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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Reconstruction, Breast Cancer

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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No venons augmentation<br>Retrospective group of patients who have not received venous augmentation during their operation. | Procedure: No venous augmentation<br>* Traditional deep inferior epigastric artery perforator flap (DIEP)<br>|
| Venous augmentation<br>Retrospective group of patients who have received venous augmentation during their operation. | Procedure: Venous augmentation<br>* Increasing the venous drainage of a deep inferior epigastric artery perforator (DIEP) flap by anastomosing the superficial inferior epigastric vein to the cephalic vein<br>* Other names: Cephalic vein turndown;|
| ERAS protocol<br>Retrospective group operated according to the traditional ERAS (enhanced recovery after surgery) protocol | Procedure: Traditional ERAS (enhanced recovery after surgery) protocol<br>* Pre-, peri-, and post-operative care as described in the ERAS protocol<br>|
| Sahlgrenska recovery protocol<br>Prospective group operated according to the Sahlgrenska recovery protocol. | Procedure: Sahlgrenska recovery protocol<br>* Pre-, peri-, and post-operative care as described in the Sahlgrenska recovery protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| Surgical corrections | Number of cosmetic corrections. All types of corrections performed in general or local anesthetics will be included. | 5 years | 
| Costs | Health economical analysis of direct and indirect cost related to the different protocols | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reconstruction, plastic surgery, microsurgery, free flap