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

Sponsor

Luiz Jose Muaccad Gama (Other)

Overall Status

Completed

CT.gov ID

NCT02674035

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disorder of Abdomen	Procedure: Correction of diastasis of the rectus abdominis muscles	Phase 4

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

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Device: 2-0 monofilament nylon suture 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 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. Other Names: Abdominoplasty
Active Comparator: Device: Single layer 2-0 monofilament 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 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. Other Names: Abdominoplasty
Active Comparator: Device: Barbed suture Quill Nylon 1 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 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. Other Names: Abdominoplasty

Arm

Intervention/Treatment

Active Comparator: Device: 2-0 monofilament nylon suture

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

Other Names:

Abdominoplasty

Active Comparator: Device: Single layer 2-0 monofilament

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

Other Names:

Abdominoplasty

Active Comparator: Device: Barbed suture Quill Nylon 1

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

Other Names:

Abdominoplasty

Outcome Measures

Primary Outcome Measures

Correction of diastasis of the rectus abdominis muscles [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.

Secondary Outcome Measures

Follow-up of diastasis of the rectus abdominis muscles [At six months]
Confirms the plication of a single layer abdominoplasty as positive in women patients at six months of surgery compared to two planes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts 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