An observational study in Breast Reconstruction and Breast Cancer, sponsored by Vastra Gotaland Region. Recruiting at 1 site in Sweden. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Vastra Gotaland Region · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 380 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Vastra Gotaland Region is the lead sponsor of 267 studies on the registry; 107 are open to participants now.
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Biological women undergoing breast reconstruction with a deep inferior epigastric artery perforator flap in Sahlgrenska university hospital.
Exclusion Criteria:
Retrospective group of patients who have not received venous augmentation during their operation.
Procedure: No venous augmentation
Retrospective group of patients who have received venous augmentation during their operation.
Procedure: Venous augmentation
Retrospective group operated according to the traditional ERAS (enhanced recovery after surgery) protocol
Procedure: Traditional ERAS (enhanced recovery after surgery) protocol
Prospective group operated according to the Sahlgrenska recovery protocol.
Procedure: Sahlgrenska recovery protocol
Increasing the venous drainage of a deep inferior epigastric artery perforator (DIEP) flap by anastomosing the superficial inferior epigastric vein to the cephalic vein
Also known as: Double venous system drainage, Cephalic vein turndown
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)
Re-operations
Any re-operations performed for any cause during the first 7 days after the operation
Time frame: 7 days
Length of stay (LOS) in hospital
Number of days the patient stays in the hospital after the operation
Time frame: 7 days
Patient reported satisfaction and quality of life
Measured 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.
Time frame: 12 months
Surgical corrections
Number of cosmetic corrections. All types of corrections performed in general or local anesthetics will be included.
Time frame: 5 years
Costs
Health economical analysis of direct and indirect cost related to the different protocols
Time frame: 5 years
Plan to share: No
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Vastra Gotaland Region