Clinical trial NCT02115477: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma of the Endometrium
Hysterectomy
Lymphadenectomy
Keywords: Uterus cancer
Hysterectomy
Lymphadenectomy
Lymphedema
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Society
name: Medical Research Council of Southeast Sweden
name: Ostergotland County Council, Sweden
name: Linkoeping University
First posted: 2014-04-16
Enrollment: 262
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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 criteria: Inclusion Criteria:

* Age \>=18 years.
* Women with endometrial carcinoma preoperatively evaluated to be uterine cancer FIGO stage1 or 2 who are planned for primary radical surgery including simple or radical hysterectomy, bilateral salpingoophorectomy,+/- pelvic and paraaortic lymphadenectomy and +/- omentectomy with curative intention.
* WHO performance status ≤ 2.
* Understand and speak Swedish fluently
* Accept to participate in the study by giving verbal and written informed consent.

Exclusion Criteria:

* Sarcoma of the uterus
* Previous pelvic or paraaortic lymphadenectomy.
* Previous having had pelvic radiation therapy.
* Ongoing treatment of arterial or venous insufficiency of the lower limbs
* Congenital or acquired malformations in the lymphatic system.
* Ongoing or previous treatment of lymphedema of the upper or lower limbs.
* Physically disability which impair mobilisation immediately postoperatively.
* Severe psychiatric disease and untreated mild/moderate psychiatric disease.
* Mentally retarded to a degree so she does not understand the meaning of the participation or cannot fill in the questionnaires.or the physician finds it ethically doubtful to enroll the patient in the study

Primary outcomes:
measure: Change in leg volume from baseline (preoperatively) to 4-6 weeks postoperatively
timeFrame: 4-6 weeks after the primary surgery
measure: Change in leg volume from baseline (preoperatively) to 6 months postoperatively
timeFrame: 6 months after the primary surgery
measure: Change in leg volume from baseline (preoperatively) to 12 months postoperatively
timeFrame: 12 months after the primary surgery
Secondary outcomes:
measure: Change in quality of life assessment from baseline (preoperatively) to 4-6 weeks postoperatively
timeFrame: 4-6 weeks from the primary surgery
measure: Change in quality of life assessment from baseline (preoperatively) to 6 months postoperatively
timeFrame: 6 months from the primary surgery
measure: Change in quality of life assessment from baseline (preoperatively) to 12 months postoperatively
timeFrame: 12 months from the primary surgery
measure: Percentage of participants with an increase in leg volume of > 15% 12 months postoperatively
timeFrame: 12 months after the primary surgery
measure: Percentage of participants who states they have lymphedema
timeFrame: 12 months from the primary surgery
Other outcomes:
measure: Risk factors for lymphedema after primary surgery with lymphadenectomy for endometrial cancer
timeFrame: Within 12 months after the surgery
Locations:
city: Eksjo
country: Sweden
facility: Highland hospital
state: Jonkopings Län
city: Falun
country: Sweden
facility: Falu Central Hospital
city: Gävle
country: Sweden
facility: Gävle County Hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Halmstad
country: Sweden
facility: Region Halland Halmstad Hospital
city: Kalmar
country: Sweden
facility: County Hospital in Kalmar
city: Karlskrona
country: Sweden
facility: Blekinge Hospital
city: Karlstad
country: Sweden
facility: Karlstad Central Hospital
city: Linkoping
country: Sweden
facility: Linkoping University Hospital
city: Skövde
country: Sweden
facility: Södra Älvborgs Sjukhus
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
city: Trollhättan
country: Sweden
facility: Norra Älvborgs Hospital
city: Umeå
country: Sweden
facility: Norrlands University Hospital
city: Uppsala
country: Sweden
facility: Akademiska University Hospital
city: Varberg
country: Sweden
facility: Region Halland Varberg hospital
city: Västervik
country: Sweden
facility: Västervik County Hospital
Study officials:
affiliation: Dept of Obs/Gyn, University Hospital, Linköping
name: Preben Kjölhede, MD, PhD
role: STUDY_CHAIR
affiliation: Dept of Oncology, University Hospital, Linköping
name: Per Rosenberg, MD,PhD
role: STUDY_CHAIR
affiliation: Dept of Oncology, University Hospital, Linköping
name: Gabriel Lindahl, MD
role: STUDY_CHAIR
affiliation: Dept of Oncology, University Hospital, Linköping
name: Eva Ahlner, RPT
role: STUDY_CHAIR
affiliation: Dept of Obs/Gyn, Region Halland Varberg Hospital, Varberg
name: Janusz Marcickiewicz, MD, PhD
role: STUDY_CHAIR
affiliation: Dept of Obs/Gyn, Univeristy Hospital, Uppsala
name: Karin Stålberg, MD, PhD
role: STUDY_CHAIR
affiliation: Dept of Obs/Gyn, Norrlands University Hospital, Umeå
name: Ulrika Ottander, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Oncology, Norrlands University Hospital, Umeå
name: Kristina Aglund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obs/Gyn, Sahlgrenska University Hospital, Göteborg
name: Åsa Åkesson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obs/Gyn, Norra Älvsborg County Hospital in Trollhättan, Trollhättan
name: Eva Blank, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obs/Gyn, Södra Älvsborgs Hospital, Borås
name: Lars Högström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obs/Gyn, Blekinge Hospital, Karlskrona
name: Eva Rundqvist, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obs/Gyn, Central Hospital, Karlstad
name: Margareta Lood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obs/Gyn, Central Hospital, Sundsvall
name: Lotta Andreen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obs/Gyn, Central Hospital, Gävle
name: Peter Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obs/Gyn, Central Hospital, Falun
name: Åsa Nyberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obs/Gyn, Highland Hospital, Eksjö
name: Lisbeth Liest, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obs/Gyn, Kalmar County Hospital, Kalmar
name: Gunnel Lindell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obs/Gyn, Västervik County Hospital, Västervik
name: Anders Rosenmüller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller AJ, Bruna J, Beninson J. A universally applicable clinical classification of lymphedema. Angiology. 1999 Mar;50(3):189-92. doi: 10.1177/000331979905000302.
citation: 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.