Prospective Randomized Control Study Research Articles

Inter-fragmentary compression using cannulated cancellous screws augmented with modified tension band wiring in transverse patella fractures

The classical Kirschner wires and tension band wiring technique, described by the AO foundation, has been the most widely used method for transverse patella fractures. In this study, we have adopted what we perceive to be an improved technique, the cannulated cancellous screws with modified tension band wiring. 20 patients with transverse patella fractures were included in our prospective single-blinded randomized control study with a duration of 3 years. All patients were operated on with modified tension band wiring with a 4 mm cannulated cancellous screw. Functional evaluation was made using the Tegner lysholm knee scoring scale. Roentgenograms were taken in AP and Lateral views to look for signs of radiological union and interfragmentary gap. The post-operative interfragmentary gap between fracture fragments with 65% of patients having a 0 mm gap, 25% of patients having a 1 mm gap, 5% of patients having a 2 mm gap, and 5% of patients having a 3 mm gap. The mean duration for the radiological union was 10 weeks. Mean Tegner lysholm score at 6 months was 88±4.7. We concluded that modified tension band wiring with cannulated cancellous screw is a safe, reliable, and better alternative method of fixation for transverse patella fractures with excellent union rate, range of motion, and functional outcome.

Idiopathic Sudden Sensorineural Hearing Loss, But Not Compatible With the Classical Definition.

The purpose of this study was to raise awareness for patients who did not meet the audiometric criteria of idiopathic sudden sensorineural hearing loss (SSNHL) but complained of acute hearing loss. Medical records of patients who were diagnosed with SSNHL from October 2021 to March 2023 were examined retrospectively. Among 223 patients with SSNHL, 40 cases with atypical SSNHL and fitting in the criteria were included in the study. The patients who were included in this study were the ones who were given one bolus dose of IV systemic steroid (250 mg methylprednisolone with a proton pump inhibitor) and betahistine 2x24 mg po for a month. Pure tone audiometry was performed during the initial visit, on the fifth day, and at the end of the one-month usage of betahistine tablets. Hearing levels on the 250, 500, 1,000, 2,000, 4,000, and 8,000 Hz of the affected ear were compared with those of the contralateral ear. Hearing improvement was calculated as the hearing gain (in decibels) on the control audiograms and the resolution of the patients' complaints. These patients were suffering from idiopathic SSNHL with minimal hearing impairment. A total of 36 of the cases had hearing recovery on the fifth-day audiogram, and the remaining four patients showed hearing improvement on the first-month audiogram. The changes between the initial and the control audiogram values were found to be statistically significant (p<0.001). Additionally, these patients showed distinctive characteristics, such as being younger than the classical SSNHL population, lacking systemic diseases (diabetes or hypertension), and having good unaffected hearing. Although there have been lots of studies to understand the pathophysiology, prognostic factors, and treatment options for SSNHL, atypical SSNHL patients have been underestimated and generally excluded from studies, and there have been a small number of studies on this issue. These patients might be accepted as having mild hearing loss. However, when the nerve injury is proven by audiograms, it is hard to decide what to do due to the lack of a treatment approach. This study is important as it focuses on atypical SSNHL cases. Further studies with larger group patients or prospective randomized-controlled group studies are needed to define these patients and decide how to treat this type of acute nerve dysfunction.

Early enteral nutrition intervention promotes multiple functional recovery in patients with traumatic intracerebral hemorrhage: A prospective randomized controlled study

ObjectiveTo delve into how early enteral nutrition intervention exert its part in promoting multiple functional recovery in patients with traumatic intracerebral hemorrhage (TICH). MethodThis prospective randomized controlled study recruited 152 traumatic intracerebral hemorrhage patients in our hospital. The observation group (n = 77) received early enteral nutrition intervention (≤ 48 h), while the control group (n = 75) were given delayed enteral nutrition (> 48 h). Further comparison was performed on the recovery of various physiologic functions between the two groups. ResultsAfter treatment, GCS score and GOS score in the observation group were significantly higher than those in the control group (P < 0.05), and mRS Score was significantly lower than that in the control group (P < 0.05). Moreover, the observation group demonstrated a considerable post-treatment elevation in adrenocorticotropic hormone (ACTH) and cortisol (Cor) levels, which were notably higher than the control group's levels (both P < 0.05). The changes in Bifidobacteria, Enterococcus, and Escherichia coli values pre and post-treatment were more remarkable in the observation group (all P < 0.05). Kaplan-Meier survival curve analysis indicated a substantial difference in survival curves between patients who provided with early enteral nutrition and those where it later (P < 0.05). ConclusionThe early application of enteral nutrition can promote neurological function recovery, improve the disorder of intestinal flora and the patient's nutritional status, reduce the increase of injury factors under stress, and lower the mortality risk among patients suffering from TICH.

A Prospective Randomized Study Comparing the Outcomes of Fixed vs Non-Fixed Middle-Sized Posterior Malleolus Fractures

Category: Ankle; Trauma Introduction/Purpose: The controversy surrounding the indications for fixation of posterior malleolar fractures remains unresolved, particularly in cases of middle-sized fragments that make up between 10-25% of the joint surface. Although several studies have been conducted, the evidence to support the need for fixation of such fragments is limited, with a lack of level 1 evidence. This study aimed to assess patients with ankle fractures involving middle-sized posterior fragments and compare those who received posterior malleolus fixation to those who did not. The hypothesis was that fixation of middle-sized (10-25%) posterior malleolar fractures would result in superior functional and radiological outcomes in the short to mid-term follow-up. Methods: A prospective randomized-controlled study was conducted to assess the effects of posterior malleolus fixation in patients with acute rotational ankle fractures involving a middle-sized fragment. Eligible patients were included and randomly allocated into two groups, Group 1 receiving open reduction and internal fixation without posterior malleolus fixation, and Group 2 receiving the same procedure with posterior malleolus fixation, following informed consent. Prior to the study, a power analysis was conducted, indicating that a minimum of 16 patients in each group would be necessary to achieve 80% power and a 5% significance level. The randomization was conducted using an even/odd numbers technique, resulting in 20 patients in each group. Patient clinical and functional status was evaluated annually postoperatively, utilizing the VAS pain scale, AOFAS and SMFA scales. Radiological evaluations were conducted through direct radiographs, utilizing articular step-off evaluation and the Kellgren Lawrence osteoarthritis grading system. Results: The groups were comparable in terms of age, BMI, gender, and fracture type distribution. There were no significant differences in average follow-up times, posterior malleolus size, or height values. However, articular step-off greater than 1mm was more common in Group 1 (p=0.04). Despite slightly better functional outcomes in Group 2, there were no significant differences between the two groups in terms of VAS pain, AOFAS, or SMFA scores (functional, bothersome, and total). However, there was a trend towards significance in the SMFA Function score difference (p=0.07). Multivariate analysis showed that Haraguchi type 1 fractures had better functional outcomes in only the SMFA Bothersome parameter (p=0.03). Patients with articular step-off greater than 1 mm had significantly worse outcomes in all SMFA and AOFAS parameters (p &lt; 0.05). Conclusion: In patients with closed rotational ankle fractures involving medium-sized (10-25%) posterior fragments, there was no significant improvement in functional or radiological outcomes with posterior fragment fixation at short to mid-term follow-up. Patients without posterior fixation were more likely to have articular step-off greater than 1 mm, which was associated with poorer functional outcomes. Despite similar outcomes in both groups, posterior fragment fixation may decrease the incidence of articular step-off and contribute to improved functional outcomes.

Quality of life amongst patients with diverting umbilical stomas in rectal surgery: a single centre prospective randomized controlled pilot study.

The umbilical stoma (umbistoma) has been proposed as a viable alternative site for a temporary defunctioning stoma. Suggested advantages of the umbistoma include decreased number of surgical incisions required, improved cosmesis and ease of reversal surgery. This study aimed to assess the patient experience of umbilical loop ileostomies in rectal surgery, with the primary outcome being patient reported quality of life (QoL). A total of 20 patients undergoing laparoscopic rectal cancer surgery were randomly allocated to have a defunctioning ileostomy at a conventional site (right iliac fossa) or at the umbilicus. Patient-reported QoL was assessed at 6 weeks using the Stoma-QoL questionnaire. Secondary outcomes were number of stomas reversed, length of time awaiting stoma reversal surgery, duration of operative time for stoma reversal, length of hospital stay following stoma reversal and rate of parastomal or post reversal incisional hernias. Patients who had an umbilical stoma scored significantly lower on the Stoma-QoL questionnaire compared to the conventional group, particularly on questions regarding feelings of tiredness, body insecurity and anxiety. No significant differences were observed between the two groups in relation to secondary outcomes. There may be potential disadvantages to the umbilical stoma with negative impacts on body image and subsequent increased social anxiety. Patient selection and adequate counselling will be important when considering an umbilical stoma. Further larger scale prospective studies are required to further validate the feasibility and longer-term safety of umbilical stomas in both clinical outcomes as well as patient QoL.

