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| ID | Type | Description | Link |
|---|---|---|---|
| The Swedish Cancer Society | Other Grant/Funding Number | CAN 2013/620 |
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| Name | Class |
|---|---|
| Swedish Cancer Society | OTHER |
| Medical Research Council of Southeast Sweden | OTHER_GOV |
| Ostergotland County Council, Sweden | OTHER |
| Linkoeping University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with lymphadenectomy | The group of women with high risk endometrial cancer who undergoes pelvic and/or paraaortic lymphadenectomy at primary surgery |
| |
| Group without lymphadenectomy | The group of women with low risk endometrial cancer who do not have lymphadenectomy at primary surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymphadenectomy | Procedure | Pelvic and/or paraaortic lymphadenectomy |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 12 months after the surgery |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Preben Kjölhede, MD, PhD | Dept of Obs/Gyn, University Hospital, Linköping | Study Chair |
| Per Rosenberg, MD,PhD | Dept of Oncology, University Hospital, Linköping | Study Chair |
| Gabriel Lindahl, MD | Dept of Oncology, University Hospital, Linköping | Study Chair |
| Eva Ahlner, RPT | Dept of Oncology, University Hospital, Linköping | Study Chair |
| Janusz Marcickiewicz, MD, PhD | Dept of Obs/Gyn, Region Halland Varberg Hospital, Varberg | Study Chair |
| Karin Stålberg, MD, PhD | Dept of Obs/Gyn, Univeristy Hospital, Uppsala | Study Chair |
| Ulrika Ottander, MD, PhD | Dept of Obs/Gyn, Norrlands University Hospital, Umeå | Principal Investigator |
| Kristina Aglund, MD, PhD | Dept of Oncology, Norrlands University Hospital, Umeå | Principal Investigator |
| Åsa Åkesson, MD, PhD | Dept of Obs/Gyn, Sahlgrenska University Hospital, Göteborg |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highland hospital | Eksjö | Jonkopings Län | 57533 | Sweden | ||
| Falu Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10088797 | Background | Miller AJ, Bruna J, Beninson J. A universally applicable clinical classification of lymphedema. Angiology. 1999 Mar;50(3):189-92. doi: 10.1177/000331979905000302. | |
| 7620649 | Background | Sitzia J. Volume measurement in lymphoedema treatment: examination of formulae. Eur J Cancer Care (Engl). 1995 Mar;4(1):11-6. doi: 10.1111/j.1365-2354.1995.tb00047.x. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D014594 | Uterine Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008197 | Lymph Node Excision |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| OTHER_GOV |
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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 |
| Principal Investigator |
| Eva Blank, MD, PhD | Dept of Obs/Gyn, Norra Älvsborg County Hospital in Trollhättan, Trollhättan | Principal Investigator |
| Lars Högström, MD, PhD | Dept of Obs/Gyn, Södra Älvsborgs Hospital, Borås | Principal Investigator |
| Eva Rundqvist, MD | Dept of Obs/Gyn, Blekinge Hospital, Karlskrona | Principal Investigator |
| Margareta Lood, MD | Dept of Obs/Gyn, Central Hospital, Karlstad | Principal Investigator |
| Lotta Andreen, MD, PhD | Dept of Obs/Gyn, Central Hospital, Sundsvall | Principal Investigator |
| Peter Smith, MD, PhD | Dept of Obs/Gyn, Central Hospital, Gävle | Principal Investigator |
| Åsa Nyberg, MD, PhD | Dept of Obs/Gyn, Central Hospital, Falun | Principal Investigator |
| Lisbeth Liest, MD | Dept of Obs/Gyn, Highland Hospital, Eksjö | Principal Investigator |
| Gunnel Lindell, MD, PhD | Dept of Obs/Gyn, Kalmar County Hospital, Kalmar | Principal Investigator |
| Anders Rosenmüller, MD | Dept of Obs/Gyn, Västervik County Hospital, Västervik | Principal Investigator |
| Falun |
| 79182 |
| Sweden |
| Gävle County Hospital | Gävle | 80187 | Sweden |
| Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
| Region Halland Halmstad Hospital | Halmstad | 30233 | Sweden |
| County Hospital in Kalmar | Kalmar | 39185 | Sweden |
| Blekinge Hospital | Karlskrona | 37185 | Sweden |
| Karlstad Central Hospital | Karlstad | 65185 | Sweden |
| Linkoping University Hospital | Linköping | 58185 | Sweden |
| Södra Älvborgs Sjukhus | Skövde | +4651085000 | Sweden |
| Sundsvall Hospital | Sundsvall | 85186 | Sweden |
| Norra Älvborgs Hospital | Trollhättan | 46185 | Sweden |
| Norrlands University Hospital | Umeå | 90185 | Sweden |
| Akademiska University Hospital | Uppsala | 75185 | Sweden |
| Region Halland Varberg hospital | Varberg | 43281 | Sweden |
| Västervik County Hospital | Västervik | 59381 | Sweden |
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |