Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 108 trials
NCT07579117
Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. The procedure will be carried out by a dedicated surgical team in which at least one operator holds certified laparoscopic surgical training issued by a recognized scientific society, ensuring appropriate technical expertise and adherence to surgical safety standards.
NCT06382272
This trial seeks to establish whether or not touch sensation can be restored to the breast via neural stimulation. Data will also be obtained to inform future feasibility (including safety), efficacy, and acceptability trials.
NCT07546968
Background: Closed-incision negative pressure wound therapy (ciNPWT) is effective in reducing postoperative complications, yet its use in free flap breast reconstruction mastectomy wound remains controversial due to concerns that external pressure may compromise the microvascular pedicle. Methods: A retrospective comparative study was conducted on 253 patients (283 flaps) undergoing immediate DIEP flap reconstruction between 2012 and 2025. Patients were stratified into a ciNPWT group and a conventional dressing group. Outcomes included flap survival, wound complications, healing time, and length of stay (LOS). Multivariable regression models adjusted for confounders, including BMI and neoadjuvant chemotherapy.
NCT07536867
This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) and Rhomboid Intercostal Block in patients undergoing Breast Cancer Surgery With Axillary Lymph Node Dissection. The primary outcome is Visual Analog Scale (VAS) during the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block performance time, block-related and systemic side effects (hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, infection), Patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire.
NCT07510269
This study aims to evaluate and compare the analgesic efficacy of two ultrasound-guided regional anesthesia techniques, the serratus anterior plane (SAP) block and the serratus posterior superior intercostal plane (SPSIP) block, in patients undergoing elective mastectomy surgery. Postoperative pain following mastectomy is a common and significant clinical problem that negatively affects patient comfort, delays mobilization, and may prolong hospital stay. Although systemic analgesics are commonly used, they are associated with adverse effects such as sedation, constipation, and potential dependency. In this randomized clinical study, female patients aged 18-75 years with ASA physical status I-III scheduled for elective mastectomy will be included after obtaining informed consent. Patients will be allocated into two groups to receive either SAP block or SPSIP block under ultrasound guidance prior to surgery. Standardized general anesthesia and perioperative analgesia protocols will be applied to all patients. The primary objective is to compare postoperative pain scores between the two groups using the Numeric Rating Scale (NRS). Secondary outcomes include time to first analgesic requirement, total analgesic consumption, intraoperative opioid use, and hemodynamic parameters. By comparing these two interfascial plane blocks, this study aims to identify a more effective analgesic technique that improves postoperative pain control, enhances patient comfort, and facilitates early mobilization following mastectomy.
NCT04447339
This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively
NCT07271589
Persistent pain after mastectomy remains a significant clinical challenge that can delay recovery, reduce quality of life, and increase long-term healthcare burden. The goal of this study is to gain a deeper understanding of the biological and clinical factors that influence pain severity after mastectomy and contribute to the transition from acute to chronic postoperative pain. Guided by a biopsychosocial framework, this research will address the following aims: 1. We will use standardized experimental pain testing before surgery to evaluate how patients respond to different types of controlled sensory stimuli. These responses may help predict who is more likely to experience severe or prolonged pain after surgery. 2. We will analyze blood samples collected before and after surgery to measure markers of inflammation and other biological responses. These data will help us explore how the body's immune and hormonal systems relate to pain severity in both the short- and longer-term recovery phases. 3. We will assess psychological and clinical factors, such as emotional health, coping style, household income, and life stressors, to understand how they contribute to patients' pain experiences throughout recovery. 4. We will examine whether routinely collected demographic and clinical characteristics can help identify patients at greater risk of experiencing higher levels of pain after surgery. This approach will allow us to better understand which patients may benefit from more tailored perioperative pain management strategies.
NCT07434232
Here, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy. Study Endpoints Primary Endpoints: Total intravenous opioid consumption during the first 24 hours following surgery. Secondary Endpoints: Postoperative analgesia, 24 hours after surgery, assessed using the Visual Analog Scale (VAS) and time to first analgesic request.
