A randomized trial comparing two different retention periods of intravesical pirarubicin instillation for intermediate risk non-muscule invasive bladder cancer (NMIBC) after transurethral resection.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 384-384
Author(s):  
Yutaka Kasejima ◽  
Wataru Takahashi ◽  
Yoshiaki Kawano ◽  
Takahiro Yamaguchi ◽  
Ken-ichiro Tanoue ◽  
...  
Keyword(s):  
Transurethral Resection ◽  
Intravesical Instillation ◽  
Intermediate Risk ◽  
Recurrence Free Survival ◽  
Prophylactic Effect ◽  
Free Survival ◽  
Significant Difference ◽  
Group A ◽  
Group B

384 Background: Anthracyclines are recommended reagents for one immediate intravesical instillation after transurethral resection (TUR) and additional adjuvant instillation in intermediate risk NMIBC to reduce the risk of recurrence. Several studies have showed that Pirarubicin (THP), an anthracycline analogue, can rapidly penetrate tumor tissue after intravesical instillation. Therefore long instillation time (e.g. 120 min) may not be required for its prophylactic effect against recurrence without compromising its efficacy. Methods: This randomised, prospective, open-label trial intended to enroll 160 pts with primary NMIBC with intermediate risk based on EORTC criteria. Pts who seemed likely to be at intermediate risk were provisionally registered and then randomised into two groups with different intravesical THP retention times before TUR, (a) 30 min versus (b) 120 min. The registration was finally confirmed by pathology results of TUR. All registered pts received initial THP instillation within 24 hr after TUR and then intended to continue weekly repetitive THP instillation for a total of 9 treatments. Follow-up period is 4 years. Primary endpoint is change from baseline in quality of life measurements (e.g. OABSS and I-PSS), which were evaluated prior to each THP intravesical instillation. Secondary endpoint is recurrence-free survival. Results: 126 pts were enrolled for provisional registration. After excluding pts due to the result of pathology by TUR, 29 pts were assigned to group (a), and 26 pts to group (b). Although not statistically significant, there is a trend that group (a) is less prone to increase in OABSS after 3rd instillation compared to group (b). Log-rank test shows that there is no significant difference in recurrence-free survival between the groups during follow-up period (HR = 2.161, 95% C.I.: 0.4317-10.82, p= 0.3484). Conclusions: Shortening intravesical instillation period to 30 min has little effect on reducing the adverse effect of THP. However, it does not compromise the prophylactic effect on recurrence in intermediate risk NMIBC pts. Clinical trial information: UMIN000006861.

Randomized study of intravesical chemotherapy using pirarubicin in patients with non-muscle-invasive bladder cancer in Japan: Comparing one immediate postoperative intravesical chemotherapy with short-term adjuvant intravesical chemotherapy after TURBT: Subanalysis in patients with intermediate risk.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4536-4536
Author(s):  
Yoshio Naya ◽  
Kazuya Mikami ◽  
Natsuki Takaha ◽  
Koji Okihara ◽  
Tsuneharu Miki ◽  
...  
Keyword(s):  
Tumor Recurrence ◽  
Survival Rates ◽  
Intravesical Instillation ◽  
Intravesical Chemotherapy ◽  
Rank Test ◽  
Intermediate Risk ◽  
Recurrence Free Survival ◽  
Free Survival ◽  
Group A ◽  
Group B

