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

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Brief Title

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)

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.
    

Study Phase

Phase 3

Study Type

Interventional




Condition

Cervical Cancer

Intervention

infection prophylaxis and management


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

214

Start Date

February 1998


Primary Completion Date

July 2000

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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Sergio L. Pecorelli, MD, , 

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT00003267

Organization ID

EORTC-55962

Secondary IDs

EORTC-55962

Responsible Party

Sponsor

Study Sponsor

European Organisation for Research and Treatment of Cancer - EORTC


Study Sponsor

Sergio L. Pecorelli, MD, Study Chair, Spedali Civili di Brescia


Verification Date

July 2012