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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominoplasty without Scarpa´s Facia | Active Comparator | Anchor-line abdominoplasty where the Scarpa's Fascia will be removed. |
|
| abdominoplasty with Scarpa's Fascia | Experimental | Anchor-line abdominoplasty where the Scarpa's Fascia will be preserved. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abdominoplasty with Scarpa's Fascia | Procedure | During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Volume of Drainage in ml. | 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. | number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Required for Drain Withdrawal. | 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. | Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lydia M Ferreira, MD, Phd | Federal University of São Paulo | Study Chair |
| Juan C Montano-Pedroso, PhD | Federal University of São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of São Paulo | São Paulo | São Paulo | 04024002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17659406 | Background | Andrades P, Prado A. Composition of postabdominoplasty seroma. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):514-8. doi: 10.1007/s00266-007-0078-3. Epub 2007 Jul 20. | |
| 17805122 | Background | 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. |
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The recruitment began in october 2014 until april 2015 at Hospital Santo Amaro (private hospital), in Guarujá city, Brazil.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anchor-line Abdominoplasty Without Scarpa's Fascia | Anchor-line abdominoplasty. The Scarpa's Fascia will be removed in this group. |
| FG001 | Anchor-line Abdominoplasty With Scarpa's Fascia | Anchor-line abdominoplasty. In this group the Scarpa's Fascia will be preserved. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Keeping Scarpa's Fascia | Abdominoplasty in anchor-line without keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups |
| BG001 | Keeping Scarpa's Fascia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age as informed by the patient |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Volume of Drainage in ml. | 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. | Posted | Mean | Standard Deviation | ml | number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days |
|
60 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anchor-line Abdominoplasty Without Scarpa's Fascia | Anchor-line Abdominoplasty where the Scarpa's Fascia will be removed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heraldo Carlos Borges Inforzato | Universidade Federal de São Paulo | 55-13-997112644 | heraldo@litoral.com.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2017 | Oct 14, 2017 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 14, 2017 | Oct 14, 2017 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D049291 | Seroma |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D061645 | Abdominoplasty |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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The patient will not know if the Scarpa´s fascia has been removed or preserved.
| Abdominoplasty without Scarpa´s Facia | Procedure | During surgical detachment of the abdominal flap the Scarpa´s fascia is removed. |
|
| Volume of Seroma Assessed by Ultrasound of the Abdominal Wall. | An ultrasound of the abdominal wall will be realized to check the volume of any residual seroma. | Done after 20 days of surgery |
| 19328174 | Background | Baroudi R, Ferreira CA. Seroma: how to avoid it and how to treat it. Aesthet Surg J. 1998 Nov-Dec;18(6):439-41. doi: 10.1016/s1090-820x(98)70073-1. |
| 15479938 | Background | 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. doi: 10.1001/jama.292.14.1724. |
| 21805192 | Background | 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. |
| 21858593 | Background | 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. |
| 16235331 | Background | Colquitt J, Clegg A, Loveman E, Royle P, Sidhu MK. Surgery for morbid obesity. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD003641. doi: 10.1002/14651858.CD003641.pub2. |
| 15577368 | Background | 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. doi: 10.1097/01.prs.0000142997.63346.95. |
| 3158172 | Background | Dellon AL. Fleur-de-lis abdominoplasty. Aesthetic Plast Surg. 1985;9(1):27-32. doi: 10.1007/BF01570680. |
| 20639797 | Background | 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. |
| 20072084 | Background | Costa-Ferreira A, Rebelo M, Vasconez 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. |
| 15277836 | Background | 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. doi: 10.1097/01.prs.0000128356.93462.7b. |
| 18000727 | Background | 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. doi: 10.1007/s11695-007-9235-7. |
| 24360407 | Background | Garcia-Garcia ML, Martin-Lorenzo JG, Campillo-Soto A, Torralba-Martinez JA, Liron-Ruiz R, Miguel-Perello 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. |
| 24149519 | Background | 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. |
| 15475226 | Background | James PT. Obesity: the worldwide epidemic. Clin Dermatol. 2004 Jul-Aug;22(4):276-80. doi: 10.1016/j.clindermatol.2004.01.010. |
| 21853405 | Background | 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. |
| 8661592 | Background | Le Louarn C. Partial subfascial abdominoplasty. Aesthetic Plast Surg. 1996 Mar-Apr;20(2):123-7. doi: 10.1007/BF02275530. |
| 15809466 | Background | 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. doi: 10.7326/0003-4819-142-7-200504050-00013. |
| 9827952 | Background | 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. doi: 10.1097/00000637-199811000-00008. |
| 22820956 | Background | 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. |
| 17312514 | Background | 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. doi: 10.1097/01.prs.0000242493.11655.68. |
| 22186572 | Background | 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. No abstract available. |
| 17471135 | Background | 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. doi: 10.1097/01.sap.0000239806.43438.54. |
| 15988280 | Background | 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. doi: 10.1097/01.prs.0000170049.94288.d2. |
| 10744246 | Background | Pitanguy I. Evaluation of body contouring surgery today: a 30-year perspective. Plast Reconstr Surg. 2000 Apr;105(4):1499-514; discussion 1515-6. |
| 19240517 | Background | 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. |
| 19730314 | Background | 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. |
| 17046623 | Background | 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. doi: 10.1016/j.bjps.2005.12.060. Epub 2006 Jul 5. |
Abdominoplasty in anchor-line keeping Scarpa's Fascia.
Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | Kg/m2 |
|
| With Scarpa's Fascia |
Abdominoplasty in anchor-line keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups |
|
|
|
| Secondary | Number of Days Required for Drain Withdrawal. | 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. | Posted | Mean | Standard Deviation | days | Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days |
|
|
|
|
| Secondary | Volume of Seroma Assessed by Ultrasound of the Abdominal Wall. | An ultrasound of the abdominal wall will be realized to check the volume of any residual seroma. | Posted | Mean | Standard Deviation | ml | Done after 20 days of surgery |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Anchor-line Abdominoplasty With Scarpa's Fascia | Anchor-line abdominoplasty where the Scarpa´s Fascia will be preserved. | 0 | 23 | 0 | 23 | 0 | 23 |
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