4536 Background: The objective is to evaluate the efficacy defining of 2-year tumor recurrence free rate of intravesical chemotherapy using pirarubicin (THP) for patients with intermediate risk. Methods: Between October 2010 and January 2015, 206 patients were enrolled in this study and finally 113 were randomized to one immediate postoperative intravesical instillation of THP 30mg (Group A), or additional intravesical instillation of THP 30mg weekly for 8 weeks after single postoperative instillation (Group B). The recurrent risk was stratified using EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder, the 2009 update. Of 113, 100 with intermediate risk were analyzed in this study. The patients were examined by cystoscopy and urine cytology every 3 months after trans urethral resection to determine bladder tumor recurrence. The primary endpoint was 2 year-recurrence-free survival rates. A statistical analysis was performed by SAS (SAS Institute Inc., Cary, USA). Results: The 2-year recurrence free survival rates were 66.2% in Group A and 86.1% in Group B, respectively (log rank test, p = 0.0043). In patients with recurrence score between 5 and 9, the 2-year recurrence free survival was 92.3% in Group B and 22.2% in Group A (log rank test, p = 0.0013). Cox regression analysis revealed that only additional instillation of THP was significant independent factor for recurrence free rate in patients with intermediate risk. There was no patient with progression during this period. Frequent adverse effects were frequent urination and micturition pain without severe adverse effect (Grade 3 or more). Limitation of this study is a failure to enroll sufficient number for statistical analysis. Conclusions: Additional instillation of THP 30mg weekly for 8 weeks reduced the risk of tumor recurrence without severe toxicity in NMIBC patients with intermediate recurrent risk.

Single or two instillations of pirarubicin as prophylaxis for recurrence after transurethral resection of Ta and T1 transitional cell bladder cancer: A prospective, randomized controlled study.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. LBA266-LBA266
Author(s):  
Takashi Saika ◽  
Tomoyasu Tsushima ◽  
Yasutomo Nasu ◽  
Hiromi Kumon ◽  
Keyword(s):  
Transurethral Resection ◽  
Intravesical Instillation ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Group A ◽  
Muscle Invasive ◽  
Group B

LBA266 Background: Although single intravesical instillation chemotherapy immediately after transurethral resection (TUR) is the standard treatment for non-muscle-invasive bladder tumors, 40% to 80% of tumors show intravesical recurrence. In this prospective randomized controlled study, we try to evaluate the prophylactic efficacy and safety of twice intravesical instillation using pirarubicin (THP) administered immediately after TUR and on the next day following TUR by comparison with single instillation immediately after TUR. Methods: Between 2005 and 2009, 250 patients with Ta and T1 solitary bladder carcinoma were enrolled in this study. Patients were randomized into two groups. Group A patients were treated with two intravesical instillations of THP 30 mg/50 ml saline immediately after TUR and within 24 hours. Group B patients were treated with single instillation of the same dose immediately after TUR as a control group. The primary endpoint was duration to the first recurrence, and the secondary endpoint was safety. Results: The enrollment was closed on 2009, and the follow-up phase is in process. Of the 250 patients, 125 in Group A and 125 in Group B could be evaluated as full analysis set. One hundred eight male and 17 female were in Group A, on the other hands, one hundred five male and 20 female were in Group B. Eighty-six cases (69%) in group A, and 88 cases (70%) in group B were primary tumor. Fifty-seven cases (46%) in group A, and 56 cases (45%) in group B were small tumor (less than 10mm). There was no difference between backgrounds of both groups. The randomization worked well. In this ad interim report, median follow up was 48 months. Two-year recurrence-free rates were 76.8% in group A and 67.5% in group B. Adverse reactions related to instillation were observed in about 20% of the patients. These toxicities were mild and transient. Only the incidence of frequency in group A was higher than that in group B (20% vs. 8%, p=0.0106). Conclusions: Intravesical instillation of THP 30 mg twice within 24 hours after TUR was effective as prophylactic therapy for non-muscle-invasive cancer with tolerable toxicity problems.

scholarly journals Postoperative Radiotherapy Omitting Level Ⅳ for Locally Advanced Supraglottic and Glottic Laryngeal Carcinoma

2021 ◽  
Vol 20 ◽  
pp. 153303382098587
Author(s):  
Yang Wu ◽  
Longzhen Zhang ◽  
Tianyou Tang ◽  
Liantao Li ◽  
Liang Li ◽  
...  
Keyword(s):  
Laryngeal Carcinoma ◽  
Postoperative Radiotherapy ◽  
Locally Advanced ◽  
Recurrence Free Survival ◽  
Remarkable Difference ◽  
Free Survival ◽  
Regional Nodal Recurrence ◽  
Significant Difference ◽  
Group A ◽  
Group B

