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

V

Vastra Gotaland Region

Status

Enrolling

Conditions

Breast Cancer
Breast Reconstruction

Treatments

Procedure: No venous augmentation
Procedure: Venous augmentation
Procedure: Sahlgrenska recovery protocol
Procedure: Traditional ERAS (enhanced recovery after surgery) protocol

Study type

Observational

Funder types

Other

Identifiers

NCT05363189
2022-01423-01

Details and patient eligibility

About

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.

Enrollment

380 estimated patients

Sex

Female

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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)

Trial design

380 participants in 4 patient groups

No venons augmentation
Description:
Retrospective group of patients who have not received venous augmentation during their operation.
Treatment:
Procedure: No venous augmentation
Venous augmentation
Description:
Retrospective group of patients who have received venous augmentation during their operation.
Treatment:
Procedure: Venous augmentation
ERAS protocol
Description:
Retrospective group operated according to the traditional ERAS (enhanced recovery after surgery) protocol
Treatment:
Procedure: Traditional ERAS (enhanced recovery after surgery) protocol
Sahlgrenska recovery protocol
Description:
Prospective group operated according to the Sahlgrenska recovery protocol.
Treatment:
Procedure: Sahlgrenska recovery protocol

Trial contacts and locations

1

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Central trial contact

Emma Hansson, MD, PhD

Data sourced from clinicaltrials.gov

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