Breast Cancer Clinical Trial
Official title:
Non-contrast Magnetic Resonance Angiography Efficacy and Safety Assessment for Perforators Mapping in Deep Inferior Epigastric Perforator Flap Breast Reconstruction
The aim of this study is to evaluate the efficacy and safety of contrast-free magnetic resonance angiography (MRA) for deep inferior epigastric perforator flap planning. The investigators propose to perform a non-contrast MRA to achieve the following extremely important objectives: to avoid radiation exposure, minimize the risk of potentially harmful effects of contrast agents, and reduce the cost of the study.The investigators assume that the use of non-contrast MRA following our protocol including certain patient's positioning, a special pulse scanning sequence and perforators' projection method is effective and allows mapping of perforators without injecting a potential harmful contrast agent.
Status | Recruiting |
Enrollment | 135 |
Est. completion date | July 30, 2024 |
Est. primary completion date | February 10, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - A female patients who underwent unilateral mastectomy due to breast cancer, in remission. - At least 1 year after completion of radiotherapy. Non-inclusion Criteria: - A history of abdominal donor site free flaps or abdominoplasty. - Inability to give consent. - The expander with magnetic ports, claustrophobia, pregnancy and breastfeeding. - Patients with severe hypertension, COPD, autoimmune disorders, SLE or poorly regulated diabetes - The presence of psychiatric illness preventing participation in the study. Exclusion Criteria: - Patient's pregnancy diagnosed during the research period. - Patient's refusal of surgery, patient's refusal of further participation in the study. - The presence of concomitant diseases preventing participation in the study. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | IMSechenovMMA | Moscow | |
Russian Federation | Lancet Clinic | Moscow |
Lead Sponsor | Collaborator |
---|---|
I.M. Sechenov First Moscow State Medical University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The concordance ratio. | The investigators are use the information about each perforators' deviation (P1, P2, etc.) based on intraoperative finding (confirmation) and MRA or CTA data by more/less than 1 cm.
Intraoperatively, the surgeon determined the distance from the umbilicus to the perforator vessel (by dropping a perpendicular line from umbilicus) and the distance from the point marked on the marking according to the MRA or CTA data to the found perforator vessel. Measurements performed using a 200 mm surgical ruler (Devemed, Germany). |
During the surgery. | |
Primary | The overall operation time (min). | The total operating time including downtime. | Immediately after the surgery. | |
Primary | The time of the pedicle cut (min). | The investigators plan to evaluate the time of the pedicle cut from the beginning of surgery and from flap harvest, for the right and left vascular pedicle individually. | During the surgery. | |
Primary | The length of the fascia incision (cm). | Intraoperatively, the surgeon measured the fascia incision length using a 200 mm surgical ruler (Devemed, Germany). | During the surgery. | |
Primary | Intraoperative evaluation of flap perfusion. | The flap perfusion was assessed for capillary refill after the vascular pedicle clipping, after the vascular pedicle cutting, and at the end of the flap ischemia time (after the microvascular anastomosis formation) by applying mild pressure, using a hemostat handle. Pressure was then released and the flap observed for capillary refill. Refill was deemed positive if it occurred within 3 s. | During the surgery. | |
Primary | Postoperative flap necrosis (%). | The presence of flap necrosis was assessed during the first five days after surgery by evaluating capillary refill in thee flap and visually assessed the presence of the flap ischemia or necrosis as a percentage of the total flap. | During the first week after surgery. | |
Secondary | The flap ischemia time (min). | Flap ischemia time was assessed from the time of vascular pedicle cutoff to completion of microvascular anastomosis formation ( up to the beginning of blood flow). | During the surgery. | |
Secondary | The length of the vascular pedicle (cm). | After flap harvesting, the surgeon measured the vascular pedicle length using a 200 mm surgical ruler (Devemed, Germany). | During the surgery. | |
Secondary | The number of perforators included in the flap. | The investigators recorded the number of perforators included in the flap on each side of the flap. | Immediately after the surgery. | |
Secondary | Inclusion of superficial vein(s) in the flap. | The investigators recorded the fact of the superficial vein(s) inclusion in the flap, their number and localization (side of the flap). | Immediately after the surgery. |
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