The Outcome of Abdominoplasty After Massive Weight Loss

Completed

• Conditions: Weight Loss

• Registration Number: NCT02679391
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2014-06
• Study Completion: 2016-01
• Study First Submitted: 2016-01-27
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-06
• Last Update Submitted: 2016-02-06
• Study First Posted: 2016-02-10
• Last Update Posted: 2016-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparing postoperative complications after abdominoplasty performed by plastic and general surgeons, where the dichotomous variables are evaluated.	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

Name	Time	Method
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.	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.