Lymphadenectomy
ProcedurePelvic and/or paraaortic lymphadenectomy
NCT Number: NCT02115477
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.
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Notify Me18 year and older
Female
Observational
Highland hospital, Eksjö, Jonkopings Län, Sweden
Not included
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pelvic and/or paraaortic lymphadenectomy
Time frame: 4-6 weeks after the primary surgery
Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically.
Time frame: 6 months after the primary surgery
Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically.
Time frame: 12 months after the primary surgery
Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically.
Time frame: 4-6 weeks from the primary surgery
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
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
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 after the primary surgery
Time frame: 12 months from the primary surgery
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: Within 12 months after the surgery
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.
Preben Kjolhede, MD, professor
Other
Prevalence, Complications and Risk Factors for Lymphedema After Pelvic and Paraaortic Lymphadenectomy in Primary Radical Surgery for Early Stage Endometrial Carcinoma.
Acronym: LASEC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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