NCT04909125
The purpose of this study is to investigate the difference in fatigue, quality of life and radiation morbidity between hypofractionated and conventional radiation to the breast, chest wall and regional lymph nodes post mastectomy or lumpectomy
NCT07388238
This randomized double-blind controlled clinical trial was conducted to compare the analgesic efficacy of ultrasound-guided Pectoral Nerve Block versus Serratus Anterior Plane Block in female patients undergoing Modified Radical Mastectomy. Sixty-four ASA I-II female patients aged 35-60 years were randomly allocated into two equal groups: Group I received PEC I block and Group II received SAPB, using 20 ml of 0.25% bupivacaine in both groups after induction of general anesthesia. Postoperative pain was assessed using the Numeric Rating Scale (NRS) for 24 hours. Hemodynamic parameters, time to first rescue analgesia, total postoperative opioid consumption, and side effects were recorded. The SAPB group showed significantly lower postoperative pain scores during the first 6 hours, significantly longer time to first rescue analgesia, and significantly lower total pethidine consumption compared to the PEC I group. In addition, mean arterial blood pressure and heart rate were significantly lower intraoperatively and during early postoperative periods in the SAPB group. The incidence of postoperative nausea and vomiting was significantly higher in the PEC I group. Conclusion: Ultrasound-guided Serratus Anterior Plane Block provides superior postoperative analgesia with better hemodynamic stability and fewer opioid-related side effects compared to Pectoral Nerve Block in patients undergoing Modified Radical Mastectomy modified radical mastectomy
NCT04607460
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.
NCT07364279
This study will be a randomized controlled trial. The purpose of the study is to evaluate the therapeutic effect of Wii Fit balance board games on balance in patients with osteoporosis post mastectomy.
NCT07147166
The goal of this randomized, prospective, interventional clinical trial is to evaluate the use of Brijjit® in reducing the incidence of hypertrophic scarring in individuals undergoing gender-affirming bilateral double incision mastectomies at a single-institution, single-surgeon site (Esther A. Kim, MD). Patients will serve as a self-control (one side of the chest receives intervention, the other serves as a control). Primary endpoints include scar appearance and quality. Secondary endpoints include patient perception of the scar using the Patient and Observer Scar Assessment Scale (POSAS). Participants will be taught how to apply Brijjit® at home if any units fall off before 6 weeks postop.
NCT07345026
The goal of this clinical trial is to evaluate whether the use of an acellular dermal matrix (SureDerm) can improve cosmetic satisfaction and is safe in women with breast cancer undergoing breast-conserving surgery. The main questions it aims to answer are: 1. Does the use of SureDerm improve patient-reported cosmetic satisfaction after breast-conserving surgery? 2. Is the use of SureDerm safe in terms of complication rates compared to standard surgery without SureDerm? Researchers will compare patients receiving SureDerm during surgery with patients undergoing standard breast-conserving surgery without SureDerm to see if cosmetic results and safety differ between the groups. Participants will: * Undergo breast-conserving surgery, with or without SureDerm (assigned randomly) * Receive standard postoperative radiotherapy * Complete questionnaires about cosmetic satisfaction (Breast-Q) at baseline, 1 month, and 12 months after surgery * Be followed for complications and cosmetic assessments by physicians
NCT07316283
Forty-six female patients aged 35-55 years who were suffering from shoulder dysfunction following mastectomy surgeries participated in this study. The participants were recruited from the outpatient clinic of the Faculty of Physical Therapy, Cairo University, and were randomly assigned into two equal groups. Group A: consisted of 23 patients who received sensorimotor training exercises in addition to a traditional physical therapy program which included shoulder range of motion exercises, capsular stretching exercises, scapular muscle strengthening exercises, shoulder Maitland mobilization, and scapular mobilization. Group B: consisted of 23 patients who received only the traditional physical therapy program, which included shoulder range of motion exercises, capsular stretching exercises, scapular muscle strengthening exercises, shoulder Maitland mobilization, and scapular mobilization. Both groups received treatment three sessions per week for a duration of eight weeks.
NCT04756791
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.
NCT07261904
The goal of this observational study is to: * To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation; * To confirm the continued safety of BIOCHROMADERM®, * To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation * To assess the long-term performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 12 months post-pigmentation (Likert scale) * To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation * To assess fading (pigment retention potential) over 12 months * To assess the number of pigmentation adjustments needed per patient throughout the study duration * To assess patient's satisfaction/self-confidence evolution post-treatment, both in terms of general breast appearance and as to the specific dermo-pigmentation stage * To assess the correlation of the esthetic satisfaction/self-confidence questionnaire outcomes with those of the Likert Scale and patient satisfaction VAS at 3 months and 12 months post-pigmentation
NCT07257874
There is difference in post operative pain between patients receiving inter- pectoral block and those receiving standard Intravenous analgesia(INJ TORADOL) in patients undergoing Modified Radical Mastectomy. To compare between these two methods , which one is better for post operative pain management.
NCT06853964
This retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
NCT05146778
In 230 patients undergoing mastectomy, the investigators will compare opioid-free anesthesia (OFA) versus conventional opioid-based anesthesia in terms of chronic pain. The enrolled patients will be randomly assigned into two groups with 1:1 ratio. Chronic pain will be evaluated at 1 year after mastectomy based on the Breast Cancer Pain Questionnaire (BCPQ). Baseline pain sensitivity test and psychologic evaluation will be done before operation.