Background: Cervical lymph nodes metastases are one of the most significant prognostic factors in patients with laryngeal carcinoma, whether treatment by surgery or by radiotherapy. The current study retrospected the postoperative radiotherapy of locally advanced supraglottic and glottic laryngeal carcinoma (at a greater risk of lymph node metastasis) to determine the effect of radiotherapy excluding cervical level Ⅳ lymph nodes. Methods: Patients of supraglottic type and glottic type were irradiated with level Ⅳ from January 2012 to June 2013, without level Ⅳ from July 2013 to December 2014, according to physicians’ decision. Ninety-three patients were selective neck irradiation (SNI) of levels Ⅱ-Ⅳ (Group A) and 87 patients were SNI of levels Ⅱ and Ⅲ (Group B). The comparison between Group A and Group B was made with observation of clinical risk of recurrence and radiation complications, as well as overall survival (OS), progress-free survival (PFS) and regional nodal recurrence-free survival. Results: No remarkable difference was observed in the distribution of recurrence, levels of relapse, OS, PFS and regional nodal recurrence-free survival between the 2 groups (p > 0.05). Mean radiation dose at level Ⅳ, thyroid and cervical esophagus showed significant difference between the 2 therapeutic groups (p < 0.01). As regard radiation complications, no significant difference was found in radiation dermatitis of any grade between the 2 groups (p > 0.05). However, there was remarkable difference in clinical hypothyroidism and radiation esophagitis between Group A and Group B (p < 0.05). Conclusions: Radiotherapy after surgery omitting level Ⅳ may improve the quality of life in patients with locally advanced supraglottic and glottic laryngeal carcinoma, won’t worsen the prognosis as well.

Comparison of triweekly cisplatin regimens in definitive chemoradiotherapy for locally advanced head and neck cancer: A propensity score matching analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18007-e18007
Author(s):  
Yu Fujiwara ◽  
Yasuyoshi Sato ◽  
Naoki Fukuda ◽  
Naomi Hayashi ◽  
Xiaofei Wang ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Propensity Score ◽  
Head And Neck ◽  
Propensity Score Matching ◽  
Neck Cancer ◽  
Recurrence Free Survival ◽  
Free Survival ◽  
Group A ◽  
Group B

e18007 Background: Concurrent chemoradiotherapy (CCRT) with cisplatin (CDDP) is a standard treatment for locally advanced head and neck cancer (LAHNC) in the definitive setting. Three cycles of 100 mg/m2 CDDP for every three weeks (Q3W) are now recommended but compliance with CCRT is relatively low due to its severe toxicity. Therefore, the potential de-escalation strategies for LAHNC have been discussed to decrease the therapeutic toxicity. Methods: Patients with LAHNC who underwent definitive CCRT with CDDP between 2012 and 2018 at The Cancer Institute Hospital of Japanese Foundation for Cancer Research were analyzed. Patients were classified into two groups based on the planned CDDP dose: (A) 100 mg/m2 and (B) 80 mg/m2 Q3W for three times. One-to-one propensity score matching was performed to minimize bias between two groups. After patients in two groups were matched by using propensity score, the overall survival (OS), recurrence-free survival (RFS), local recurrence-free survival (LRFS), and metastatic recurrence-free survival (MRFS) were analyzed by the Kaplan-Meier method with the Cox proportional hazards model. The follow-up term was set as two years to evaluate the early survival benefit. The dose and density of CDDP and the objective adverse events were also assessed. Results: A total of 304 patients were included with the median age of 62 (Interquartile range [IQR]: 54-67) years. Among them, 249 patients (82%) were male. Patients were treated with 100 mg/m2 CDDP (n = 145) and 80 mg/m2 CDDP (n = 159) regimens. After the propensity score matching, 119 patients were included in each group, respectively. There were no significant differences in baseline characteristics between two propensity-matched cohorts. The median follow-up time was 24 months in each group. Two-year OS was 93.0% (95% confidence interval [CI]: 88.4-97.8) in group A and 94.9% (91.0-99.0) in group B. Two-year RFS was 86.5% (80.6-92.9) in group A and 83.1% (76.6-90.1) in group B, respectively. No significant difference was observed in OS (Hazard ratio [HR] = 1.42, 95% CI: 0.49-4.08, p = 0.52), RFS (HR = 0.81, 95% CI: 0.42-1.57, p = 0.54), LRFS (HR = 0.57, 95% CI: 0.24-1.36, p = 0.20), and MFS (HR = 1.32, 95% CI: 0.52-3.35, p = 0.56). The median cumulative dose of CDDP was significantly higher in group A (300 mg, interquartile range [IQR]: 240-300) than in group B (240 mg, IQR:160-240) but the frequency of hematological, hepatic, renal, electrolytic, and grade 3-5 any adverse events was not significantly different between two groups. Conclusions: Our study showed no survival difference at 2-year follow-up between 100 mg/m2 and 80 mg/m2 CDDP regimens of definitive CCRT for LAHNC. This result could support the tide of the de-escalation strategy in head and neck cancer treatment. Longer follow-up is necessary and further prospective trials comparing CDDP dosage are warranted.

