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Completed

NCT Number: NCT02674035

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.

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Key information

Conditions

Age range

25 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Fábio Xerfan Nahas

São Paulo, 04024-002, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Abdominoplasty

Primary outcomes

  1. Correction of diastasis of the rectus abdominis muscles

    Time frame: 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 outcomes

  1. Follow-up of diastasis of the rectus abdominis muscles

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Luiz Jose Muaccad Gama

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2016
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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