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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Disorder of Abdomen

Intervention / Treatment
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* Procedure: Correction of diastasis of the rectus abdominis muscles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Device: 2-0 monofilament nylon suture<br>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. | Procedure: Correction of diastasis of the rectus abdominis muscles<br>* 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.<br>* Other names: Abdominoplasty;|
| Active Comparator: Device: Single layer 2-0 monofilament<br>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. | Procedure: Correction of diastasis of the rectus abdominis muscles<br>* 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.<br>* Other names: Abdominoplasty;|
| Active Comparator: Device: Barbed suture Quill Nylon 1<br>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. | Procedure: Correction of diastasis of the rectus abdominis muscles<br>* 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.<br>* Other names: Abdominoplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Compare from the baseline the efficacy and time required to correct the diastasis at 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominoplasty, Sutures, Abdominal deformities, Plication, Monofilament nylon suture, Barbed suture