Lymphedema After Primary Surgery for Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Not included

Official Title
-----------------
Prevalence, Complications and Risk Factors for Lymphedema After Pelvic and Paraaortic Lymphadenectomy in Primary Radical Surgery for Early Stage Endometrial Carcinoma.

Conditions
-----------------
Carcinoma of the Endometrium, Hysterectomy, Lymphadenectomy

Intervention / Treatment
-----------------
* Procedure: Lymphadenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group with lymphadenectomy<br>The group of women with high risk endometrial cancer who undergoes pelvic and/or paraaortic lymphadenectomy at primary surgery | Procedure: Lymphadenectomy<br>* Pelvic and/or paraaortic lymphadenectomy<br>|
| Group without lymphadenectomy<br>The group of women with low risk endometrial cancer who do not have lymphadenectomy at primary surgery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in leg volume from baseline (preoperatively) to 4-6 weeks postoperatively | Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically. | 4-6 weeks after the primary surgery | 
| Change in leg volume from baseline (preoperatively) to 6 months postoperatively | Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically. | 6 months after the primary surgery | 
| Change in leg volume from baseline (preoperatively) to 12 months postoperatively | Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically. | 12 months after the primary surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life assessment from baseline (preoperatively) to 4-6 weeks postoperatively | Quality of life measured by means of The EuroQol (EQ-5D), the Short-Form 36 (SF-36) and the condition specific quality of life form LYMQOL. | 4-6 weeks from the primary surgery | 
| Change in quality of life assessment from baseline (preoperatively) to 6 months postoperatively | Quality of life measured by means of The EuroQol (EQ-5D), the Short-Form 36 (SF-36) and the condition specific quality of life form LYMQOL. | 6 months from the primary surgery | 
| Change in quality of life assessment from baseline (preoperatively) to 12 months postoperatively | Quality of life measured by means of The EuroQol (EQ-5D), the Short-Form 36 (SF-36) and the condition specific quality of life form LYMQOL. | 12 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 | 
| Percentage of participants who states they have lymphedema | Occurrence of lymphedema subjectively graded as 2 or more on an ordinal scale from 1 to 4. 1 express no swelling of the legs and 4 express severe swelling. | 12 months from the primary surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uterus cancer, Hysterectomy, Lymphadenectomy, Lymphedema