Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
1 september 2026 uppdaterad av: Research Inc
This prospective single-group study will evaluate an investigator-developed rectus abdominis plication performed during abdominoplasty.
Standardized ultrasound will measure inter-rectus distance before surgery and at 3 and 12 months.
The primary outcome is change in mean inter-rectus distance at one year.
Recurrence, abdominal wall function, BODY-Q satisfaction, surgical complications, and reoperation will also be assessed.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
Adults undergoing primary abdominoplasty with rectus diastasis will receive a standardized plication described in a locked operative manual.
Baseline and postoperative ultrasound will measure the inter-rectus distance at three fixed abdominal levels.
Operative variables and protocol adherence will be recorded.
Follow-up visits through month 12 will assess anatomical durability, recurrence, abdominal wall function, patient-reported satisfaction, and complications.
The study is designed to generate reproducible one-year safety and effectiveness estimates and to identify factors associated with recurrence.
Studietyp
Interventionell
Inskrivning (Beräknad)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jose D Salazar, MD, Plastic surgeon
- Telefonnummer: +57 311 6058486
- E-post: heimdal007@gmail.com
Studieorter
-
-
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Medellín, Colombia
- Rekrytering
- IQ interquirofanos
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Kontakt:
- Jose D Salazar, MD, Plastic surgeon
- Telefonnummer: +57 311 6058486
- E-post: heimdal007@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Age 18 to 65 years.
- Scheduled for primary abdominoplasty with rectus plication.
- Rectus diastasis documented clinically or by baseline ultrasound.
- Stable body weight for at least 3 months before surgery.
- Ability to complete ultrasound and clinical follow-up through 12 months.
- Written informed consent.
Exclusion Criteria:
- Prior major abdominal wall reconstruction or mesh repair that prevents standardized plication assessment.
- Ventral or incisional hernia requiring a separate reconstructive procedure.
- Pregnancy, breastfeeding, or planned pregnancy during the 12-month follow-up.
- Uncontrolled systemic disease or contraindication to elective abdominoplasty.
- BMI greater than 35 kg/m2 unless the final operative protocol intentionally includes this population.
- Inability to obtain technically adequate baseline ultrasound measurements.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Investigator-Developed Rectus Plication
Participants undergo abdominoplasty with the standardized investigator-developed plication and complete one-year anatomical, functional, and safety follow-up.
|
A standardized plication is performed during abdominoplasty.
The locked operative appendix will specify patient position, exposure, cranial and caudal limits, suture material, number of layers, stitch configuration, target tension, intraoperative measurements, and management of associated hernia if permitted.
Linked arm/group(s): Investigator-Developed Rectus Plication.
Inter-rectus distance will be measured at fixed levels during a standardized respiratory phase and abdominal muscle state.
Three measurements per level will be averaged by a trained assessor.
Linked arm/group(s): Investigator-Developed Rectus Plication.
|
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Aktiv komparator: abdominoplasty without plication
Participants undergo abdominoplasty without the standardized investigator-developed plication and complete one-year anatomical, functional, and safety follow-up.
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Inter-rectus distance will be measured at fixed levels during a standardized respiratory phase and abdominal muscle state.
Three measurements per level will be averaged by a trained assessor.
Linked arm/group(s): Investigator-Developed Rectus Plication.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Mean waist perimeter
Tidsram: Baseline and postoperative month 12. 12 months
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waist perimeter in cm will be measured by a meter at fixed supraumbilical levels.
Change is 12-month minus baseline distance; a more negative value indicates greater narrowing.
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Baseline and postoperative month 12. 12 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of Plication-Related Major Complications
Tidsram: From surgery through postoperative month 12.
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Proportion of participants with abdominal compartment symptoms requiring intervention, plication disruption, symptomatic recurrence, reoperation, thromboembolic event, respiratory compromise attributed to increased abdominal pressure, or other serious event adjudicated as related to plication.
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From surgery through postoperative month 12.
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Change in Abdominal Wall Physical Function
Tidsram: Baseline, postoperative month 3, and postoperative month 12.
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Change in the selected validated abdominal/core function instrument or BODY-Q Physical Function score.
The final instrument and scoring rules will be locked before enrollment.
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Baseline, postoperative month 3, and postoperative month 12.
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Change in BODY-Q Abdomen Satisfaction Score
Tidsram: Baseline, postoperative month 6, and postoperative month 12.
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Rasch-transformed 0-to-100 BODY-Q Abdomen score; higher values indicate greater satisfaction with abdominal appearance.
Use requires the appropriate license and authorized translation.
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Baseline, postoperative month 6, and postoperative month 12.
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Incidence of Standard Abdominoplasty Complications
Tidsram: From surgery through postoperative day 30. 30 days
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Proportion with seroma requiring aspiration, hematoma, surgical-site infection, wound dehiscence, skin necrosis, venous thromboembolism, or unplanned reoperation.
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From surgery through postoperative day 30. 30 days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: jose D Salazar
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Amro C, Ryan IA, Jog A, Broach RB, Fischer JP, Altieri MS, Azoury SC. Outcomes of Abdominal Contouring in Patients with and without Weight Loss Surgery: A Propensity-Matched Comparison Study. Plast Reconstr Surg. 2026 Mar 1;157(3):464-473. doi: 10.1097/PRS.0000000000012384. Epub 2025 Aug 13.
- Swanson E. Abdominal Fascial Plication and the Risk of Venous Thromboembolism in Abdominoplasty Patients: A Systematic Review of the Literature. Ann Plast Surg. 2025 Mar 1;94(3):378-383. doi: 10.1097/SAP.0000000000004149. Epub 2024 Nov 6.
- Restifo RJ. An In-Depth Analysis of 1370 Consecutive Abdominoplasties: Fascial Plication Increases Risk of Venous Thromboembolism, and Scoring for Plication Improves the Caprini Risk Assessment Model. Aesthet Surg J. 2024 Nov 15;44(12):NP870-NP882. doi: 10.1093/asj/sjae139.
- Marchica P, Costa AL, Brambullo T, Marini M, Masciopinto G, Gardener C, Grigatti M, Bassetto F, Vindigni V. Retrospective Analysis of Predictive Factors for Complications in Abdominoplasty in Massive Weight Loss Patients. Aesthetic Plast Surg. 2023 Aug;47(4):1447-1458. doi: 10.1007/s00266-022-03235-5. Epub 2023 Jan 6.
- Staalesen T, Olsen MF, Elander A. The Effect of Abdominoplasty and Outcome of Rectus Fascia Plication on Health-Related Quality of Life in Post-Bariatric Surgery Patients. Plast Reconstr Surg. 2015 Dec;136(6):750e-761e. doi: 10.1097/PRS.0000000000001772.
- Wilting R, Lier B, de Vries CE, Dalaei F, Poulsen L, Luketina R, Repo JP, Paul M, Hoogbergen M; BODY-Q Network. Health-Related Quality-of-Life Effects of Rectus Repair during Body Contouring Surgery in Postbariatric Patients: A Prospective Study. Plast Reconstr Surg. 2024 Oct 1;154(4):735-745. doi: 10.1097/PRS.0000000000011168. Epub 2023 Oct 30.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 januari 2024
Primärt slutförande (Faktisk)
1 september 2026
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
1 september 2026
Först inskickad som uppfyllde QC-kriterierna
1 september 2026
Första postat (Faktisk)
8 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 011 (Nahrain Medical Research Collective (NMRC))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
no contemplated in the patient informed consent
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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