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

Phase 4

Completed

• Conditions: Disorder of Abdomen
• Interventions: Procedure: Correction of diastasis of the rectus abdominis muscles

• Registration Number: NCT02674035
• Lead Sponsor: Luiz Jose Muaccad Gama

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.

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2015-11-08
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-02
• Last Update Submitted: 2016-02-02
• Study First Posted: 2016-02-04
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Device: 2-0 monofilament nylon suture	Correction of diastasis of the rectus abdominis muscles	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.
Device: Single layer 2-0 monofilament	Correction of diastasis of the rectus abdominis muscles	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.
Device: Barbed suture Quill Nylon 1	Correction of diastasis of the rectus abdominis muscles	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Fábio Xerfan Nahas; 🇧🇷 Sao Paulo, SP, Brazil