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

Sponsor

Vastra Gotaland Region (Other)

Overall Status

Recruiting

CT.gov ID

NCT05363189

Collaborator

(none)

380

Enrollment

Location

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Reconstruction Breast Cancer	Procedure: Venous augmentation Procedure: Traditional ERAS (enhanced recovery after surgery) protocol Procedure: Sahlgrenska recovery protocol Procedure: No venous augmentation

Study Design

Study Type:

Observational

Anticipated Enrollment :

380 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 2, 2022

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
No venons augmentation Retrospective group of patients who have not received venous augmentation during their operation.	Procedure: No venous augmentation Traditional deep inferior epigastric artery perforator flap (DIEP)
Venous augmentation Retrospective group of patients who have received venous augmentation during their operation.	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 Other Names: Double venous system drainage Cephalic vein turndown
ERAS protocol Retrospective group operated according to the traditional ERAS (enhanced recovery after surgery) protocol	Procedure: Traditional ERAS (enhanced recovery after surgery) protocol Pre-, peri-, and post-operative care as described in the ERAS protocol
Sahlgrenska recovery protocol Prospective group operated according to the Sahlgrenska recovery protocol.	Procedure: Sahlgrenska recovery protocol Pre-, peri-, and post-operative care as described in the Sahlgrenska recovery protocol

Outcome Measures

Primary Outcome Measures

Re-operations [7 days]
Any re-operations performed for any cause during the first 7 days after the operation
Length of stay (LOS) in hospital [7 days]
Number of days the patient stays in the hospital after the operation

Secondary Outcome Measures

Patient reported satisfaction and quality of life [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.
Surgical corrections [5 years]
Number of cosmetic corrections. All types of corrections performed in general or local anesthetics will be included.
Costs [5 years]
Health economical analysis of direct and indirect cost related to the different protocols

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska university hospital	Gothenburg		Sweden	413 45

Sponsors and Collaborators

Vastra Gotaland Region

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vastra Gotaland Region

ClinicalTrials.gov Identifier:

NCT05363189

Other Study ID Numbers:

2022-01423-01

First Posted:

May 5, 2022

Last Update Posted:

May 17, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vastra Gotaland Region

breast reconstruction

plastic surgery

microsurgery

free flap

Study Results

No Results Posted as of May 17, 2022