Clinical trial NCT02679391: The Outcome of Abdominoplasty After Massive Weight Loss
Official title: The Outcome of Abdominoplasty After Massive Weight Loss; Comparison of Results From Plastic and General Surgical Units - a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Loss
Keywords: Abdominoplasty
Early complications
Guidelines
Sequelae
bariatric patients
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 209
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Comparing postoperative complications after abdominoplasty performed by plastic and general surgeons, where the dichotomous variables are evaluated.
timeFrame: 1 month follow up
Secondary outcomes:
measure: 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.
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Robert Brännström, MD. PhD
role: STUDY_DIRECTOR
References:
citation: 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.