Mastopexy With Autologous Augmentation in Women After Massive Weight Loss

Status Completed

Clinical Trial Summary

The purpose of this study is to compare two different techniques of mastopexy with autologous augmentation, the Lower Pole Subglandular Advancement Mastoplasty (LOPOSAM) and Rubins Mastopexy with autologous augmentation, in massive weight loss patients to see if one technique is superior to the other.

Clinical Trial Description

In Massive Weight Loss (MWL) patients the breasts often appear deflated following the prominent volume decrease. The breast is not only deflated, the supportive fibrous tissue is lax and the structural properties have changed. In the typical patient the breast base has sunk along with the inframammary crease and the shape of the breast is wide and flat with a significant ptosis.

One way of helping these women is to offer a mastopexy with autologous augmentation. There are several different surgical techniques for treating the ptotic and deflated breast in MWL patients.

In this study the investigators compare the investigators own technique, LOPOSAM, with Rubins Mastopexy with autologous augmentation.

In Rubins Mastopexy, an extensive re-arrangement of the skin, fat and breast tissue is done and this is supposed to give good long term results. The procedure is however time consuming and extensive.

The LOPOSAM technique is less extensive and therefore less time consuming and the investigators hypothesis is therefore that the technique has a lower complication rate.

Women that is referred for mastopexy after MWL and meet the criteria for post bariatric surgery, set by the Danish National Board of Health, and is found to be a suitable candidate for mastopexy with autologous augmentation is invited to participate in the study.

Sample size assessment has shown that 22 women (11 in each group) is needed and this number of patients is expected to be recruited in 6-9 months.

The study design is a prospective randomized trial.

Preoperative breast measurements and clinical photographs will be compared with measurements and clinical photographs at 3, 6 and 12 months postoperative

The primary outcome is operation time but secondary outcomes include economics, breast measurements, cosmetic result and complication rates.

With this trial, the investigators hope to demonstrate whether or not one of the two techniques is superior to the other and therefore should be the preferred technique. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02572271
Study type	Interventional
Source	Odense University Hospital
Contact
Status	Completed
Phase	N/A
Start date	September 2015
Completion date	November 16, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04506996` - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2	N/A
Active, not recruiting	`NCT04420936` - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program	N/A
Terminated	`NCT03316105` - Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers	N/A
Completed	`NCT03700736` - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups	N/A
Active, not recruiting	`NCT04353726` - Knowledge-based Dietary Weight Management.	N/A
Completed	`NCT02948283` - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia	Phase 1
Completed	`NCT03377244` - Healthy Body Healthy Souls in the Marshallese Population	N/A
Completed	`NCT02877004` - LLLT for Reducing Waste Circumference and Weight	N/A
Active, not recruiting	`NCT04327141` - Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women	N/A
Completed	`NCT03929198` - Translation of Pritikin Program to the Community	N/A
Recruiting	`NCT05249465` - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention	N/A
Recruiting	`NCT05942326` - Sleep Goal-focused Online Access to Lifestyle Support	N/A
Completed	`NCT00535600` - Effects of Bariatric Surgery on Insulin
Not yet recruiting	`NCT03601273` - Bariatric Embolization Trial for the Obese Nonsurgical	Phase 1
Active, not recruiting	`NCT04357119` - Common Limb Length in One-anastomosis Gastric Bypass	N/A
Completed	`NCT03210207` - Gastric Plication in Mexican Patients	N/A
Completed	`NCT02948517` - Time Restricted Feeding for Weight Loss and Cardio-protection	N/A
Completed	`NCT03139760` - POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability	N/A
Completed	`NCT02945410` - Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity	N/A
Recruiting	`NCT02559479` - A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms