Breast ReconstructionBestDIEPNCT05363189
Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)
An observational study of Breast Reconstruction and Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Reconstruction, Breast Cancer
- What is being tested?
- Venous augmentation, Traditional ERAS (enhanced recovery after surgery) protocol and Sahlgrenska recovery protocol
- Type of treatment
- Surgery or procedure
- How many people
- 380 participants
- Where
- 1 siteSweden
- Study dates
- 2 May 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Biological women undergoing breast reconstruction with a deep inferior epigastric artery perforator flap in Sahlgrenska university hospital.
Who may be able to join
- Operated or will be operated with a DIEP flap in the department
- >18 years of age
Who cannot join
- Inability to leave informed consent
- Inability to understand and speak Swedish (for the questionnaire)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska university hospital
Gothenburg, 413 45
Emma Hansson, PhD, +46 31 342 10 00, emma.hansson.2@gu.se
About this study
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.
- Conditions
- Breast Reconstruction, Breast Cancer
- Being tested
- Venous augmentation, Traditional ERAS (enhanced recovery after surgery) protocol, Sahlgrenska recovery protocol, No venous augmentation
- Keywords
- breast reconstruction, plastic surgery, microsurgery, free flap
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous augmentationProcedure or surgery
Also called Double venous system drainage, Cephalic vein turndown
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) protocolProcedure or surgery
Pre-, peri-, and post-operative care as described in the ERAS protocol
Sahlgrenska recovery protocolProcedure or surgery
Pre-, peri-, and post-operative care as described in the Sahlgrenska recovery protocol
No venous augmentationProcedure or surgery
Traditional deep inferior epigastric artery perforator flap (DIEP)
| Study group | Role | What they receive |
|---|---|---|
| No venons augmentation | Retrospective group of patients who have not received venous augmentation during their operation. Receives: Procedure: No venous augmentation | |
| Venous augmentation | Retrospective group of patients who have received venous augmentation during their operation. Receives: Procedure: Venous augmentation | |
| ERAS protocol | Retrospective group operated according to the traditional ERAS (enhanced recovery after surgery) protocol Receives: Procedure: Traditional ERAS (enhanced recovery after surgery) protocol | |
| Sahlgrenska recovery protocol | Prospective group operated according to the Sahlgrenska recovery protocol. Receives: Procedure: Sahlgrenska recovery protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-operations
Any re-operations performed for any cause during the first 7 days after the operation
Measured: 7 days
Length of stay (LOS) in hospital
Number of days the patient stays in the hospital after the operation
Measured: 7 days
Secondary outcomes (3)
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.
Measured: 12 months
Surgical corrections
Number of cosmetic corrections. All types of corrections performed in general or local anesthetics will be included.
Measured: 5 years
Costs
Health economical analysis of direct and indirect cost related to the different protocols
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start2 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363189
- Sponsor's protocol ID
- 2022-01423-01
- Acronym
- BestDIEP
- Status last verified
- Jun 2025
- First submitted
- 2 May 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)
- ClinicalTrials.gov ID
- NCT05363189
- Acronym / sponsor ID
- BestDIEP / 2022-01423-01
- Conditions
- Breast Reconstruction, Breast Cancer
- Keywords
- breast reconstruction, plastic surgery, microsurgery, free flap
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 2 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No venons augmentation | – | Procedure: No venous augmentationRetrospective group of patients who have not received venous augmentation during their operation. |
| Venous augmentation | – | Procedure: Venous augmentationRetrospective group of patients who have received venous augmentation during their operation. |
| ERAS protocol | – | Procedure: Traditional ERAS (enhanced recovery after surgery) protocolRetrospective group operated according to the traditional ERAS (enhanced recovery after surgery) protocol |
| Sahlgrenska recovery protocol | – | Procedure: Sahlgrenska recovery protocolProspective group operated according to the Sahlgrenska recovery protocol. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Biological women undergoing breast reconstruction with a deep inferior epigastric artery perforator flap in Sahlgrenska university hospital.
Key inclusion criteria (2 listed)
- Operated or will be operated with a DIEP flap in the department
- >18 years of age
Key exclusion criteria (2 listed)
- Inability to leave informed consent
- Inability to understand and speak Swedish (for the questionnaire)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous augmentationAlso: Double venous system drainage, Cephalic vein turndownIncreasing the venous drainage of a deep inferior epigastric artery perforator (DIEP) flap by anastomosing the superficial inferior epigastric vein to the cephalic vein | Procedure or surgery | Venous augmentation |
| Traditional ERAS (enhanced recovery after surgery) protocolPre-, peri-, and post-operative care as described in the ERAS protocol | Procedure or surgery | ERAS protocol |
| Sahlgrenska recovery protocolPre-, peri-, and post-operative care as described in the Sahlgrenska recovery protocol | Procedure or surgery | Sahlgrenska recovery protocol |
| No venous augmentationTraditional deep inferior epigastric artery perforator flap (DIEP) | Procedure or surgery | No venons augmentation |
Primary outcome
Re-operations
Time frame: 7 days
Any re-operations performed for any cause during the first 7 days after the operation
Length of stay (LOS) in hospital
Time frame: 7 days
Number of days the patient stays in the hospital after the operation
3 secondary outcomes
Patient reported satisfaction and quality of life
Time frame: 12 months
Surgical corrections
Time frame: 5 years
Costs
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Reconstruction and Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Hansson, MD, PhD (0046313421000, emma.em.hansson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-operations (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.