scholarly journals Video-assisted thoracoscopic thymectomy is feasible for large thymomas: a propensity-matched comparison

2020 ◽  
Vol 30 (4) ◽  
pp. 565-572
Author(s):  
Wenhan Weng ◽  
Xiao Li ◽  
Shushi Meng ◽  
Xianping Liu ◽  
Peng Peng ◽  
...  
Keyword(s):  
Overall Survival ◽  
Propensity Score ◽  
Propensity Score Matching ◽  
Recurrence Free Survival ◽  
Free Survival ◽  
Propensity Score Matching Analysis ◽  
Video Assisted ◽  
Significant Difference ◽  
Group A ◽  
Group B

Abstract OBJECTIVES Video-assisted thoracoscopic thymectomy is becoming the preferable approach for early-stage thymoma. However, large thymomas are still recognized as a relative contraindication due to the possible risk of incomplete resection or capsular disruption. Thus, the aim of this study is to evaluate the feasibility of video-assisted thoracoscopic thymectomy for large thymomas. METHODS Patients diagnosed with Masaoka stage I–IV thymoma between April 2001 and December 2018 were retrospectively reviewed. All patients were divided into 2 groups: thymoma &lt;5.0 cm (group A) and thymoma ≥5.0 cm (group B). Propensity score matching analysis was performed to compare postoperative results. Recurrence-free survival and overall survival were compared for oncological evaluation. RESULTS A total of 346 patients were included in this study. In the propensity score matching analysis, 126 patients were included both in group A and group B. There was no significant difference between these 2 groups in terms of the R0 resection rate (95.2% vs 94.4%, P = 1.000), conversion rate (1.6% vs 3.2%, P = 0.684), operation time (119.4 ± 48.4 vs 139.1 ± 46.6 min, P = 0.955), blood loss (93.2 ± 231.7 vs 100.5 ± 149.3 ml, P = 0.649), duration of chest drainage (2.7 ± 1.6 vs 2.8 ± 2.0 days, P = 0.184), length of hospitalization (5.0 ± 3.9 vs 5.2 ± 2.9 days, P = 0.628) or postoperative complications (5.9% vs 8.5%, P = 0.068). There was no significant difference between these 2 groups in terms of the overall survival (P = 0.271) and recurrence-free survival (P = 0.288). CONCLUSIONS Video-assisted thoracoscopic thymectomy is a safe and effective approach for large thymomas (≥5 cm) with comparable surgical and oncological results.

Management of fresh odontoid fractures using posterior C1–2 fixation without fusion: a long-term clinical follow-up study

2021 ◽  
pp. 1-11
Keyword(s):  
Scale Score ◽  
Neck Disability Index ◽  
Implant Removal ◽  
Odontoid Fractures ◽  
Significant Difference ◽  
Flexion Extension ◽  
Group A ◽  
Group B

OBJECTIVE Posterior C1–2 fixation without fusion makes it possible to restore atlantoaxial motion after removing the implant, and it has been used as an alternative technique for odontoid fractures; however, the long-term efficacy of this technique remains uncertain. The purpose of the present study was to explore the long-term follow-up outcomes of patients with odontoid fractures who underwent posterior C1–2 fixation without fusion. METHODS A retrospective study was performed on 62 patients with type II/III fresh odontoid fractures who underwent posterior C1–2 fixation without fusion and were followed up for more than 5 years. The patients were divided into group A (23 patients with implant removal) and group B (39 patients without implant removal) based on whether they underwent a second surgery to remove the implant. The clinical outcomes were recorded and compared between the two groups. In group A, the range of motion (ROM) of C1–2 was calculated, and correlation analysis was performed to explore the factors that influence the ROM of C1–2. RESULTS A solid fracture fusion was found in all patients. At the final follow-up, no significant difference was found in visual analog scale score or American Spinal Injury Association Impairment Scale score between the two groups (p > 0.05), but patients in group A had a lower Neck Disability Index score and milder neck stiffness than did patients in group B (p < 0.05). In group A, 87.0% (20/23) of the patients had atlantoodontoid joint osteoarthritis at the final follow-up. In group A, the C1–2 ROM in rotation was 6.1° ± 4.5° at the final follow-up, whereas the C1–2 ROM in flexion-extension was 1.8° ± 1.2°. A negative correlation was found between the C1–2 ROM in rotation and the severity of tissue injury in the atlantoaxial region (r = –0.403, p = 0.024) and the degeneration of the atlantoodontoid joint (r = –0.586, p = 0.001). CONCLUSIONS Posterior C1–2 fixation without fusion can be used effectively for the management of fresh odontoid fractures. The removal of the implant can further improve the clinical efficacy, but satisfactory atlantoaxial motion cannot be maintained for a long time after implant removal. A surgeon should reconsider the contribution of posterior C1–2 fixation without fusion and secondary implant removal in preserving atlantoaxial mobility for patients with fresh odontoid fractures.

A Comparative Study of Epidemiology, Clinicopathologic Features and Outcome of Colorectal Cancer Patients between Ain Shams University Hospitals and Luxor International Hospital

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Tarek Hussein Kamel ◽  
Amr Lotfy Farag ◽  
Dr/Sherif Hassanin Ahmed ◽  
Chresteen Talaat Samy Hanna
Keyword(s):  
Colorectal Cancer ◽  
Comparative Study ◽  
Disease Free Survival ◽  
University Hospital ◽  
Treatment Modalities ◽  
Clinicopathologic Features ◽  
Free Survival ◽  
Significant Difference ◽  
Group A ◽  
Group B

Abstract Background Colorectal cancer (CRC) is one of the leading causes of mortality and morbidity in the world. It is the third most common malignancy after lung & breast and the fourth leading cause of cancer-related deaths worldwide, accounting for approximately 1,400,000 new cases and about 700,000 deaths worldwide. Objectives The aim of this retrospective study is to compare the epidemiology, clinicopathologic features, different treatment modalities and outcomes regarding disease free survival (DFS), progression free survival (PFS) & overall survival (OS) of colorectal cancer disease between cases presented to Ain shams university hospital & to Luxor international hospital in 3 consecutive years. Patients and Methods The study is retrospective comparative study. Clinical oncology department in Ain Shams University Hospital and Luxor International Hospital. The data Collected from January 2013 to December 2015. This study analyzed hospital records of patients who diagnosed with colorectal cancer (CRC) and allocated into two groups: Group A: CRC patients presented to Ain-Shams University Hospital from January 2013 to December 2015, group B: CRC patients presented to Luxor International Hospital from January 2013 to December 2015. Results There was no statistically significant difference regarding age parameter in LIH when compared to ASU, but the study was consistent with higher incidence in patients who were aged more than forty- accounted about 70.5% in all CRC cases. Cases less than 40 years old, in group A were 35.2%, while in Group B were 23.5%. Even there was no statistically significant difference but it may be attributable to more westernization in Lower Egypt. Other explanation may be due to decreased low socioeconomic status and different lifestyle factors in more developing region what increase risk of colorectal cancer. Among our cases, there is no statistically significant difference regarding gender between the two hospitals. Both sexes almost were affected equally, females appeared to be at a slightly higher risk of developing CRC cancer with current prevalence 1.3:1 in ASU group, and 1.1:1 in LIH group. Conclusion The need to increase awareness about CRC in Egypt especially upper Egypt, is recommended. An awareness campaign should be performed to promote detection of CRC at its earliest and most curable stage by recognizing early symptoms and enabling early referrals for colonoscopy. Those at higher risk should be offered more intensive surveillance. Similarity of the data from different centers suggests that this is the picture of colorectal cancer typical of Egypt.

scholarly journals Comparison Between With Kirschner-wires Only And Combined Screw Fixation in Proximal Reverse Chevron osteotomy(PCMO) For Hallux Valgus Deformity

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0002
Author(s):  
Hwa Jun Kang ◽  
Hong-Geun Jung ◽  
Jong-Soo Lee ◽  
Sungwook Kim ◽  
Mao Yuan Sun
Keyword(s):  
Hallux Valgus ◽  
Screw Fixation ◽  
Fixation Method ◽  
Kirschner Wires ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
Severe Hallux Valgus

Category: Bunion Introduction/Purpose: Kirschner-wires fixation, sometimes we have encountered pin irritation or pull-out. This is the reason why we consider additional fixation. Moreover, there are few reports according to comparison of fixation method, and Most of them focused on comparison K-wires or screw fixation only. Purpose of study is to compare clinical and radiographic outcome between Kirschner-wires only and combined screw fixation. Methods: The study included two different groups according to fixation methods. One with Kirschner-wires fixation (KW group) included 117 feet(of 98 patients), the other with combined screw fixation (KWS group) 56 feet (of 40 patients) with moderate to severe hallux valgus. Clinically, the preoperative and final follow-up visual analog scale (VAS) pain scores, the preoperative and final follow-up American Orthopaedic Foot & Ankle Society (AOFAS) hallux metatarsophalangeal (MTP)-interphalangeal (IP) scores, and patient satisfaction after the surgery were evaluated. Radiographically, the hallux valgus angle (HVA), intermetatarsal angle (IMA), medial sesamoid position (MSP), and first to fifth metatarsal width (1-5MTW) were analyzed before and after surgery. Results: The mean AOFAS score improved preoperative 65.5 to 95.3 at final follow up in group A, while preoperative 56.5 to 88.6 at final follow up. Pain VAS decreased from 5.7 to 0.5 in group A, whereas from 6.2 to 1.6 in group B. The mean HVA all improved from preoperative 38.5 to 9.3 at final follow up in group A and 34.7 to 9.1 in group B. The mean IMA and MSP also improved significantly at final follow up. In comparative analysis, the IMA did not show significant difference between postoperative and final state in group A, while showed significant increase in group B. Conclusion: We achieved favorable clinical and radiographic outcomes with minimal complications in patient with moderate to severe hallux valgus in both groups. However, this study shows no statistically significant difference in IMA during follow-up period and lower recurrence rate. Therefore we need to consider combined fixation method to provide better stability and can expect lower recurrence rate.

scholarly journals A study to evaluate and compare the expulsion and continuation rates of post placental insertion of Cu 375 and CuT 380A in Indian women at a premier hospital in New Delhi, India

2017 ◽  
Vol 6 (9) ◽  
pp. 3992 ◽  
Author(s):  
Mansi Kumar ◽  
Mahesh Kumar ◽  
Parul Aggarwal ◽  
Archna Gangania ◽  
Rupali Dewan
Keyword(s):  
Removal Rate ◽  
New Delhi ◽  
Contraceptive Device ◽  
Indian Women ◽  
Significant Difference ◽  
Group A ◽  
Post Placental ◽  
Group B ◽  
Continuation Rates

Background: The Study was planned to evaluate and compare the expulsion and continuation rates of post placental insertion of Cu 375 and CuT380A in Indian women at Safdarjung Hospital New Delhi, after approval was obtained from Institutional Ethical committee.Methods: Study group consisted of 300 women, divided into two groups: Group A and Group B. The data was analysed by using ‘student “t” test/ non-parametric ‘Wilcoxon Mann Whitney’ for quantitative variables to evaluate the safety, efficacy and acceptability.Results: Mean age was 24.99 years (range: 19-35years), All women were married (off which 64% literate) and Mean parity in group A was 1.97 and 2.06 in group B. Mean pain score during intrauterine contraceptive device (IUCD) insertion on visual analogue scale was 2.93 in group A and 3 in group B and was not statistically different. 84% women completed 12 months follow up in group A and 83.33% women in group B. Strings were visible in 74% women in group A and in 34% women in group B at 1 month of IUCD insertion. Visibility of strings increased in successive follow up visits and was visible in >80% of women at the end of one year in the both groups. String visibility after intra-Caesarean insertion was delayed. Fifty one percent (n=77) subjects in group A and 54% (n=81) in group B experienced amenorrhea up to six months. Menorrhagia was reported in 7.33% in group A and women 8.66% in group B at the end of 1 year of follow up. Pain was complained by 26 out of 150 (17.3%) women in group A as compared to 36 out of 150 (24%) women in group B after 1 month of insertion. There was no case of PID in group A whereas there were 3 cases of PID in group B. There was no perforation/trauma and pregnancy in either group.Conclusions: Overall expulsion rate was 13% and removal rate was 5% in our study. Continuation rate was 83.3% in Cu 375 and 80.6% in CuT380A at 12 months. There was no significant difference between the IUCDs regarding the safety, efficacy and complications such as expulsion, bleeding etc.

The role of tolvaptan in prevention of hyponatremia in patients undergoing transurethral resection of prostate surgery- A randomized double blind study

2021 ◽  
Vol 8 (2) ◽  
pp. 321-325
Author(s):  
Dinesh Kumar Singh ◽  
B B Baj ◽  
Vipin Goyal
Keyword(s):  
Transurethral Resection ◽  
Blind Study ◽  
Transurethral Resection Of Prostate ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

The aim of our study to determine the role of tolvaptan in prevention of hyponatremia in transurethral resection of prostate surgery. This is randomized double-blind study conducted in 60 ASA grade status 1 and 2 patients age group between 45-80 yrs undergoing TURP under spinal anaesthesia in urology operation theatre in Mahatma Gandhi hospital Jaipur after receiving permission from hospital ethical committee. A detailed history, complete physical examination and routine investigation were done for all patients followed by informed written consent was obtained. Patients are randomly divided into 2 groups. In group A -30 patients who received orally tab tolvaptan 15 mg and group B-30 patients who received orally tab multivitamin 2 hrs before surgery after doing electrolytes of the patients in the morning. In both groups age (in yrs), wt (in kg), ASA grade, volume of irrigating fluid (in litres), volume of prostate resected (in gm) and duration of surgery (in minutes) all demographic and surgical details data were compared. Electrolytes were compared in both groups pre and post-operatively and statistical analysis was done.There was significant difference in post-operative sodium level between the two groups (A and B). The mean level of sodium significantly reduced post-operatively in group –B (control grp). The mean level of sodium significantly increased post-operatively in group –A (tolvaptan grp). We conclude single dose of tolvaptan -15 mg found to effective in prevention of hyponatremia in patients undergoing TURP.

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