Lymphedema After Primary Surgery for Endometrial Cancer (LASEC)

Preben Kjolhede, MD, professor

Status

Completed

Conditions

Carcinoma of the Endometrium

Hysterectomy

Lymphadenectomy

Treatments

Procedure: Lymphadenectomy

Study type

Observational

Funder types

Other

Identifiers

NCT02115477

The Swedish Cancer Society (Other Grant/Funding Number)

Version 2013-09-22/2014-03-21

Details and patient eligibility

About

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.

Full description

Not included

Enrollment

262 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 ≤ 2.
Understand and speak Swedish fluently
Accept to participate in the study by giving verbal and written informed consent.

Exclusion criteria

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