Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00003267
First received: November 1, 1999
Last updated: July 10, 2012
Last verified: July 2012

November 1, 1999
July 10, 2012
February 1998
July 2000   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003267 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer
A Randomized Phase III Trial for Evaluation of Usefulness of Pelvic Drains After Radical Hysterectomy and Node Dissection (RHND)

RATIONALE: The use of pelvic drains may help to prevent complications following radical hysterectomy and pelvic lymphadenectomy. It is not known whether receiving pelvic drains during surgery is more effective than receiving no pelvic drains during surgery in patients with uterine, cervical, or vaginal cancer.

PURPOSE: Randomized phase III trial to determine if the use of pelvic drains following radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with uterine, cervical, or vaginal cancer.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Supportive Care
  • Cervical Cancer
  • Endometrial Cancer
  • Infection
  • Perioperative/Postoperative Complications
  • Vaginal Cancer
  • Procedure: infection prophylaxis and management
  • Procedure: management of therapy complications
  • Procedure: surgical procedure
Not Provided
Franchi M, Trimbos JB, Zanaboni F, V D Velden J, Reed N, Coens C, Teodorovic I, Vergote I. Randomised trial of drains versus no drains following radical hysterectomy and pelvic lymph node dissection: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group (EORTC-GCG) study in 234 patients. Eur J Cancer. 2007 Apr 25; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
214
Not Provided
July 2000   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Germany,   Italy,   Netherlands,   Portugal,   Spain
 
NCT00003267
EORTC-55962, EORTC-55962
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Sergio L. Pecorelli, MD Spedali Civili di Brescia
European Organisation for Research and Treatment of Cancer - EORTC
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP