An observational study in Carcinoma of the Endometrium, Hysterectomy and Lymphadenectomy, sponsored by Preben Kjolhede, MD, professor. Completed at 16 sites in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-25.
Sponsored by Preben Kjolhede, MD, professor · Observational
The purposes of this study are
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
1,347 studies on the registry are indexed under Endometrial Neoplasms; 452 are open to participants now.
This study's enrollment of 262 is above the median of 200 across 328 observational studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Preben Kjolhede, MD, professor is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All women admitted to the participating clinics for primary surgery of endometrial carcinoma FIGO stage 1 and 2 will be asked to participate in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The group of women with high risk endometrial cancer who undergoes pelvic and/or paraaortic lymphadenectomy at primary surgery
Procedure: Lymphadenectomy
The group of women with low risk endometrial cancer who do not have lymphadenectomy at primary surgery
Pelvic and/or paraaortic lymphadenectomy
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months after the primary surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months from the primary surgery
Percentage of participants with an increase in leg volume of > 15% 12 months postoperatively
Time frame: 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.
Time frame: 12 months from the primary surgery
Risk factors for lymphedema after primary surgery with lymphadenectomy for endometrial cancer
Risk factors defined in terms of number of lymphnodes removed, site of lymphnodes, peri- and postoperative complications, adjuvant chemotherapy, adjuvant radiation therapy, age, histopathological subtype, surgical FIGO stage, DNA-ploidy status of the tumor, comorbidity and relapse of the cancer.
Time frame: Within 12 months after the surgery
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Preben Kjolhede, MD, professor