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

Disorder of Abdomen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674035
• Other study ID #: U1111-1175-1484
• Status: Completed
• Phase: Phase 4
• First received: November 8, 2015
• Last updated: February 2, 2016
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 30 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder of Abdomen

Intervention

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.

Locations

Country	Name	City	State
Brazil	Fábio Xerfan Nahas	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Luiz Jose Muaccad Gama

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes