Lymphedema After Primary Surgery for Endometrial Cancer

NCT02115477 | Completed

• 2 other identifiers: Version 2013-09-22/2014-03-21The Swedish Cancer Society
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 16

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.

Conditions

Carcinoma of the Endometrium; Hysterectomy; Lymphadenectomy

Keywords

Uterus cancer; Hysterectomy; Lymphadenectomy; Lymphedema

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Change in quality of life assessment from baseline (preoperatively) to 4-6 weeks postoperatively

  4-6 weeks from the primary surgery

• Change in quality of life assessment from baseline (preoperatively) to 6 months postoperatively

  6 months from the primary surgery

• Change in quality of life assessment from baseline (preoperatively) to 12 months postoperatively

  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

  12 months from the primary surgery

Other Outcomes (1)

• Risk factors for lymphedema after primary surgery with lymphadenectomy for endometrial cancer

  Within 12 months after the surgery

Study Arms (2)

Group with lymphadenectomy

The group of women with high risk endometrial cancer who undergoes pelvic and/or paraaortic lymphadenectomy at primary surgery

Procedure: Lymphadenectomy

Group without lymphadenectomy

The group of women with low risk endometrial cancer who do not have lymphadenectomy at primary surgery

Interventions

Lymphadenectomy PROCEDURE

Pelvic and/or paraaortic lymphadenectomy

Group with lymphadenectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Preben Kjolhede, MD, professor: lead
• Swedish Cancer Society: collaborator
• Medical Research Council of Southeast Sweden: collaborator
• Ostergotland County Council, Sweden: collaborator
• Linkoeping University: collaborator

Study Sites (16)

Highland hospital

Eksjö, Jonkopings Län, 57533, Sweden

Location

Falu Central Hospital

Falun, 79182, Sweden

Location

Gävle County Hospital

Gävle, 80187, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Region Halland Halmstad Hospital

Halmstad, 30233, Sweden

Location

County Hospital in Kalmar

Kalmar, 39185, Sweden

Location

Blekinge Hospital

Karlskrona, 37185, Sweden

Location

Karlstad Central Hospital

Karlstad, 65185, Sweden

Location

Linkoping University Hospital

Linköping, 58185, Sweden

Location

Södra Älvborgs Sjukhus

Skövde, +4651085000, Sweden

Location

Sundsvall Hospital

Sundsvall, 85186, Sweden

Location

Norra Älvborgs Hospital

Trollhättan, 46185, Sweden

Location

Norrlands University Hospital

Umeå, 90185, Sweden

Location

Akademiska University Hospital

Uppsala, 75185, Sweden

Location

Region Halland Varberg hospital

Varberg, 43281, Sweden

Location

Västervik County Hospital

Västervik, 59381, Sweden

Location

Related Publications (2)

• Miller AJ, Bruna J, Beninson J. A universally applicable clinical classification of lymphedema. Angiology. 1999 Mar;50(3):189-92. doi: 10.1177/000331979905000302.

  PMID: 10088797 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.

  PMID: 7620649 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Neoplasms; Lymphedema

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• 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

  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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2014
• First Posted: April 16, 2014
• Study Start: April 17, 2014
• Primary Completion: December 17, 2018
• Study Completion: December 17, 2018
• Last Updated: October 25, 2019

Record last verified: 2019-10

Locations

SE (16)