153. PROPENSITY MATCHING ANALYSIS OF NEOADJUVANT CHEMORADIOTHERAPY AND NEOADJUVANT IMMUNOTHERAPY COMBINED WITH CHEMOTHERAPY IN THE TREATMENT OF LOCALLY ADVANCED ESCC

Abstract Background The combination of neoadjuvant chemoradiotherapy (NCR) with surgical resection remains the standard treatment option for locally advanced esophageal squamous cell carcinoma (ESCC). Chemotherapy combined with immunotherapy has become a first-line treatment option for advanced and metastatic ESCC. The study of neoadjuvant chemotherapy combined with immunotherapy (NCI) in locally advanced ESCC is in full swing, and its effectiveness and safety need further study. Methods The data of patients with locally advanced ESCC who underwent neoadjuvant therapy combined with surgery in our hospital from 2014 to 2022 were included, and a retrospective control study was carried out. The perioperative and pathological results of patients in the NCI group and NCR group were analyzed by 1:1 propensity score matching to determine the effectiveness and safety of NCI. Result A total of 214 patients were included in the study, including 136 patients with NCR and 78 patients with NCI. After 1:1 propensity score matching, 66 patients in each group were included in the final analysis. There was no significant difference in baseline characteristics, including age, gender, smoking and drinking history, comorbidity, cT stage, cN stage, cTNM stage, etc. The pathological results showed that the pCR rate of the NCR group was 27.3% (18/66), while the pCR rate of the NCI group was 25.8% (20/57), with no statistical difference (p &amp;gt; 0.05). The interval between neoadjuvant therapy and surgery in the NCR group was 47.1 ± 13.2 days, significantly longer than that of 34.7 ± 8.8 days in the NCI group (p &amp;lt; 0.001). There was no significant difference in the overall postoperative complications, pneumonia, and anastomotic leakage rates between the two groups of patients. Conclusion The results of this study indicate that there is no significant difference in the incidence of perioperative complications and pathological response between NCI and NCR group. As a new treatment option, the efficacy and safety of NCI are not inferior to NCR, but prospective randomized controlled studies are still needed to verify our results.

Is Intraoperative Bleeding Control Useful After Tourniquet Release in Arthroscopic Anterior Cruciate Ligament Reconstruction?

Background Arthroscopic anterior cruciate ligament (ACL) reconstruction is a common orthopedic surgery, and rehabilitation is very important to achieve successful postoperative results. Postoperative hemarthrosis causes pain and limitation of movement, which prolongs the rehabilitation period. For these reasons, various strategies are used to reduce hemarthrosis in patients undergoing ACL reconstruction. This study aimed to evaluate the effect of bleeding control after releasing the tourniquet in ACL reconstruction surgery on the amount of hemarthrosis and pain in the postoperative period. Methodology A total of 60 patients who underwent arthroscopic single-bundle ACL reconstruction were enrolled in this prospective randomized control study. Bleeding control with the radiofrequency (RF) probe after releasing the tourniquet was done at the end of the arthroscopic ACL reconstruction in 30 patients (coagulation group) while bleeding control was not done for the other 30 patients (control group). Both groups were compared in terms of the degree of hemarthrosis using the Coupens and Yates classification in the early postoperative period and the degree of pain using the Visual Analog Scale (VAS) score and postoperative complications. Results In both groups, isolated ACL reconstruction was performed in 10 patients, additional partial meniscectomy in three patients, and additional arthroscopic meniscus repair in 17 patients. There was no statistically significant difference between the coagulation and control groups in terms of VAS (p > 0.05) and the degree of hemarthrosis (p > 0.05). Although the duration of tourniquet application was similar in both groups (p = 0.78), the duration of anesthesia was significantly longer in the coagulation group (p = 0.001). There was no significant difference between the groups in terms of postoperative complications. Conclusions Bleeding control with the RF probe after tourniquet release does not yield superior outcomes. More research with larger populations is needed to confirm these findings.

Angle Stable Plate Fixation vs Hemicallotasis in Medial Opening Wedge High Tibial Osteotomy: A Comparative Study.

