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

Recruiting

• Conditions: Breast Cancer; Breast Reconstruction

• 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: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03
• 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

Primary Outcome Measures

Name	Time	Method
Length of stay (LOS) in hospital	7 days	Number of days the patient stays in the hospital after the operation
Re-operations	7 days	Any re-operations performed for any cause during the first 7 days 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