Trial Information

A Randomized Phase III Trial for Evaluation of Usefulness of Pelvic Drains After Radical Hysterectomy and Node Dissection (RHND)

OBJECTIVES: I. Evaluate postoperative complications associated with the use or omission of
pelvic drains following radical hysterectomy and node dissection that includes suturing of
the vaginal cuff and no peritonealization.

OUTLINE: This is a randomized, two-arm study. All patients receive radical hysterectomy
(Rutledge-Piver II-III type) and pelvic lymphadenectomy, without pelvic and parietal
peritonealization, with suturing of the vaginal cuff and closure of fascia and cutaneous
layers; lumboaortic node dissection is optional. Patients are randomized during surgery to
one of two arms: those on arm I receive pelvic drains and those on arm II do not. Those in
arm I have drains applied in the pelvis, and lymph is collected by vaginal and/or
transabdominal drains located in both retroperitoneal fossa. Drains are removed when the
loss is less than 50 mL in 24 hours. Patients in both arms are followed at 2-3 months and 12
months after surgery.

PROJECTED ACCRUAL: 214 patients will be accrued for this study within 2 years.