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

NCT02674035 | Completed Phase 4 DMC

• 1 other identifier: U1111-1175-1484
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Abdomen

Keywords

Abdominoplasty; Sutures; Abdominal deformities; Plication; Monofilament nylon suture; Barbed suture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Follow-up of diastasis of the rectus abdominis muscles

  At six months

Study Arms (3)

Device: 2-0 monofilament nylon suture

ACTIVE COMPARATOR

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

Device: Single layer 2-0 monofilament

ACTIVE COMPARATOR

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

Device: Barbed suture Quill Nylon 1

ACTIVE COMPARATOR

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

Interventions

Correction of diastasis of the rectus abdominis muscles PROCEDURE

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.

Also known as: Abdominoplasty

Device: 2-0 monofilament nylon suture; Device: Barbed suture Quill Nylon 1; Device: Single layer 2-0 monofilament

Eligibility Criteria

• Age: 25 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luiz Jose Muaccad Gama: lead

Study Sites (1)

Fábio Xerfan Nahas

São Paulo, São Paulo, 04024-002, Brazil

Location

MeSH Terms

Interventions

Abdominoplasty

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Luiz José Muaccad Gama, MD

  Universidade Federal de São Paulo - UNIFESP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 8, 2015
• First Posted: February 4, 2016
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)