Quality of Life Clinical Trial
— LTMOfficial title:
Long Term Morbidity and Quality of Life After Multivisceral Resection for Primary Retroperitoneal Soft Tissue Sarcomas: a Prospective Observational Study
Verified date | August 2019 |
Source | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
No prospective data exist about long term morbidity and quality of life after multivisceral
surgical resection for retroperitoneal soft tissue sarcoma (RSTS).
In order to assess the safety of this surgical approach and the effect on the Quality of Life
over the long period we propose a prospective observational study.
The hypothesis is that the surgical treatment has no significant impact in determining a
lower Quality of Life in the long term.
Objectives Primary objective Estimate the difference between baseline and 4 and 12 months
scores of the "global health status / QoL" scale in patients primarily treated for localized
RSTS, as determined in QLQ-C30 version 3.0.
Secondary objectives
- Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of
renal failure.
- Evaluate the difference between baseline and 4 and 12 months scores of DN4 / LEFS / BPI
questionnaires.
- Evaluate the difference between baseline and 4 and 12 months scores of the following
scales from QLC-C30: PF2, RF2, EF, CF, SF, FA, FI.
- Evaluate the difference between baseline and 4 and 12 months scores of the following
scales and single items from QLC-C29: Blood and mucus in stool, Stool frequency, Sexual
interest, Impotence, Dyspareunia.
- To correlate the surgical resection pattern (number and type of organs resected) and the
tumor features (size, grading and histological subtype) with the long-term morbidity and
quality of life.
Eligibility Inclusion criteria
- Adult patients (age > 18 years) with primary localized RSTS surgically treated at our
institution
- Written, voluntary, informed consent
Exclusion criteria
- Recurrent disease
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | January 2021 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients affected by primary retroperitoneal sarcoma and candidated to complete surgery (multivisceral resection) Exclusion Criteria: - Recurrent Disease |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global Health Status | Change between baseline and 4 and 12 months scores of the "global health status / QoL" scale in patients primarily treated for localized RSTS, as determined in QLQ-C30 version 3.0. | 4 and 12 months postoperatively | |
Secondary | Renal failure | Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of renal failure. | 12 months postoperatively | |
Secondary | DN4 questionnaire for neuropathic pain | Change between baseline and 4 and 12 months scores | 4 and 12 months postoperatively | |
Secondary | LEFS questionnaire for lower limb function | Change between baseline and 4 and 12 months scores | 4 and 12 months postoperatively | |
Secondary | BPI questionnaire for chronic pain | Change between baseline and 4 and 12 months scores | 4 and 12 months postoperatively | |
Secondary | QLC-C30, Functional Scales | Change between baseline and 4 and 12 months scores | 4 and 12 months postoperatively | |
Secondary | QLC-C29 | Change between baseline and 4 and 12 months scores | 4 and 12 months postoperatively |
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