scholarly journals Effect of Autologous Fibrin Glue on Seroma Reduction after Modified Radical Mastectomy for Breast Cancer: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Mohammed Faisal ◽  
Sara Salem ◽  
Noha Kamel ◽  
Haidy Abd El- Zaher ◽  
Ahmed Abo Bakr ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Fibrin Glue ◽  
Controlled Trial ◽  
Radical Mastectomy ◽  
Control Group ◽  
Modified Radical Mastectomy ◽  
Randomized Controlled ◽  
Drain Removal ◽  
Autologous Fibrin Glue

Abstract Introduction: Breast cancer stands out as the second most common cancer in the world with incidence 35.1% of all malignancies among females in Egypt. Fluid build-up after breast surgery is still the most annoying complication which leads to worse outcome. We aimed to evaluate whether autologous fibrin glue might lessen the formation of seroma following modified radical mastectomy. Methods: This was a randomized controlled trial designed to configure the effect of autologous fibrin glue given in the study group using the drain in comparison to a control group who received the drain only; seroma volume was calculated every 24 hrs. For all of the cases. The drains were removed when the daily drainage was less than 30 ml for 3 consecutive days. Results: We recruited 30 patients to each of the two groups. Age, pathology, breast cancer stage, number of lymph nodes and tumour size did not differ significantly between groups. A comparison of the median days to drain removal showed 8 days reduction in median days to drain removal compared in the intervention group (7 days) than the control (15 days). The patients in the fibrin glue group had a significantly lower cumulative drain output volume (mean ± SD of 505.6 ± 209.3 ml) than those in the control group (1674.1 ± 1373.8 ml). Additionally, the patients treated with fibrin glue had a significantly shorter postoperative length of stay (8.5 (7–10) days) than the controls (15 (10–23) days. Conclusions: Autologous fibrin glue significantly decrease seroma formation post-modified radical mastectomy. Research Registry Unique Identifying Number: researchregistry5372.

scholarly journals Effect of Autologous Fibrin Glue on Seroma Reduction after Modified Radical Mastectomy for Breast Cancer: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Mohammed Faisal ◽  
Sara Salem ◽  
Noha Kamel ◽  
Haidi Abd El Zaher ◽  
Ahmed Abo Bakr ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Fibrin Glue ◽  
Controlled Trial ◽  
Radical Mastectomy ◽  
Control Group ◽  
Modified Radical Mastectomy ◽  
Randomized Controlled ◽  
Drain Removal ◽  
Autologous Fibrin Glue

Abstract Introduction Breast cancer stands out as the second most common cancer in the world with incidence 35.1% of all malignancies among females in Egypt. Fluid build-up after breast surgery is still the most annoying complication which leads to worse outcome. We aimed to evaluate whether autologous fibrin glue might lessen the formation of seroma following modified radical mastectomy. Methods This was a randomized controlled trial designed to configure the effect of autologous fibrin glue given in the study group using the drain in comparison to a control group who received the drain only; seroma volume was calculated every 24 hrs. For all of the cases. The drains were removed when the daily drainage was less than 30 ml for 3 consecutive days. Results We recruited 30 patients to each of the two groups. Age, pathology, breast cancer stage, number of lymph nodes and tumour size did not differ significantly between groups. A comparison of the median days to drain removal showed 8 days reduction in median days to drain removal compared in the intervention group (7 days) than the control (15 days). The patients in the fibrin glue group had a significantly lower cumulative drain output volume (mean ± SD of 505.6 ± 209.3 ml) than those in the control group (1674.1± 1373.8 ml). Additionally, the patients treated with fibrin glue had a significantly shorter postoperative length of stay (8.5 (7–10) days) than the controls (15 (10–23) days. Conclusions Autologous fibrin glue significantly decrease seroma formation post-modified radical mastectomy. Research Registry Unique Identifying Number: researchregistry5372.

scholarly journals Randomized Controlled Trial of Modified Radical Mastectomy with and Without Quilting Technique and Its Effect on Seroma Formation

2021 ◽  
pp. 1-4
Author(s):  
Munazzah Aziz ◽  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Radical Mastectomy ◽  
Seroma Formation ◽  
Control Group ◽  
Modified Radical Mastectomy ◽  
Randomized Controlled ◽  
Group I ◽  
Flap Fixation ◽  
Group Ii

Objective: To determine the frequency of seroma formation after flap fixation by quilting technique in MRM patients as compared to control group. Study Design: Randomized controlled trial. Place and Duration of study: This study was conducted from 11th November ,2017 to 10th May , 2018 in Department of Surgery, Holy family Hospital, Rawalpindi. Patients and Method: A total of 60 patients were included in the study having histologically proven breast cancer stage 2 or 3 in age group of 40-70 years undergoing modified radical mastectomy. Patients were allocated to group1 or 2 by random selection. In group I patients, flap fixation was done by quilting technique during MRM . In group II , no quilting was done. Post operative follow up was done after 05 days in OPD and development of seroma was observed clinically. Results: Mean age of patients was 55.23 ± 7.94 years. Mean BMI was 30.05 ± 2.63 kg/m2. Seroma formation was seen in 04 patients (13.33%) in group I (flap fixation by quilting technique ) and 19 patients (63.33%) in group II (control group) with p-value of 0.0001. Conclusion: This study concluded that there is significantly low incidence of post mastectomy seroma formation in MRM patients with quilting technique as compared to the conventional method of wound closure in MRM

scholarly journals Thoracic Paravertebral Blockade Reduces Chronic Postsurgical Pain in Breast Cancer Patients: A Randomized Controlled Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (12) ◽  
pp. 3539-3547
Author(s):  
Zeng-Mao Lin ◽  
Mu-Han Li ◽  
Feng Zhang ◽  
Xue Li ◽  
Chun-Li Shao ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Neuropathic Pain ◽  
Controlled Trial ◽  
Cancer Surgery ◽  
Breast Cancer Surgery ◽  
Control Group ◽  
Single Shot ◽  
Randomized Controlled ◽  
Chronic Postsurgical Pain

Abstract Objective To evaluate the effect of multilevel single-shot thoracic paravertebral blockade (PVB) on the occurrence of chronic postsurgical pain (CPSP) in patients undergoing breast cancer surgery. Design A randomized controlled trial with two parallel groups. Setting A tertiary hospital. Methods Patients scheduled for breast cancer surgery were randomized to receive either ultrasound-guided multilevel single-shot PVB from T2 to T5 (the PVB group) or nothing (the control group). Surgery was then performed under general anesthesia. Patients were followed up for 12 months after surgery. The primary end point was incidence of CPSP at six months after surgery. Results A total of 218 patients were enrolled and randomized; of these, 208 and 204 completed six- and 12-month follow-up, respectively. The incidence of CPSP at six months was significantly lower in the PVB group (12.5% [13/104]) than in the control group (24.0% [25/104], relative risk = 0.52, 95% CI = 0.28–0.96, P = 0.031). Pain scores within 48 hours both at rest and with movement were lower in the PVB group than the control group (P = 0.006 and P < 0.001, respectively). The percentages of patients with neuropathic pain were also lower in the PVB group than the control group at both six and 12 months after surgery (P = 0.016 and 0.028, respectively). Adverse events did not differ between groups. Conclusions For patients undergoing breast cancer surgery, multilevel single-shot PVB reduces the incidence of CPSP at six months; it also improves early postoperative analgesia and reduces neuropathic pain at six and 12 months after surgery.

Cluster Symptoms Reduction via Telephone-Based Intervention in Thai Breast Cancer Patients Undergoing 4-Cycle Adjuvant Chemotherapy: A Randomized-Controlled Trial

2021 ◽  
Vol 104 (6) ◽  
pp. 887-894
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Adjuvant Chemotherapy ◽  
Energy Conservation ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Randomized Controlled ◽  
Experimental Group

Background: Cluster symptoms are a common occurrence in breast cancer patients undergoing chemotherapy. The telephone is a well-recognized, convenient device for reaching out to patients for monitoring and managing their symptoms in an efficient, prompt, and appropriate manner. Objective: To investigate the efficacy of telephone-based intervention to achieve energy conservation among breast cancer patients with the aim of alleviating fatigue, pain, sleep disturbance, and depression. Materials and Methods: The present study was a two-armed, randomized control trial conducted in the university hospital between March and September 2019. Seventy-four breast cancer patients, receiving four courses of adjuvant chemotherapy, were randomly recruited and assigned into the experimental group and the control group. One face-to-face intervention interview for energy conservation was conducted, followed by 20-minutes telephone brief counselling and assessment sessions, scheduled on day 1, 2, 7, and 14. Results: The scores for symptoms of median fatigue and pain in the experimental group were shown to be significantly reduced at the end of the study as compared to those scores within the control group (p<0.05). Similarly, scores for median sleep time and depression were greater at the end of cycle 1 and highest in cycle 2 (p<0.05, 0.001, respectively). Physical activity levels were also higher in the experimental group than in the control group in every cycle, with a statistical significance (p<0.001). Conclusion: The present study intervention demonstrated an effectiveness for the reduction of cluster symptoms. Further studies would be needed in a larger population scale in the customary, randomized controlled trial manner. Keywords: Cancer; Energy conservation; Fatigue; Pain; Sleep; Telephone

