Cryosurgery as a Single Agent and in Combination with Intralesional Corticosteroids Is Effective on Young, Small Keloids and Induces Characteristic Histological and Immunohistological Changes: A Prospective Randomized Trial

Dermatology ◽  
2020 ◽  
pp. 1-11
Author(s):  
Christos C. Zouboulis ◽  
Eftychia Zouridaki

<b><i>Background:</i></b> As the pathogenesis of keloids is poorly understood, there is no sound biological basis of keloid management. Few controlled therapeutic studies have been published, and recurrences are a major reason for treatment failure. <b><i>Objective:</i></b> To detect efficacy and safety of cryosurgery regimens on keloids and the occurring biological changes caused by the treatment. <b><i>Methods:</i></b> This prospective randomized study compared efficacy and tolerability as well as histological/immunohistochemical effects of liquid nitrogen contact cryosurgery as a single regimen (group A) and combined with intralesional corticosteroids (group B) on young (&#x3c;2 years old), small (≤10 cm<sup>2</sup>) keloids in 40 patients (2-sided effect, α-error 1%, power 95%). <b><i>Results:</i></b> Marked flattening of the lesions was achieved by both regimens. Median lesional volumes decreased from 106 to 7 mm<sup>3</sup> in group A (<i>p</i> = 0.001) and from 138 to 6 mm<sup>3</sup> in group B (<i>p</i> &#x3c; 0.0001; ns, between groups). Good to excellent responses were registered in 83.3 and 90% of patients in groups A and B, respectively, by evaluating the lesional volume, in 80 and 95% of patients by the physician’s evaluation and in 95% of patients in either group by the patient’s assessment. Follow-up of 6–36 months revealed no further significant changes. Cryosurgery was generally well tolerated, with minor pain during treatment not requiring (27.5%) or requiring local anaesthesia (5%) – but not analgesics –, and hypopigmentation (25%). Histological examination showed increased vessel number and lumen dilatation after treatment in group B and reduction of rete ridge length in both groups with more prominent changes in group A. Tenascin C staining demarcated keloids from normal skin before therapy, while after therapy the entire treated tissue was labelled. Interferon-γ expression was significantly decreased after therapy both regarding positively stained cells and intensity in both groups. <b><i>Conclusion:</i></b> Cryosurgery without and with intralesional corticosteroids is effective and safe on young, small keloids not only as a destructive physical procedure, but also by inducing biochemical and immunological scar rejuvenation.

2020 ◽  
Vol 33 (1) ◽  
pp. 41-47
Author(s):  
Mohsena Akhter ◽  
Ishrat Bhuiyan ◽  
Zulfiqer Hossain Khan ◽  
Mahfuza Akhter ◽  
Gulam Kazem Ali Ahmad ◽  
...  

Background: Scabies is one of the most common skin diseases in our country. It is caused by the mite Sarcoptes scabiei var hominis, which is an ecto-parasite infesting the epidermis. Scabies is highly contagious. Prevalence is high in congested or densely populated areas. Individuals with close contact with an affected person should be treated with scabicidal which is available in both oral and topical formulations. The only oral but highly effective scabicidal known to date is Ivermectin. Amongst topical preparations, Permethrin 5 % cream is the treatment of choice. Objective: To evaluate the efficacy & safety of oral Ivermectin compared to topical Permethrin in the treatment of scabies. Methodology: This prospective, non-randomized study was conducted at the out-patient department of Dermatology and Venereology of Shaheed Suhrawardy Medical College & Hospital over a period of 6 months, from August 2016 to January 2017. The study population consisted of one hundred patients having scabies, enrolled according to inclusion criteria. They were divided into two groups. group A was subjected to oral Ivermectin and the group B to Permethrin 5% cream. Patients were followed up on day 7 and 14 for assessment of efficacy and safety. Result: The mean scoring with SD in group A (Ivermectin) and group B (Permethrin) were 8.26 ± 2.22 and 7.59 ± 2.01 respectively at the time of observation. The difference between the mean score of the two group is not significant (p=0.117) the mean scoring with SD in group A and group B were 4.54 ± 2.05 and 1.64 ± 1.84 respectively at 7thdays. The difference between the mean score of the two group is significant (p<0.001). The mean scoring with SD in group A and group B were 2.68± 2.35 and .36± 1.10 respectively at 14th day difference between the mean score of the group is significant (p<0.001). Conclusion: Topical application of permethrin 5% cream is more effective and safer than oral Ivermectin in the treatment of scabies. TAJ 2020; 33(1): 41-47


