Trial Radar IA | ||
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Lo studio clinico NCT07237828 (DRAIN) per Cancro al seno è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
Drain Removal on Postoperative Safety and Patient Satisfaction in R-E-NSM With Prepectoral DIBR (DRAIN) 379 Randomizzato
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07237828 (DRAIN) è uno studio interventistico per Cancro al seno, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 dicembre 2025, con l'obiettivo di raggiungere 379 partecipanti. Sotto la guida di Du Zhenggui, dovrebbe concludersi entro il 30 giugno 2032. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 20 novembre 2025.
Sommario breve
Breast cancer is a malignant tumor that seriously threatens the health of women, with an increasing incidence rate. The current main treatment methods include multidisciplinary diagnosis and treatment such as surgery, radiotherapy, chemotherapy, and endocrine therapy, among which surgery is the key. Postoperative care is also very important. Traditional breast surgery requires long-term placement of drainage tubes af...Mostra di più
Descrizione dettagliata
This study is a multicenter, open, randomized controlled trial. Prior to group allocation, participants were stratified by axillary lymph node dissection. The proportion of patients undergoing axillary lymph node dissection is 25%, while the proportion of patients not undergoing axillary lymph node dissection is 75%. Following stratification, participants within each stratum were randomized in a 3:1 ratio to the inte...Mostra di più
Titolo ufficiale
Drainage Removal After Reverse-Sequence Endoscopic Nipple-Sparing Mastectomy With Direct-to-Implant Prepectoral Breast Reconstruction on Postoperative Safety and Patient Satisfaction : A National Multicenter, Open, Randomized Controlled Study
Patologie
Cancro al senoPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- DRAIN
- 2025(440)
Numero NCT
Data di inizio (effettiva)
2025-12-01
Ultimo aggiornamento pubblicato
2025-11-20
Data di completamento (stimata)
2032-06-30
Arruolamento (previsto)
379
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Parole chiave
Breast Cancer
Minimal invasive surgery
Nipple-sparing mastectomy
Endoscopic surgery
Minimal invasive surgery
Nipple-sparing mastectomy
Endoscopic surgery
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleIntervention group Remove drainage tubes on postoperative day 5 | Drain Removal Timing After Endoscopic Breast Reconstruction Surgery The optimal timing for earlier or later removal of drainage tubes after endoscopic breast reconstruction surgery. |
Nessun interventoControl group Remove drainage tubes when the daily drainage volume is less than 30 ml/day for two consecutive days after surgery. | N.D. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Aesthetic outcome evaluation--BREAST-Q scores | The Satisfaction with Breasts module of BREAST-Q questionnaire is utilized to assess patient-reported aesthetic outcomes. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores | Preoperative (baseline), 3-month postoperative |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Drainage tube indwelling duration | The duration of drainage tube indwelling refers to the total time from the postoperative insertion of the drainage tube to its removal, measured in days | Perioperative |
Quality of Life--EORTC Quality of Life scores | EORTC Scores are a series of questionnaires developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related quality of life (HRQoL) of cancer patients. These questionnaires are widely used in clinical trials and clinical practice to help evaluate treatment outcomes and patients' quality of life. The scoring range is from 0 to 100. A higher score in the functional domains indicates better functioning, while a higher score in the symptom domains indicates more severe symptoms. | 14 days postoperative and 3 months postoperative |
wound care | The differences in the number of dressing changes and wound care procedures. | 3 months postoperative |
Complications | Skin flap thermal injury, skin flap ischemia/necrosis, nipple and areola complex(NAC) ischemia/necrosis, surgical site infection, incision dehiscence, surgical site bleeding or hematoma, seroma needing repeated aspiration or drain reinsertion, capsular contracture, prosthesis outline appearance, rippling, implant displacement, implant loss, readmission | 3 months, 1 year and 2 years postoperative |
Aesthetic outcome evaluation--BREAST-Q scores | The Satisfaction with Breasts module of BREAST-Q questionnaire is utilized to assess patient-reported aesthetic outcomes. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores | 2 years postoperative |
