Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Quality of Life

Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap.

Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.

Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.

Breast reconstruction

A randomized clinical trial with two arms: irradiated women and non-irradiated women. Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.

Quality of Life, Aesthetic Result and Health Economy in Breast Reconstruction

GoBreast - a Prospective Randomized Trial on Breast Reconstruction Methods

Breast-q. Measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.

EuroQol-5 domensions-3 levels is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health.

Beck Depression Inventory (BDI 21) for mood assessment. Scale range is 0-63 and higher scores indicate worse outcome.

Short form health survey (SF-36). The scale ranges from 0 to 100 and a higher score indicates a better quality of life.

Complications described according to Clavien-Dindo

Analysis of number of implants removed over time

Vastra Gotaland Region

Breast Diseases

Skin Diseases

Women without breast implants participating in the mammography screening program.

Women with breast implants participating in the mammography screening program.

Breast screening mammograms use X-rays to look for cancers that are too small to see or feel.

Mammography screening

Emma Hansson, MD,PhD

Emma Hansson, PhD

The purpose of the study is to survey how many women have breast implants in the mammography screening population and the effect of implants on the number and type of examinations and on costs.

Biological women included in the mammography screening program.

Effect of Breast Implants om Mammography Screening

Health economic analysis of the effects of implants on mammography screening

Prevalence of breast implants in a mammography screening population.

Survey of if breast implants infer extra examinations (mammography, ultrasounds, biopsies, diagnostic operations) in connection with screening mammography.

Retrospective group of patients who have not received venous augmentation during their operation.

Retrospective group of patients who have received venous augmentation during their operation.

Retrospective group operated according to the traditional ERAS (enhanced recovery after surgery) protocol

Prospective group operated according to the Sahlgrenska recovery protocol.

Increasing the venous drainage of a deep inferior epigastric artery perforator (DIEP) flap by anastomosing the superficial inferior epigastric vein to the cephalic vein

Venous augmentation

Pre-, peri-, and post-operative care as described in the ERAS protocol

Traditional ERAS (enhanced recovery after surgery) protocol

Pre-, peri-, and post-operative care as described in the Sahlgrenska recovery protocol

Sahlgrenska recovery protocol

Traditional deep inferior epigastric artery perforator flap (DIEP)

No venous augmentation

Emma Hansson, MD, PhD

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.

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

Any re-operations performed for any cause during the first 7 days after the operation

Number of days the patient stays in the hospital after the operation

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.

Number of cosmetic corrections. All types of corrections performed in general or local anesthetics will be included.

Health economical analysis of direct and indirect cost related to the different protocols

Symptoms and General Pathology

Rare Diseases

Hypertrophy

Pathological Conditions, Anatomical

Gigantomastia

Women who have had/have breast cancer and will have/have had a breast reconstruction.

Women who have had/will have a breast reduction due to breast hypertrophy.

Breast reconstruction after breast cancer.

Breast reduction due to breast hypertrophy.

Breast reduction

The main purpose of the project is to validate patient reported outcomes measures (PROMs) in reconstructive breast surgery. BREAST-Q will be evaluated for Swedish and Sweden.Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ5D), and SF-36 will be validated for reconstructive breast surgery. In addition, the complication classification system according to Clavien-Dindo will be validated for reconstructive breast surgery.

Women who are biological women and identify as cis-women.

Validation of Scales in Reconstructive Breast Surgery

Breast-Q measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.

EuroQol-5 dimensions-3 levels (EQ5D) is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health.

The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).

It comprises eight subdomains: physical functioning (10 items), role limitations caused by physical health problems (4 items), role limitations caused by emotional problems (3 items), social functioning (2 items), emotional well-being (5 items), energy/fatigue (4 items), pain (2 items), and general health perceptions (5 items) where patients score their health during the last four weeks on Likert scales. Every item score is transformed linearly to the per cent of total possible score (0-100) and then averaged by the values of the scale. A subscore is calculated for each domain and in addition two summary scores, physical and mental health, are calculated.

The Clavien-Dindo system is based on ranking the severity of the intervention required to treat a given complication, as follows: grade I includes deviations from the postoperative course without the need for pharmacological treatment or surgical/endoscopic/radiological intervention; grade II complications require pharmacological treatment, blood transfusion, or total parental nutrition; grade III complications require surgical/endoscopic/radiological intervention; grade IV includes life-threatening complications, including those involving the central nervous system, that require intensive care treatment; and grade V includes complications that result in death.

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

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.

Facies

Skin Neoplasms

Patients with facial cancer or disfigurement who require reconstructive surgery will be offered participation in this study.

3D photography is available at our unit department of clinical photography. Photos will be taken and the associated NHS software (Canfield Imaging scientific, inc) used to sit down with the patients and model their reconstruction, thereby reducing anxiety and improving awareness of their treatment plan.

3D photography and computer modelling

Prateush Singh, MBBChir

prateush singh, mbbchir

The aim of this study is to improve patient satisfaction and outcomes in facial reconstructive surgery by using 3D clinical photography and computer modelling to help illustrate and plan the patients' reconstructive journey.

It will be conducted at the Royal Free Hospital department of Plastic and Reconstructive Surgery, where patients with facial deformities or suspected diagnoses of skin cancer will be referred from their GP or dermatology services. As is routine standard of care, they will be reviewed in outpatient settings and the next management steps initiated. Our study will introduce compulsory 2D and 3D photography and patient satisfaction questionnaires. The photographs will be used to sit down with the participant and illustrate the intended surgical reconstruction, keeping them up to date and fully informed of the surgical plan. The questionnaire, FACE-Q, already validated for facial skin cancer surgery and reconstruction, will be used to assess their satisfaction at each stage of their reconstructive journey.

The results of the study will benefit each participant and illustrate an improvement in satisfaction so that such 3D photography, surgical planning with computer models produced by these 3D images will become a routine part of future patients with facial disfigurement or cancer requiring reconstruction.

This study will form part of a PhD academic qualification at UCL for one of the research registrars.

Setting: Royal Free Hospital, London. Single site. Study Population: Adult patients aged over 18 presenting with;

• Facial defects resulting from cancer or trauma

Consent from the patients will be obtained as soon as possible, during outpatient consultation.

Study design: observational case series, feasibility study. As this is an open observational study, there will be no randomization. As numbers of participant's attending with facial skin cancer defects requiring reconstruction is small, there will not be any sampling.

Expected number of participants: 10. Number determined after discussion with Chief Investigators as adequate to determine feasibility or incorporating 3D photography, computer modelling and questionnaires to improve satisfaction. Statistical input from supervisor and chief investigator, Professor Eva Krumhuber, department of experimental psychology.

Duration of study: 12 months Methodology: Clinic Consultation Patients will be referred to our craniofacial clinic with either pre-defect or pre-biopsy lesions suspicious of being skin malignancies, or following biopsy or defect resulting from excision, trauma or Mohs surgery.

If the lesion is suspicious for cancer but has not been diagnosed, this is discussed with the patient and a biopsy booked. During the consultation the patient is sent for clinical 2D and 3D photography in the Royal Free Hospital Department of Clinical Photography.

If the patient presents to clinic with the defect, multiple pre-defect 2D photographs are requested from the patient and stored on the hospital protected plastic surgery department shared drive.

Photography All patients will undergo outpatient 2D and 3D photography in the Royal Free Hospital Department of Clinical Photography.

Computer modelling All images will be processed using the Vectra XT software from Canfield Imaging Scientific, inc. used at the Royal Free Hospital Department of Clinical Photography. From this, 3D images can be layered, accurate calculations made and the size of defects accurately measured and templated. 3D models can be manipulated to illustrate each stage of the reconstruction.

Treatment modality Treatment modalities will involve standard of care surgical management, pre-assessment and post-operative care. This includes skin cancer and craniofacial MDT multidisciplinary team discussions to plan and decide treatment. This will all take place at Royal Free Hospital, London.

Patient questionnaires Patients will be asked to complete FACE-Q questionnaires at each consultation and after each stage of their reconstruction at initial consultation, 6 weeks post op, 3 months, 6 months and 1 year follow up.

FACE-Q is a validated questionnaire patient reported outcome measure including measures for satisfaction with facial appearance, health-related quality of life, recovery, early life impact, adverse effects and satisfaction with process of care (Klassen et al. 2010).

Follow up For patient who have undergone biopsy, they will be reviewed in the plastic surgery dressings clinic 1 week post op to review the wound; their histology will be discussed in the skin MDT 4-6 weeks later and the patient informed in a consultation of the results.

If further excision or reconstruction is required, the patient will undergo the required imaging and computer modelling and undergo the operative procedure. They will then be reviewed a week later in our dressings clinic and at the next stage of their procedure in 3-4 weeks if staged reconstruction is required. After the final reconstruction, they will be reviewed in outpatient clinic at 6 weeks, 3 months, 6 months and 1 year follow up.

Data collection and storage:

Data will be collected from source (medical notes, questionnaires, and images), and collected on a case record form (CRF) and then transferred to an electronic database. The master database will be recorded by code and will hence be anonymized. Some parts of the medical records and the data collected for the study will be looked at by authorised persons such as the members of the research team, regulatory authorities, the Trust, and the sponsors of this study. They may also be looked at by authorised people to check that the study is being carried out correctly. All will have a duty of confidentiality.

Anonymised extracts of the database may be transferred securely to UCL for analysis. Anonymised images may be shared with researchers in the department of surgery and interventional sciences at UCL.

In some circumstances the data in an anonymous form may be used for preparation of the trial report, and for submission to Government agencies as part of the procedures.

The data may be required for further studies, in which case further Research Ethics Committee approval will be sought. Access to personal data is strictly controlled and limited to authorised personnel only.

Personal data will be stored on paper forms held in a secure, locked office accessible to authorised personnel only. At the end of the study, personal data in paper form (completed Case Record Forms) will be archived securely.

The dataset will be used for the sole purpose set out in this protocol. Anonymised raw data will not be shared with any other organisation or named individual.

In the study, data will be collected from patients in accordance with the patient consent form, patient information sheet and as described in this protocol.

The data will be appropriately maintained by authorised members of the research team for statistical analysis.

The Chief Investigator will nominate an individual to process, store and dispose of study data in accordance with all applicable legal and regulatory requirements, including the Data Protection Act 1998 and any amendments thereto.

Non anonymised data will not be transferred to any party not identified in the protocol and will not be processed and/or transferred other than in accordance with the patients' consent.

facial skin cancers must be excised- this tissue will be sent to the Royal Free Hospital department of histopathology for review as is standard of care for these patients.

Computer Modelling to Plan Surgical Reconstruction

Computer Modelling Using 2D and 3D Photographs of Patients Faces to Improve Surgical Reconstructive Planning in a Clinical Case Series of Patients With Facial Defects and Improve Patient Satisfaction

no data will be shared with researchers outside of the research team

using the validated FACE-Q questionnaire for patients with skin cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quality of Life, Aesthetic Result and Health Economy in Breast Reconstruction	NCT03963427	Breast Cancer F... Surgery--Compli...	Breast reconstr...	18 Years - 60 Years	Vastra Gotaland Region
Effect of Breast Implants om Mammography Screening	NCT05222100	Breast Cancer	Mammography scr...	40 Years - 75 Years	Vastra Gotaland Region
Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)	NCT05363189	Breast Reconstr... Breast Cancer	Venous augmenta... Traditional ERA... Sahlgrenska rec... No venous augme...	18 Years - 100 Years	Vastra Gotaland Region
Validation of Scales in Reconstructive Breast Surgery	NCT05233891	Breast Cancer Breast Hypertro...	Breast reconstr... Breast reductio...	18 Years - 100 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
Computer Modelling to Plan Surgical Reconstruction	NCT04968704	Surgery Cancer of Skin	3D photography ...	18 Years -	Royal Free Hospital NHS Foundation Trust
Computer Modelling to Plan Surgical Reconstruction	NCT04968704	Surgery Cancer of Skin	3D photography ...	18 Years -	Royal Free Hospital NHS Foundation Trust
Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)	NCT05363189	Breast Reconstr... Breast Cancer	Venous augmenta... Traditional ERA... Sahlgrenska rec... No venous augme...	18 Years - 100 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

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