2021 ◽  
pp. 112067212110053
Author(s):  
Moustafa Salamah ◽  
Ashraf Mahrous Eid ◽  
Hani Albialy ◽  
Sherif Sharaf EL Deen

Purpose: To compare the efficacy of two different suture types in levator plication for correction of congenital ptosis. Subjects and methods: Prospective comparative interventional randomized study involving 42 eyes of 42 patients aged more than 6 years with congenital ptosis and good levator action. The exclusion criteria were as follows: bilateral ptosis, history of previous surgery, fair or poor levator action, and associated other ocular diseases. Patients were randomized into group A, in which double-armed 5/0 polyester Ethibond were used, and group B, in which double-armed 5/0 Coated Vicryl® (polyglactin 910) suture material we used. Outcomes including eyelid height and stability of eyelid height over time were compared with follow-up data. The MRD was 4.05 ± 0.36 mm and 3.95 ± 0.34 after 1 week for both groups A and B, respectively. At the end of study follow up period (24 weeks), the MRD was 3.60 ± 0.42 mm in group A, and 2.52 ± 0.85 mm in group B. Conclusion: No difference in eyelid height between two groups in early postoperative period, but the postoperative eyelid height was more stable over time in the 5/0 polyester Ethibond group (group A) than in the 5/0 Coated Vicryl® (polyglactin 910) group (group B).


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11545-11545
Author(s):  
Daniel Pink ◽  
Dimosthenis Andreou ◽  
Anne Flörcken ◽  
Alexander Golf ◽  
Stephan Richter ◽  
...  

11545 Background: Single-agent PD-1 inhibitors have modest activity in the treatment of most STS. Potential strategies to increase efficacy include combination therapies targeting the tumor microenvironment. Considering that apart from direct growth inhibition and death of malignant cells, trabectedin (Tr) also induces macrophage depletion and/or different immunologic effects, suggesting a possible synergistic effect of combined Tr plus anti-PD-1 treatment. We therefore aimed to evaluate the efficacy and safety of combined Tr and nivolumab (Ni) as a second-line treatment in STS. Methods: The prospective, explorative, two group, non-randomized phase II NiTraSarc trial enrolled pretreated patients (pt) with advanced STS (Group A: lipo- or leiomyosarcomas, Group B: non-L-sarcomas). Pt were initially treated with 3 cycles of Tr 1.5 mg/m2, followed by the combination of Tr 1.5 mg/m2 + Ni 240 mg (“late combination cohort” (LCC)) for up to 16 cycles. After positive results of a preplanned interim analysis, pt received the combination therapy starting with cycle 2 (“early combination cohort” (ECC)). 92 pt were recruited to the trial (55 in Group A, 37 in Group B). Primary efficacy endpoint is progression-free survival rate after 6 months (PFSR6) according to RECIST v.1.1. This is a first analysis of the primary efficacy endpoint in Group B based on a modified intention-to-treat (mITT) population of evaluable 36 pt: 23 and 13 pt from the LCC and ECC, respectively. Results: The most common Group B subtypes comprised undifferentiated pleomorphic/not otherwise specified sarcoma (UPS/NOS, 13pt) and fibromyxoid sarcoma (FMS, 6pt). After a median follow-up of 5 months (m) PFSR6 was 13.9% for all pt, 8.7% in LCC and 23.1% in ECC. Median duration of disease stabilization (DoDS) was 4m in all pt, the LCC and the ECC. Two pt had a partial response (PR), 10 had disease stabilization (SD), while 13 pt progressed, and 11 had missing data. By subtype: PR- UPS/NOS=2 (DoDS 12.7m/12.5m). SD: UPS/NOS=3, epithelioid=2, synovial=2, FMS=1, fibrosarcoma=1, other=1. All 36 pt experienced at least one adverse event (AE) reaching a total of 579 AEs, 141 (24.4%) of which were considered to be grade ≥3 treatment-related AEs. The main grade ≥3 AEs were: leukopenia (47.2% of pt), neutropenia (41.7% of pt), thrombocytopenia (33.3% of pt), increased ALT (30.6% of pt), and anemia (27.8% of pt). Conclusions: Tr+Ni was well tolerated and showed activity in at least some patients with non-L-sarcomas (mostly UPS/NOS) especially in the ECC. Analyses of the collected data, including PD-L1 expression profile, with the goal to establish whether Tr+Ni should be further pursued in these patients, are ongoing. ClinicalTrials.gov Identifier: NCT03590210; EudraCT: 2017-001083-38. Clinical trial information: NCT03590210.


