- Who is it for?
- Ages 25 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Disorder of Abdomen
- What is being tested?
- Correction of diastasis of the rectus abdominis muscles
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2012to Jun 2014
- Phase
- Phase 4
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female gender
- Age: 25 to 50 years of age
- History of at least one pregnancy
- Body mass index (BMI) between 18 and 30 kg/m2
- Desire to undergo abdominoplasty as a single procedure without receiving liposuction or other cosmetic surgeries
- Deformities of the skin and subcutaneous tissues in the abdominal region
- Musculoaponeurotic defect
Who cannot join
- Smoking habit;
- Abdominal wall scar (except for a Pfannenstiel scar related to a Cesarean section);
- Abdominal wall hérnias;
- History of deep-vein thrombosis;
- Chronic obstructive pulmonary disease;
- Câncer;
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- Hypertension;
- Diabetes or other chronic systemic diseases;
- Use of corticosteroids.
- Patients lost to follow-up and those who did not undergo ultrasound examination were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Thirty women with similar abdominal deformities, who had had at least one pregnancy, were randomized into three groups to undergo abdominoplasty. Plication of the anterior rectus sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in a single layer with either a continuous 2-0 monofilament nylon suture (group I) or using a continuous barbed suture (group II). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels.
Read the detailed description
Inclusion criteria were female gender; 25 to 50 years of age; history of at least one pregnancy; body mass index (BMI) between 18 and 30 kg/m2; desire to undergo abdominoplasty as a single procedure without receiving liposuction or other cosmetic surgeries; deformities of the skin and subcutaneous tissues in the abdominal region; and musculoaponeurotic defect.
Non-inclusion criteria were smoking habit; abdominal wall scar (except for a Pfannenstiel scar related to a Cesarean section); abdominal wall hérnias; history of deep-vein thrombosis; chronic obstructive pulmonary disease; câncer; hypertension; diabetes or other chronic systemic diseases; and use of corticosteroids. Patients lost to follow-up and those who did not undergo ultrasound examination were excluded from the study.
Primary outcome: Get a technique that provides a safe correction with lasting results and in every segment of time.
Secondary clinical outcome: confirms the plication of a single layer as positive in women patients at two years of surgery compared to two planes.
- Conditions
- Disorder of Abdomen
- Being tested
- Correction of diastasis of the rectus abdominis muscles
- Keywords
- Abdominoplasty, Sutures, Abdominal deformities, Plication, Monofilament nylon suture, Barbed suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correction of diastasis of the rectus abdominis musclesProcedure or surgery
Also called Abdominoplasty
Thirty women with similar abdominal deformities, who had had at least one pregnancy, were randomized into three groups to undergo abdominoplasty. Plication of the anterior rectus sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in a single layer with either a continuous 2-0 monofilament nylon suture (group I) or using a continuous barbed suture (group II). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels.
| Study group | Role | What they receive |
|---|---|---|
| Device: 2-0 monofilament nylon suture | Active comparator | Plication of the anterior rectus sheath (correction of diastasis of the rectus abdominis muscles) was performed in two layers with Device 2-0 monofilament nylon suture (control group). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels. Receives: Procedure: Correction of diastasis of the rectus abdominis muscles |
| Device: Single layer 2-0 monofilament | Active comparator | Single layer with a Device 2-0 monofilament nylon suture (correction of diastasis of the rectus abdominis muscles) (group I). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels. Receives: Procedure: Correction of diastasis of the rectus abdominis muscles |
| Device: Barbed suture Quill Nylon 1 | Active comparator | Using a continuous Device Barbed suture Quill Nylon 1 (correction of diastasis of the rectus abdominis muscles) (group II). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels. Receives: Procedure: Correction of diastasis of the rectus abdominis muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of diastasis of the rectus abdominis muscles
Get a technique that provides a safe abdominoplasty correction with lasting results and in every segment of time.
Measured: Compare from the baseline the efficacy and time required to correct the diastasis at 3 weeks
Secondary outcomes (1)
Follow-up of diastasis of the rectus abdominis muscles
Confirms the plication of a single layer abdominoplasty as positive in women patients at six months of surgery compared to two planes.
Measured: At six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of AbdomenStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luiz Jose Muaccad Gama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luiz Jose Muaccad Gama, Federal University of São Paulo
- Investigators
- Luiz José Muaccad Gama, MD, Principal investigator, Universidade Federal de São Paulo - UNIFESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674035
- Sponsor's protocol ID
- U1111-1175-1484
- Status last verified
- Feb 2016
- First submitted
- 8 Nov 2015
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plication of the Rectus Abdominis in Two Planes and in One Continuous Suture Plan
- ClinicalTrials.gov ID
- NCT02674035
- Acronym / sponsor ID
- U1111-1175-1484
- Conditions
- Disorder of Abdomen
- Keywords
- Abdominoplasty, Sutures, Abdominal deformities, Plication, Monofilament nylon suture, Barbed suture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Luiz Jose Muaccad GamaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Feb 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.
Thirty women with similar abdominal deformities, who had had at least one pregnancy, were randomized into three groups to undergo abdominoplasty. Plication of the anterior rectus sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in a single layer with either a continuous 2-0 monofilament nylon suture (group I) or using a continuous barbed suture (group II). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels.
Detailed description
Inclusion criteria were female gender; 25 to 50 years of age; history of at least one pregnancy; body mass index (BMI) between 18 and 30 kg/m2; desire to undergo abdominoplasty as a single procedure without receiving liposuction or other cosmetic surgeries; deformities of the skin and subcutaneous tissues in the abdominal region; and musculoaponeurotic defect.
Non-inclusion criteria were smoking habit; abdominal wall scar (except for a Pfannenstiel scar related to a Cesarean section); abdominal wall hérnias; history of deep-vein thrombosis; chronic obstructive pulmonary disease; câncer; hypertension; diabetes or other chronic systemic diseases; and use of corticosteroids. Patients lost to follow-up and those who did not undergo ultrasound examination were excluded from the study.
Primary outcome: Get a technique that provides a safe correction with lasting results and in every segment of time.
Secondary clinical outcome: confirms the plication of a single layer as positive in women patients at two years of surgery compared to two planes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Device: 2-0 monofilament nylon suture | Active comparator | Procedure: Correction of diastasis of the rectus abdominis musclesPlication of the anterior rectus sheath (correction of diastasis of the rectus abdominis muscles) was performed in two layers with Device 2-0 monofilament nylon suture (control group). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels. |
| Device: Single layer 2-0 monofilament | Active comparator | Procedure: Correction of diastasis of the rectus abdominis musclesSingle layer with a Device 2-0 monofilament nylon suture (correction of diastasis of the rectus abdominis muscles) (group I). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels. |
| Device: Barbed suture Quill Nylon 1 | Active comparator | Procedure: Correction of diastasis of the rectus abdominis musclesUsing a continuous Device Barbed suture Quill Nylon 1 (correction of diastasis of the rectus abdominis muscles) (group II). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels. |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female gender
- Age: 25 to 50 years of age
- History of at least one pregnancy
- Body mass index (BMI) between 18 and 30 kg/m2
- Desire to undergo abdominoplasty as a single procedure without receiving liposuction or other cosmetic surgeries
Key exclusion criteria (10 listed)
- Smoking habit;
- Abdominal wall scar (except for a Pfannenstiel scar related to a Cesarean section);
- Abdominal wall hérnias;
- History of deep-vein thrombosis;
- Chronic obstructive pulmonary disease;
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 |
|---|---|---|
| Correction of diastasis of the rectus abdominis musclesAlso: AbdominoplastyThirty women with similar abdominal deformities, who had had at least one pregnancy, were randomized into three groups to undergo abdominoplasty. Plication of the anterior rectus sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in a single layer with either a continuous 2-0 monofilament nylon suture (group I) or using a continuous barbed suture (group II). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels. | Procedure or surgery | Device: 2-0 monofilament nylon suture, Device: Barbed suture Quill Nylon 1, Device: Single layer 2-0 monofilament |
Primary outcome
Correction of diastasis of the rectus abdominis muscles
Time frame: Compare from the baseline the efficacy and time required to correct the diastasis at 3 weeks
Get a technique that provides a safe abdominoplasty correction with lasting results and in every segment of time.
1 secondary outcome
Follow-up of diastasis of the rectus abdominis muscles
Time frame: At six months
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 4 Feb 2016.
- Individual participant dataSharing planned: No
Related trials for Disorder of Abdomen
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Liver Resection, Liver Tumours
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.
Luiz José Muaccad Gama, MD principal investigator
Universidade Federal de São Paulo - UNIFESP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Correction of diastasis of the rectus abdominis muscles in people with Disorder of Abdomen, run by Luiz Jose Muaccad Gama at 1 site in Brazil.
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 7 inclusion and 10 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 4 Feb 2016. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Correction of diastasis of the rectus abdominis muscles (time frame: Compare from the baseline the efficacy and time required to correct the diastasis at 3 weeks). 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 4 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.