Morbidity Of Latissimus Dorsi Flap Reconstruction in Breast Cancer Surgery(MILD Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 290
- 试验地点
- 1
研究概览
简要总结
This prospective, longitudinal, quasi-experimental study aims to evaluate shoulder morbidity in breast cancer patients undergoing partial or total breast reconstruction using a latissimus dorsi (LD) flap, compared with patients who do not undergo LD flap reconstruction. Although LD flaps remain valuable in selected clinical situations—such as in obese patients, smokers, or settings where free flaps are not feasible—they have been associated with potential long-term shoulder dysfunction. Additional treatments such as axillary lymph node dissection (ALND) and radiotherapy (RT) may further worsen shoulder mobility and functional outcomes.
The study will include women aged 18–65 years undergoing breast-conserving surgery or mastectomy with immediate LD flap reconstruction. A historical control group (without LD flap reconstruction) will be obtained from the AiSLe study. Exclusion criteria include pre-existing shoulder pathology, prior ipsilateral breast cancer surgery, neurological disease, uncontrolled comorbidities, and inability to participate in follow-up.
Participants will undergo detailed baseline, postoperative, 6-month, and 18-month assessments. Shoulder function will be measured using the Constant–Murley Score (CMS) and goniometric range-of-motion (ROM). Additional evaluations include BREAST-Q satisfaction, cosmetic assessment using Modified Harris Scale and BCCT.core software, lymphedema assessment, sensory abnormalities, and documentation of postoperative complications (Clavien–Dindo). For patients receiving radiotherapy, dosimetric parameters of the shoulder-girdle structures will be analyzed to explore correlations with morbidity.
A total of 290 patients will be included (145 LD flap patients and 145 matched controls). Statistical analysis will involve propensity score matching, comparisons using t-tests or non-parametric equivalents, and chi-square tests for categorical variables, with significance at p<0.05.
The primary aim is to determine whether LD flap reconstruction results in increased shoulder morbidity at 6 months post-treatment. Secondary aims include long-term morbidity, complication rates, patient satisfaction, cosmetic outcomes, and the impact of radiotherapy and shoulder-region radiation dose
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients aged 18-65 years who are undergoing breast conservation surgery or total mastectomy with or without axillary lymph node dissection (ALND) with LD flap with or without implant will be included in the study arm
- •Patients who are able and willing to provide informed consent and comply with study protocols, including follow-up visits.
排除标准
- •Patients with prior shoulder pathology (e.g., rotator cuff injuriesor traumatic shoulder deformities, frozen shoulder, shoulder arthritis, developmental abnormalities involving the shoulder girdle, e.g. Polands syndrome) or pre- existing shoulder limitations that could confound the results of shoulder morbidity assessment.
- •Patients with previous breast surgery for cancer (other than biopsy or minor excision biopsy) on the same side that may affect the evaluation of shoulder morbidity or reconstruction outcomes.
- •Patients with a history of chronic pain syndromes, neurological disorders (e.g., stroke, multiple sclerosis), or significant psychiatric illness that might affect their ability to participate in the study or report outcomes accurately.
- •Pregnant or breastfeeding women, as these factors may alter recovery patterns and complicate the assessment of morbidity.
- •5.Patients with active infections or any uncontrolled comorbidities (e.g.,uncontrolled diabetes, cardiovascular disease, i.e. ASA III and above) that may interfere with the recovery process and skew results.
- •Patients who are unable to attend follow-up appointments or comply with study protocols, such as participating in physical assessments postoperatively.
研究者
Dr Shalaka Joshi
Tata Memorial Centre