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

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 Overview

• Status: Completed
• Conditions: Disorder of Abdomen
• Intervention / Treatment: Procedure: Correction of diastasis of the rectus abdominis muscles

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04024-002
      • Fábio Xerfan Nahas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Luiz Jose Muaccad Gama
• Investigators: Principal Investigator: Luiz José Muaccad Gama, MD, Universidade Federal de São Paulo - UNIFESP

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 8, 2015
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 2, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Abdominoplasty; Sutures; Plication; Barbed suture; Abdominal deformities; Monofilament nylon suture
• Other Study ID Numbers: U1111-1175-1484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO