The Outcome of Abdominoplasty After Massive Weight Loss
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|ClinicalTrials.gov Identifier: NCT02679391|
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : February 10, 2016
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||209 participants|
|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|
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).
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).
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)
- 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 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679391
|Study Director:||Robert Brännström, MD. PhD||Karolinska Institutet|