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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05363189
Acronym
BestDIEP
Enrollment
380
Registered
2022-05-05
Start date
2022-05-02
Completion date
2026-12-31
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Reconstruction

Keywords

breast reconstruction, plastic surgery, microsurgery, free flap

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.

Interventions

PROCEDUREVenous 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

PROCEDURETraditional ERAS (enhanced recovery after surgery) protocol

Pre-, peri-, and post-operative care as described in the ERAS protocol

PROCEDURESahlgrenska recovery protocol

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

PROCEDURENo venous augmentation

Traditional deep inferior epigastric artery perforator flap (DIEP)

Sponsors

Vastra Gotaland Region
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 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)

Design outcomes

Primary

MeasureTime frameDescription
Length of stay (LOS) in hospital7 daysNumber of days the patient stays in the hospital after the operation
Re-operations7 daysAny re-operations performed for any cause during the first 7 days after the operation

Secondary

MeasureTime frameDescription
Patient reported satisfaction and quality of life12 monthsMeasured with BREAST-Q reconstruction. The patient scores different items om a scale and a sum score of 0-100 is calculated for each domain. A higher score indicates a higher satisfaction/quality of life.
Surgical corrections5 yearsNumber of cosmetic corrections. All types of corrections performed in general or local anesthetics will be included.
Costs5 yearsHealth economical analysis of direct and indirect cost related to the different protocols

Countries

Sweden

Contacts

Primary ContactEmma Hansson, MD, PhD
emma.em.hansson@vgregion.se0046313421000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026