Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Satisfaction

Treatments: Device: PENS; Other: Specific training

Study type: Interventional

Funder types: Other

Identifiers

NCT02434419

HURJC2015-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

PENS with training

Experimental group

Description:

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

Treatment:

Other: Specific training

Device: PENS

Specific training

Active Comparator group

Description:

Patients undergoing specific training during 12 weeks postoperatively

Treatment:

Other: Specific training

No intervention

No Intervention group

Description:

No specific treatment was assigned to these patients postoperatively