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

This study is no longer recruiting patients.

Sponsored by: EORTC Gynecological Cancer Cooperative Group
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
perioperative/postoperative complications
stage II cervical cancer
stage I cervical cancer
stage I endometrial cancer
stage II endometrial cancer
stage II vaginal cancer
Infection
stage I vaginal cancer
 Procedure: radical hysterectomy
 Procedure: pelvic lymphadenectomy
 Device: pelvic drains
Phase III

MedlinePlus related topics:  Cervical Cancer;   Uterine Cancer;   Vaginal Cancer

Study Type: Interventional
Study Design: Educational/Counseling/Training

Official Title: Phase III Randomized Study of Pelvic Drains Following Radical Hysterectomy and Node Dissection

Further Study Details: 

Study start: February 1998

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.

PROTOCOL 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.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

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

--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

Location Information


Austria
      Kaiser Franz Josef Hospital, Vienna (Wien),  A-1100,  Austria

Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium

      Universitair Ziekenhuis Antwerpen, Edegem,  B-2650,  Belgium

France
      Institut Gustave Roussy, Villejuif,  F-94805,  France

Germany
      University Medical Center, Freiburg,  D-79106,  Germany

Italy
      Azienda Ospedaliera Di Parma, Parma,  43100,  Italy

      Instituto Scientifico H.S. Raffaele, Milano (Milan),  20132,  Italy

      Istituto Nazionale per lo Studio e la Cura dei Tumori, Milano (Milan),  20133,  Italy

      Ospedale Civile, Voghera (PV),  27058,  Italy

      Ospedale di Circolo e Fondazione Macchi, Varese,  21100,  Italy

      Universita di Brescia, Brescia,  25124,  Italy

      University and I.R.C.C.S. Policlinico San Matteo, Pavia,  27100,  Italy

Netherlands
      Academisch Ziekenhuis Utrecht, Utrecht,  3508 GA,  Netherlands

      Antoni van Leeuwenhoekhuis, Amsterdam,  1066 CX,  Netherlands

      Leiden University Medical Center, Leiden,  2300 ZA,  Netherlands

      Medisch Spectrum Twente, ENSCHEDE,  7500 KA,  Netherlands

Portugal
      Hospitais da Universidade de Coimbra (HUC), Coimbra,  3049,  Portugal

Spain
      Instituto Valenciano De Oncologia, Valencia,  46009,  Spain

Study chairs or principal investigators

Sergio L. Pecorelli,  Study Chair,  EORTC Gynecological Cancer Cooperative Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ®

Study ID Numbers:  CDR0000066163; EORTC-55962
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003267
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources