Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Seroma

Breast Diseases

Skin Diseases

Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

A negative pressure drain will be inserted below the lower flap directing to the axilla.

Insertion of a single drain

Two drains will be inserted into the axilla and below the lower flap in the double drains group.

Insertion of double drains

One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Ultrasonography after removal of the drains

It is not known whether decreasing the number of drains used decreases patients' discomfort and duration of hospital stay without increasing seroma formation after mastectomies.

Hypothesis. Use of one drain increases patient comfort without increasing seroma formation after modified radical mastectomy (MRM) as compared to double drains.

Material and Method: Sixty patients undergoing MRM at Diskapi Yildirim Beyazit Training and Research Hospital will be randomised into single versus double drains groups. A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group or two similar drains will be inserted into the axilla and below the lower flap in the double drains group. Drains will be removed if the output is less than 30 ml. Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Age, body mass index smoking history, coexisting diseases of the patients duration of the hospital stay, duration of the drains in place, total drain output in the first three days after the operation and the need and frequency of aspirations due to seroma formation will be recorded. Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains, The duration of the longer staying drain in the double drain group will be recorded for the duration of the drain in place parameter.

Background: Seroma is one of the most common complications after mastectomies. Seroma formation results in delays in wound healing, incisional dehiscence, infections and long hospital stay. Although there are studies proving that drains do not prevent seroma formation, the use of drains for that purpose is still very common. Decreasing the number of drains used after mastectomies has been shown to decrease patients' discomfort and duration of hospital stay without increasing seroma formation.

Objective: To investigate the effects of single versus double drains on patient comfort and seroma formation after modified radical mastectomy (MRM) Material and Method: Sixty patients undergoing MRM at Diskapi Yildirim Beyazit Training and Research Hospital will be randomised into single versus double drains groups. A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group or two similar drains will be inserted into the axilla and below the lower flap in the double drains group. Drains will be removed if the output is less than 30 ml. Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Age, body mass index smoking history, coexisting diseases of the patients duration of the hospital stay, duration of the drains in place, total drain output in the first three days after the operation and the need and frequency of aspirations due to seroma formation will be recorded. Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains, The duration of the longer staying drain in the double drain group will be recorded for the duration of the drain in place parameter. Two groups will be compared with chi-square, student's t-test or Mann-Whitney U test. P\<0.005 will be considered as significant.

Single Versus Double Drains After Mastectomy

Comparison of Single Versus Double Drains After Modified Radical Mastectomy

Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).

Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography..

Ankara Diskapi Training and Research Hospital

Melih Akinci

Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.

Single Drain

Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.

Double Drain

Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Total

Age, Continuous

Sex: Female, Male

Melih Akinci, MD, Associate Prof

Patient Comfort Scale

Seroma Formation

Length of Hospital Stay

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Respiratory Aspiration

Patients are placed in the prone crawl position for whole breast irradiation and are treated with 15 x 2,67 Gy (± boost treatment if required as per international guidelines)

Breast cancer patients are placed in a prone position with the ipsilateral arm besides the body rather than extended besides the head on a dedicated couch that provides the required support for maintaining this position.

Prone crawl positioning

Liv Veldeman, MD, PhD

The aim of this study is to validate the obtained results of setup precision, comfort and setup time. The possibility of using breath hold for heart sparing in combination with prone crawl position will be tested. Forty patients (20 with left-sided and 20 with right-sided breast carcinoma) presenting for WBI without LNI after breast-conserving surgery will be included after signing informed consent.

This is a phase II non-randomized trial, where 40 patients will be treated for breast cancer requiring whole breast irradiation as per standard of care. Patients will be simulated and treated using the novel prone crawl position to a total dose of 40.05 Gy in 15 fractions of 2.67 Gy.

The trial aims to evaluate setup precision, patient comfort and setup time in the prone crawl positioning. Feasibility of deep inspiration breathhold will be tested and dosimetric parameters evaluated.

This is done through registration of setup errors at the time of treatment, questionnaires for comfort/discomfort scoring, time registration, toxicity scoring, and dosimetric analysis in treatment planning systems.

Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery

Setup errors are analyzed using Van Herk parameters obtained by rigid coregistration of treatment imaging with simulation imaging

Patient comfort as assessed by questionnaire

Time taken for setting up the patient for each fraction

The reproducibility and stability of deep inspiration breathhold is investigated by performing multiple breathhold manoevres during CT imaging at baseline, and comparing the relative geometric position of organs between on the acquired images for each patient. This will be evaluated by calculating the overlap index and dice similarity coefficien between these images.

Acute side effects due to radiotherapy using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 toxicity scoring system, scoring toxicities from grade 0 (no toxicity) to grade 5 (death)

Analysis is dose using the Dose-volume histogram (DVH) of targets and organs at risk, as obtained on CT simulation images. These DVH's are used to assess amount of radiation received by each organ and treatment target and assess the risk of treatment failure or treatment harm.

University Hospital, Ghent

Patients will be given modernized patient instructions prior to radiotherapy treatment.

Modernized patient instructions

Patients will be given the patient instructions currently in use prior to radiotherapy treatment.

Existing patient instructions

Kathryn Hitchcock, MD, PhD

Daily patient participation is critical to the successful, life-saving delivery of radiotherapy. There is very little in the literature describing the best way to prepare patients to give optimal participation. This study aims to look at an already-prepared conversion of patient instruction materials and measure whether the improvement in clarity and specificity produces the desired changes in patient decision-making and emotional comfort.

Modernizing Instructions to Improve Treatment Participation of Subjects During Their First Radiotherapy

Determine the number of unintentional missed days of treatment during a course of radiotherapy

Evaluate patient-reported comfort with participation in radiotherapy.

Determine the average number of unplanned clinic visits during radiotherapy.

Determine the average number of emergency department visits during radiotherapy.

Determine the average number of hospitalizations during radiotherapy.

Determine the rate of completion of the prescribed number of radiotherapy treatments.

Determine the percentage of patients fully participating in their radiotherapy treatment, as assessed by Likert scale ratings given by the therapist. Patients will be rated by the therapist on factors such as correct patient-initiated alignment of body, holding still, and following breath-hold directions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single Versus Double Drains After Mastectomy	NCT02202252	Breast Cancer Mastectomy	Insertion of a ... Insertion of do... Ultrasonography...	18 Years - 80 Years	Ankara Diskapi Training and Research Hospital
Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery	NCT05179161	Breast Cancer F...	Prone crawl pos...	18 Years -	University Hospital, Ghent
Modernizing Instructions to Improve Treatment Participation of Subjects During Their First Radiotherapy	NCT06246409	Cancer	Modernized pati... Existing patien...	18 Years - 99 Years	University of Florida
Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery	NCT05179161	Breast Cancer F...	Prone crawl pos...	18 Years -	University Hospital, Ghent

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