Spots Global Cancer Trial Database for Lymphedema After Primary Surgery for Endometrial Cancer
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Trial Identification
Brief Title: Lymphedema After Primary Surgery for Endometrial Cancer
Official Title: Prevalence, Complications and Risk Factors for Lymphedema After Pelvic and Paraaortic Lymphadenectomy in Primary Radical Surgery for Early Stage Endometrial Carcinoma.
Study ID: NCT02115477
Interventions
Study Description
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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Highland hospital, Eksjo, Jonkopings Län, Sweden
Falu Central Hospital, Falun, , Sweden
Gävle County Hospital, Gävle, , Sweden
Sahlgrenska University Hospital, Göteborg, , Sweden
Region Halland Halmstad Hospital, Halmstad, , Sweden
County Hospital in Kalmar, Kalmar, , Sweden
Blekinge Hospital, Karlskrona, , Sweden
Karlstad Central Hospital, Karlstad, , Sweden
Linkoping University Hospital, Linkoping, , Sweden
Södra Älvborgs Sjukhus, Skövde, , Sweden
Sundsvall Hospital, Sundsvall, , Sweden
Norra Älvborgs Hospital, Trollhättan, , Sweden
Norrlands University Hospital, Umeå, , Sweden
Akademiska University Hospital, Uppsala, , Sweden
Region Halland Varberg hospital, Varberg, , Sweden
Västervik County Hospital, Västervik, , Sweden
Contact Details
Name: Preben Kjölhede, MD, PhD
Affiliation: Dept of Obs/Gyn, University Hospital, Linköping
Role: STUDY_CHAIR
Name: Per Rosenberg, MD,PhD
Affiliation: Dept of Oncology, University Hospital, Linköping
Role: STUDY_CHAIR
Name: Gabriel Lindahl, MD
Affiliation: Dept of Oncology, University Hospital, Linköping
Role: STUDY_CHAIR
Name: Eva Ahlner, RPT
Affiliation: Dept of Oncology, University Hospital, Linköping
Role: STUDY_CHAIR
Name: Janusz Marcickiewicz, MD, PhD
Affiliation: Dept of Obs/Gyn, Region Halland Varberg Hospital, Varberg
Role: STUDY_CHAIR
Name: Karin Stålberg, MD, PhD
Affiliation: Dept of Obs/Gyn, Univeristy Hospital, Uppsala
Role: STUDY_CHAIR
Name: Ulrika Ottander, MD, PhD
Affiliation: Dept of Obs/Gyn, Norrlands University Hospital, Umeå
Role: PRINCIPAL_INVESTIGATOR
Name: Kristina Aglund, MD, PhD
Affiliation: Dept of Oncology, Norrlands University Hospital, Umeå
Role: PRINCIPAL_INVESTIGATOR
Name: Åsa Åkesson, MD, PhD
Affiliation: Dept of Obs/Gyn, Sahlgrenska University Hospital, Göteborg
Role: PRINCIPAL_INVESTIGATOR
Name: Eva Blank, MD, PhD
Affiliation: Dept of Obs/Gyn, Norra Älvsborg County Hospital in Trollhättan, Trollhättan
Role: PRINCIPAL_INVESTIGATOR
Name: Lars Högström, MD, PhD
Affiliation: Dept of Obs/Gyn, Södra Älvsborgs Hospital, Borås
Role: PRINCIPAL_INVESTIGATOR
Name: Eva Rundqvist, MD
Affiliation: Dept of Obs/Gyn, Blekinge Hospital, Karlskrona
Role: PRINCIPAL_INVESTIGATOR
Name: Margareta Lood, MD
Affiliation: Dept of Obs/Gyn, Central Hospital, Karlstad
Role: PRINCIPAL_INVESTIGATOR
Name: Lotta Andreen, MD, PhD
Affiliation: Dept of Obs/Gyn, Central Hospital, Sundsvall
Role: PRINCIPAL_INVESTIGATOR
Name: Peter Smith, MD, PhD
Affiliation: Dept of Obs/Gyn, Central Hospital, Gävle
Role: PRINCIPAL_INVESTIGATOR
Name: Åsa Nyberg, MD, PhD
Affiliation: Dept of Obs/Gyn, Central Hospital, Falun
Role: PRINCIPAL_INVESTIGATOR
Name: Lisbeth Liest, MD
Affiliation: Dept of Obs/Gyn, Highland Hospital, Eksjö
Role: PRINCIPAL_INVESTIGATOR
Name: Gunnel Lindell, MD, PhD
Affiliation: Dept of Obs/Gyn, Kalmar County Hospital, Kalmar
Role: PRINCIPAL_INVESTIGATOR
Name: Anders Rosenmüller, MD
Affiliation: Dept of Obs/Gyn, Västervik County Hospital, Västervik
Role: PRINCIPAL_INVESTIGATOR
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