A comparing study between open and close of retroperitonium on lymphedema of the lower extremities after surgeries of both uterine cervical and endometrial cancer (a randomized study by multi-institutes)

UMIN ID: UMIN000001248

Registered date:31/12/2011

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: uterine cervical and endometrial cancer
• Date of first enrollment: 2008/07/15
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Close of the retroperitoneum
open of the retroperitonemu

Outcome(s)

• Primary Outcome: The primary endpoint of thes study is to compare the cumulative incidences of lymphedema between the open peritoneum method (including use of hyaluronic acid-carboxycellulose membrane) and the closed peritoneum method during anthree-year postoerative period. The lymphedema is diagnosed by medical doctors according to the criteria of this study.
• Secondary Outcome: The secondary endpoint of this stydy is as follows, evaluation of the degree of lymphedema, investigation of the relationship between the incidences of lymphocyst and lymphedema of lower extremities,investigation of the relationship between the incidences of Trichophyton infection on the foot and lympyedema of lower extremities.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude criteria: 1) Patients with a primary lymphedema or a past history of lymphedema due to infection. 2) Patients who are regarded as inadequate due to other reasons (e.g. severe varix of llower extremities).

Related Information

• Primary Sponsor: The development reserarch cancer treatments aiming improvement of QOL
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare Third Research Project on General Strategy Against Cancer