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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00003267

Collaborator

(none)

214

Enrollment

Locations

11.9

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Endometrial Cancer Infection Perioperative/Postoperative Complications Vaginal Cancer	Procedure: infection prophylaxis and management Procedure: management of therapy complications Procedure: surgical procedure	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

214 participants

Allocation:

Randomized

Primary Purpose:

Supportive Care

Official Title:

A Randomized Phase III Trial for Evaluation of Usefulness of Pelvic Drains After Radical Hysterectomy and Node Dissection (RHND)

Study Start Date :

Feb 1, 1998

Actual Primary Completion Date :

Jul 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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