Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Iodine

Cadexomer iodine

Diclofenac

Diclofenac hydroxyethylpyrrolidine

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Participants in this group underwent preoperative planning with a contrast-free magnetic resonance angiography (MRA) using an enhanced protocol that eliminates the use of potentially hazardous contrast agent and radiation exposure while providing high accuracy of visualization.

Control group. Participants in this group underwent preoperative planning using the standard commonly used method - computed tomography angiography (CTA) with IV (intravenous) iodine-containing contrast injection.

Device: MRA scan Philips Ingenia 1.5 T (Royal Philips, Netherlands)

Preprocedural patient's preparation: the study was performed on an empty stomach (at least 8 hours of fasting).

Type of patient positioning. MRA scanning was performed in the prone position.

Additional devices. The investigators placed the patient on her abdomen on a special coordinate system mesh, for the most precise and convenient way of marking.

Scanning protocol. The investigators added T2 pulse sequence to increase the accuracy of muscle localization assessment and the point of vessel immersion into the muscle at TR and TE using a fat suppression program, wich allows receiving information from moving objects (including blood within the vascular lumen).

Scan viewer program. OsiriX 10.0 Release

Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.

Device: Device: Toshiba Aquilion 64 CTA scan machine (Toshiba Medical Systems, Tokyo, Japan).

Preprocedural patient's preparation: A catheter was placed in the antecubital vein of one arm, and a bolus injection of 80 ml contrast medium (Omnipaque 300 mg/ml, GE Healthcare, Oslo, Norway, registration number P N015799/01 from July 31, 2003, international nonproprietary name is a Iohexol) was administered through a power injector (M. Schilling GmbH Medical Products, Germany) at 4 ml/s.

Type of patient positioning. CTA scanning was performed in the supine position.

Scan viewer program. OsiriX 10.0 Release

CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.

Elina I. Abdeeva, MD

Elina I. Abdeeva, MD, PhD

Dmitry V. Melnikov

Elina I Abdeeva, MD

Dmitry V. Melnikov, MD, PhD

Semyon I. Ivanov, MD

Victor A. Gombolevskiy, MD, PhD

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.

Rationale. Contrast-free MRA is a new concept for preoperative planning in breast reconstruction that combines the advantages of magnetic resonance imaging (no ionising radiation exposure), requires no potentially harmful contrast agent, and at the same time is highly accurate.

Aim. The aim of the study is to evaluate the efficacy and safety of the contrast-free magnetic resonance angiography (MRA) for perforators mapping in deep inferior epigastric perforator flap planning.

Study design. A retro- and prospective non-randomised non-blinded cohort multicenter study is conducted at the at the Department of Plastic Surgery (Sechenov University, Moscow), and at the Department of Reconstructive and Plastic Surgery (Lancet Clinic, Moscow), with all patients recruited through a single surgical team and all imaging performed at a single institution.

Study population. The investigators plan to conduct a pilot phase of this study using non-contrast MRA in 100 patients and to compare imaging modalities used in deep inferior epigastric perforator flap breast reconstruction (computed tomography angiography with contrast, n=35 and non-contrast magnetic resonance angiography, n=100). Power analysis determine that no less than 35 patients in control group in this study considering 80 % power with 95 % significance. The first group (experimental, MRA "-" group) will be included patients who refused computed tomography angiography (CTA) with contrast due to a number of reasons such as fear of contrast agent administration, history of iodine allergy, fear of radiation exposure, etc was underwent MRA without contrast, and the second group (control, CTA "+" group) will be involved iodine-tolerance patients with healthy kidneys who underwent preoperative planning with a standard technique - CTA with IV iodine-containing contrast injection.

Interventions. Participants in first group (experimental, MRA "-" group) underwent preoperative planning with a contrast-free magnetic resonance angiography (MRA) using an improved contrast-free MRA protocol. MRA was performed on a magnetic resonance machine Philips Ingenia 1.5 T (Royal Philips, Netherlands). High accuracy is achieved by the following actions: certain preprocedural patient's preparation and positioning, special pulse scanning sequence and perforators projection method.

Preprocedural patient's preparation. The investigators added to the MRA protocol a requirement of performing the study on an empty stomach (at least 8 hours of fasting) in order to reduce gastrointestinal activity.

Modified type of patient positioning. The investigators suggest performing MRA scanning in the prone position in order to both limit abdominal wall movement (related to breathing, peristalsis, and aortic pulsation) and to provide the closest location of the target area (vessels) to the coil.

Furthermore, this move allowed to introduce a further trick that facilitated the surgeons' work at the marking stage: the investigators placed the patient on her abdomen on a 3D printed special mesh made of ABS (Acrylonitrile Butadiene Styrene) (the patent for invention № RU 2023118155). The mesh served as a coordinate system, crosshairs of which accommodate capsules with liquid (A), which allows obtaining on the image not only vessels but also all points of capsules to form a basic standardized mesh, coinciding on the image and on the patient's body that is necessary for the most precise and convenient way of marking.

Due to the image directly used for preoperative marking, the protocol of the MRA scans description was not used.

Special pulse sequence and additional series of MRA scans. MRA is performed on a magnetic resonance machine Philips Ingenia 1.5 T in the T2 pulse sequence (to increase the accuracy of muscle localization assessment and the point of vessel immersion into the muscle) at TR and TE using a fat-suppression program with no IV contrast injection, which allows receiving information from moving objects (including blood within the vascular lumen). The investigators have incorporated an additional series of T2 scans without fat suppression with high resolution (thickness of slices from 0.8 to 1.2 mm) and visualization of the muscle fibers, which allows us to determine the site where the vessels pierce the muscle, intramuscular course of the perforating vessels, and the topography of the area of interest with accurate determination of the perforating vessel relative to the anatomical landmarks.

Following scanning, the images were analysed by a plastic surgeon in the OsiriX 10.0 program. The main benefit of the images was extracted by creating multiplanar reconstructions (MPR) in Maximum Intensity Processing (MIP) mode. This mode allows the evaluation of the vessels in length, their lumen diameters and the study of their correlations and distances from each other for the purpose of target vessel selection.The MRA images required simultaneous evaluation in two planes: frontal and sagittal or frontal and axial. This allowed to the investigators to evaluate the localize the point of vessel immersion into the muscle, the extent and direction of the vessel in the muscle thickness and to localize the point of vessel penetration over the muscle with further direction of the vessel course and the point of communications between superficial and deep systems.

The second group participants (control, CTA "+"group) underwent the standard commonly used computed tomography angiography (CTA) IV (intravenous) iodine-containing contrast injection, and in the supine position. CTA was performed on a Toshiba Aquilion 64 CTA scan machine (Toshiba Medical Systems, Tokyo, Japan) according to the Research and Practical Center of Medical Radiology guidelines №12 from March 22, 2017.

Informed consent is obtained from each participant.

Main study parameters. The investigators plan to evaluate the results according to the following criteria: the concordance ratio, the overall operation time, the time of the pedicle cut, the length of the fascia incision, the intraoperative flap perfusion, the presence of early postoperative complications and their nature, the presence of emergent vascular revision surgery. In addition, the investigators plan to evaluate the following parameters: the flap ischemia time, the number of perforators included in the flap, the fact of superficial vein(s) inclusion in the flap, the length of the vascular pedicle.

All patients in both groups will be female.

Non-contrast Magnetic Resonance Angiography in Deep Inferior Epigastric Perforator Flap Breast Reconstruction Planning

Non-contrast Magnetic Resonance Angiography Efficacy and Safety Assessment for Perforators Mapping in Deep Inferior Epigastric Perforator Flap Breast Reconstruction

Due to the local ethics committee the investigators are unable to provide this data.

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).

The total operating time including downtime.

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.

Intraoperatively, the surgeon measured the fascia incision length using a 200 mm surgical ruler (Devemed, Germany).

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.

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.

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).

After flap harvesting, the surgeon measured the vascular pedicle length using a 200 mm surgical ruler (Devemed, Germany).

The investigators recorded the number of perforators included in the flap on each side of the flap.

The investigators recorded the fact of the superficial vein(s) inclusion in the flap, their number and localization (side of the flap).

I.M. Sechenov First Moscow State Medical University

Symptoms and General Pathology

Hemorrhage

Blood Loss, Surgical

Intraoperative Complications

Coagulants

Tranexamic Acid

Antifibrinolytic Agents

Hemostatics

Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA

Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline

Experimental group will receive TXA intraoperatively (15mg/kg IV, once at beginning of case then re dose at 4hrs if operation goes longer) at the time of their surgery.

Tranexamic acid

Control group will receive same volume equivalent of saline intravenously at the time of their surgery.

Placebo

Rachel Park, MD

Rachel H Park, MD

John Stranix, MD

Tranexamic acid (TXA) is a synthetic, competitive lysine receptor inhibitor on plasminogen. It ultimately stabilizes the fibrin matrix, therefore used as a hemostatic agent for various indications. While there has been indications for orthopedic and trauma surgery, there is no clear data for its role in patients who are undergoing free tissue transfer. Studies have shown that patients undergoing free tissue transfer can have transfusion rates ranging from 7.2% to 34.9%, which data also showing association between transfusion requirement and higher free flap failure rate. There has been a few retrospective studies that evaluated the effect of TXA in free tissue transfer and the results showed no increased risk of microanastomosis failure but some showing decreased blood loss. This study aims to further analyze the role of TXA in patients undergoing breast free flap reconstruction with randomized, prospective trial. Control group will not receive TXA while experimental group will receive TXA. Both groups will receive standard of care breast free flap surgery as well as post-op care, which is streamlined with ERAS protocol. Their pre and post-op hemoglobin will be compared, as well as rates of transfusion, surgical outcome and surgical complications including hematoma, flap failure, and any other medical complications such as DVT/PE.

Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

Role of Intravenous Tranexamic Acid Use in Patients Undergoing Breast Free Flap Reconstruction: Randomized Controlled Trial

Post-op day 1 Hemoglobin - Pre-op Hemogobin

Thromboembolic event, hematoma, seroma, flap compromise/ failure

University of Virginia

Assistant Professor of Plastics Surgery

Behaviors and Mental Disorders

Quality of Life

Participants undergoing unilateral reconstruction: patient will serve as internal control with contralateral breast and reconstructed breast will be compared to all other reconstructed breasts. Participants undergoing bilateral reconstruction: reconstructed breasts will be compared to all other reconstructed breasts

Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which do not have their nerves reconstructed during surgery

Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which have a nerve connected (neurotized) during surgery.

Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with artificial implants

Breast Reconstruction with Artificial Implant

Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with the patient's own tissue

Autologous Breast Reconstruction

Nerve will be reconstructed during autologous breast tissue reconstruction

Neurotization

Andrea Moreira, MD

Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and when nerve sensation to the breast skin returns after mastectomy.

Autologous Tissue Reconstruction: The purpose of this study is to determine whether the tissue being used to reconstruct your breast can provide sensation by using your own nerves. Typically all sensation is lost immediately after this type of surgery and returns to varying degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and one from the chest wall) together, we can attain meaningful sensation in the transferred tissues thereby improving your quality of life following surgery.

To determine the timing and distribution of sensation recovery of breast after mastectomy and breast reconstruction, both with autologous and implant-based reconstruction. Also, to determine the role of innervated free tissue transfer in breast reconstruction.

Specific Aims

1. Determine the timing and degree of return of breast in women who underwent mastectomy with autologous tissue or with implant based reconstruction.
2. Determine sensation following neurotized free flap reconstruction
3. Determine whether neurotization has an impact on quality of life measures post operatively

Study Design Patients will be enrolled prospectively in this data collection study in which they will receive the standard of care for breast cancer resection and oncologically safe and accepted means of breast reconstruction with tissue expander and/or prosthetic implants. Patients will receive additional, non-invasive sensory testing, performed at standard follow up intervals in clinic by their reconstructive team. All patients participating in the study will be consented for enrollment at the pre-operative visit by either the surgeon or physician assistant. As this is a prospective study, all women fitting inclusion criteria over a 6-month minimal, but projected goal 12-month period will be included.

Participants who are having implant reconstruction will act as controls for all other breast reconstructions. If the participant is having autologous tissue reconstruction, she will be randomly put into one of the study groups. Neither the study doctor nor the participant can choose the treatment. Assignment is done randomly, like the flip of a coin. If the participant is having only one breast reconstructed, she will be randomly assigned to either receive the nerve reconstruction or not.

If the participant is having both of her breasts reconstructed, one side will receive the nerve reconstruction and one will not. The participant will not know which group you have been assigned to until the completion of the study or if voluntarily withdraw from the study

Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer

Return of Breast Sensation Following Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer: An Evaluation of Clinical, Sensory, and Quality of Life Outcomes

Differences of at least 20% comparing control to experimental breasts would be clinically meaningful. Composite measure will be calculated by combining the follow binomial factors: detection of temperature difference (feeling hot and cold), detection of sharp versus dull pressure, detection of vibration, discerning point pressure

A total of 19 Likert scale questions will be given to participants in the pre- and post-Surgical Sensation Questionnaire regarding sensation and appearance of breast before and after reconstruction.

Case Comprehensive Cancer Center

Women undergoing immediate breast reconstruction due to breast cancer or a high risk for breast cancer

Women undergoing delayed breast reconstruction due to breast cancer or a high risk for breast cancer

All types of implant based breast reconstructions

Implant-based breast reconstruction

All types of autologous breast reconstructions

Autologous breast reconstruction

All types of breast reconstructions combining autologous and implant based techniques

Combined methods

Emma Hansson, PhD

Linn Weick, MA

A breast reconstruction after mastectomy, either due to breast cancer or a high lifetime risk for cancer, is performed to increase the patient's quality of life. However, there are studies that show that some women regret their decision to have breast reconstruction. There are also studies demonstrating similarities in the general patterns of psychosocial adjustment and quality of life among women with breast cancer who have undergone breast-conserving surgery, mastectomy alone, and mastectomy combined with breast reconstruction. Hence, it is unclear which women actually beneﬁt from a breast reconstruction. The concept of quality of life is connected to patient satisfaction and body image/investment. Therefore, the aim of this project is to examine the effects of patient expectations and body image on the patient reported outcomes of breast reconstruction, to improve preoperative information and postoperative care for women considering a breast reconstruction.

Biological women with breast cancer or high risk for breast cancer who want post-mastectomy breast reconstruction

Effects of Expectations and Body Image in Breast Reconstruction

Psychological Effect of Expectations and Body Image on Outcomes of Breast Reconstruction

Translation into Swedish according to MAPI-guidelines. Validation of psychometric properties in a Swedish population.The scale consists of five modules: expectations for support from medical staff , expectations for pain, expectations for coping, expectations for breast appearance when clothed and expectations for breast sensation. The score for each independent scale range from 0-100. A higher score means greater expectations.

Translation into Swedish according to MAPI-guidelines. Validation of psychometric properties in a Swedish population. ASI-Ris a 20-item self-report questionnaire designed to measure body-image investment. It consists of two subscales, self-evaluative salience (SES) and motivational salience (MS). It is a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). Twelve items relate to SES and eight items relate to MS. The total score is the mean of the 20 items, and the score of the subscales is the mean of the items relating to each subscale. A high score indicates greater body-image investment.

Translation into Swedish according to MAPI-guidelines. Validation of psychometric properties in a Swedish population.Multidimensional body-self relations questionnaire- appearance scales.It is a 34-item self-report questionnaire designed to measure appearance related components of body-image. In consists of five subscales: appearance evaluation, appearance orientation, body areas satisfaction, overweight preoccupation, and self-classified weight. It is a 5-point Likert-scale ranging from 1 to 5.

Breast Q reconstruction includes two domains and six different modules: health-related quality of life (HR-QOL; including physical, psychosocial, and sexual well-being) and patient satisfaction (including satisfaction with breasts, outcome, and care). Each scale produces an independent score from 0-100. A higher score means greater satisfaction or better QOL.

Breast Q expectations.The scale consists of five modules: expectations for support from medical staff , expectations for pain, expectations for coping, expectations for breast appearance when clothed and expectations for breast sensation. The score for each independent scale range from 0-100. A higher score means greater expectations.

MBSRQ-AS - Multidimensional body-self relations questionnaire- appearance scales.It is a 34-item self-report questionnaire designed to measure appearance related components of body-image. In consists of five subscales: appearance evaluation, appearance orientation, body areas satisfaction, overweight preoccupation, and self-classified weight. It is a 5-point Likert-scale ranging from 1 to 5.

ASI-R - Appearance schemas inventory-revised: is a 20-item self-report questionnaire designed to measure body-image investment. It consists of two subscales, self-evaluative salience (SES) and motivational salience (MS). It is a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). Twelve items relate to SES and eight items relate to MS. The total score is the mean of the 20 items, and the score of the subscales is the mean of the items relating to each subscale. A high score indicates greater body-image investment.

Measured with one of the sub scales of Breast Q reconstruction

Measured with a post-operative pain dairy with VAS scales (o means no pain and 10 means the worst possible pain imaginable)

Actual sick leave according to the Swedish authorities

Actual number of out-patient visits, according to the medical chart

HADS - Hospital Anxiety and Depression Scale: is a 14-item self-report questionnaire that is designed to measure anxiety and depression. It has two domains, where seven items relate to anxiety and seven relate to depression. It is a 4-point Likert-scale ranging from 0-3. Each domain has a maximum score of 21. For both domains, scores of less than 7 indicate non-cases, whereas scores of 8-10 indicate mild anxiety or depression, 11-14 moderate and 15-21 severe.

Demographic factors that might affect expectations and satisfaction, such as age, comorbidity, and previous cosmetic breast surgery, and medical factors such as timing of reconstructions, reason for mastectomy, type of cancer and cancer treatment received.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Non-contrast Magnetic Resonance Angiography in Deep Inferior Epigastric Perforator Flap Breast Reconstruction Planning	NCT06061835	Breast Cancer Postsurgical Ac...	Non-contrast MR... CTA with iodine...	18 Years - 70 Years	I.M. Sechenov First Moscow State Medical University
Role of TXA in Patients Undergoing Breast Free Flap Reconstruction	NCT06428682	Breast Cancer Blood Loss, Sur...	Tranexamic acid Placebo	18 Years -	University of Virginia
Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer	NCT03135392	Mastectomy Breast Reconstr...	Breast Reconstr... Autologous Brea... Neurotization	18 Years -	Case Comprehensive Cancer Center
Effects of Expectations and Body Image in Breast Reconstruction	NCT04714463	Breast Cancer	Implant-based b... Autologous brea... Combined method...	18 Years -	Vastra Gotaland Region
Effects of Expectations and Body Image in Breast Reconstruction	NCT04714463	Breast Cancer	Implant-based b... Autologous brea... Combined method...	18 Years -	Vastra Gotaland Region
Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer	NCT03135392	Mastectomy Breast Reconstr...	Breast Reconstr... Autologous Brea... Neurotization	18 Years -	Case Comprehensive Cancer Center

Spots Global Cancer Trial Database for autologous breast reconstruction