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

Phase 3

Completed

• Conditions: Cervical Cancer; Endometrial Cancer; Infection; Perioperative/Postoperative Complications; Vaginal Cancer

• Registration Number: NCT00003267
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

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 Timeline

• Study Start: 1998-02
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-07
• Study First Submitted QC: 2004-07-21
• Study First Posted: 2004-07-22
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (18)

Kaiser Franz Josef Hospital; 🇦🇹 Vienna (Wien), Austria

Azienda Ospedaliera Di Parma; 🇮🇹 Parma, Italy

Universita di Brescia; 🇮🇹 Brescia, Italy

University and I.R.C.C.S. Policlinico San Matteo; 🇮🇹 Pavia, Italy

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Instituto Scientifico H.S. Raffaele; 🇮🇹 Milano (Milan), Italy

Institut Gustave Roussy; 🇫🇷 Villejuif, France

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

University Medical Center; 🇩🇪 Freiburg, Germany

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

Ospedale di Circolo e Fondazione Macchi; 🇮🇹 Varese, Italy

Ospedale Civile; 🇮🇹 Voghera (PV), Italy

Academisch Ziekenhuis Utrecht; 🇳🇱 Utrecht, Netherlands

Hospitais da Universidade de Coimbra (HUC); 🇵🇹 Coimbra, Portugal

Instituto Valenciano De Oncologia; 🇪🇸 Valencia, Spain

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands