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NCT Number: NCT05363189

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

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.

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Key information

Conditions

Breast Reconstruction Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Venous augmentation

Procedure

Increasing the venous drainage of a deep inferior epigastric artery perforator (DIEP) flap by anastomosing the superficial inferior epigastric vein to the cephalic vein

Other names: Double venous system drainage, Cephalic vein turndown

Traditional ERAS (enhanced recovery after surgery) protocol

Procedure

Pre-, peri-, and post-operative care as described in the ERAS protocol

Sahlgrenska recovery protocol

Procedure

Pre-, peri-, and post-operative care as described in the Sahlgrenska recovery protocol

No venous augmentation

Procedure

Traditional deep inferior epigastric artery perforator flap (DIEP)

Primary outcomes

  1. Re-operations

    Time frame: 7 days

    Any re-operations performed for any cause during the first 7 days after the operation

  2. Length of stay (LOS) in hospital

    Time frame: 7 days

    Number of days the patient stays in the hospital after the operation

Secondary outcomes

  1. Patient reported satisfaction and quality of life

    Time frame: 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.

  2. Surgical corrections

    Time frame: 5 years

    Number of cosmetic corrections. All types of corrections performed in general or local anesthetics will be included.

  3. Costs

    Time frame: 5 years

    Health economical analysis of direct and indirect cost related to the different protocols

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Hansson, MD, PhD

CONTACT

[email protected]

0046313421000

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Acronym: BestDIEP

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 5, 2022
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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