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History of Changes for Study: NCT02434419
Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis
Latest version (submitted May 4, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 4, 2015 None (earliest Version on record)
Comparison Format:
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Study NCT02434419
Submitted Date:  May 4, 2015 (v1)
Open or close this module Study Identification
Unique Protocol ID: HURJC2015-02
Brief Title: Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis
Official Title: Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis After Bariatric Surgery
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Completed
Study Start: January 2014
Primary Completion: April 2015 [Actual]
Study Completion: April 2015 [Actual]
First Submitted: April 30, 2015
First Submitted that
Met QC Criteria:		 May 4, 2015
First Posted: May 5, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:		 May 4, 2015
Last Update Posted: May 5, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hospital General Universitario Elche
Responsible Party: Principal Investigator
Investigator: Jaime Ruiz-Tovar, MD, PhD
Official Title: MD, PhD
Affiliation: Hospital General Universitario Elche
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Satisfaction
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 45 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Specific training
Patients underwent specific training exercises to improve pectoral fitness.
Active Comparator: Specific training
Patients undergoing specific training during 12 weeks postoperatively
Specific training
Patients underwent specific training exercises to improve pectoral fitness.
No Intervention: No intervention
No specific treatment was assigned to these patients postoperatively
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Satisfaction degree. 7-points Likert scale was used for the quantification.
[ Time Frame: 12 weeks of treatment ]

The patients were asked to quantify their satisfaction degree with the esthetic results of their breasts after the treatment.
Open or close this module Eligibility
Minimum Age:
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Study Officials: Jaime Ruiz-Tovar, MD, PhD
Principal Investigator
Hospital General Elche
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services