The Outcome of Abdominoplasty After Massive Weight Loss
NCT ID: NCT02679391
Last Updated: 2016-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
209 participants
OBSERVATIONAL
2010-01-31
2016-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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).
No interventions assigned to this group
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).
No interventions assigned to this group
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)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Smoking
* BMI \>35
* Psychological imbalance or psychiatric non-treated diseases
* Advanced cardio-vascular diseases
ALL
Yes
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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prof. Ulf Gunnarsson
Professor
Principal Investigators
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Robert Brännström, MD. PhD
Role: STUDY_DIRECTOR
Karolinska Institutet
References
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Swedenhammar E, Stark B, Hallstrand AH, Ehrstrom M, Gahm J. Surgical Training and Standardised Management Guidelines Improved the 30-Day Complication Rate After Abdominoplasty for Massive Weight Loss. World J Surg. 2018 Jun;42(6):1647-1654. doi: 10.1007/s00268-017-4341-8.
Other Identifiers
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ES2012/1997-31/4
Identifier Type: -
Identifier Source: org_study_id
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