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

Recruiting

• Conditions: Breast Cancer; Breast Reconstruction
• Interventions: Procedure: Traditional ERAS (enhanced recovery after surgery) protocol; Procedure: No venous augmentation; Procedure: Sahlgrenska recovery protocol; Procedure: Venous augmentation

• Registration Number: NCT05363189
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-02
• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 380

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Patient reported satisfaction and quality of life	12 months	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.
Surgical corrections	5 years	Number of cosmetic corrections. All types of corrections performed in general or local anesthetics will be included.
Costs	5 years	Health economical analysis of direct and indirect cost related to the different protocols

Trial Locations

Locations (1)

Sahlgrenska university hospital; 🇸🇪 Gothenburg, Sweden