Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer - Article
Clinical Trial: Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer
This study is no longer recruiting patients.
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
stage I vaginal cancer
| Procedure: radical hysterectomy |
Procedure: pelvic lymphadenectomy
Device: pelvic drains
|Phase III |
MedlinePlus related topics: Cervical Cancer; Uterine Cancer; Vaginal Cancer
Study Type: Interventional
Study Design: Educational/Counseling/Training
Study start: February 1998
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.
PROTOCOL ENTRY CRITERIA:
- 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
- Biologic therapy: Not specified
- Chemotherapy: No prior neoadjuvant chemotherapy
- Endocrine therapy: Not specified
- Radiotherapy: No prior radiotherapy
- Surgery: See Disease 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
Kaiser Franz Josef Hospital, Vienna (Wien), A-1100, Austria
U.Z. Gasthuisberg, Leuven, B-3000, Belgium
Universitair Ziekenhuis Antwerpen, Edegem, B-2650, Belgium
Institut Gustave Roussy, Villejuif, F-94805, France
University Medical Center, Freiburg, D-79106, Germany
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
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
Hospitais da Universidade de Coimbra (HUC), Coimbra, 3049, Portugal
Instituto Valenciano De Oncologia, Valencia, 46009, Spain
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
Cache Date: April 9, 2005