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Is recovery after surgery for gynecological cancer affected by the choice of regional anestesia?

Phase 1
Conditions
Recovery after open abdominal surgery for gynecological cancer
Therapeutic area: Diseases [C] - Cancer [C04]
Registration Number
EUCTR2013-001873-25-SE
Lead Sponsor
County Council of Östergötland
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Female
Target Recruitment
60
Inclusion Criteria

•Women 18 – 70 years.
•Women with gynecological cancer (suspected or verified) planned for explorative laparatomy through a middle-line with a curative purpose.
•WHO performance status < 2.
•ASA 1-2.
•Women that understand and can express themselves in Swedish.
•Women that after verbal and written information accept participation in the study and have signed an informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

•Women where surgery is expected to include part/s, other than the abdominal surgery, where intrathecal or epidural analgesia is not expected to be effective
•Women with contra indications for intrathecal or epidural anesthesia.
•Women who are physically disabled and therefore nor expected to be mobilized on the day after surgery in the same way as non-disabled.
•Women with a mental retardation that makes it impossible to fill in the relevant questionnaires or makes it impossible to understand the meaning of participation, or if it is ethically doubtful to include the women.
•Women with severe psychiatric or mental disorder and any condition, which would exclude the women from conducting regional anesthesia in the standardized manner of the study.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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