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

Phase 3
Not Enrolling
Cervical Cancer, Endometrial Cancer, Infection, Perioperative/Postoperative Complications, Vaginal Cancer

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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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven cervical, vaginal, or endometrial carcinoma
for which abdominal radical hysterectomy (Rutledge-Piver II or III type) and pelvic node
dissection is indicated The following are excluded: Extensive intraoperative
retroperitoneal blood loss (more than 3000 mL) Excessive postsurgical hemorrhage or oozing
of the wound area requiring postoperative drainage Concurrent urinary or bowel
injury/deviation or surgical procedures for urinary incontinence (Burch etc.) Application
of prophylactic abdominal mesh for subsequent radiotherapy

PATIENT CHARACTERISTICS: Age: Not specified Performance status: WHO 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
neoadjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior
radiotherapy Surgery: See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Sergio L. Pecorelli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Spedali Civili di Brescia


United States: Federal Government

Study ID:




Start Date:

February 1998

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Infection
  • Perioperative/Postoperative Complications
  • Vaginal Cancer
  • stage I cervical cancer
  • stage II cervical cancer
  • stage I vaginal cancer
  • stage II vaginal cancer
  • stage I endometrial carcinoma
  • stage II endometrial carcinoma
  • infection
  • perioperative/postoperative complications
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Postoperative Complications
  • Vaginal Neoplasms
  • Adenoma