Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery
Sponsor
Federal University of São Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT01942707
Collaborator
(none)
46
1
2
69
0.7
Study Details
Study Description
Brief Summary
46 female postbariatric patients will be submitted to anchor-line abdominoplasty with drains insertion. Patients will be randomized to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Morbid obesity has been increasing in Brazil and the world and bariatric surgery is the most effective and long-lasting treatment. This leads to large weight losses leading to large body deformities due to excess skin and subcutaneous tissue. The most common post-bariatric plastic surgery is post-bariatric abdominoplasty which main complication is seroma. PURPOSE: To evaluate the effect of Scarpa fascia preservation in seroma reduction. METHODS: A total of 46 patients were randomly assigned to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.
Study Design
Study Type:
Interventional
Actual Enrollment
:
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
The patient will not know if the Scarpa´s fascia has been removed or preserved.
Primary Purpose:
Prevention
Official Title:
Study of Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery
Study Start Date
:
Mar 1, 2013
Anticipated Primary Completion Date
:
Apr 1, 2018
Anticipated Study Completion Date
:
Dec 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Abdominoplasty without Scarpa´s Facia Anchor-line abdominoplasty where the Scarpa's Fascia will be removed. |
Procedure: Abdominoplasty without Scarpa´s Facia
During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.
|
| Experimental: abdominoplasty with Scarpa's Fascia Anchor-line abdominoplasty where the Scarpa's Fascia will be preserved. |
Procedure: abdominoplasty with Scarpa's Fascia
During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.
|
Outcome Measures
Primary Outcome Measures
- Total Volume of Drainage in ml. [number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days]
We will measure the total volume of drainage, in ml, obtained by the drains in the abdominal region. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours. Total volume of drainage will be calculated as the sum of the volumes obtained daily.
Secondary Outcome Measures
- Number of Days Required for Drain Withdrawal. [Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days]
Number of days required for drain withdrawal. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours.
- Volume of Seroma Assessed by Ultrasound of the Abdominal Wall. [Done after 20 days of surgery]
An ultrasound of the abdominal wall will be realized to check the volume of any residual seroma.
Eligibility Criteria
Criteria
Ages Eligible for Study:
24 Years
to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
BMI between 22 and 30 Kg/m2
-
Female post-bariatric patient
Exclusion Criteria:
-
neoplasms
-
Diabetes
-
lymphatic system diseases
-
abdominal scars except C section and bariatric surgery scars
-
mental disorders
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Federal University of São Paulo | São Paulo | SP | Brazil | 04024002 |
Sponsors and Collaborators
- Federal University of São Paulo
Investigators
- Study Chair: Lydia M Ferreira, MD, Phd, Federal University of São Paulo
- Study Chair: Juan C Montano-Pedroso, PhD, Federal University of São Paulo
Study Documents (Full-Text)
More Information
Publications
- Andrades P, Prado A, Danilla S, Guerra C, Benitez S, Sepulveda S, Sciarraffia C, De Carolis V. Progressive tension sutures in the prevention of postabdominoplasty seroma: a prospective, randomized, double-blind clinical trial. Plast Reconstr Surg. 2007 Sep 15;120(4):935-946. doi: 10.1097/01.prs.0000253445.76991.de.
- Andrades P, Prado A. Composition of postabdominoplasty seroma. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):514-8. Epub 2007 Jul 20.
- Baroudi R, Ferreira CA. Seroma: how to avoid it and how to treat it. Aesthet Surg J. 1998 Nov-Dec;18(6):439-41.
- Bercial ME, Sabino Neto M, Calil JA, Rossetto LA, Ferreira LM. Suction drains, quilting sutures, and fibrin sealant in the prevention of seroma formation in abdominoplasty: which is the best strategy? Aesthetic Plast Surg. 2012 Apr;36(2):370-3. doi: 10.1007/s00266-011-9807-8. Epub 2011 Aug 20.
- Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728.
- Bussolaro RA, Garcia EB, Zanella MT, Ferreira LM. Impaired abdominal skin sensory function in morbid obesity and after bariatric surgery. Obes Surg. 2012 Mar;22(3):353-9. doi: 10.1007/s11695-011-0485-z.
- Colquitt J, Clegg A, Loveman E, Royle P, Sidhu MK. Surgery for morbid obesity. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD003641. Review. Update in: Cochrane Database Syst Rev. 2009;(2):CD003641.
- Costa LF, Landecker A, Manta AM. Optimizing body contour in massive weight loss patients: the modified vertical abdominoplasty. Plast Reconstr Surg. 2004 Dec;114(7):1917-23; discussion 1924-6.
- Costa-Ferreira A, Rebelo M, Vásconez LO, Amarante J. Scarpa fascia preservation during abdominoplasty: a prospective study. Plast Reconstr Surg. 2010 Apr;125(4):1232-1239. doi: 10.1097/PRS.0b013e3181d0ac59.
- Dellon AL. Fleur-de-lis abdominoplasty. Aesthetic Plast Surg. 1985;9(1):27-32.