Varus alignment associated with medial compartment degeneration is the most common presentation of knee osteoarthritis and often presents in young active adults where arthroplasty might be unsuitable. To compare the accuracy of the angle stable medial high tibia plate and self-adjusting HTO (high tibial osteotomy) fixator in achieving correction of varus deformity of the knee by medial opening wedge HTO and to evaluate functionality between the groups. Prospective randomized control study. Forty patients each underwent medial opening wedge high tibial osteotomy with acute correction and stabilization using the angle stable plate (ASP group) or with the hemicallotasis technique using the self-adjusting HTO external fixator (HCO group). Anatomical and functional outcomes were compared to the pre-operative values at the 6th and 12th month. The FTA (femoro-tibial axis), mechanical axis, and functional scores improved significantly in both groups. There was also a significant change in the patellar height and tibial slope. Except for a better KOOS (Knee Injury and Osteoarthritis Outcome Score) in the angle stable plate group at the 6-month follow-up, there were no significant differences between the groups. Both methods of performing a medially based proximal tibial osteotomy gave equivalent outcomes at the 1-year follow-up.

Outcomes and evaluation of endoscopic retrograde cholangiopancreatography via Gastro-Laryngeal Tube in adult patients: a prospective randomised control study

ABSTRACT Objectives In conventional endoscopic retrograde cholangiopancreatography (ERCP), the patient lies prone or in a semi-prone position under deep sedation and maintains spontaneous ventilation. Sedative-induced respiratory depression and unprotected airway compromise patients’ safety. The gastro-laryngeal tube (G-LT) is a novel reusable supraglottic airway device with two separate ports for endoscopy and ventilation. This study attempts to evaluate the performance characteristic of G-LT. Methods One hundred and forty patients undergoing ERCP were enrolled and randomized. In Group G, patients underwent ERCP with G-LT, whereas Group S patients underwent ERCP conventionally. G-LT insertion attempts, esophageal visualization times, vital parameters, propofol consumption, endoscopists’ and anesthesiologists’ satisfaction scores, time to achieve Modified Aldrete Score of ≥ 9, and complications were recorded. Results Both groups showed similar demographic parameters and 100% procedure completion rates. G-LT group showed shortened esophageal visualization times (4.71 ± 1.687 s vs 7.37 ± 1.515 s) and increased propofol consumption (423.14 ± 106.982 mg vs 178.00 ± 100.125 mg). Group G showed better endoscopic maneuvrability and lesser hemodynamic variability. Sore throat, dysphagia, and mucosal trauma were higher in the G-LT group. Conclusion G-LT provides less intra-procedural hemodynamic changes, quicker esophageal visualization, and better scope maneuvrability at the cost of higher propofol consumption, sore throat, dysphagia, and mucosal trauma. Trial Registration Clinical Trial Registry of India CTRI/2021/06/034212 (Registered on: 14/06/2021)

A Comparative Evaluation of Intra-articular Bupivacaine vs Bupivacaine and Dexmedetomidine for Postoperative Analgesia in Arthroscopic Knee Surgeries.

Background The studywas done to determinethe duration of postoperative analgesia brought on by incorporating intra-articular Bupivacaine with Dexmedetomidine as an adjuvant following knee arthroscopies. Methods A prospective randomized control study was conducted on 60 patients of ASA classes I and II, between the ages of 20 and 60 years, undergoing arthroscopic surgeries of the knee under spinal anaesthesia. The patients were divided into group B and group D, each containing 30 patients. The participants in group B were administered Inj. Bupivacaine 0.5% 19 mL + 1 mL of normal saline intra-articularly and the participants in group D were administered Inj. Bupivacaine 0.5% 19 mL, Inj. Dexmedetomidine 1 μg/kg and normal saline post-surgery. Thenumber of analgesics used in the first 24 hours, pain levels using the visual analogue scale and the timing of administration of the first analgesic dose between the two study groups were evaluated. Results In comparison to the Bupivacaine group, the Dexmedetomidine group required fewer rescue analgesics. The visual analogue visual scale score in group B at four hours and six hours was 2.7 ± 1.39 and2.9 ± 1.03, respectively, and in group D at four hours and six hours was 1.9 ± 1.09 and 1.83 ± 0.91. The visual analoguescale scores at these times were statistically significant. The visual analogue scale scores at 12 hours and 24 hours were statistically not significant. Conclusion Dexmedetomidine added to Intra-articular Bupivacaine provides an increased duration of postoperative analgesia in patients undergoing arthroscopic surgeries of the knee. The combination offers improved analgesia and reduces the overall dosage of rescue analgesics needed without causing substantial side effects.

