Lymphadenectomy In Ovarian Neoplasms

NCT00712218 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2020-03-04

No results posted yet for this study

Summary

To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking.

Secondary: progression-free survival, complications and quality of life; Exploratory: Role of number of resected lymph nodes for primary and secondary objectives

Conditions

Interventions

PROCEDURE

No Lymphadenectomy (LNE)

No lymphadenectomy is performed in patients of the control group

PROCEDURE

Lymphadenectomy (LNE)

Patients allocated to the lymphadenectomy group undergo systematic lymphadenectomy in addition to surgery for complete resection. Complete mobilization of the colon by resection of the paracolic gutters is necessary for the preparation of the lymphadenectomy. Afterwards the peritoneum has to be opened until the Treitzsche's Band for visualization of the renal vein. Systematic pelvic and para-aortic lymphadenectomy is based on anatomical studies and defined according to a recently published single centre series as systematic resection of lymph nodes in the following regions \[24, \].

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER
  • Philipps University Marburg

    lead OTHER

Principal Investigators

  • Uwe Wagner, MD, Prof · University Marburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Austria
  • Belgium
  • Czechia
  • Germany
  • Italy
  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00712218 on ClinicalTrials.gov