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The Outcome of Abdominoplasty After Massive Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679391
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
prof. Ulf Gunnarsson, Karolinska Institutet

Brief Summary:
The primary aim of this study is to compare early surgical complications after abdominoplasty performed by plastic and general surgeons. Secondary aims were to assess whether specific guidelines might have impact on the rate of complications. The hypothesis is that general surgeons have more complications.

Condition or disease
Weight Loss

Detailed Description:

Bariatric surgery has gained widespread acceptance and 6,800 patients are yearly operated in Sweden. Approximately 30 % of these patients require abdominoplasties for functional disabilities being a total of 2,300 patients. Today the plastic surgeons of the departments of Plastic and Reconstructive Surgery do not have the capacity to accommodate this demand. A Department of General Surgery started to perform abdominoplasties.

This is a retrospective cohort study. Charts were retrieved from 69 consecutive patients operated by general surgeons at Capio S:t Görans Hospital, Stockholm, Sweden (group A) from 13th of May to 19th of December 2011. Charts from 70 consecutive patients operated by plastic surgeons at the Department of Plastic and Reconstructive Surgery, Karolinska University Hospital, Stockholm, Sweden (group B) were studied from 14th of January 2010 to 7th of December 2012. Collected data consist of patient demographics, operation methods, and complications observed at 30 days' follow-up. The outcome of a third group of about 70 patients operated between 22th of January 2013 to 3th of June 2014 at S:t Görans Hospital (group C) are compared to the outcome of groups B and A. Guidelines for the surgical technique as well as pre-and postoperative care were refined between the operations of group A and C.

Statistics Anova and regression analysis will be applied. And for dichotomous data Chi-Square test and Fischers exact test will be calculated. Power was calculated with the test of proportion for two independent groups and 5 per cent significance.

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Study Type : Observational
Actual Enrollment : 209 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Outcome of Abdominoplasty After Massive Weight Loss; Comparison of Results From Plastic and General Surgical Units - a Retrospective Cohort Study
Study Start Date : January 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Group/Cohort
A
69 consecutive operated patients by general surgeons at Capio S:t Görans Hospital 2011. All post weight loss. , 96% female, BMI by the time of operation 26, mean age 41 (SD 9.5). Their mean weight loss in BMI units: 17.8 (SD 5.12).
B
70 consecutive operated patients by plastic surgeons at Karolinska University Hospital 2010-2012. All post weight loss. 86% female, BMI by the time of oepration 26, mean age 38.6 (SD 11.4). Their mean weight loss in BMI units: 17.4 (SD 4.8).
C
70 consecutive operated patients by general surgeons at Capio S:t Görans Hospital 2013-2014. All post weight loss. 90% female, BMI by the time of operation 26, mean age 46.8 (SD 10.1). Their mean weight loss in BMI units: 16.3 (SD 5.11)



Primary Outcome Measures :
  1. Comparing postoperative complications after abdominoplasty performed by plastic and general surgeons, where the dichotomous variables are evaluated. [ Time Frame: 1 month follow up ]
    Dichotomous data yes/no collected in Excel from the charts. The complications are: wound infection, wound dehiscence, seromas, bleeding, transfusions, tissue necrosis, systemic disorder, lung embolism, Deep venous thrombolism, reoperation, hospital stay over 2 Days and Patients with no adverse effect.


Secondary Outcome Measures :
  1. Secondary aims were to assess whether specific guidelines might have impact on the rate of complications, concerning the same complications as mentioned in the primary outcome. [ Time Frame: 4 years ]
    Between two of the cohorts new guidelines was introduced, and the same dichotomous data (yes/no) was collected and with logistic regression analyzed to assess if the applied guidelines made any effect on the complications. The guidelines, if followed, was yes/no.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients that were accepted for abdominoplasties after massive weight loss in accordance with the inclusion and exclusion criterias. Consecutively operated.
Criteria

Inclusion Criteria:

  • Abdominal skin ptosis > 3 cm
  • Weight stability > 6 months
  • Smoke free > 6 weeks prior to surgery
  • BMI ≤28 or a significant weight reduction equivalent to 80 per cent of excess weight

Exclusion Criteria:

  • Weight instability
  • Smoking
  • BMI >35
  • Psychological imbalance or psychiatric non-treated diseases
  • Advanced cardio-vascular diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679391


Sponsors and Collaborators
Karolinska Institutet
Investigators
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Study Director: Robert Brännström, MD. PhD Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: prof. Ulf Gunnarsson, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02679391    
Other Study ID Numbers: ES2012/1997-31/4
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by prof. Ulf Gunnarsson, Karolinska Institutet:
Abdominoplasty
Early complications
Guidelines
Sequelae
bariatric patients
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Body Weight Changes