Lymphedema After Primary Surgery for Endometrial Cancer

Hysterectomy Clinical Trial

— LASEC  

Official title:

Prevalence, Complications and Risk Factors for Lymphedema After Pelvic and Paraaortic Lymphadenectomy in Primary Radical Surgery for Early Stage Endometrial Carcinoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115477
• Other study ID #: Version 2013-09-22/2014-03-21
• Secondary ID: The Swedish Canc
• Status: Completed
• Start date: April 17, 2014
• Est. completion date: December 17, 2018

Study information

• Verified date: October 2019
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Not included

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: December 17, 2018
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma of the Endometrium
• Hysterectomy
• Lymphadenectomy
• Lymphedema

Intervention

Procedure:
• Lymphadenectomy
Pelvic and/or paraaortic lymphadenectomy

Locations

Country	Name	City	State
Sweden	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

Sponsors (5)

Lead Sponsor	Collaborator
Preben Kjolhede, MD, professor	Linkoeping University, Medical Research Council of Southeast Sweden, Ostergotland County Council, Sweden, Swedish Cancer Society

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Miller AJ, Bruna J, Beninson J. A universally applicable clinical classification of lymphedema. Angiology. 1999 Mar;50(3):189-92. — View Citation

Sitzia J. Volume measurement in lymphoedema treatment: examination of formulae. Eur J Cancer Care (Engl). 1995 Mar;4(1):11-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Change in quality of life assessment from baseline (preoperatively) to 6 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.	6 months from the primary surgery
Secondary	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
Secondary	Percentage of participants with an increase in leg volume of > 15% 12 months postoperatively		12 months after the primary surgery
Secondary	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