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

Last updated: July 10, 2012
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Overall Status: Completed

Phase

3

Condition

Cervical Cancer

Endometrial Cancer

Pelvic Cancer

Treatment

N/A

Clinical Study ID

NCT00003267
EORTC-55962
EORTC-55962
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 214
Study Start date:
February 01, 1998
Estimated Completion Date:

Study Description

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.

Connect with a study center

  • Kaiser Franz Josef Hospital

    Vienna (Wien), A-1100
    Austria

    Site Not Available

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650
    Belgium

    Site Not Available

  • U.Z. Gasthuisberg

    Leuven, B-3000
    Belgium

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, F-94805
    France

    Site Not Available

  • University Medical Center

    Freiburg, D-79106
    Germany

    Site Not Available

  • Universita di Brescia

    Brescia, 25124
    Italy

    Site Not Available

  • Instituto Scientifico H.S. Raffaele

    Milano (Milan), 20132
    Italy

    Site Not Available

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Milano (Milan), 20133
    Italy

    Site Not Available

  • Azienda Ospedaliera Di Parma

    Parma, 43100
    Italy

    Site Not Available

  • University and I.R.C.C.S. Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100
    Italy

    Site Not Available

  • Ospedale Civile

    Voghera (PV), 27058
    Italy

    Site Not Available

  • Antoni van Leeuwenhoekhuis

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede, 7500 KA
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden, 2300 ZA
    Netherlands

    Site Not Available

  • Academisch Ziekenhuis Utrecht

    Utrecht, 3508 GA
    Netherlands

    Site Not Available

  • Hospitais da Universidade de Coimbra (HUC)

    Coimbra, 3049
    Portugal

    Site Not Available

  • Instituto Valenciano De Oncologia

    Valencia, 46009
    Spain

    Site Not Available

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