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

Breast Cancer Clinical Trial

— BestDIEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363189
• Other study ID #: 2022-01423-01
• Status: Recruiting
• Start date: May 2, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: Vastra Gotaland Region
• Contact: Emma Hansson, MD, PhD
• Phone: 0046313421000
• Email: emma.em.hansson[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Reconstruction

Intervention

Procedure:
• Venous augmentation
Increasing the venous drainage of a deep inferior epigastric artery perforator (DIEP) flap by anastomosing the superficial inferior epigastric vein to the cephalic vein
• Traditional ERAS (enhanced recovery after surgery) protocol
Pre-, peri-, and post-operative care as described in the ERAS protocol
• Sahlgrenska recovery protocol
Pre-, peri-, and post-operative care as described in the Sahlgrenska recovery protocol
• No venous augmentation
Traditional deep inferior epigastric artery perforator flap (DIEP)

Locations

Country	Name	City	State
Sweden	Sahlgrenska university hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-operations	Any re-operations performed for any cause during the first 7 days after the operation	7 days
Primary	Length of stay (LOS) in hospital	Number of days the patient stays in the hospital after the operation	7 days
Secondary	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
Secondary	Surgical corrections	Number of cosmetic corrections. All types of corrections performed in general or local anesthetics will be included.	5 years
Secondary	Costs	Health economical analysis of direct and indirect cost related to the different protocols	5 years