Clinical trial · Observational
Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
NCT00604994CI-TRIAL-00011806LEGScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project will conduct a prospective, longitudinal, observational cohort study to assess the onset and incidence of lymphoedema, as well as investigate factors associated with its development among women newly diagnosed with gynaecological cancers in 2008 to 2011.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Female Genital Diseases | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Vulval Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Malignant
- description
- Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina
- label
- Benign
- description
- Patients without malignant gynaecological cancers
Primary outcomes (4)
- measure
- Time of onset of lymphoedema after gynaecological cancer treatment.
- timeFrame
- 2 years
- measure
- Incidence of lymphoedema after gynaecological cancer treatment.
- timeFrame
- 2 years
- measure
- Point prevalence of lymphoedema after gynaecological cancer treatment.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scheduled for surgery of benign or malignant gynaecological diseases as determined jointly by the surgeon and the patient. * Non-pregnant female patients. * Over 18 years of age at time of surgery. * Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up. * Patients who are capable of, and have given, informed consent to their participation in the study. Exclusion Criteria: * Patients with a pacemaker. * Allergies against adhesive electrodes and extensive internal metal plates are ineligible for BIS measurement.
References
Publications (0)
Data not yet available
No reference posted for this study.