Prospective cohort study to assess quality of life, surgical outcomes, and perioperative complications following implant-based breast reconstruction

Prospective cohort study to assess quality of life, surgical outcomes, and perioperative complications following implant-based breast reconstruction - Reko-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034493

Enrollment

300

Registered

2024-06-20

Start date

2021-02-25

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50.9

Interventions

Group 1: Patients with implant-based breast reconstruction after mastectomy (03/2021 - 02/2024)

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: i. >18 years old, fully capable of giving consent ii. Signed informed consent form iii. Histologically confirmed breast carcinoma or precancerous lesion (DCIS/LCIS) or genetic high-risk mutation, each with an indication for mastectomy and planned implant-based reconstruction

Exclusion criteria

Exclusion criteria: None defined, as this is not an interventional study. All patients will be treated according to guidelines.

Design outcomes

Primary

Measure	Time frame
Quality of Life, measured using the BreastQ at 3 years after surgery	—

Secondary

Measure	Time frame
Quality of life, measured using the BreastQ at 1 year and 5 years Surgical outcome (photo analysis with bcct.core and structured clinical examination) at 1, 3 and 5 years post-operation Complications/reoperations perioperatively, up to 1 year and up to 3 and 5 years post-operation	—

Countries

Germany

Contacts

Public ContactMoritz Hamann

Rotkreuzklinikum München gGmbH - Hauptabteilung Gynäkologie

moritz.hamann@swmbrk.de+49 89 1303 30

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026