Single-Injection Depot Progesterone Before Surgery and Survival in Women With Operable Breast Cancer: A Randomized Controlled Trial

2011 ◽  
Vol 29 (21) ◽  
pp. 2845-2851 ◽  
Author(s):  
Rajendra Badwe ◽  
Rohini Hawaldar ◽  
Vani Parmar ◽  
Mandar Nadkarni ◽  
Tanuja Shet ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Lymph Node ◽  
Single Injection ◽  
Controlled Trial ◽  
Group Versus ◽  
Operable Breast Cancer ◽  
Control Group ◽  
Node Positive ◽  
Randomized Controlled

Purpose Many nonrandomized studies have suggested better outcome for patients with breast cancer who undergo surgery during the luteal (progestogenic) phase of their menstrual cycle, but this is controversial. We investigated the effect of a single preoperative injection of hydroxyprogesterone in women with operable breast cancer (OBC) in a randomized controlled trial (ClinicalTrials.gov identifier, NCT00123669). Patients and Methods One thousand patients with OBC were randomly assigned to receive surgery or an intramuscular injection of depot hydroxyprogesterone 500 mg 5 to 14 days before surgery. Primary and secondary end points were disease-free survival (DFS) and overall survival (OS), respectively. An analysis by axillary lymph node status was preplanned. Results At a median follow-up of 65 months among 976 eligible patients, 273 recurrences and 202 deaths were recorded. In the progesterone group versus control group, 5-year DFS and OS rates were 73.9% v 70.2% (hazard ratio [HR], 0.87; 95% CI, 0.68 to 1.09; P = .23) and 80.2% v 78.4% (HR, 0.92; 95% CI, 0.69 to 1.21; P = .53), respectively. In 471 node-positive patients, the 5-year DFS and OS rates in the progesterone group versus control group were 65.3% v 54.7% (HR, 0.72; 95% CI, 0.54 to 0.97; P = .02) and 75.7% v 66.8% (HR, 0.70; 95% CI, 0.49 to 0.99; P = .04), respectively. In multivariate analysis, DFS was significantly improved with progesterone in node-positive patients (adjusted HR, 0.71; 95% CI, 0.53 to 0.95; P = .02), whereas there was no significant effect in node-negative patients (P for interaction = .04). Conclusion A single injection of hydroxyprogesterone before surgery did not improve outcomes in all women with OBC. This intervention showed significant improvement in node-positive women that may be considered hypothesis generating. If replicated in other studies, this could be a simple and inexpensive intervention, especially in developing countries where the incidence of lymph node metastasis is high.

Randomized Controlled Trial of Mindfulness-Based Cancer Recovery Versus Supportive Expressive Group Therapy for Distressed Survivors of Breast Cancer (MINDSET)

2013 ◽  
Vol 31 (25) ◽  
pp. 3119-3126 ◽  
Author(s):  
Linda E. Carlson ◽  
Richard Doll ◽  
Joanne Stephen ◽  
Peter Faris ◽  
Rie Tamagawa ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Social Support ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Stress Symptoms ◽  
Over Time

Purpose To compare the efficacy of the following two empirically supported group interventions to help distressed survivors of breast cancer cope: mindfulness-based cancer recovery (MBCR) and supportive-expressive group therapy (SET). Patients and Methods This multisite, randomized controlled trial assigned 271 distressed survivors of stage I to III breast cancer to MBCR, SET, or a 1-day stress management control condition. MBCR focused on training in mindfulness meditation and gentle yoga, whereas SET focused on emotional expression and group support. Both intervention groups included 18 hours of professional contact. Measures were collected at baseline and after intervention by assessors blind to study condition. Primary outcome measures were mood and diurnal salivary cortisol slopes. Secondary outcomes were stress symptoms, quality of life, and social support. Results Using linear mixed-effects models, in intent-to-treat analyses, cortisol slopes were maintained over time in both SET (P = .002) and MBCR (P = .011) groups relative to the control group, whose cortisol slopes became flatter. Women in MBCR improved more over time on stress symptoms compared with women in both the SET (P = .009) and control (P = .024) groups. Per-protocol analyses showed greater improvements in the MBCR group in quality of life compared with the control group (P = .005) and in social support compared with the SET group (P = .012). Conclusion In the largest trial to date, MBCR was superior for improving stress levels, quality of life, and social support for distressed survivors of breast cancer. Both SET and MBCR also resulted in more normative diurnal cortisol profiles than the control condition. The clinical implications of this finding require further investigation.

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