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

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ClinicalTrials.gov Identifier: NCT00003267
Recruitment Status : Completed
First Posted : July 22, 2004
Last Update Posted : July 11, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Endometrial Cancer Infection Perioperative/Postoperative Complications Vaginal Cancer Procedure: infection prophylaxis and management Procedure: management of therapy complications Procedure: surgical procedure Phase 3

Detailed 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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: A Randomized Phase III Trial for Evaluation of Usefulness of Pelvic Drains After Radical Hysterectomy and Node Dissection (RHND)
Study Start Date : February 1998
Actual Primary Completion Date : July 2000

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003267


Locations
Austria
Kaiser Franz Josef Hospital
Vienna (Wien), Austria, A-1100
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
France
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
University Medical Center
Freiburg, Germany, D-79106
Italy
Universita di Brescia
Brescia, Italy, 25124
Instituto Scientifico H.S. Raffaele
Milano (Milan), Italy, 20132
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), Italy, 20133
Azienda Ospedaliera Di Parma
Parma, Italy, 43100
University and I.R.C.C.S. Policlinico San Matteo
Pavia, Italy, 27100
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Ospedale Civile
Voghera (PV), Italy, 27058
Netherlands
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
Medisch Spectrum Twente
Enschede, Netherlands, 7500 KA
Leiden University Medical Center
Leiden, Netherlands, 2300 ZA
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3508 GA
Portugal
Hospitais da Universidade de Coimbra (HUC)
Coimbra, Portugal, 3049
Spain
Instituto Valenciano De Oncologia
Valencia, Spain, 46009
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Sergio L. Pecorelli, MD Spedali Civili di Brescia
More Information
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Publications of Results:

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003267     History of Changes
Other Study ID Numbers: EORTC-55962
First Posted: July 22, 2004    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Vaginal Diseases
Postoperative Complications
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Pathologic Processes