Prevalence, Complications and Risk Factors for Lymphedema After Pelvic and Paraaortic Lymphadenectomy in Primary Radical Surgery for Early Stage Endometrial Carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 16
- 主要终点
- Change in leg volume from baseline (preoperatively) to 6 months postoperatively
研究概览
简要总结
The purposes of this study are
- to determine the prevalence, size and impact on quality of life of lymphedema of the lower extremities after primary radical surgery with hysterectomy +/- pelvic - and paraaortic lymphadenectomy in women with endometrial uterine carcinoma FIGO (International Federation of Gynecology and Obstetrics) stage 1 and 2
- to analyze risk factors for development of lymphedema in this specific group of patients.
Our hypotheses are that women who have lymphadenectomy more often suffer from lymphedema, subjectively and objectively, and have an impaired quality of life.
This is a Swedish multicenter study carried out in 17 departments of Obstetrics and Gynecology and in 3 departments of Oncology. All participants are treated according to the Swedish National Guidelines for Endometrial Cancer.
130 women with endometrial cancer who have a hysterectomy with lymphadenectomy (high-risk endometrial carcinomas) and 130 women with endometrial cancer who have a hysterectomy without lymphadenectomy (low-risk endometrial carcinomas) are prospectively enrolled in the study.
The participants are examined preoperatively and on 3 occasions postoperatively, i.e. 4-6 weeks , 6 months and 12 months postoperatively.
Determination of occurrence of lymphedema of the lower extremities are determined objectively by 1) a standardized clinical evaluation according to Bruna et al.[1] and 2) determining the leg volume according to the cone model by Sitzia [2] by systematically measuring of leg circumferences. In addition, occurrence of lymphedema is measured subjectively by the participants.
On the same four occasions as the leg circumference measurements are conducted the patients complete two generic health related quality of life forms (the EuroQol EQ-5D and the Short-Form 36 SF-36) and the condition specific quality of life form for limb lymphedema (LYMQOL).
Demographic and clinical data are systematically collected until one year postoperatively including occurrence of complications and given adjuvant oncological therapy such as chemo- and radiation therapy.
On each occasion of clinical control a vaginal ultrasound examination is carried out in order to register pelvic and abdominal lymphocele formation or lymphatic fluid effusion intraabdominally.
详细描述
Not included
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
- •Age >=18 years.
- •Women with endometrial carcinoma preoperatively evaluated to be uterine cancer FIGO stage1 or 2 who are planned for primary radical surgery including simple or radical hysterectomy, bilateral salpingoophorectomy,+/- pelvic and paraaortic lymphadenectomy and +/- omentectomy with curative intention.
- •WHO performance status ≤
- •Understand and speak Swedish fluently
- •Accept to participate in the study by giving verbal and written informed consent.
排除标准
- •Sarcoma of the uterus
- •Previous pelvic or paraaortic lymphadenectomy.
- •Previous having had pelvic radiation therapy.
- •Ongoing treatment of arterial or venous insufficiency of the lower limbs
- •Congenital or acquired malformations in the lymphatic system.
- •Ongoing or previous treatment of lymphedema of the upper or lower limbs.
- •Physically disability which impair mobilisation immediately postoperatively.
- •Severe psychiatric disease and untreated mild/moderate psychiatric disease.
- •Mentally retarded to a degree so she does not understand the meaning of the participation or cannot fill in the questionnaires.or the physician finds it ethically doubtful to enroll the patient in the study
结局指标
主要结局
Change in leg volume from baseline (preoperatively) to 6 months postoperatively
时间窗: 6 months after the primary surgery
Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically.
Change in leg volume from baseline (preoperatively) to 4-6 weeks postoperatively
时间窗: 4-6 weeks after the primary surgery
Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically.
Change in leg volume from baseline (preoperatively) to 12 months postoperatively
时间窗: 12 months after the primary surgery
Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically.
次要结局
- Change in quality of life assessment from baseline (preoperatively) to 4-6 weeks postoperatively(4-6 weeks from the primary surgery)
- Change in quality of life assessment from baseline (preoperatively) to 12 months postoperatively(12 months from the primary surgery)
- Percentage of participants who states they have lymphedema(12 months from the primary surgery)
- Change in quality of life assessment from baseline (preoperatively) to 6 months postoperatively(6 months from the primary surgery)
- Percentage of participants with an increase in leg volume of > 15% 12 months postoperatively(12 months after the primary surgery)
研究者
Preben Kjolhede, MD, professor
Professor
University Hospital, Linkoeping