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L'essai clinique NCT06712524 pour Breast-conserving Plastic Surgery, Granulomatous Mastitis est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Effect of Different Surgical Approaches of Granulomatous Mastitis

En recrutement
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L'étude clinique NCT06712524 est un essai interventionnel pour Breast-conserving Plastic Surgery, Granulomatous Mastitis. Son statut actuel est : en recrutement. L'étude a débuté le 1 novembre 2024 et vise à recruter 240 participants. Dirigé par Hubei Cancer Hospital, l'essai devrait être terminé d'ici le 31 décembre 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 2 décembre 2024.
Résumé succinct
The objective of this study was to prospectively investigate the effects of different surgical approaches on the recurrence rate and aesthetic outcome of patients with granulomatous mastitis. The patients were divided into traditional surgery group and plastic surgery group.
Description détaillée
Granulomatous mastitis is a rare benign inflammatory breast disease first described by Kessler and Wollock in 1972. It resembles inflammatory breast cancer disease in imaging and mainly affects women of childbearing age. Treatment methods include steroid therapy, antibiotics and surgical treatment. However, due to the adverse reactions of drug treatment and the high recurrence rate after traditional surgery, there is no definitive preferred treatment form at present, and most clinicians are still in the stage of empirical treatment.

Breast-conserving plastic surgery has been widely used by surgeons because it can remove a larger range of breast cancer, so it has higher safety and aesthetics compared with traditional breast conserving surgery. So, if patients with mastitis are treated surgically, will they also benefit from breast-conserving surgery? At present, the commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on. Therefore, this study prospectively grouped mastitis patients who selected surgery, and divided them into traditional surgery group and plastic breast-conserving surgery group. The postoperative recurrence, adverse reactions, aesthetics and satisfaction of the two groups were compared.

It is hoped that this study will bring a new research direction for the surgical treatment of mastitis and provide a clearer guiding significance for clinical decision-making.

Titre officiel

A Prospective Real-world Study of the Effect of Different Surgical Approaches on the Recurrence Rate and Aesthetic Outcome of Granulomatous Mastitis

Conditions
Breast-conserving Plastic SurgeryGranulomatous Mastitis
Autres identifiants de l'essai
  • LLHBCH2024YN-093
Numéro NCT
Date de début (réel)
2024-11-01
Dernière mise à jour publiée
2024-12-02
Date de fin (estimée)
2027-12-31
Inscription (estimée)
240
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Granulomatous mastitis
breast conserving plastic surgery
Aesthetics scores
Objectif principal
Traitement
Plan d'attribution
Non aléatoire
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalBreast-conserving plastic surgery group
Breast-conserving plastic surgery
Breast-conserving Plastic Surgery
The commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on.
Comparateur actifTraditional breast surgery group
Traditional breast surgery
Traditional Breast Surgery
Traditional breast surgery
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Recurrence rate
The recurrence rate of mastitis patients was compared between traditional surgery group and plastic surgery group.
2, 3, 5 year
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Aesthetics scores
The patients' satisfaction and quality of life after surgery were evaluated by BREAST Q questionnaire. The full score is 100, with higher scores indicating higher patient satisfaction and quality of life. Occurring rate of complications including the occurring rate of infection, hemorrhage, time in hospital in each group were recorded in patients' medical record.
2, 3, 5 year
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Femme

Only the subjects who meet all the following criteria may be included in this study:

  1. Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form;
  2. 18≤Age≤75 years old, female;
  3. Histologically confirmed granulomatous mastitis;
  4. low and moderate risk for anesthesia.

The subjects who meet any of the following criteria shall not be included in this study:

  1. Absolute and relative contraindication for surgery;
  2. Previous history of breast cancer or other malignancies;
  3. Pregnancy;
  4. Any serious complications which caused patients not suitable to participate this study.
Hubei Cancer Hospital logoHubei Cancer Hospital
Partie responsable de l'essai
Hongmei Zheng, PhD, Investigateur principal, Doctor, Hubei Cancer Hospital
Contact central de l'essai
Contact: Hongmei Zheng, Doctor, 18971624606, [email protected]
1 Centres de l'essai dans 1 pays

Hubei

Hubei Cancer Hospital, Wuhan, Hubei, 430060, China
Xinhong Wu, Doctor, Contact, 15902736236, [email protected]
Xinjun Liang, Doctor, Investigateur principal
En recrutement