Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)
BestDIEP
1 other identifier
observational
380
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2022
CompletedStudy Start
First participant enrolled
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
May 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
July 3, 2025
June 1, 2025
4.7 years
May 2, 2022
June 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Re-operations
Any re-operations performed for any cause during the first 7 days after the operation
7 days
Length of stay (LOS) in hospital
Number of days the patient stays in the hospital after the operation
7 days
Secondary Outcomes (3)
Patient reported satisfaction and quality of life
12 months
Surgical corrections
5 years
Costs
5 years
Study Arms (4)
No venons augmentation
Retrospective group of patients who have not received venous augmentation during their operation.
Venous augmentation
Retrospective group of patients who have received venous augmentation during their operation.
ERAS protocol
Retrospective group operated according to the traditional ERAS (enhanced recovery after surgery) protocol
Sahlgrenska recovery protocol
Prospective group operated according to the Sahlgrenska recovery protocol.
Interventions
Increasing the venous drainage of a deep inferior epigastric artery perforator (DIEP) flap by anastomosing the superficial inferior epigastric vein to the cephalic vein
Pre-, peri-, and post-operative care as described in the ERAS protocol
Pre-, peri-, and post-operative care as described in the Sahlgrenska recovery protocol
Traditional deep inferior epigastric artery perforator flap (DIEP)
Eligibility Criteria
Biological women undergoing breast reconstruction with a deep inferior epigastric artery perforator flap in Sahlgrenska university hospital.
You may qualify if:
- Operated or will be operated with a DIEP flap in the department
- \>18 years of age
You may not qualify if:
- Inability to leave informed consent
- Inability to understand and speak Swedish (for the questionnaire)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sahlgrenska university hospital
Gothenburg, 413 45, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2022
First Posted
May 5, 2022
Study Start
May 2, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
July 3, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share