Prospective Study Evaluating Postoperative Pain and Functional Recovery After Mastectomy and Immediate Breast Reconstruction by Implant: Prepectoral Versus Subpectoral Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Describe postoperative pain and functional results
研究概览
简要总结
This is a prospective, single-center, non-randomized study of immediate breast reconstruction (IBR) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy.
The technique used is chosen according to the characteristics of the breast, the morphology of the patient and her wishes after informed information on the different techniques. The aim is not to compare the two techniques but rather to evaluate the early functional results of these two methods in order to better understand them and to propose a management adapted to each.
The main objective will be to evaluate the postoperative pain by BPI questionnaire.
The investigators also wish to observe the functional results of the homolateral upper limb by DASH questionnaire, the quality of life by BREAST Q questionnaire and the occurrence of complications.
详细描述
describe the occurrence of complications between pre-pectoral and retro-pectoral technique in patients with breast cancer who have total mastectomy.
evaluate the postoperative pain by Brief Pain Inventory (BPI) self assesment observe the functional results of the homolateral upper limb by Disabilities of the Arm, Shoulder and Hand (DASH) self assesment observe quality of life by BREAST Q questionary
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Major patients
- •With breast cancer and indication for total mastectomy
- •With a desire for immediate breast reconstruction
- •Total mastectomy procedure and Immediate Breast Reconstruction by Pre-pectoral or Retro-Pectoral prosthesis
- •Information of the patient and collection of his/her non-opposition
- •Affiliation with a social securitý scheme, or beneficiary of such a scheme
排除标准
- •Prophylactic mastectomies
- •Metastatic patients
- •Patients requiring another surgical technique
- •Person in an emergency situation, person of legal age under legal protection (adult under guardianship, curators or safeguard of justice), or unable to express consent,
- •Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons
- •Pregnant or likely to be pregnant
研究组 & 干预措施
pre-pectoral prosthesis
breast cancer patients with an indication for total mastectomy + immediate breast reconstruction (IBR) by prosthesis using a pre-pectoral technique
干预措施: mastectomy + immediate breast reconstruction (Procedure)
retropectoral prosthesis
breast cancer patients with an indication for total mastectomy + immediate breast reconstruction (IBR) by prosthesis using the retropectoral technique
干预措施: mastectomy + immediate breast reconstruction (Procedure)
结局指标
主要结局
Describe postoperative pain and functional results
时间窗: 6 month
Brief Pain Inventory (BPI) short form - 4 scales from 1 (No pain) to 10 (max pain) + 7 scales from 1 (no discomfort) to 10 (max discomfort) to determine if the pain interfered with activities of daily living
次要结局
- Describe the occurrence of postoperative complications(3 months)
- Describe the length of operative stay (for the initial reconstruction), for all patients and according to the methods of reconstruction performed(3 months)
- Describe the duration of drainage for all patients and according to the methods of reconstruction performed(3 months)
- Assessing quality of life and aesthetic satisfaction(6 months)
- Evaluate the function of the homolateral upper limb(6 months)
- Describe the number of surgery(s) required to obtain a good aesthetic result(3 months)
- Describe the number of consultations for seroma punctures, for all patients and according to the methods of reconstruction performed(3 months)