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Mastectomy clinical trials

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NCT ID: NCT04891510 Recruiting - Clinical trials for Breast Reconstruction

A Comparative Analysis of REVOLVE, LipoGrafter, and the Standard Decantation Technique in Autologous Fat Grafting During Breast Surgery

Start date: May 19, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.

NCT ID: NCT04860843 Recruiting - Nerve Block Clinical Trials

Nerve Blocks in Alloplastic Breast Reconstruction

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Pain management is a major concern in oncologic breast surgery and reconstruction. Significant risks for acute and chronic pain after surgery might be reduced through improved pain control pre-operatively. Addition of regional anesthesia to a multimodal peri-operative pain management protocol offers a promising solution for improved recovery. For patients undergoing mastectomy with immediate alloplastic breast reconstruction, this RCT compares TPVB+Pecs local anesthetic block with TPVB local anesthetic block and Pecs placebo normal saline block for their effect on acute pain, chronic pain, opioid consumption, opioid-related side effects, patient-reported quality of recovery after surgery, and length of stay.

NCT ID: NCT04741737 Recruiting - Mastectomy Clinical Trials

Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

According to the standard treatment guidelines established until recently, in the case of ipsilateral breast tumor recurrence without systemic metastasis, salvage mastectomy or lumpectomy can be performed when either partial or whole breast radiation therapy is possible. On the other hand, there are currently no standard treatment guidelines for axillary treatment, and the evidence for this is limited. Axillary lymph node metastasis was reported to occur in about 26% of breast cancer patients who had negative sentinel lymph nodes from previous surgery for primary breast cancer and only local recurrence occurred. It is still important in the decision of treatment or adjuvant radiation therapy. However, it is known that most of the patients with ipsilateral breast recurrence do not have axillary lymph node metastasis. Therefore, performing axillary axillary surgery in all of these patients does not help the patient's survival in many cases, but rather can lead to complications such as lymphedema and seroma and postoperative wound infection. A question about the implementation of axillary lymph node resection has been raised and for this reason, it is necessary to study whether surveillance lymph node biopsy is still effective in patients with recurrence in the ipsilateral breast. Most of the studies on ipsilateral breast tumor recurrence without systemic metastasis reported to date are case reports or small retrospective studies. In addition, the combined meta-analysis also has limitations in that the study design is not uniform, and there are many cases in which primary breast cancer surgery performed total mastectomy or axillary lymph node dissection. This study is a multicenter prospective study designed to validate the clinical effectiveness of repeat-SLNB conducted in patients with ipsilateral breast tumor recurrence among patients who previously underwent breast conservation and sentinel lymph node biopsy for unilateral primary breast cancer.

NCT ID: NCT04687956 Recruiting - Breast Cancer Clinical Trials

Primary Surgical Prevention of Breast Cancer-related Lymphedema

LYMPHA
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.

NCT ID: NCT04666961 Recruiting - Mastectomy Clinical Trials

Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ

HORNEO01
Start date: February 3, 2021
Phase: Phase 2
Study type: Interventional

Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of the lesions, which most often manifest as diffuse microcalcifications. This mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients. Neoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy. Adjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence. The HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ. The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS.

NCT ID: NCT04607460 Recruiting - Migraine Clinical Trials

EMG Biofeedback Treatment for Chronic Low Back Pain, Cancer Pain and Migraines

BEAT-Pain
Start date: December 3, 2020
Phase: N/A
Study type: Interventional

The purpose of this pilot efficacy study is to examine the effects of EMG-biofeedback (EMG-BF) on pain-related outcomes in Chronic Low Back Pain (CLBP) patients, Recent mastectomy and lumpectomy patients, and patients with episodic migraine. EMG-BF facilitates neuromuscular retraining and muscle relaxation by using audio and visual stimuli using an EMG surface electrode-based biosensor and a software installed on a tablet or smart phone. For this pilot efficacy study, we will recruit 125 patients with chronic low back pain, 125 patients who are expected to undergo mastectomy and 80 patients with episodic migraine. Participants will be randomly assigned to either the JOGO Digital Therapeutics EMG Biofeedback device or treatment as usual control group. Patients assigned to the intervention group will be asked to complete self-report questionnaires assessing demographics, pain intensity, negative affect, physical function, pain catastrophizing and sleep, will undergo QST and will be asked to wear Actiwatches to keep track of health behaviors, prior to and after completing the intervention. The intervention consists of weekly sessions during which participants will be instructed on how to use the device by a trained biofeedback instructor. Patients in the control group will undergo sensory testing procedures at baseline and after treatment period but will receive no active treatment. The aims of this study are to examine the impact of EMG-BF on pain and QST and the impact of EMG-BF on psychosocial function. We hypothesize that patients that will undergo the EMG-BF will demonstrate reductions in pain, physical functioning, sleep, pain catastrophizing, anxiety and depression.

NCT ID: NCT04558138 Recruiting - Mastectomy Clinical Trials

RCT Implant Based Breast Reconstruction

Start date: August 20, 2020
Phase: N/A
Study type: Interventional

The main objective of this study is to evaluate patients undergoing mastectomy with immediate implant-based breast reconstruction and compare the outcomes of patients who are discharged the day of surgery versus patients who are discharged on post-operative day one. The primary aim of the study will be to compare the postoperative outcomes and complications between the two study groups within 30 days of discharge. The secondary aims of the study will be to compare patient satisfaction, quality of life and discharge perceptions.

NCT ID: NCT04029467 Recruiting - Breast Cancer Clinical Trials

Effect of Dexmedetomidine on the Duration of Pain Control in ESP Block for Breast Surgery

Start date: July 17, 2019
Phase: Phase 4
Study type: Interventional

Patients undergoing Partial or total mastectomy with axillary LN dissection will receive prior to induction of general anaesthesia ESP block at T4 level at the same side of the surgery. one group will receive ropivacaine 0.375% and the other will get ropivacaine 0.375% with dexmedetomidine 0.5mcg/kg as an adjuvant. time to first narcotic requirement will be documented and therefore an assessment of the duration of action of the block will be made

NCT ID: NCT03959709 Recruiting - Breast Cancer Clinical Trials

Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction

Start date: August 22, 2019
Phase: N/A
Study type: Interventional

Despite the popularity and proved safety of prepectoral implant-based reconstruction, there is little evidence on long-term results and variables which could influence surgical outcome. So far, no specific guidelines or indications have been developed for prepectoral technique and heterogeneous inclusion criteria had been used in previous reports. There is a lack of studies documenting outcomes following ADM-assisted prepectoral breast reconstruction, and there are no randomised controlled trial studies that drawing a direct comparison of clinical or patient-reported outcomes between subpectoral and prepectoral groups. The investigators hypothesized that immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement would result in less early postoperative pain but more reported implant rippling, requirement of more fat grafting and an equitable safety profile compared with ADM-assisted implant-based breast reconstruction with subpectoral implant placement. The aim of this study is to evaluate the postsurgical pain, complications and patient-reported outcomes of prepectoral breast reconstruction versus subpectoral implant placement in immediate breast reconstruction.

NCT ID: NCT03757793 Recruiting - Clinical trials for Breast Reconstruction

Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction

Start date: September 28, 2018
Phase:
Study type: Observational

The study will evaluate the use of near infrared spectrometry (NIRS)in detecting early microvascular complications in deep inferior epigastric artery perforator (DIEP)-flap(s).