2020 ◽  
Vol 2020 ◽  
pp. 1-7 ◽  
Author(s):  
Paolo Gentileschi ◽  
Emanuela Bianciardi ◽  
Leandro Siragusa ◽  
Valeria Tognoni ◽  
Domenico Benavoli ◽  
...  

Background. Weight regain after laparoscopic sleeve gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short term. We report the results of a randomized study comparing LSG and laparoscopic banded sleeve gastrectomy (LBSG) over a 4-year follow-up. Objectives. To evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the midterm. Methods. Between 01/2014 and 01/2015, we randomly assigned 50 patients to receive one of the two procedures. Patients’ management was exactly the same, apart from the band placement. We analyzed differences in weight loss, operative time, complication rate, and mortality, with a median follow-up of 4 years. Results. Twenty five patients were assigned to receive LSG (Group A) and 25 LBSG (Group B). The mean preoperative BMI (body mass index) was 47.3 ± 6.58 kg/m2 and 45.95 ± 5.85 kg/m2, respectively. There was no significant difference in the operative time. No intraoperative or postoperative complications occurred. At 12-month follow-up, the mean BMI was 29.72 ± 4.40 kg/m2 in Group A and 27.42 ± 4.47 kg/m2 in Group B (p=0.186). After a median follow-up of 4 years, the mean BMI in Group B was significantly lower than Group A (24.10 ± 4.52 kg/m2 vs 28.80 ± 4.62 kg/m2; p=0.00199). Conclusions. LBSG is a safe procedure, with no impact on postoperative complications. The banded sleeve showed a significant greater weight loss in the midterm follow-up. Considering the issue of weight regain observed after LSG, the placement of a perigastric ring during the first procedure may be a strategy to improve the results. This trial is registered with NCT04228185.


2016 ◽  
Vol 15 (1) ◽  
pp. 17-21
Author(s):  
Sakhawat Mahmud Khan ◽  
Md Matiar Rahaman Khan ◽  
Shahin Akhter ◽  
Md Mizanur Rahman

Background: Lower urinary tract symptoms suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) are a very common disease in elderly men .The incidence of benign prostatic hyperplasia is age related.Objectives: To compare the efficacy and safety of Tamsulosin and Terazosin in the treatment of symptomatic Benign Prostatic Hyperplasia.Methods: This was a prospective study carried out in the Department of Urology, Chittagong Medial College Hospital, Chittagong, Bangladesh during the period of July to December 2014. Total 40 patients of 45-80 years of age were consequently selected according to inclusion criteria. After completion of baseline clinical evaluation and investigations, participants were divided into two groups, group A and group B. Group A (n=20) was given Terazosin 1mg daily for 3 days at bed time and then 2 mg daily at bed time for 2 months. Group B (n=20) was given Tamsulosin, 0.4 mg per day for 2 months. Efficacy was evaluated of each group after 2 month follow up and lastly a comparison was made between them. The parameters monitored were International Prostate Symptoms Score (IPSS) Maximum urine flow rate (Qmax) and Post Voidal Residual Volume (PVR). Tamsulosin 0.4 mg and Terazosin 2 mg once daily for 8 weeks both are effective in relieving symptoms of BPH but Tamsulosin is superior to Terazosin in improvement of total IPSS (p<0.001) and Qmax (p<0.01) PVR (p<0.01) at the end point.Results: Outcome of parameters at follow up after 2 months. Tamsulosin group showed significant improvement of IPSS (p<0.05) PVR (p<0.001) and Qmax (p<0.001) than Terazosin. The incidence of adverse events by administration of Tamsulosin was less than that by Terazosin.Conclusion: Tamsulosin appears to have more efficacy and safety than Terazosin in symptomatic BPH.Chatt  Shi Hosp Med Coll J; Vol.15 (1); Jan 2016; Page 17-21


2020 ◽  
Vol 20 (2) ◽  
pp. 94-98
Author(s):  
Md Zahid Hussain ◽  
SM Khan ◽  
AKMA Islam ◽  
S Akhter ◽  
Suhel Al Mujahid Reza ◽  
...  

Background: The primary aim of the medical therapy for BPH is to improve quality of life by relieving the lower urinary tract symptoms and prevent complications. Objectives: To compare efficacy and safety of double dose of tamsulosin monotherapy with combination of conventional dose of tamsulosin and finasteride in symptomatic BPH. Methods: This was a prospective study carried out in the Department of Urology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh during the period of July 2005 to June 2006. Total 60 patients of 45-80 years of age were consequently selected according to inclusion criteria. After completion of baseline clinical evaluation and investigations, participants were divided into two groups, group A and group B. Group A were given tamsulosin 0.4 mg for 1 week. Then double dose of tamsulosin (0.8 mg) were given from 2nd week for 12 months. Group B were given tamsulosin 0.4 mg and finasteride 5 mg for the same duration. Efficacy was evaluated at 6 month and 12 month follow up visit and a comparison was made between them. During follow up each was observed for any adverse effect. The parameters monitored were International Prostate Symptom Score (IPSS), Maximum urine flow rate (Qmax), Post Voidal Residual Volume (PVR) and Prostate volume. Results : Both double dose of tamsulosin 0.8 mg and combination of conventional dose of tamsulosin 0.4 mg and finasteride 5 mg are effective in relieving symptoms of BPH but combination dose is superior to double dose monotherapy. Outcome parameters at end point follow up after 12 months showed significant improvement of IPSS (p<0.05), PVR(p<0.001), Q max (p<0.001) and prostate volume (p<0.001) in combination group than double dose group .The incidence of adverse events were also significantly less in combination group (p<0.05). Conclusion: Combination of conventional dose of tamsulosin with finasteride appears to have more efficacy and safety than double dose of tamsulosin in symptomatic BPH. Bangladesh Journal of Urology, Vol. 20, No. 2, July 2017 p.94-98


2021 ◽  
pp. 65-66
Author(s):  
Kumar Vikram ◽  
Sanjay Kumar ◽  
Manoj Kumar ◽  
Debarshi Jana

Background: One of the most common cause of pain during defecation in young patients is chronic ssure in ano. Surgical treatment of choice for chronic ssure in ano is internal sphincterotomy. This procedure can be performed by open or closed method. The aim of the study was to compare the closed and open anal internal sphincterotomy in patients admitted in our hospital with chronic anal ssure. Subjects and Methods: 105 patients admitted in department of general surgery with chronic ssure in ano were divided into two groups. 50 patients (Group A) who were treated by closed method and 55 patients (Group B) who were managed by open lateralanal sphincterotomy method. A3 months follow up done in both postsurgery to observe for pain, bleeding, infection, incontinence, and recurrence. Results: Signicant difference was observed in postoperative acute complications between the two methods of internal anal sphincterotomy. Conclusion: Lateral anal sphincterotomy is the treatment of choice for chronic anal ssure, either open or closed method. However, the closed method was observed to have lesserpost operative complication compared to the open method


2020 ◽  
Vol 26 (1) ◽  
Author(s):  
Babatunde K. Hamza ◽  
Muhammed Ahmed ◽  
Ahmad Bello ◽  
Tunde Talib Sholadoye ◽  
Musliu Adetola Tolani ◽  
...  

Abstract Background Circumcision has been practiced since antiquity and is one of the most commonly performed surgical procedures. The aim of the study was to compare the efficacy and safety of the two most common techniques: Freehand and Plastibell techniques of circumcision. Methods The study was a prospective randomized study that was conducted on uncircumcised males at or below the age of 5 years that presented for circumcision. All boys who satisfied the inclusion criteria and whose parents consented, were randomized into two groups. Group A had freehand circumcision, while Group B had Plastibell circumcision. Patients were followed up at day 7 and day 28 postoperatively. The variables compared were operating time, cost, complications and parents’ satisfaction. All the data obtained were entered into a proforma. The data obtained were analyzed using SPSS version 20. Results A total of 110 boys were circumcised, 55 boys in each group. The median ages in the Plastibell and freehand groups were one and three months respectively. The mean operating time was significantly shorter in the Plastibell group compared to freehand (3.53 min versus 16.7 min). Total cost implication per procedure was also cheaper in Plastibell compared to freehand (₦3700 versus ₦6600). However, complications were more in the Plastibell group compared to freehand (29.1% versus 9.1%; P = 0.008). These complications in Plastibell group were age related. Parents in both groups were equally satisfied with the outlook on day 28. Conclusion Plastibell circumcision has the advantage of being faster and cheaper than freehand circumcision. Complications were more in the Plastibell group, and they were found to be age related.


2020 ◽  
Vol 3 (1) ◽  
pp. 167-171
Author(s):  
Anand Shanmugaiah ◽  
Saravanan Pandian

Background: One of the the most common cause of pain during defecationin young patientsis chronic fissure in ano. Surgical treatment of choice for chronic fissure in ano is internal sphincterotomy. This procedure can be performed by open or closed method. The aim of the study was to compare the closed and open anal internal sphincterotomy in patients admitted in our hospital with chronic anal fissure. Subjects and Methods: 105 patients admitted in department of general surgery with chronic fissure in ano were divided into two groups. 50 patients (Group A) who were treated by closed method and 55 patients (Group B) who were managed by open lateralanal sphincterotomy method. A 3 months follow up done in both post-surgery to observe for pain, bleeding, infection, incontinence, and recurrence. Results: Significant difference was observed in postoperative acute complications between the two methods of internal anal sphincterotomy. Conclusion: Lateral anal sphincterotomy is the treatment of choice for chronic anal fissure, either open or closed method. However, the closed method was observed to have lesserpost operative complication compared to the open method.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3582-3582 ◽  
Author(s):  
C. G. Alexopoulos ◽  
A. A. Kotsori

3582 Background: The current policy concerning the duration of chemotherapy in metastatic colorectal cancer (MCC) varies considerably (Clin Oncol 1997;9:248) while no benefit of continuous versus intermittent 5-FU was found in a published randomized study (Lancet 2003;361:457). Serious cumulative toxicity is not usually a problem with long-term 5-FU/FA, but this is not the case with contemporary triple regimens (FOLFIRI, FOLFOX). We, therefore, performed a randomized study of continuous versus intermittent FOLFIRI as first line chemotherapy in MCC. Methods: Patients with MCC and ECOG 0–2 were given 6 biweekly courses of FOLFIRI (Irinotecan 180mg/m2 + De Gramont). Patients with response or stable disease were randomized to continue with another 6 FOLFIRI (group A) or discontinue until relapse when 6 FOLFIRI were readministered (group B). Time to progression (TTP) was calculated from study entrance until 1st progression for group A, and 2nd progression for group B, and overall survival (OS) from study entrance until death. Results: Fifty eight (M=38, F=20) patients entered into the study. Two (3.4%) withdrew before evaluation, 1 (1.7%) died of stroke, 1 (1.7%) was lost to FU and 15 (26%) progressed before or at the completion of 6 FOLFIRI. Thirty nine (67%) patients (M=25, F=14), median age 69 (38–79) responded (21=54%) or had stable disease (18=46%) and were randomized: 19 (49%) to group A and 20 (51%) to group B. Median TTP was 8 months 95% CI: 5.3–10.7) for group A and 9 (95% CI: 7.8–10) for group B (p=NS). 10/19 (52%) in group A received 2nd line chemotherapy vs 7/20 (35%) in group B (p=NS). With a median follow-up of 13 months, 21 patients are alive (12 in group A and 9 in group B). Median OS was 21 months (95% CI: 15 - 26.7) in group A vs 15 (95% CI: 12.6 - 17.3) in group B (p=NS), and 18 months (95% CI: 15.5 - 21) for all 39 patients. Conclusions: In MCC, when response or stability has been achieved after 6 courses ofFOLFIRI there seemstobe little more benefit from continuing chemotherapy than from retreating patients at relapse No significant financial relationships to disclose.


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