Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis

Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis After Bariatric Surgery

A prospective randomized clinical trial of patients undergoing bariatric surgery.

Patients were randomly assigned into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).

The assigned treatment began 15 days after surgery and was maintained during 12 weeks.

Study Overview

• Status: Completed
• Conditions: Satisfaction
• Intervention / Treatment: Device: PENS; Other: Specific training

Detailed Description

A prospective randomized clinical trial of patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (RYGB) during 2014 was performed.

Patients were randomly assigned using a random-number table into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).

The assigned treatment began 15 days after surgery and was maintained during 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• patients with body mass index (BMI) >40 Kg/m2 or BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity, undergoing a bariatric procedure.

Exclusion Criteria:

• all kind of previous breast surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PENS with training; Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively	Device: PENS; The participants underwent one 30-min session every week for 12 consecutive weeks. PENS was delivered by a needle electrode inserted in the medioclavicular line, 2 cm below the clavicle at a 90° angle towards the skin at a depth of approximately 1 cm. PENS was undertaken at frequency of 20 Hz at the highest amplify (0-20 mA) without causing pain. PENS was delivered simultaneously in both pectoral muscles.; Other: Specific training; Patients underwent specific training exercises to improve pectoral fitness.
Active Comparator: Specific training; Patients undergoing specific training during 12 weeks postoperatively	Other: Specific training; Patients underwent specific training exercises to improve pectoral fitness.
No Intervention: No intervention; No specific treatment was assigned to these patients postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction degree. 7-points Likert scale was used for the quantification.	The patients were asked to quantify their satisfaction degree with the esthetic results of their breasts after the treatment.	12 weeks of treatment

Collaborators and Investigators

• Sponsor: Hospital General Universitario Elche
• Investigators: Principal Investigator: Jaime Ruiz-Tovar, MD, PhD, Hospital General Elche

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Estimate): May 5, 2015
• Last Update Submitted That Met QC Criteria: May 4, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: HURJC2015-02