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Plication of the Rectus Abdominis in Two Planes and in One Continuous Suture Plan

Plication of the Rectus Abdominis in Two Planes and in One Continuous Suture Plan

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02674035
Enrollment
30
Registered
2016-02-04
Start date
2012-06-30
Completion date
2014-06-30
Last updated
2016-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Abdomen

Keywords

Abdominoplasty, Sutures, Abdominal deformities, Plication, Monofilament nylon suture, Barbed suture

Brief 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 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.

Interventions

PROCEDURECorrection of diastasis of the rectus abdominis muscles

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.

Sponsors

Luiz Jose Muaccad Gama
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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; * Use of corticosteroids. * Patients lost to follow-up and those who did not undergo ultrasound examination were excluded from the study

Design outcomes

Primary

MeasureTime frameDescription
Correction of diastasis of the rectus abdominis musclesCompare from the baseline the efficacy and time required to correct the diastasis at 3 weeksGet a technique that provides a safe abdominoplasty correction with lasting results and in every segment of time.

Secondary

MeasureTime frameDescription
Follow-up of diastasis of the rectus abdominis musclesAt six monthsConfirms the plication of a single layer abdominoplasty as positive in women patients at six months of surgery compared to two planes.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026