Evaluation of RNA Based Biomarker Expression in Acute Kidney Injury after ESWL

Background Extracorporeal shock wave lithotripsy (ESWL) was introduced more than three decades as an authentic modern modality for the treatment of urinary stone disease. It is considered first choice of treatment for nearly all kinds of urinary tract calculi. Objective To evaluate the damage effect of ESWL on kidney tissue by measuring non-coding lncRNA profile in serum before and after ESWL session and assess their usefulness as diagnostic biomarkers for AKI and the relationship between the selected RNA based biomarker panel and clinicopathological changes of patients. Patients and Methods It is a prospective randomized control study assessing the damage effect of ESWL on kidney tissue by measuring non-coding lnc-RNA profile in serum before and after ESWL session(s) in 20 patients and compare it to control group of 20 healthy persons with no known urogenital disease and no known history of urologic pathology. Results The results favored outcomes of pre procedure lncRNA showed a statistically significant reduction after 48 hours after the procedure (p = 0.017). In comparison with control group the lncRNA showed a statistically significant difference between patients and controls at 2 hours and 48 hours after the procedure (p = 0.03 and 0.01, respectively). Conclusion Although ESWL is considered a safe and effective procedure in the treatment of renal stone disease yet it may cause acute renal injury. In this study, serum lncRNA rises significantly following acute renal injury caused by ESWL. Hence, serum lncRNA together with other kidney function tests as serum urea, creatinine can be used as acute renal injury markers following ESWL in patients with renal stone disease.

Computer-assisted intraoperative 3D-navigation for liver surgery: a prospective randomized-controlled pilot study.

Liver surgery is the standard of care for primary and many secondary liver tumors. Due to variability and complexity in liver anatomy preoperative imaging is necessary to determine resectability and for planning the surgical strategy. In the last few years, computer-assisted resection planning has been introduced in liver surgery. Aim of this trial was the evaluation of computer-assisted three-dimensional (3D)-navigation for liver surgery. This study was a prospective randomized-controlled pilot trial and patients were randomized in navigated or non-navigated group. Primary end point was the quotient of intraoperative resected volume and planned resection volume. Secondary end points included operation time, resection margin and postoperative complications. 3D reconstructions were performed with MeVis Distant Services (MeVis AG, Bremen, Germany). The navigation system CAS-One Liver (CAScination AG, Bern, Switzerland) was used for intraoperative computer-assisted 3D-navigation. The data of 16 patients with 20 liver tumors were used in this analysis. Of these, 8 liver tumors were resected with the utilization of intraoperative navigation. Two postoperative complications were classified grade IIIa or higher. There was no difference in duration of operation (189 vs. 180 min, P=0.970), rate of postoperative complications (n=1 vs. n=1, P=0.696) and length of hospital stay (9 vs. 7 days, P=0.368) between the two groups. Minimal resection margin (0.15 vs. 0.40 cm, P=0.384) and quotient of planned to intraoperative resection volume (0.94 vs. 1.11, P=0.305) were also similar. Intraoperative navigation is a technology that can be safely used during liver resection. Surgical accuracy is not yet superior to the current standard of intraoperative orientation. Further technological advances with suitable deformation algorithms and augmented reality systems will enable a further improvement of the technical feasibility.

PROSPECTIVE RANDOMISED STUDY COMPARING ENDOSCOPIC DISCECTOMY WITH PERCUTANEOUS RADIO-FREQUENCYCOABLATION IN PATIENT WITH CONTAINED LUMBAR DISC PROLAPSE

Background: This study is to compare functional outcome in patients with radiculopathy with contained lumbar disc prolapse treated with endoscopic discectomy and percutaneous radio frequency co ablation. In this study, the radicular pain using VAS score and prospective functional results using SLR test were measured. Materials and Methods: Prospective randomised control study carried out in Department of Orthopaedics from the period Nov 2016 to Nov 2018. Source of data for study was the patients reporting to Orthopaedic OPD who fulfill the inclusion criteria. Total 30 patients were included in the study. Data was subjected to statistical analysis using Statistical package for social sciences (SPSS v 21.0, IBM). Inter group comparison (2 groups) was done using Mann Whitney U test. Intra group comparison was done using Wilcoxon Signed rank test (upto 2 observations) Friedmans (for &gt;2 observations) followed by followed by pair wise comparison using Wilcoxon Signed rank test. Results: The functional outcome in patients treated with radiofrequency coablation are better than patients treated with endoscopic discectomy. Conclusion: Both Radio-frequency co-ablation and percutaneous transforaminal endoscopic discectomy appear to be safe and effective minimally invasive day care treatment option for patients with contained lumbar disc prolapse with radiculopathy.

Impact of duraplasty on clinical outcome in surgical management of chiari malformation type I

: In Chiari malformation type I (CIM), the cerebellar tonsils and the medial parts of the inferior cerebellar lobules are displaced downward through the foramen magnum into the upper cervical spinal canal. The primary surgical treatment for the Chiari I malformation is foramen magnum decompression. This study was undertaken to assess the clinical outcome in terms of clinical symptoms improvement in patients with Chiari malformation type I treated with foramen magnum decompression with duraplasty vs. primary repair of dura.: A total of 32, 24 patients retrospectively and 8 cases prospectively were studied after being diagnosed and operated on for Chiari malformation type I. Patients with Chiari types II, III, and IV were not allowed to participate. Before and one year after surgery, a questionnaire was utilized to measure improvements in neck pain and impairment caused by it, head aches and disability caused by it, and overall health. The findings of both groups' questionnaires were analysed and compared.: The third decade (34.38%) was the most prevalent age group for presentations, followed by the fourth decade (31.25 %). The ratio of males to females was 1.2:1. Sensory disturbances were the most frequent presenting symptom, found in 25 patients (78.13%), and followed by neck discomfort in 14 patients (43.75%). Leg weakness was the most frequent symptom, which was reported in 20 patients (62.50%). The foramen magnum decompression and duraplasty was done in 18 patients, whereas the foramen magnum decompression and primary repair was done in 14 patients. In the duraplasty group, there were greater problems. The Duraplasty group had an overall clinical improvement rate of 88.89%, while the non duraplasty group had a lower overall clinical improvement rate of 50%. Specific complaints such as neck discomfort improved at a comparable rate (88.89%) in the duraplasty group compared to the non-duraplasty group (80%).: Although foramen magnum decompression with duraplasty is preferable to foramen magnum decompression with primary repair, duraplasty is associated with a slightly greater risk of complication. Selected patients benefit from foramen magnum decompression alone, but further prospective randomized control studies are needed to learn more.

The optimal time for laparoscopic excision of ovarian endometrioma: a prospective randomized controlled trial

ObjectiveThis study aimed to explore the optimal time of laparoscopic cystectomy for unilateral ovarian endometrioma patients and evaluate the influence on ovarian reserve.Materials and methodsThis prospective randomized controlled study included 88 women with unilateral ovarian endometrioma at a tertiary teaching hospital. All patients received their first identified diagnosis of ovarian endometrioma by ultrasound (> 4 cm and ≤ 10 cm) and were administered an oral contraceptive pill (OC) for one cycle before laparoscopy. They were randomly divided into two groups: laparoscopy at the late luteal phase (group LLP) (n = 44) (termination of OC for two days) and laparoscopy at the early follicular phase (group EFP) (n = 44) (day 3 after menstruation). Basic clinical characteristics were recorded. Serum Anti-Müllerian hormone (AMH) levels were measured at various times to predict ovarian reserve. Serum levels of Anti-Müllerian hormone (AMH) were measured at several time sites to predict the ovarian reserve; AMH and leukocyte esterase (LE) levels of the endometrioma wall were measured.ResultsBefore surgery, serum AMH levels decreased in both groups from preoperative to one week and six months postoperatively. In contrast, the difference values of group EFP were larger than those of group LLP at postoperative one week and postoperative six months (1.87 ± 0.97 vs. 1.31 ± 0.93, P = 0.07; 1.91 ± 1.06 vs. 1.54 ± 0.93, P = 0.001). The mean rates of postoperative serum AMH decline were 37.92% and 46.34% in group EFP, significantly higher than those in group LLP (25.83% vs. 31.43%, P < 0.001). Ovarian endometrioma wall AMH of group LLP was significantly lower than that of group EFP ([22.86 ± 3.74] vs. [31.02 ± 5.23], P < 0.001). Meanwhile, ovarian endometrioma LE concentration of group LLP was significantly higher than that of group EFP ([482.83 ± 115.88] vs. [371.68 ± 84.49], P<0.001). There was also a significant inverse correlation between leukocyte esterase and AMH concentration in an ovarian endometrioma cyst wall (r=-0.564, P<0.001).Conclusion(s)The optimal time for laparoscopic cystectomy for patients with first identified unilateral ovarian endometrioma is the late luteal phase, which reduces ovarian tissue loss and preserves ovarian reserve effectively and safely.

P-298 Women undergoing IVF-ICSI cycles after mild Covid-19 infection do not show a poor ovarian response: A prospective randomized controlled study

Abstract Study question Does mild COVID-19 infection in women undergoing IVF-ICSI cycles affect their ovarian reserve ? Summary answer A recent past mild COVID-19 infection does not seem to alter the ovarian reserve testing and ovarian response to stimulation in women undergoing IVF-ICSI cycles. What is known already Since December 2019, the world has been facing a COVID-19 pandemic. Besides its effect on mortality, COVID-19 infection raises questions about short and longterm effects on general health. Clinical manifestations are highly heterogeneous and involve many different organs. The SARS-CoV-2 virus penetrates human cells by directly binding with angiotensin-converting enzyme 2 (ACE2) receptors present on the cell surface.The ACE2 receptors are present in testes and in ovarian tissue. In the ovary, ACE2 plays a role in the response to gonadotrophins, steroidogenesis regulation, and in follicle development, angiogenesis and degeneration and therefore, SARS-CoV-2 could be responsible for adversely affecting ovarian reserve. Study design, size, duration A prospective randomized controlled study was conducted between June 2020 and December 2021. Women with primary or secondary infertility undergoing IVF-ICSI between the age of 25-40 years were included. All the women underwent a COVID testing by RT-PCR and were subsequently tested for ovrian reserve by assessing their AMH and AFC (USG). Participants/materials, setting, methods The study population consisted of 128 women, 22% of whom were COVID RT-PCR positive. None of the tested women presented with a history of severe COVID-19 infection. They were randomized into two groups depending on whether they were positive for past COVID-19 infection or negative. These women were then subjected to AMH testing and estimation of AFC by transvaginal ultrasonography. Main results and the role of chance The difference between the initial AMH concentration and AMH concentration tested during ART treatment was not significantly different between the COVID RDT positive group and COVID RDT negative group (–1.24 ng/ml [–0.35 to –1.61) versus –0.56ng/ml [–0.15 to –1.11], P = 0.22). Similarly the AFC (Antral Follicle Count) was also not significantly different between the two groups of patients. The results of this prospective study showed that, based on AMH concentrations, mild COVID-19 infection did not affect ovarian reserve in our population of asymptomatic women who underwent an ART protocol susequently. Limitations, reasons for caution First, it has been shown that the AMH concentration is modified during ART treatment as this hormone is secreted by granulosa cells of small growing follicles thus reflecting the granulosa cell activity. Second, a relatively small number of women were included in the analysis and larger study groups are required. Wider implications of the findings The wider implication of our study is that AMH concentrations were tested in the same women at different time points and could, therefore, analyse any potential modification of the ovarian reserve after COVID-19 infection. This information can be used to reassure the population who have been afflicted by COVID-19 infection. Trial registration number not applicable

Artificial intelligence assists operators in real-time detection of focal liver lesions during ultrasound: A randomized controlled study

PurposeDetection of hepatocellular carcinoma (HCC) is crucial during surveillance by ultrasound. We previously developed an artificial intelligence (AI) system based on convolutional neural network for detection of focal liver lesions (FLLs) in ultrasound. The primary aim of this study was to evaluate whether the AI system can assist non-expert operators to detect FLLs in real-time, during ultrasound examinations. MethodThis single-center prospective randomized controlled study evaluated the AI system in assisting non-expert and expert operators. Patients with and without FLLs were enrolled and had ultrasound performed twice, with and without AI assistance. McNemar’s test was used to compare paired FLL detection rates and false positives between groups with and without AI assistance. Results260 patients with 271 FLLs and 244 patients with 240 FLLs were enrolled into the groups of non-expert and expert operators, respectively. In non-experts, FLL detection rate in the AI assistance group was significantly higher than the no AI assistance group (36.9 % vs 21.4 %, p < 0.001). In experts, FLL detection rates were not significantly different between the groups with and without AI assistance (66.7 % vs 63.3 %, p = 0.32). False positive detection rates in the groups with and without AI assistance were not significantly different in both non-experts (14.2 % vs 9.2 %, p = 0.08) and experts (8.6 % vs 9.0 %, p = 0.85). ConclusionsThe AI system resulted in significant increase in detection of FLLs during ultrasound examinations by non-experts. Our findings may support future use of the AI system in resource-limited settings where ultrasound examinations are performed by non-experts.The study protocol was registered under the Thai Clinical Trial Registry (TCTR20201230003), which is part of the WHO ICTRP Registry Network. The registry can be accessed via the following URL: https://trialsearch.who.int/Trial2.aspx?TrialID=TCTR20201230003.

Influence of Patient-Reported Outcome Measures by Surgical Versus Conservative Management in Adult Ankle Fractures: A Systematic Review and Meta-Analysis.

