Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 380
- Locations
- 1
- Primary Endpoint
- Re-operations
Study Overview
Brief Summary
Women who have their breast reconstructed with autologous tissue seem to be more satisfied with their breast. However, autologous breast reconstruction entails a bigger operation, and the usage of more health care resources, than some other methods, such as implant-based techniques. The main objectives of the present study are to investigate if pre- peri- and postoperative protocols can be safely modified, so the operation demands less resources, while maintaining a low complication rate and a high patient satisfaction.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Operated or will be operated with a DIEP flap in the department
- •>18 years of age
Exclusion Criteria
- •Inability to leave informed consent
- •Inability to understand and speak Swedish (for the questionnaire)
Outcomes
Primary Outcomes
Re-operations
Time Frame: 7 days
Any re-operations performed for any cause during the first 7 days after the operation
Length of stay (LOS) in hospital
Time Frame: 7 days
Number of days the patient stays in the hospital after the operation
Secondary Outcomes
- Patient reported satisfaction and quality of life(12 months)
- Surgical corrections(5 years)
- Costs(5 years)