Study to Evaluate the Efficacy of Early Detection of Lower Extremity Lymphedema After Lymphadenectomy in Gynecological Cancer and Implantation of the Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Efficacy of the implantation of a standardized postoperative follow-up for the early detection of lymphedema secondary to lymphadenectomy in gynecological cancer
研究概览
简要总结
This study aims to detect and treat early lower limb lymphedema secondary to lymphadenectomy with the aim of increasing the quality of life of patients with this chronic condition.
To this end, a group of patients (treatment group) will be referred to the Rehabilitation service for a previous consultation and after surgery where lymphedema could be detected early. In addition, the usual follow-up will be carried out in Gynecology Oncology consultation (GO). In the second group, also called control, will be performed the usual follow-up in GO.
For this we randomize to one of these two groups. The research project has the favorable report of the Center's Clinical Research Ethics Committee
详细描述
METHODOLOGY:
- Type of study: A) Randomized clinical trial B) Prospective cohort observational study
- Study period: from January 2017 to December 2017.
- Scope: health area of the province of Gipuzkoa and the University Hospital of Donostia as a reference center.
- Selection of the population:
4.1. The inclusion criteria will be: A) Diagnostic gynecological cancer patients submitted to bilateral laparoscopic pelvic lymphadenectomy as laparotomics (B: Sentinel Node Biopsy study, SNB) within the usual surgical protocol, with expected survival greater than 12 weeks and adequate liver, renal and medullary functions to accept And sign informed consent 4.2. The exclusion criteria for the study will be: Blood clotting or hematological disorders, previous thromboembolic disease and history of lymphatic system disease (lymphedema or lymphocele), contraindication for physiotherapy or who do not wish to participate and / or do not sign informed consent.
4.3. Sample size: A) Assuming that according to previous studies the overall incidence of lymphedema after LPL is 21% (Hareyama et al), its estimated that a minimum sample of 44 patients will bi needed in order to be able to demonstrate at least 4-fold detection (Torres et al) of Lymphedemas with early follow-up with alpha = 0.05 and beta = 0.2, estimating that habitual follow-up detects 13% of lymphedema ( Mohler III et al).
4.4. Recruitment Process: Will be selected consecutively and offered to participate in the study. 5. 5.1 Intervention: A) After diagnosis and programming for surgery at the GO consultation, circometry is performed by a trained nurse. During the admission, the nurse delivers and explains recommendations sheet and is offered to participate in the clinical trial giving him the Informed Consent (IC) and Information Sheet created for this purpose. In case of accepting and signing the IC, it is randomized (total randomization) according to system of envelopes with code.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
randomization according to system of envelopes with code
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A) Diagnostic gynecological cancer patients submitted to bilateral laparoscopic pelvic lymphadenectomy as laparotomics (B: Sentinel Node Biopsy study, SNB) within the usual surgical protocol, with expected survival greater than 12 weeks and adequate liver, renal and medullary functions to accept And sign informed consent
排除标准
- •The exclusion criteria for the study will be: Blood clotting or hematological disorders, previous thromboembolic disease and history of lymphatic system disease (lymphedema or lymphocele), contraindication for physiotherapy or who do not wish to participate and / or do not sign informed consent.
研究组 & 干预措施
Usual follow-up
The usual follow-up will be carried out in GO consultation (0,1,6,12 months)
干预措施: Usual follow-up (Other)
Early lymphedema detection
Face-to-face consultation in Rehabilitation for early detection of lymphedema after surgery. Lower Limb measurement and care education
干预措施: Early lymphedema detection (Other)
结局指标
主要结局
Efficacy of the implantation of a standardized postoperative follow-up for the early detection of lymphedema secondary to lymphadenectomy in gynecological cancer
时间窗: 12 months
Lower Limb measurement secondary to lymphadenectomy in gynecological cancer
次要结局
- Implementation of educational strategy for patients and professionals(12 months)
研究者
IBON JAUNARENA
Oncology Gynecologist
Hospital Donostia