Lymphedema After Primary Surgery for Endometrial Cancer

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.

Conditions

• Carcinoma of the Endometrium
• Hysterectomy
• Lymphadenectomy

Interventions

PROCEDURE

Lymphadenectomy

Pelvic and/or paraaortic lymphadenectomy

Sponsors & Collaborators

• Swedish Cancer Society

  collaborator OTHER

• Medical Research Council of Southeast Sweden

  collaborator OTHER_GOV

• Ostergotland County Council, Sweden

  collaborator OTHER

• Linkoeping University

  collaborator OTHER_GOV

• Preben Kjolhede, MD, professor

  lead OTHER

Principal Investigators

• Preben Kjölhede, MD, PhD · Dept of Obs/Gyn, University Hospital, Linköping

• Per Rosenberg, MD,PhD · Dept of Oncology, University Hospital, Linköping

• Gabriel Lindahl, MD · Dept of Oncology, University Hospital, Linköping

• Eva Ahlner, RPT · Dept of Oncology, University Hospital, Linköping

• Janusz Marcickiewicz, MD, PhD · Dept of Obs/Gyn, Region Halland Varberg Hospital, Varberg

• Karin Stålberg, MD, PhD · Dept of Obs/Gyn, Univeristy Hospital, Uppsala

• Ulrika Ottander, MD, PhD · Dept of Obs/Gyn, Norrlands University Hospital, Umeå

• Kristina Aglund, MD, PhD · Dept of Oncology, Norrlands University Hospital, Umeå

• Åsa Åkesson, MD, PhD · Dept of Obs/Gyn, Sahlgrenska University Hospital, Göteborg

• Eva Blank, MD, PhD · Dept of Obs/Gyn, Norra Älvsborg County Hospital in Trollhättan, Trollhättan

• Lars Högström, MD, PhD · Dept of Obs/Gyn, Södra Älvsborgs Hospital, Borås

• Eva Rundqvist, MD · Dept of Obs/Gyn, Blekinge Hospital, Karlskrona

• Margareta Lood, MD · Dept of Obs/Gyn, Central Hospital, Karlstad

• Lotta Andreen, MD, PhD · Dept of Obs/Gyn, Central Hospital, Sundsvall

• Peter Smith, MD, PhD · Dept of Obs/Gyn, Central Hospital, Gävle

• Åsa Nyberg, MD, PhD · Dept of Obs/Gyn, Central Hospital, Falun

• Lisbeth Liest, MD · Dept of Obs/Gyn, Highland Hospital, Eksjö

• Gunnel Lindell, MD, PhD · Dept of Obs/Gyn, Kalmar County Hospital, Kalmar

• Anders Rosenmüller, MD · Dept of Obs/Gyn, Västervik County Hospital, Västervik

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-17

Primary Completion

2018-12-17

Completion

2018-12-17

Countries

• Sweden

Study Locations