Clinical trial NCT00003267: Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer
Official title: A Randomized Phase III Trial for Evaluation of Usefulness of Pelvic Drains After Radical Hysterectomy and Node Dissection (RHND)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2004-07-22
Enrollment: 214
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna (Wien)
country: Austria
facility: Kaiser Franz Josef Hospital
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Freiburg
country: Germany
facility: University Medical Center
city: Brescia
country: Italy
facility: Universita di Brescia
city: Milano (Milan)
country: Italy
facility: Instituto Scientifico H.S. Raffaele
city: Milano (Milan)
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori
city: Parma
country: Italy
facility: Azienda Ospedaliera Di Parma
city: Pavia
country: Italy
facility: University and I.R.C.C.S. Policlinico San Matteo
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
city: Voghera (PV)
country: Italy
facility: Ospedale Civile
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoekhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Utrecht
country: Netherlands
facility: Academisch Ziekenhuis Utrecht
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra (HUC)
city: Valencia
country: Spain
facility: Instituto Valenciano De Oncologia
Study officials:
affiliation: Spedali Civili di Brescia
name: Sergio L. Pecorelli, MD
role: STUDY_CHAIR
References:
citation: 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.