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Recruiting NCT05363189

NCT05363189 Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)

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Clinical Trial Summary
NCT ID NCT05363189
Status Recruiting
Phase
Sponsor Vastra Gotaland Region
Condition Breast Reconstruction
Study Type OBSERVATIONAL
Enrollment 380 participants
Start Date 2022-05-02
Primary Completion 2026-12-31

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 100 Years
Study Type OBSERVATIONAL
Interventions
Venous augmentationTraditional ERAS (enhanced recovery after surgery) protocolSahlgrenska recovery protocol

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 380 participants in total. It began in 2022-05-02 with a primary completion date of 2026-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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)

Contact & Investigator

Central Contact

Emma Hansson, MD, PhD

✉ emma.em.hansson@vgregion.se

📞 0046313421000

Frequently Asked Questions

Who can join the NCT05363189 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Breast Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05363189 currently recruiting?

Yes, NCT05363189 is actively recruiting participants. Contact the research team at emma.em.hansson@vgregion.se for enrollment information.

Where is the NCT05363189 trial being conducted?

This trial is being conducted at Gothenburg, Sweden.

Who is sponsoring the NCT05363189 clinical trial?

NCT05363189 is sponsored by Vastra Gotaland Region. The trial plans to enroll 380 participants.

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