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

NCT00003267 | Completed Phase 3

• 1 other identifier: EORTC-55962
• Study Type: interventional
• Target: 214
• Locations: 8 countries
• Sites: 18

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.

Conditions

Cervical Cancer; Endometrial Cancer; Infection; Perioperative/Postoperative Complications; Vaginal Cancer

Keywords

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

Interventions

infection prophylaxis and management PROCEDURE

management of therapy complications PROCEDURE

surgical procedure PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (18)

Kaiser Franz Josef Hospital

Vienna (Wien), A-1100, Austria

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

University Medical Center

Freiburg im Breisgau, D-79106, Germany

Location

Universita di Brescia

Brescia, 25124, Italy

Location

Instituto Scientifico H.S. Raffaele

Milano (Milan), 20132, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milano (Milan), 20133, Italy

Location

Azienda Ospedaliera Di Parma

Parma, 43100, Italy

Location

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

Pavia, 27100, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Ospedale Civile

Voghera (PV), 27058, Italy

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 ZA, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3508 GA, Netherlands

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, 3049, Portugal

Location

Instituto Valenciano De Oncologia

Valencia, 46009, Spain

Location

Related Publications (1)

• 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.

  PMID: 17466514 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Infections; Postoperative Complications; Vaginal Neoplasms

Interventions

Therapeutics; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vaginal Diseases

Study Officials

• Sergio L. Pecorelli, MD

  Spedali Civili di Brescia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 22, 2004
• Study Start: February 1, 1998
• Primary Completion: July 1, 2000
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

NL (4); PT (1); ES (1); IT (7); BE (2); FR (1); AU (1); DE (1)