Trial reportPloS one2022
The PreQ-20 TRIAL: A prospective cohort study of the oncologic safety, quality of life and cosmetic outcomes of patients undergoing prepectoral breast reconstruction.
Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04642508 (The PreQ-20 TRIAL, a Prospective Cohort Study of the Oncologic Safety, Quality of Life and Cosmetic Outcomes of Patients Undergoing Prepectoral Breast Reconstruction), which is not on this map. Cited by 2 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The PreQ-20 TRIAL, a Prospective Cohort Study of the Oncologic Safety, Quality of Life and Cosmetic Outcomes of Patients Undergoing Prepectoral Breast Reconstruction
Who cites it
2 citing papers in PubMed.
- Local Flaps to Cover Skin Necrosis after Skin-sparing Mastectomy and Prepectoral Reconstruction from PreQ-20 Trial.Plastic and reconstructive surgery. Global open · 2024Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMastectomy currently constitutes a necessary surgical procedure in the oncologic setting and in the context of high risk. Prepectoral breast reconstruction (PBR) has been proposed as a surgical alternative to retropectoral techniques by providing less postoperative morbidity and a better cosmetic result. However, there is a lack of prospective studies that have evaluated its safety and patient-reported satisfaction.
methodsWe conducted a prospective cohort study to assess the safety, quality of life and cosmetic sequelae of PBR in women with breast cancer and high risk. The study's main objective is to assess the safety of PBR in terms of postsurgical complications and the feasibility of reconstruction (loss of implants). The secondary objectives are to evaluate oncologic safety (local relapses, residual glandular tissue) and to identify factors related to quality of life and cosmetic sequelae. The evaluation of residual tissue will be conducted by MRI 12 to 18 months after the surgery, and the quality-of-life assessment will be performed using the Breast-Q questionnaire. An initial patient evaluation will be conducted 12-18 months after the surgery, and a second evaluation will be performed at 5 years. The estimated sample size is 81 patients. DISCUSSION: The PreQ-20 study will analyze the impact of PBR on 3 separate measures: safety, quality of life and cosmetic sequelae. Unlike other studies that analyzed these three measures jointly for women with breast cancer and high risk, this study will individualize the results for these 2 patient groups. This differentiation is necessary from the methodological point of view, given that the 2 patient groups have separate clinical and emotional implications. The assessment of these groups will focus on the following aspects: postoperative complications, local relapses, evaluation of residual glandular tissue and incidence rate of primary tumors in the same, the cosmetic sequelae and the satisfaction and the quality-of-life assessment by the patients.
trial registrationClinicalTrials.gov: NCT04642508.
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