Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer
NCT ID: NCT00003267
Last Updated: 2012-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
214 participants
INTERVENTIONAL
1998-02-28
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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infection prophylaxis and management
management of therapy complications
surgical procedure
Eligibility Criteria
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Exclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior neoadjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Sergio L. Pecorelli, MD
Role: STUDY_CHAIR
Spedali Civili di Brescia
Locations
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Kaiser Franz Josef Hospital
Vienna (Wien), , Austria
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Institut Gustave Roussy
Villejuif, , France
University Medical Center
Freiburg im Breisgau, , Germany
Universita di Brescia
Brescia, , Italy
Instituto Scientifico H.S. Raffaele
Milano (Milan), , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), , Italy
Azienda Ospedaliera Di Parma
Parma, , Italy
University and I.R.C.C.S. Policlinico San Matteo
Pavia, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Ospedale Civile
Voghera (PV), , Italy
Antoni van Leeuwenhoekhuis
Amsterdam, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
Hospitais da Universidade de Coimbra (HUC)
Coimbra, , Portugal
Instituto Valenciano De Oncologia
Valencia, , Spain
Countries
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References
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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 May;43(8):1265-8. doi: 10.1016/j.ejca.2007.03.011. Epub 2007 Apr 26.
Other Identifiers
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EORTC-55962
Identifier Type: -
Identifier Source: secondary_id
EORTC-55962
Identifier Type: -
Identifier Source: org_study_id