Hysterectomy Clinical Trial
Official title:
Prevalence, Complications and Risk Factors for Lymphedema After Pelvic and Paraaortic Lymphadenectomy in Primary Radical Surgery for Early Stage Endometrial Carcinoma.
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.
Not included ;
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