- Di Martino M, Nahas FX, Barbosa MVJ, Montecinos Ayaviri NA, Kimura AK, Barella SM, Novo NF, Ferreira LM. Seroma in lipoabdominoplasty and abdominoplasty: a comparative study using ultrasound. Plast Reconstr Surg. 2010 Nov;126(5):1742-1751. doi: 10.1097/PRS.0b013e3181efa6c5.
- Farah AB, Nahas FX, Ferreira LM, Mendes Jde A, Juliano Y. Sensibility of the abdomen after abdominoplasty. Plast Reconstr Surg. 2004 Aug;114(2):577-82; discussion 583.
- Fraccalvieri M, Datta G, Bogetti P, Verna G, Pedrale R, Bocchiotti MA, Boriani F, Obbialero FD, Kefalas N, Bruschi S. Abdominoplasty after weight loss in morbidly obese patients: a 4-year clinical experience. Obes Surg. 2007 Oct;17(10):1319-24.
- García-García ML, Martín-Lorenzo JG, Campillo-Soto A, Torralba-Martínez JA, Lirón-Ruiz R, Miguel-Perelló J, Mengual-Ballester M, Aguayo-Albasini JL. [Complications and level of satisfaction after dermolipectomy and abdominoplasty post-bariatric surgery]. Cir Esp. 2014 Apr;92(4):254-60. doi: 10.1016/j.ciresp.2013.04.024. Epub 2013 Dec 18. Spanish.
- Gloy VL, Briel M, Bhatt DL, Kashyap SR, Schauer PR, Mingrone G, Bucher HC, Nordmann AJ. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ. 2013 Oct 22;347:f5934. doi: 10.1136/bmj.f5934. Review.
- James PT. Obesity: the worldwide epidemic. Clin Dermatol. 2004 Jul-Aug;22(4):276-80. Review.
- Koller M, Hintringer T. Scarpa fascia or rectus fascia in abdominoplasty flap elevation: a prospective clinical trial. Aesthetic Plast Surg. 2012 Apr;36(2):241-3. doi: 10.1007/s00266-011-9795-8. Epub 2011 Aug 19.
- Le Louarn C. Partial subfascial abdominoplasty. Aesthetic Plast Surg. 1996 Mar-Apr;20(2):123-7.
- Maggard MA, Shugarman LR, Suttorp M, Maglione M, Sugerman HJ, Livingston EH, Nguyen NT, Li Z, Mojica WA, Hilton L, Rhodes S, Morton SC, Shekelle PG. Meta-analysis: surgical treatment of obesity. Ann Intern Med. 2005 Apr 5;142(7):547-59.
- Mohammad JA, Warnke PH, Stavraky W. Ultrasound in the diagnosis and management of fluid collection complications following abdominoplasty. Ann Plast Surg. 1998 Nov;41(5):498-502.
- Montano-Pedroso JC, Garcia EB, Omonte IR, Rocha MG, Ferreira LM. Hematological variables and iron status in abdominoplasty after bariatric surgery. Obes Surg. 2013 Jan;23(1):7-16. doi: 10.1007/s11695-012-0720-2.
- Nahas FX, di Martino M, Ferreira LM. Fibrin glue as a substitute for quilting suture in abdominoplasty. Plast Reconstr Surg. 2012 Jan;129(1):212e-213e. doi: 10.1097/PRS.0b013e3182365d65.
- Nahas FX, Ferreira LM, Ghelfond C. Does quilting suture prevent seroma in abdominoplasty? Plast Reconstr Surg. 2007 Mar;119(3):1060-4; discussion 1065-6.
- Neaman KC, Hansen JE. Analysis of complications from abdominoplasty: a review of 206 cases at a university hospital. Ann Plast Surg. 2007 Mar;58(3):292-8. Review.
- Persichetti P, Simone P, Scuderi N. Anchor-line abdominoplasty: a comprehensive approach to abdominal wall reconstruction and body contouring. Plast Reconstr Surg. 2005 Jul;116(1):289-94.
- Pitanguy I. Evaluation of body contouring surgery today: a 30-year perspective. Plast Reconstr Surg. 2000 Apr;105(4):1499-514; discussion 1515-6.
- Rossetto LA, Garcia EB, Abla LF, Neto MS, Ferreira LM. Quilting suture in the donor site of the transverse rectus abdominis musculocutaneous flap in breast reconstruction. Ann Plast Surg. 2009 Mar;62(3):240-3. doi: 10.1097/SAP.0b013e318180c8e2.
- Saldanha OR, Federico R, Daher PF, Malheiros AA, Carneiro PRG, Azevedo SFD, Saldanha Filho OR, Saldanha CB. Lipoabdominoplasty. Plast Reconstr Surg. 2009 Sep;124(3):934-942. doi: 10.1097/PRS.0b013e3181b037e3.
- Stewart KJ, Stewart DA, Coghlan B, Harrison DH, Jones BM, Waterhouse N. Complications of 278 consecutive abdominoplasties. J Plast Reconstr Aesthet Surg. 2006;59(11):1152-5. Epub 2006 Jul 5. Review.
