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	Treatment or Intervention	Phase
perioperative/postoperative complications stage II cervical cancer stage I cervical cancer stage I endometrial cancer stage II endometrial cancer stage II vaginal cancer Infection stage I vaginal cancer	Procedure: radical hysterectomy  Procedure: pelvic lymphadenectomy  Device: pelvic drains	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior neoadjuvant chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy
• Surgery: See Disease Characteristics

--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

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

Study chairs or principal investigators

Sergio L. Pecorelli,  Study Chair,  EORTC Gynecological Cancer Cooperative Group   

Study ID Numbers:  CDR0000066163; EORTC-55962
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003267
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08