Clinical trial NCT02674035: Plication of the Rectus Abdominis in Two Planes and in One Continuous Suture Plan
Official title: Plication of the Rectus Abdominis in Two Planes and in One Continuous Suture Plan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Disorder of Abdomen
Keywords: Abdominoplasty
Sutures
Abdominal deformities
Plication
Monofilament nylon suture
Barbed suture
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correction of diastasis of the rectus abdominis muscles
timeFrame: Compare from the baseline the efficacy and time required to correct the diastasis at 3 weeks
Secondary outcomes:
measure: Follow-up of diastasis of the rectus abdominis muscles
timeFrame: At six months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Fábio Xerfan Nahas
state: SP
Study officials:
affiliation: Universidade Federal de São Paulo - UNIFESP
name: Luiz José Muaccad Gama, MD
role: PRINCIPAL_INVESTIGATOR
References: