Prospective Randomized Trial Research Articles

Re: Gyawali, Sushil; Luitel, Bhoj Raj; Bhattarai, Amit Sharma; Sharma, Uttam Kumar. Comparison of efficacy of intercostal nerve block versus peritract infiltration with 0.25% bupivacaine in percutaneous nephrolithotomy: A prospective randomized clinical trial. Indian Journal of Urology 40(1):p 37-43, Jan-Mar 2024.

Re: Gyawali, Sushil; Luitel, Bhoj Raj; Bhattarai, Amit Sharma; Sharma, Uttam Kumar. Comparison of efficacy of intercostal nerve block versus peritract infiltration with 0.25% bupivacaine in percutaneous nephrolithotomy: A prospective randomized clinical trial. Indian Journal of Urology 40(1):p 37-43, Jan-Mar 2024.

Comparing two photodynamic therapy protocols for high-grade cervical intraepithelial neoplasia

SignificancePhotodynamic therapy (PDT) is a therapeutical modality which offers a minimally invasive alternative for high-grade cervical intraepithelial neoplasia (CIN) treatment. Approachthis prospective randomized controlled clinical trial aims to compare two PDT protocols for histopathologically similar high-grade CIN treatment. In protocol 1, only ectocervix is treated; in protocol 2, the patients had both the ectocervix and endocervix illuminated simultaneously with LED plus LASER (a cylindrical diffuser fiber was coupled inside the squamocolumnar junction). In both groups was applied 20% MAL overnight and the irradiance delivered was 120 mW/cm2, for 21 minutes, in a fluency rate of 150 J/cm2. Resultsafter two years of follow-up, group 1 showed 96% cure and group 2, 87%. Conclusionsno significant difference was observed between the two protocols. However, the number of patients who completed the two-year follow-up is still low and we expect better conclusions with more patients followed.

Effects of intracameral dexamethasone injection versus topical steroids post phacoemulsification operation

Introduction Cataract surgery is one of the most commonly performed surgeries worldwide, with nearly 20 million cases annually. Ophthalmologists usually use a prophylactic perioperative regimen consisting of topical corticosteroids and nonsteroidal anti-inflammatory drugs to reduce the risk of inflammation. However, patient compliance and other problems concerning administration with elderly patients self-administering medication drops can vary widely and a wide proportion of them fail to comply with a long-term regimen. Aim Evaluation of intracameral dexamethasone injection efficacy and safety versus topical anti-inflammatory eyedrop regimens for postphacoemulsification inflammation for better postoperative management of cataract patients. Methodology A prospective randomized clinical trial. Participants were divided into two groups in group A, dexamethasone sodium-phosphate (0.4 mg/0.1 mL) was injected intracamerally at the end of phacoemulsification surgeries without topical steroids postoperatively. Group B: took the routine postoperative anti-inflammatory steroidal and nonsteroidal eye drop regimen. Results Included the corneal thickness that showed no discernible change between postoperative numbers in both groups. Nevertheless, there was a statistically significant increase in CCT postoperatively in both groups. The intraocular pressure decreased significantly after 1 month of phacoemulsification operation in both groups simultaneously. Postoperative cell density and hexagonality were significantly lower in both groups compared with preoperative values. There was also no significant difference between both groups regarding the anterior chamber cells’ index. Moreover, the Dexamethasone-injected group showed better compliance on the postoperative visits regarding their prescriptions taken after the operation compared with the Prednisone acetate eye drops group. Conclusions Better results regarding the severity of the endothelial damage with the use of a single intraoperative injection post phacoemulsification compared with the group who did not get injected but took postoperative prednisone acetate eye drops. The obligatory single intraoperative injection of dexamethasone has handled the poor compliance of some patients’ post phacoemulsification.

Corneal endothelial safety profile in minimally invasive glaucoma surgery.

To compare 5-year corneal endothelial safety of 3 minimally invasive glaucoma surgery (MIGS) devices (iStent inject , Hydrus Microstent, CyPass Micro-Stent). U.S. multicenter trials. Post hoc 5-year analysis from prospective randomized single-masked pivotal trials. Mild to moderate open-angle glaucoma subjects received a MIGS implant with phacoemulsification (implant + phaco) or phaco alone (control). In addition, 5-year end points comparing the implant and control groups included proportion of eyes with significant endothelial cell loss (ECL) (>30% or ≥30% vs baseline) and mean endothelial cell density (ECD). Comparable proportions of eyes in the iStent inject + phaco and control groups had significant 60-month ECL (9.4% vs 6.3%, respectively, diff: 3.2%, 95% CI, -5.0% to 11.3%, P = .77). Hydrus (20.8% vs 10.6%, diff: 10.2%, 95% CI, 3.2% to 17.2%, P = .01) and CyPass (27.2% vs 10.0%, diff: 17.2%, 95% CI, 5.6% to 28.7%, P = .02) had more eyes with ECL vs controls (iStent inject 1.49X, Hydrus 1.96X, CyPass 2.72X vs controls). Mean ECD over 60 months for iStent inject was indistinguishable vs control, whereas greater ECL was observed primarily 3 months postoperative (Hydrus) or accelerated after 2 years (CyPass). No iStent inject or Hydrus subjects developed persistent corneal edema, whereas 7 CyPass-implanted eyes developed ECL-related complications. Through 5 years postoperative, there were no differences in proportion of eyes with significant ECL or mean ECD between the iStent inject and control groups. There was greater 5-year ECL and lower ECD in the Hydrus and CyPass groups vs controls. The Hydrus ECL rate mirrored control after 3 months; the CyPass ECL rate accelerated vs control.

A prospective randomized trial comparing the pocket-creation method and conventional method of endoscopic submucosal dissection in early gastric cancers and precancerous lesions

BackgroundEndoscopic submucosal dissection (ESD) is widely used as a standard treatment regimen for early gastric cancers (EGCs). However, such an approach is time consuming and has a high risk of perforation and bleeding in some corner-site lesions because of the obscured view and difficulty in submucosal lifting. The newly developed pocket-creation method (PCM) provides a clearer view and better traction of the submucosal layer than conventional ESD (c-ESD). Nevertheless, no prospective randomized study has evaluated the efficacy of the PCM in EGCs and precancerous lesions. MethodsThis was a prospective randomized controlled trial. Patients with superficial gastric neoplastic lesions ≥ 20 mm were randomly assigned to the PCM-ESD group or c-ESD group. The primary outcome was dissection speed. ResultsThere were 28 patients in the PCM-ESD group and 27 in the c-ESD group. The median dissection speed was significantly higher in the PCM-ESD group than in the c-ESD group (21.5 mm2/min vs 14.3 mm2/min, P < .001). Meanwhile, the operation time in the PCM-ESD group was significantly shorter than that in the c-ESD group (30 vs 40 min, P = .047). In multiple linear regression analysis, the treatment method was independently associated with the resection speed of ESD. ConclusionPCM-ESD was an effective and safe treatment for EGCs and precancerous lesions.

Six versus four or five cycles of first-line etoposide and platinum-based chemotherapy combined with thoracic radiotherapy in patients with limited-stage small-cell lung cancer: A propensity score-matched analysis of a prospective randomized trial.

The recommended treatment for limited-stage small-cell lung cancer (LS-SCLC) is a combination of thoracic radiotherapy (TRT) and etoposide plus cisplatin (EP) chemotherapy, typically administered over 4-6 cycles. Nonetheless, the optimal duration of chemotherapy is still not determined. This study aimed to compare the outcomes of patients with LS-SCLC who received either 6 cycles or 4-5 cycles of EP chemotherapy combined with TRT. In this retrospective analysis, we utilized data from our prior prospective trial to analyze the outcomes of 265 LS-SCLC patients who received 4-6 courses of EP combined with concurrent accelerated hyperfractionated TRT between 2002 and 2017. Patients were categorized into two groups depending on their number of chemotherapy cycles: 6 or 4-5 cycles. To assess overall survival (OS) and progression-free survival (PFS), we employed the Kaplan-Meier method after conducting propensity score matching (PSM). Among the 265 LS-SCLC patients, 60 (22.6%) received 6 cycles of EP chemotherapy, while 205 (77.4%) underwent 4-5 cycles. Following PSM (53 patients for each group), the patients in the 6 cycles group exhibited a significant improvement in OS and PFS in comparison to those in the 4-5 cycles group [median OS: 29.8 months (95% confidence interval [CI], 23.6-53.1 months) vs. 22.7 months (95% CI, 20.8-29.1 months), respectively, p = 0.019; median PFS: 17.9 months (95% CI, 13.7-30.5 months) vs. 12.0 months (95% CI, 9.8-14.2 months), respectively, p = 0.006]. The two-year and five-year OS rates were 60.38% and 29.87% in the 6 cycles group, whereas 47.17% and 15.72% in the 4-5 cycles group, respectively. Patients diagnosed with LS-SCLC who were treated with EP regimen chemotherapy combined with TRT exhibited notably enhanced survival when administered 6 cycles of chemotherapy, as compared to those who underwent only 4-5 cycles.

SLAP Trial: Shock Wave Lithotripsy and Mechanical Percussion Therapy Post ESWL for Renal Calculi.

We conducted a prospective randomised control trial. Included patients were males and females greater than 18 years of age with single or multiple ipsilateral renal calculi of total ≤10 mm on plain X-ray and noncontrast CT KUB. ESWL was performed at a single centre, at supine position under general anaesthesia with maximum 3000 shocks at a rate of 100 shocks per minute. Patients were discharged and randomised to either the control arm or MPI therapy. MPI therapy was self-directed in a home setting for 10 minutes a day, three times per week. Both arms had standard follow-up at 12 weeks with a plain X-ray KUB. Patients in the control group were offered cross over to the MPI arm after 12 weeks if residual stone fragments were detected. Statistical analysis was performed using SPSS software via Chi squared and Fisher's exact tests. Ethical approval was obtained via the Prince Charles Hospital HREC Committee, HREC/2022/QPCH/84961. 70 patients met inclusion criteria and underwent ESWL, and 5 were withdrawn. 33 patients were randomised to the MPI group and 32 to the control group. MPI significantly increased the stone clearance rate anywhere in the kidney (87.9% in the MPI group versus 59.4% in the control group, p=0.089), as well as the clearance rate in the lower pole (91.7% in the MPI group versus 63.2% in the control group, p=0.022). Delayed percussion did not improve the clearance rate over primary percussion (p=0.835). This study has shown that MPI can be effectively performed in a home setting without the need for medical supervision and results in improved stone clearance rates post ESWL. The main limitations to the study were the use of X-ray over CT during the follow-up and variability in MPI compliance and administration. Further research is warranted into standardising home MPI protocols. This trial is registered with ANZCTR387061.

Is there an advantage to delayed molar implant placement in those with chronic apical periodontitis?

This paper is a single-centre, double-blinded, prospective randomised control trial, comparing immediate vs delayed implant placement clinically and radiographically in patients with chronic periodontitis, specifically assessing the molar region. Seventy-four patients were recruited to the study over a one-year period, all of whom returned for follow up throughout the study. The study adhered to the principles outlined in the Declaration of Helsinki and obtained ethical approval from the affiliated University Hospital of Qingdao. Written consent was gained from patients in line with the CONSORT guidance. The patients were recruited from the Department of Oral and Maxillofacial Surgery at the University of Qingdao between January 2019 and January 2020. The study included anyone above the age of 18, who had a molar with chronic apical periodontitis and lesions of less than 8 mm. Exclusions included pregnancy, uncontrolled diabetes, smokers, bisphosphonate use, history of head/neck tumours, coagulation disorders, and acute infections of adjacent teeth/tissue. Of the patients who met the inclusion criteria, all were randomly numbered by a stomatologist and placed into either the control group or the experimental group by a computerised system (Microsoft Excel). This study looked at the placement of 74 implants in 74 patients, including 40 female and 34 malepatients in total. The delayed implant placement allowed for healing of 3 months in the mandible and 6 months in the maxilla. The width of the implants placed was 6 mm and the lengths were between 7 mm and 12 mm.The periodontal probing depth, modified sulcus bleeding index, andmodified plaque index were all clinically examined. In terms of other parameters assessed, CBCT was used to look at alveolar bone mass. All surgery and implant placement was carried out by the same surgeon and the clinical measurements were all taken by one dentist. The results showed no significant difference in implant stability quotient immediately and 6 months post-surgery (0.110 and 0.066, respectively), when comparing the experimental and control group. Similarly, there was no significant difference in PD, mSBI or mPI between the groups. On assessment of CBCT scans however there was a significant difference between the two groups in the buccal horizontal marginal bone loss (P = 0.003), lingually there was not. Vertical bone loss also showed no significant difference in comparison. At one-year post-implant placement, there was a survival rate of 100% in both groups assessed. IBM SPSS statistics was used for statistical analysis. Multiple tests including the Shapirowilk test, the student t-test and the Mann-Whitney U-test were carried out on the data and all statistical tests were two tailed. Statistical significance was set at <0.05 throughout study of results. The conclusion of this study suggests that immediate implant placement in chronic periodontitis patients, specifically in the molar region, may be clinically viable. With flap surgery and complete removal of inflammatory granulation tissue, the study suggests no significant disadvantage to alveolar bone healing or osseointegration. The various limiting factors of this study should be taken into consideration, and it must be highlighted that longer and larger studies are necessary to allow for more accurate understanding of the long-term outcomes.

Perioperative hyperoxia- impact on myocardial biomarkers, strain and outcome in high-risk patients undergoing non-cardiac surgery: Protocol for a prospective randomized controlled trial

BackgroundSupplemental oxygen is used during every general anesthesia. However, for the maintenance phase of a general anesthesia, in most cases the longest part of anesthesia, only scarce evidence of dosing supplemental oxygen exists. Oxygen is a well-known coronary vasoconstrictor and thus may contribute to cardiovascular complications especially in vulnerable high-risk patients with coronary artery disease undergoing major non-cardiac surgery. Myocardial biomarkers are early indicators of myocardial injury. Oxygen supply demand mismatches due to coronary artery disease aggravated by hyperoxia might be displayed by changes from the biomarker's baseline-values. This study is designed to detect changes in myocardial biomarkers levels associated with perioperative hyperoxia. MethodsThis prospective randomized controlled interventional trial investigates the impact of maintaining perioperative high oxygen supplementation in high-risk patients undergoing non-cardiac vascular surgery on cardiac biomarkers, myocardial strain and outcome in 110 patients. Patients are allocated to be supplemented with either 0.3 (normal) or 0.8 (high) fraction of inspired oxygen (FiO2) perioperatively. Included is a short crossover phase during which transesophageal echocardiography is used to evaluate myocardial function at FiO2 0.3 and 0.8 by strain analysis in each patient. Patients will be followed up for complications at 30 days and 1 year. ConclusionThe trial is designed to evaluate perioperative changes from baseline myocardial biomarkers associated with perioperative FiO2. Furthermore, exploration and correlation of changes in biomarkers, acute early changes in myocardial function and clinical outcomes induced by different FiO2 may be possible.

Perioperative and Post-Hospital Whole-Course nutrition management in patients with pancreatoduodenectomy - a Single-Center prospective randomized controlled trial.

Whole-course nutrition management (WNM) has been proven to improve outcomes and reduce complications. We conducted this randomized controlled trial to validate its effectiveness in patients undergoing pancreatoduodenectomy. From December 1, 2020, to November 30, 2023, this single-center randomized clinical trial was conducted at the Department of Hepatobiliopancreatic Surgery in a major hospital in Beijing, China. Participants who were undergoing pancreatoduodenectomy were enrolled and randomly allocated to either the WNM group or the control group. The primary outcome was the incidence of postoperative complications. Subgroup analysis in patients who were at nutritional risk was performed. Finally, a six-month follow-up was conducted and the economic benefit was evaluated using an incremental cost-effectiveness ratio (ICER). A total of 84 patients were randomly assigned (1:1) into the WNM group and the control group. The incidences of total complications (47.6% vs. 69.0%, P=0.046), total infections (14.3% vs. 33.3%, P= 0.040) and abdominal infection (11.9% vs. 31.0%, P= 0.033) were significantly lower in the WNM group. In the subgroup analysis of patients at nutritional risk, 66 cases were included (35 cases in the WNM group and 31 cases in the control group). The rate of abdominal infection (11.4% vs. 32.3%, P= 0.039) and postoperative length of stay (23.1±10.3 vs. 30.4±17.2, P= 0.046) were statistically different between the two subgroups. In the six-month follow-up, more patients reached the energy target in the WNM group (97.0% vs. 79.4%, P=0.049) and got a higher daily energy intake (1761.3±339.5 vs. 1599.6±321.5, P=0.045). The ICER suggested that WNM saved 31,511 Chinese Yuan (CNY) while reducing the rate of total infections by 1% in the ITT population and saved 117,490 CNY in patients at nutritional risk, while WNM saved 31,511 CNY while reducing the rate of abdominal infections by 1% in the ITT population and saved 101,359 CNY in patients at nutritional risk. In this trial, whole-course nutrition management was associated with fewer total postoperative complications, total and abdominal infections, and was cost-effective, especially in patients at nutritional risk. It seems to be a favorable strategy for patients undergoing PD.

Intralesional injection of hyaluronic acid compared with verapamil in acute phase of Peyronie’s disease: A prospective randomized clinical trial

ABSTRACT Purpose The aim of this work was to analyze and contrast the effectiveness and safety of intralesional HA in the acute stage of PD with that of verapamil injection. Methods In this prospective, randomized clinical trial, 42 PD-affected, sexually active men between the ages of >18 and 70 participated. Two groups of patients were recruited; group A obtained weekly intralesional treatment with HA for 12 weeks, whereas group B obtained weekly intralesional therapy with verapamil for 12 weeks. Physical examinations and Duplex Doppler ultrasound were performed on all patients. Results The penile curvature was significantly decreased at 12 weeks after therapy in contrast to baseline in group A (34.1 ± 6.77° vs. 24.7 ± 9.72°, p = 0.005), and was significantly decreased at 12 weeks after therapy compared to baseline in group B (36.2 ± 7.43° vs. 30.8 ± 8.63 °, p = 0.047). The decrease in penile curvature at 12 weeks after therapy was noticeably better in group A in contrast to group B (24.7 ± 9.72° vs. 30.8 ± 8.63°, p = 0.038). Conclusion HA is emerging as a valid choice for the treatment of PD in terms of resolution of the acute phase of the disease, and it is plausible to posit that the use of HA may contribute to the stabilization of the disease and decrease the need for the subsequent choice of a possible surgical strategy, with the ability to reduce penile pain and have a stronger impact on penile curvature and patient satisfaction.

Periarticular Injections with Liposomal Bupivacaine in Comparison with Traditional (Bupivacaine/Ropivacaine) Periarticular Injections in Total Hip Arthroplasty: A Systematic Review

Objectives This systematic review aims to comprehensively evaluate the current literature to determine whether local infiltration liposomal bupivacaine (LB) used in total hip arthroplasty (THA) results in reduced pain scores and opioid consumption compared to traditional local anesthetics. Methods A systematic review was conducted using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines using Ovid Medline, PubMed, Scopus, and ScienceDirect databases. Articles were screened independently by two investigators based on inclusion criteria of 1) prospective randomized control trials or retrospective cohort studies, 2) conducted after the 2015 Food and Drug Administration (FDA) expansion of LB indication to local surgical infiltration, 3) compared LB as a periarticular injection to other local anesthetics used as a periarticular injection, and 4) available in English. Primary outcomes of pain scores and opioid consumption were reported. Secondary outcomes of interest included mobility, length of stay, costs, incidence of adverse events, and readmission rates. Bupivacaine costs $3 per dose, while LB costs $334 per dose. Results A total of seven articles were identified with the inclusion criteria. Four studies concluded that LB improves patient outcomes of pain scores and opioid consumption in patients receiving THA. Three studies found no benefit to using LB compared to their controls. Four studies found no significant reduction in the length of stay between the groups. There were no reported differences in the incidence of adverse events or total costs between the two groups. Conclusion There are minimal benefits of reduced pain scores or opioid consumption when using LB opioid-sparing protocols compared to current protocols for patients undergoing THA. Level of Evidence III

Continuous Superior Trunk Block versus Single-Shot Superior Trunk Block with Intravenous Dexmedetomidine for Postoperative Analgesia in Arthroscopic Shoulder Surgery: A Prospective Randomized Controlled Trial.

Background/Objectives: Intravenous dexmedetomidine (DEX) can increase the analgesia duration of peripheral nerve block; however, its effect in combination with superior trunk block (STB) remains unclear. We examined whether combining single-shot STB (SSTB) with intravenous DEX would provide noninferior postoperative analgesia comparable to that provided by continuous STB (CSTB). Methods: Ninety-two patients scheduled for elective arthroscopic rotator cuff repair were enrolled in this prospective randomized trial. Patients were randomly assigned to the CSTB or SSTB + DEX group. Postoperatively, each CSTB group patient received 15 mL of 0.5% ropivacaine and a continuous 0.2% ropivacaine infusion. Each SSTB group patient received a 15 mL postoperative bolus injection of 0.5% ropivacaine. DEX was administered at 2 mcg/kg for 30 min post anesthesia, then maintained at 0.5 mcg/kg/h till surgery ended. Pain scores were investigated every 12 h for 48 h post operation, with evaluation of rebound pain incidence and opioid consumption. Results: The SSTB + DEX group had significantly higher median pain scores at 12 h post operation (resting pain, 8.0 vs. 3.0; movement pain, 8.0 vs. 5.0) and a higher incidence of rebound pain (56% vs. 20%) than the CSTB group. However, no significant between-group differences were observed in pain scores postoperatively at 24, 36, or 48 h. The CSTB group required less opioids and fewer rescue analgesics within 12-24 h post operation than the SSTB + DEX group. Conclusions: Compared with CSTB, SSTB + DEX required additional adjuvant or multimodal analgesics to reduce the risk and intensity of postoperative rebound pain in patients who underwent arthroscopic rotator cuff repair.

Prognostic Significance of the Cribriform Pattern in Prostate Cancer: Clinical Outcomes and Genomic Alterations.

Given the diverse clinical progression of prostate cancer (PC) and the evolving significance of histopathological factors in its management, this study aimed to explore the impact of cribriform pattern 4 (CP4) on clinical outcomes in PC patients and examine its molecular characteristics. This retrospective study analyzed data from The Cancer Genome Atlas (TCGA) database and included PC patients who underwent radical prostatectomy (RP) and had pathology slides available for the assessment of CP4. A multivariable competing risk regression analysis was used to assess the association between CP4 and progression-free survival (PFS) while adjusting for established PC prognostic factors. The frequency of genomic alterations was compared between patients with and without CP4 using the Fisher's exact test. Among the 394 patients analyzed, 129 (32.74%) had CP4. After a median follow-up of 40.50 months (IQR: 23.90, 65.60), the presence of CP4 was significantly associated with lower PFS (AHR, 1.84; 95% CI, 1.08 to 3.114; p = 0.023) after adjusting for covariates. Seven hub genes-KRT13, KRT5, KRT15, COL17A1, KRT14, KRT16, and TP63-had significantly lower mRNA expression levels in patients with CP4 compared to those without. PC patients with CP4 have distinct genomic alterations and are at a high risk of disease progression following RP. Therefore, these patients may benefit from additional post-RP treatments and should be the subject of a prospective randomized clinical trial.

A randomized trial evaluating a novel hydrogel packing system compared to standard packing during image-guided high-dose rate brachytherapy boost for cervical cancer

INTRODUCTIONThe purpose of this prospective randomized trial was to compare the use of a novel vaginal hydrogel packing system (BrachyGel) to standard vaginal packing (VP) during high dose rate (HDR) brachytherapy (BT) for locally advanced cervical cancer (LACC). METHODSThis cross-over study included LACC patients receiving HDR BT boost (intracavitary +/- interstitial). All patients received alternating gauze or BrachyGel VP on Arms A and B. Patients, physicians, and physicists evaluated BT characteristics via a 4-point Likert scale. Adverse events (AEs) were prospectively collected and scored per CTCAE. RESULTSThe 20 patients enrolled. The mean bladder D2cc difference between gauze and BrachyGel in Arm A was 0.117 Gray (Gy) and in Arm B 0.013 Gy. The mean difference in rectum D2cc in Arm A and Arm B was -0.189 Gy and -0.191 Gy, respectively. The mean dose to 90% of the high-risk clinical target volume (HR-CTV) for gauze compared to BrachyGel was -0.032 Gy (95% CI: 0.472, 0.409). Patient-reported discomfort was similar with BrachyGel and gauze (“mild/moderate” 70.0% vs 74.0%, respectively). The clarity of VP was similar between BrachyGel and gauze (86.8% vs 89.7%, respectively). The completeness of VP was more frequently “excellent/good” with BrachyGel (79.0%) compared to gauze (56.4%). The ease of packing was more frequently “extremely easy” with BrachyGel (21.2% vs 0%). No serious AEs were reported. CONCLUSIONThis randomized trial found no clinically significant difference in OAR or HR-CTV dosimetry between BrachyGel and standard VP. BrachyGel performed well compared to gauze for the patient and physician use experience.

Comparison of Letrozole vs Clomiphene Citrate for induction of ovulation in polycystic ovarian syndromeAn Iraqi study

Polycystic ovary syndrome is a common endocrine disorder in young women and manifests as infertility in 55-75%. Clomiphene citrate is still the standard drug for inducing or augmenting ovulation. It is not, however, equally successful in all situations. L Metromile is an aromatase inhibitor and is one of the alternative treatments to Clomiphene. This study aims to answer the question (does letrozole add anything to the art Of ovulation induction and represent a real alternative to Clomiphene? To compare the effects of letrozole (5 mg) and clomiphene citrate (100 mg) for ovulation induction in women with polycystic ovary syndrome. A prospective randomized trial study was done at Tikrit Teaching Hospital. The study comprised a total of 40 infertile women with polycystic ovary syndrome; Patients were randomized to treatment with 5 mg Of letrozole daily (20 patients) or 100 mg of clomiphene citrate daily (20 patients) for 5 days starting on day 3 Of menses. Timed intercourse was advised 24-36 hours after hCG injection. Then, both groups were followed by sonography every other day from day 10 Of the menstrual cycle for the number and size Of follicles and endometrial thickness were assessed. The study revealed that the C . C group induce ovum with size &gt; 18mm 12 (60%) versus 17 (85%) among Letrzol group, while &lt; 18mm in about 8 C.C group as compared with 3 (15%) in Letrzol group, this relation was statistically not significant. The study revealed that C.C group induce &gt; 1 follicle 8 (40%) versus 2 (10%) among Letrzol group, while I follicle induced in about 6 (30%) in C.C group as compared with 16 (80%) in Letrzol group, this relation was statistically significant. The endometrium thickness was 4-5 mm in 14 (70%) among C.C group, and 17 (85%) in Letrzol group , while uterine thickness was 6-9.5mm in 6 (30%) among C.C group and 3 (15%) among Letrzol group, this relation was statistically not significant, study conclude that Letrozole should be considered as first line drug to get away from clomiphene's unwanted effects like thin endometrium and multifolliculogesis.

Effect of anti-reflux suture on gastroesophageal reflux symptoms after one anastomosis gastric bypass: a randomized controlled trial.

Gastroesophageal reflux disease (GERD) is an issue after one anastomosis gastric bypass (OAGB) and modification of OAGB with adding an anti-reflux system may decrease the incidence of postoperative GERD. This study aimed to compare the efficacy of the anti-reflux mechanism to treat preoperative GERD and prevent de novo GERD. A prospective randomized clinical trial study was conducted on patients with a body mass index of 40 and more from August 2020 to February 2022. Patients undergoing one anastomosis gastric bypass with and without anti-reflux sutures (groups A and B, respectively). These patients had follow-ups for one year after the surgery. GERD symptoms were assessed in all the patients using the GERD symptom questionnaire. The mean age was 39.5 ± 9.8 years and 40.7 ± 10.2 years in groups A and B respectively. GERD symptoms remission occurred in 76.5% and 68.4% of patients in groups A and B, respectively. The incidence of de novo GERD symptoms was lower in group A, compared to group B (6.2% and 16.1% in groups A and B respectively), without any statistically significant difference (p-value: 0.239). GERD symptoms and de novo GERD after OAGB seems to be under-reported after OAGB. This study suggests that applying an anti-reflux suture can decrease de novo GERD symptoms.

Optimizing the consent process for emergent laparoscopic cholecystectomy using an interactive digital education platform: a randomized control trial.

Informed consent is essential for any surgery. The use of digital education platforms (DEPs) can enhance patient understanding of the consent discussion and is a method to standardize the consent process in elective, ambulatory settings. The use of DEP as an adjunct to standard verbal consent (SVC) has not been studied in an acute care setting. We conducted a prospective randomized control trial with patients presenting to the emergency department of a tertiary care hospital with acute biliary pathology requiring a laparoscopic cholecystectomy (LC) between August 2021 and April 2023. Participants were randomized 1:1 to receive either a DEP module with SVC or SVC alone. Baseline procedure-specific knowledge and self-reported understanding of risks and benefits of LC were collected using a questionnaire. Primary outcome was immediate post-intervention knowledge assessed using a 21-question multiple choice questionnaire. Secondary outcomes were delayed procedure-specific knowledge and participants' satisfaction with the consent discussion. We recruited 79 participants and randomized them 1:1 into the intervention group (DEP + SVC, n = 40) and the control group (SVC, n = 39). Baseline demographics and baseline procedure-specific knowledge were similar between groups. The immediate post-intervention knowledge was significantly higher for participants in the intervention versus the control group with a Cohen's d effect size of 0.68 (85.2(10.6)% vs. 78.2(9.9)%; p = 0.004). Similarly, self-reported understanding of risks and benefits of LC was significantly greater for participants in the intervention versus the control group with a Cohen's effect size of 0.76 (68.5(16.4)% vs. 55.1(18.8)%; p = 0.001). For participants who completed the delayed post-intervention assessment (n = 29), there continued to be significantly higher retention of acquired knowledge in the intervention group with a Cohen's effect size of 0.61 (86.5(8.5)% vs. 79.8 (13.1)%; p = 0.024). There was no difference in participants' self-reported satisfaction with the consent discussion between groups (69.5(6.7)% vs. 67.2(7.7)%; p = 0.149). The addition of digital education platform to standard verbal consent significantly improves patient's early and delayed understanding of risks and benefits of LC in an acute care setting.

Comparison of propofol and desflurane for postoperative neurocognitive function in patients with aneurysmal subarachnoid hemorrhage: A prospective randomized trial.

Following aneurysmal subarachnoid hemorrhage, 40-50% of survivors experience cognitive dysfunction, which affects their quality of life. Anesthetic agents play a pivotal role in aneurysm surgeries. However, substantial evidence regarding their effects on neurocognitive function is lacking. This study evaluated the effects of propofol and desflurane on postoperative neurocognitive function and serum S-100B levels. One hundred patients were equally randomized to receive either propofol (Group P) or desflurane (Group D). Cognitive function was assessed using the Montreal Cognitive Assessment scale at three different time points: Preoperatively, at the time of discharge, and one month after surgery. Perioperative serum levels of S-100B were also measured. The preoperative mean cognitive score in Group P was 21.64 + 4.46 and in Group D was 21.66 + 4.07 (P = 0.79). At discharge, a significant decrease in cognitive scores was observed compared to preoperative scores (Group P- 20.91 + 3.94, P = 0.03 and Group D-19.28 + 4.22, P = 0.00); however, scores were comparable between the two groups (P = 0.09). One month following surgery, mean cognitive scores were 22.63 + 3.57 in Group P and 20.74 + 3.89 in Group D, and the difference was significant (P = 0.04). Higher memory and orientation scores were observed in Group P than in Group D at one month (P < 0.05) in the subgroup analysis. Both groups had similar serum S-100B levels. The mean cognitive scores one month after surgery improved significantly with propofol compared with desflurane, but without clinical significance. Individual domain analysis demonstrated that orientation and memory scores were better preserved with propofol.

Comparison of ultrasound-guided erector spinae plane block versus transmuscular quadratus lumborum block for postoperative analgesia after caesarean delivery: A prospective randomized non-inferiority clinical trial.

Regional techniques are a part of multimodal analgesia following cesarean delivery. Cesarean delivery warrants a regional technique, which can provide somatic and visceral analgesia-like quadratus lumborum block (QLB) and erector spinae plane block (ESPB). In this study, we investigated the non-inferiority of ESPB at T12 and transmuscular-QLB (TQLB) at L2-L3 for postoperative analgesia in cesarean delivery. In this prospective, randomized, non-inferiority trial, 124 patients undergoing cesarean delivery were enrolled to receive bilateral TQLB or ESPB with 20 mL of 0.25% ropivacaine on each side. All patients received prophylactic acetaminophen and ketorolac for 2 days. Our primary objective was to compare the total tramadol consumption in the first 48 h between the two groups. Secondary objectives were to compare cumulative tramadol consumption, postoperative Numeric Rating Scale (NRS) score at rest, and with movement at various time points, the time for first rescue analgesic requirement, development of complications related to the block, and patient satisfaction with analgesia between the two groups. The total tramadol consumption in 48 h (47.3 ± 34.9 mg in ESPB and 50.9 ± 38.7 mg in TQLB), duration of first rescue analgesic (22.8 ± 15.8 h in ESPB and 22.7 ± 15.6 h in TQLB), and patient satisfaction were similar between the two groups. Both groups had similar pain scores except at rest at 6 h and on movement at 4 h, 6 h, and 36 h, whereas the ESPB group had lower NRS scores (P < 0.05). The analgesic effect of bilateral ESPB at T12 was non-inferior to that of bilateral TQLB post-caesarean delivery.