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Recruiting Observational

Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)

NCT05363189 · tracked via the Priya Life Science Sweden tracker
Phase
Observational
Started
2022-05-02
Last updated
2025-07-03

Condition(s) studied

Breast ReconstructionBreast Cancer

Investigational drug(s) / intervention(s)

Venous augmentationTraditional ERAS (enhanced recovery after surgery) protocolSahlgrenska recovery protocolNo venous augmentation

Venous augmentation: Increasing the venous drainage of a deep inferior epigastric artery perforator (DIEP) flap by anastomosing the superficial inferior epigastric vein to the cephalic vein

Traditional ERAS (enhanced recovery after surgery) protocol: Pre-, peri-, and post-operative care as described in the ERAS protocol

Sahlgrenska recovery protocol: Pre-, peri-, and post-operative care as described in the Sahlgrenska recovery protocol

No venous augmentation: Traditional deep inferior epigastric artery perforator flap (DIEP)

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
100 Years
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)

Primary outcome measure(s)

  • Re-operations — 7 days
    Any re-operations performed for any cause during the first 7 days after the operation
  • Length of stay (LOS) in hospital — 7 days
    Number of days the patient stays in the hospital after the operation

Trial sites (1)

FacilityCityRegionStatus
Sahlgrenska university hospital Gothenburg Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05363189 on ClinicalTrials.gov ↗ ← All trials in Sweden