Responsible Party:
Heraldo Carlos Borges,
M D - Professor,
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01942707
Other Study ID Numbers:
- INFORZATO55
First Posted:
Sep 16, 2013
Last Update Posted:
Mar 29, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Heraldo Carlos Borges,
M D - Professor,
Federal University of São Paulo
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The recruitment began in october 2014 until april 2015 at Hospital Santo Amaro (private hospital), in Guarujá city, Brazil. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Anchor-line Abdominoplasty Without Scarpa's Fascia | Anchor-line Abdominoplasty With Scarpa's Fascia |
|---|---|---|
| Arm/Group Description | Anchor-line abdominoplasty. The Scarpa's Fascia will be removed in this group. | Anchor-line abdominoplasty. In this group the Scarpa's Fascia will be preserved. |
| Period Title: Overall Study | ||
| STARTED | 23 | 23 |
| COMPLETED | 23 | 23 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | No Keeping Scarpa's Fascia | Keeping Scarpa's Fascia | Total |
|---|---|---|---|
| Arm/Group Description | Abdominoplasty in anchor-line without keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups | Abdominoplasty in anchor-line keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups | Total of all reporting groups |
| Overall Participants | 23 | 23 | 46 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
37.086
(8.06)
|
38.1304
(8.05)
|
37.6087
(8.074)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
23
100%
|
23
100%
|
46
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
| More than one race |
23
100%
|
23
100%
|
46
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| Brazil |
23
100%
|
23
100%
|
46
100%
|
| BMI (Kg/m2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Kg/m2] |
26.4
(3)
|
28.2
(1.9)
|
27.3
(2.6)
|
Outcome Measures
| Title | Total Volume of Drainage in ml. |
|---|---|
| Description | We will measure the total volume of drainage, in ml, obtained by the drains in the abdominal region. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours. Total volume of drainage will be calculated as the sum of the volumes obtained daily. |
| Time Frame | number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Without Scarpa's Fascia | With Scarpa's Fascia |
|---|---|---|
| Arm/Group Description | Abdominoplasty in anchor-line without keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups | Abdominoplasty in anchor-line keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups |
| Measure Participants | 23 | 23 |
| Mean (Standard Deviation) [ml] |
428.9
(222.6)
|
249.1
(98.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Without Scarpa's Fascia, With Scarpa's Fascia |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 179 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 222 |
|
| Estimation Comments | ||
| Title | Number of Days Required for Drain Withdrawal. |
|---|---|
| Description | Number of days required for drain withdrawal. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours. |
| Time Frame | Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Without Scarpa's Fascia | With Scarpa's Fascia |
|---|---|---|
| Arm/Group Description | Abdominoplasty in anchor-line without keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups | Abdominoplasty in anchor-line keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups |
| Measure Participants | 23 | 23 |
| Mean (Standard Deviation) [days] |
5.4
(1.9)
|
4.2
(1.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Without Scarpa's Fascia, With Scarpa's Fascia |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.2 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 1.9 |
|
| Estimation Comments | ||
| Title | Volume of Seroma Assessed by Ultrasound of the Abdominal Wall. |
|---|---|
| Description | An ultrasound of the abdominal wall will be realized to check the volume of any residual seroma. |
| Time Frame | Done after 20 days of surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Without Scarpa's Fascia | With Scarpa's Fascia |
|---|---|---|
| Arm/Group Description | Abdominoplasty in anchor-line without keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups | Abdominoplasty in anchor-line keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups |
| Measure Participants | 23 | 23 |
| Mean (Standard Deviation) [ml] |
21.6
(40.7)
|
16.8
(25)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Without Scarpa's Fascia, With Scarpa's Fascia |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.809 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.8 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 40.7 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | 60 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Anchor-line Abdominoplasty Without Scarpa's Fascia | Anchor-line Abdominoplasty With Scarpa's Fascia | ||
| Arm/Group Description | Anchor-line Abdominoplasty where the Scarpa's Fascia will be removed. | Anchor-line abdominoplasty where the Scarpa´s Fascia will be preserved. | ||
All Cause Mortality |
||||
| Anchor-line Abdominoplasty Without Scarpa's Fascia | Anchor-line Abdominoplasty With Scarpa's Fascia | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 0/23 (0%) | ||
Serious Adverse Events |
||||
| Anchor-line Abdominoplasty Without Scarpa's Fascia | Anchor-line Abdominoplasty With Scarpa's Fascia | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 0/23 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Anchor-line Abdominoplasty Without Scarpa's Fascia | Anchor-line Abdominoplasty With Scarpa's Fascia | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 0/23 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Heraldo Carlos Borges Inforzato |
|---|---|
| Organization | Universidade Federal de São Paulo |
| Phone | 55-13-997112644 |
| heraldo@litoral.com.br |
Responsible Party:
Heraldo Carlos Borges,
M D - Professor,
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01942707
Other Study ID Numbers:
- INFORZATO55
First Posted:
Sep 16, 2013
Last Update Posted:
Mar 29, 2018
Last Verified:
Mar 1, 2018