NCT02115477: LASEC

Lymphedema After Primary Surgery for Endometrial Cancer

Completed Last updated 25 October 2019

What this trial tests

trial testing Lymphadenectomy in Carcinoma of the Endometrium in 262 participants. Completed in 17 December 2018.

Timeline

17 April 2014

Primary endpoint
17 December 2018

17 December 2018

Quick facts

Lead sponsor	Preben Kjolhede, MD, professor
Status	Completed
Study type	OBSERVATIONAL
Enrollment	262
Start date	17 April 2014
Primary completion	17 December 2018
Estimated completion	17 December 2018
Sites	16 locations across Sweden

Drugs / interventions tested

• Lymphadenectomy

Conditions studied

• Carcinoma of the Endometrium — all drugs for Carcinoma of the Endometrium →
• Hysterectomy — all drugs for Hysterectomy →
• Lymphadenectomy — all drugs for Lymphadenectomy →

Sponsor

Preben Kjolhede, MD, professor

Who can join

18 and older, female only, with Carcinoma of the Endometrium or Hysterectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Risk factors for lymph ascites after surgery for endometrial cancer and impact on lymphedema of the legs. A prospective longitudinal Swedish multicenter study.
   Wedin M, Stålberg KG, Ottander U, Åkesson Å, et al · · 2025 · cited 4× · PMID 40035366 · DOI 10.1111/aogs.15077