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

NCT ID: NCT05363189

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-02

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Breast Reconstruction Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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No venons augmentation

Retrospective group of patients who have not received venous augmentation during their operation.

No venous augmentation

Intervention Type PROCEDURE

Traditional deep inferior epigastric artery perforator flap (DIEP)

Venous augmentation

Retrospective group of patients who have received venous augmentation during their operation.

Venous augmentation

Intervention Type 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

ERAS protocol

Retrospective group operated according to the traditional ERAS (enhanced recovery after surgery) protocol

Traditional ERAS (enhanced recovery after surgery) protocol

Intervention Type PROCEDURE

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

Sahlgrenska recovery protocol

Prospective group operated according to the Sahlgrenska recovery protocol.

Sahlgrenska recovery protocol

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Traditional ERAS (enhanced recovery after surgery) protocol

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

Intervention Type PROCEDURE

Sahlgrenska recovery protocol

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

Intervention Type PROCEDURE

No venous augmentation

Traditional deep inferior epigastric artery perforator flap (DIEP)

Intervention Type PROCEDURE

Other Intervention Names

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Double venous system drainage Cephalic vein turndown

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sahlgrenska university hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Emma Hansson, MD, PhD

Role: CONTACT

0046313421000

Facility Contacts

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Emma Hansson, PhD

Role: primary

+46 31 342 10 00

Other Identifiers

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2022-01423-01

Identifier Type: -

Identifier Source: org_study_id

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