Minimal Harvest Dorsalis Major Flap Breast Reconstruction: Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- functional evaluation of the shoulder and upper limb (mobility and pain)
研究概览
简要总结
The dorsalis major flap is an interesting therapeutic option in breast reconstruction because of reliability and reproducibility.
In recent years, the minimal flap technique has been developed, which consists of removing only a portion of the of the large dorsal muscle to reduce the painful and functional sequelae of this surgery.
The objective of this prospective study is to evaluate the functional and aesthetic results in patients who have undergone who have undergone this procedure (prospective cohort) or who will undergo this procedure or prosthetic reconstruction (prospective cohort).
The investigators also wish to evaluate the quality of life of patients after reconstruction with a minimal harvest dorsalis flap or a prosthesis or prosthesis in the prospective cohort.
详细描述
Retrospective Cohort :
- Clinical data reconstruction and follow-up up to 1 year
- DASH questionnaire
- Breast Q
- aesthetic evaluation (patient and surgeon and other health professional)
Prospective Cohort :
- Clinical data reconstruction and follow-up up to 1 year
- DASH questionnaire (pre-op, at 6 month and at 12 month)
- Breast Q(pre-op, at 6 month and at 12 month)
- aesthetic evaluation (patient and surgeon and other health professional) (at 6 month and at 12 month)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with a desire for breast reconstruction
- •Indication for mastectomy or with a history of mastectomy, with or without preservation of the skin skin,
- •Breast reconstruction procedure by LDPM performed between January 2017 and September2021, (retrospective cohort )
- •Breast reconstruction procedure by LDPM or by prosthesis performed from February 2022 (prospective cohort)
- •Information to the patient and collection of her non-opposition
- •Affiliation to a social security system, or beneficiary of such a system
排除标准
- •Performance of a breast reconstruction by a technique other than LDPM or prosthesis
- •Patient opposed to the use of her data for research
- •Person in an emergency situation, adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to express his consent,
- •Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological psychological reasons.
研究组 & 干预措施
A Retrospective
A = retrospective cohort including all patients treated at the ICO Angers between January 2017 and September 2021
干预措施: Breast reconstruction (Procedure)
B Prospective
B = prospective including all patients treated at the ICO from February 2022 (2 years of recruitment)
干预措施: Breast reconstruction (Procedure)
结局指标
主要结局
functional evaluation of the shoulder and upper limb (mobility and pain)
时间窗: 6 month
Disabilities of the Arm, Shoulder and Hand (DASH) (0 = no disability to 100 = maximum disability)
次要结局
- occurrence of postoperative complications(6 month)
- quality of life through the Breast-Q questionnaire(6 months)
- satisfaction of aesthetic by the patient and by the surgeon(6 month)