Quality of Life--BREAST-Q scores | The Psychosocial Well-Being, Sexual Well-Being, and Physical Well-Being of the Chest modules of BREAST-Q questionnaire are used to evaluate quality of life (QoL) outcomes. Transformed scores range from 0 to 100, with higher values indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be recorded, along with pre- to postoperative differences in transformed scores | Preoperative (baseline), 3 months and 2 years postoperative |
Surgical margin involvement | Surgical margin involvement was defined as ink on tumor on postoperative paraffin-embedded pathological examination | 2-3 weeks postoperative after paraffin-embedded pathological report available |
The total volume of drainage | The volume of drainage refers to the total amount of fluid drained from the time of tube placement to the time of tube removal, measured in milliliters. | Perioperative |
Aesthetic outcome evaluation--Harris score | The Harris score was used to record the subjective judgment of symmetry of the reconstructed breast compared to the contralateral breast. The results were categorized as excellent (treated breast nearly identical to untreated breast), good (treated breast slightly different than untreated), fair (treated breast clearly different than untreated), and poor (treated breast seriously distorted). | 2-year postoperative |
Aesthetic outcome evaluation--Ueda score | Doctor-reported aesthetic outcomes will be evaluated by three professional breast surgeons using the Ueda scale, based on postoperative photographs. Scores range from 0 to 10 points, with higher values indicating better results. The categorized as follows: Excellent (≥9 points), Good (7-8 points), Fair (5-6 points), Poor (≤4 points). Both raw scores and categorizations will be documented | 2-year postoperative |
Local Recurrence-Free Survival(LRFS) | The time interval from initiation of treatment to the first recurrence at the primary tumor site.If local recurrence appears, record the time and location of recurrence | 2-year postoperative and 5-year postoperative |
Disease-Free Survival(DFS) | The period from treatment initiation to any disease recurrence (local, regional, or distant) or death.If above event appears, record the time and disease location. | 2-year postoperative and 5-year postoperative |
Overall Survival(OS) | The time from treatment initiation (or diagnosis) to death from any cause. If death appears, record the time and reason. | 2-year postoperative and 5-year postoperative |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Femmina
- Female patients aged 18-70 years (inclusive);
- Patients scheduled for unilateral or bilateral reverse-sequence endoscopic nipple-sparing- mastectomy with immediate prepectoral direct-to-implant breast reconstruction, with the option of concurrent contralateral endoscopic breast augmentation;
- Patients with preoperative pathological confirmation of carcinoma in situ, invasive cancer, or those undergoing prophylactic mastectomy;
- Patients with a maximum tumor diameter≤5 cm (before/after neoadjuvant chemotherapy), and no clinical or radiological evidence of nipple, skin, chest wall invasion, or distant metastasis;
- BMI < 40 kg/m²;
- Implant volume < 600 mL;
- Patients who are able and willing to sign the informed consent form.
- History of breast surgery within 1 year prior to this operation (excluding VABB and biopsy);
- Tumor invasion of the skin, pectoralis major muscle, chest wall, or nipple-areola complex;
- Advanced tumor stage (M1);
- Breast cancer during pregnancy or lactation;
- Scars below the nipple level and a history of previous radiotherapy;
- Patients with severe comorbidities before surgery, poorly controlled diabetes, immunodeficiency, or poor general condition that cannot tolerate surgery;
- HbA1c > 7.5%;
- Active smoking history (≥20 cigarettes per day);
- Intraoperative flap burns, intraoperative nipple excision; postoperative complications such as infection, flap ischemia, or surgical cavity bleeding within 1-4 days after surgery; or other causes leading to incisions on the surface of the breast; patients who undergo nipple excision within 1 month after surgery should be excluded from the study;
- Currently participating in other clinical studies that may affect participation in this trial.
- Refusal to sign the informed consent form.
Du ZhengguiParte responsabile dello studio
Du Zhenggui, Promotore-investigatore, Clinical Professor, West China Hospital
Contatti principali dello studio
Contatto: Zhenggui Du, Dr, +86 13880768222, [email protected]
Contatto: Tianyuan Li, +86 15510183188, [email protected]
1 Centri dello studio in 1 paesi
Sichuan
West China Hospital, SiChuan University, Chengdu, Sichuan, 610041, China
Zhenggui Du, Dr, Contatto, +86 13880768222, [email protected]
Tianyuan Li, Contatto, +86 15510183188, [email protected]