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

Luiz Jose Muaccad Gama

Status and phase: Completed; Phase 4

Conditions: Disorder of Abdomen

Treatments: Procedure: Correction of diastasis of the rectus abdominis muscles

Study type: Interventional

Funder types: Other

Identifiers

NCT02674035

U1111-1175-1484

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 25 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

Device: 2-0 monofilament nylon suture

Active Comparator group

Description:

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.

Treatment:

Procedure: Correction of diastasis of the rectus abdominis muscles

Device: Single layer 2-0 monofilament

Active Comparator group

Description:

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.

Treatment:

Procedure: Correction of diastasis of the rectus abdominis muscles

Device: Barbed suture Quill Nylon 1

Active Comparator group

Description:

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.

Treatment:

Procedure: Correction of diastasis of the rectus abdominis muscles