The Outcome of Abdominoplasty After Massive Weight Loss

NCT ID: NCT02679391

Last Updated: 2016-02-10

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Weight Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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prof. Ulf Gunnarsson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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.

Reference Type DERIVED
PMID: 29185021 (View on PubMed)

Other Identifiers

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ES2012/1997-31/4

Identifier Type: -

Identifier Source: org_study_id

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