Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis

Phase 3

Completed

• Conditions: Satisfaction
• Interventions: Device: PENS; Other: Specific training

• Registration Number: NCT02434419
• Lead Sponsor: Hospital General Universitario Elche

Brief Summary

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.

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 Timeline

• Study Start: 2014-01
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-05-04
• Last Update Submitted: 2015-05-04
• Study First Posted: 2015-05-05
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PENS with training	Specific training	Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively
PENS with training	PENS	Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively
Specific training	Specific training	Patients undergoing specific training during 12 weeks postoperatively

Primary Outcome Measures

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