Background and Objective: This meta-analysis was performed to compare the effectiveness of surgical treatment and conservative treatment in adult ankle fractures. Methods: Pubmed, Embase, and Cochrane-Library databases were searched to retrieve prospective randomized-controlled studies that compared the efficacy of surgical treatment and conservative treatment in adult ankle fractures. The meta package in R language was used to organize and analyze the obtained data. Results: A total of eight studies involving 2081 patients was considered eligible, including 1029 patients receiving surgical treatment and 1052 receiving conservative treatment. This systematic review and meta-analysis was prospectively registered on PROSPERO, and the registration number is CRD42018520164. Olerud and Molander ankle-fracture scores (OMAS) and the health survey 12-item Short-Form (SF-12) were used as main outcome indicators, and the follow-up outcomes were grouped according to the follow-up time. Meta-analysis results showed significantly higher OMAS scores in patients receiving surgical treatment than those with conservative treatment at six months (MD = 1.50, 95% CI: 1.07; 1.93) and over 24 months (MD = 3.10, 95% CI: 2.46; 3.74), while this statistical significance was absent at 12-24 months (MD = 0.08, 95% CI: -5.80; 5.96). At six months and 12 months after treatment, patients receiving surgical treatment exhibited significantly higher SF12-physical results than those receiving conservative treatment (MD = 2.40, 95% CI: 1.89; 2.91). The MD of SF12-mental data at six months after meta-analysis was -0.81 (95% CI: -1.22; 0.39), and the MD of SF12-mental data at 12+ months was -0.81 (95% CI: -1.22; 0.39). There was no significant difference in SF12-mental results between the two treatment methods after six months, but after 12 months, the SF12-mental results of patients receiving surgical treatment were significantly lower than those of conservative treatment. Conclusions: In the treatment of adult ankle fractures, surgical treatment is more efficacious than conservative treatment in improving early and long-term joint function and physical health of patients, but it is associated with long-term adverse mental health.

Antioxidant supplementation during treatment of outpatient dogs with parvovirus enteritis ameliorates oxidative stress and attenuates intestinal injury: A randomized controlled trial

A prospective randomized controlled clinical study was conducted to determine whether antioxidant supplementation as an adjunct therapy alters hemogram, oxidative stress, serum intestinal fatty acid binding protein-2 (IFABP-2) level, fecal viral load, clinical score (CS) and survivability in outpatient canine parvovirus enteritis (CPVE) dogs. The dogs with CPVE were randomized to one of the five treatment groups: supportive treatment (ST) alone, ST with N-acetylcysteine (ST+NAC), resveratrol (ST+RES), coenzyme Q10 (ST+CoQ10) or ascorbic acid (ST+AA). The primary outcome measures were reduction of CS and fecal HA titre, and enhancement of survivability. Secondary outcome measures were reduction of oxidative stress indices and IFABP-2 level from day 0 to day 7. The mean CS and HA titre were significantly (P < 0.05) decreased from day 0 to 7 in ST and all antioxidant groups. The supplementations of NAC, RES and AA along with ST markedly (P < 0.05) reduced the concentrations of malondialdehyde, nitric oxide and IFABP-2 on day 7 as compared to ST alone. Additionally, NAC and RES supplementations markedly (P < 0.05) improved the total leukocyte count and neutrophil count in CPVE-affected dogs. NAC and RES could serve as better antioxidants for the amelioration of oxidative stress in CPVE but, the antioxidants did not confer any additional benefits in reduction of CS, fecal HA tire, or survivability when compared with ST alone.

The impact of obesity on vaginal hysterectomy and laparoscopically-assisted vaginal hysterectomy outcomes: A randomised control trial

ObjectivesThis prospective randomised control trial aimed to compare outcome measures of vaginal hysterectomy (VH) and laparoscopically-assisted vaginal hysterectomy (LAVH) in obese vs. non-obese women undergoing hysterectomy for benign uterine conditions with a non-prolapsed uterus. The primary objective of the study was to estimate operation time, uterine weight and blood loss amongst obese and non-obese patients undergoing VH and LAVH. The secondary objective was to determine any difference in hospital stay, the need for post-operative analgesia, intra- and immediate post-operative complications, and the rate of conversion to laparotomy for obese vs. non-obese patients undergoing VH and LAVH. Study designA prospective randomised control study was undertaken in the Department of Obstetrics and Gynaecology of the Charlotte Maxeke Johannesburg Academic Hospital (CMJAH). Women admitted between January 2017 and December 2019 for hysterectomy due to benign conditions, meeting the inclusion criteria set by the unit (vaginally accessible uterus, uterine size ≤ 12 weeks of gestation or ≤ 280gr on ultrasound examination, pathology confined to the uterus) were included in the study. The VH procedures were performed by the residents in training, under the supervision of specialists with large experience in vaginal surgery. All the LAVHs were performed by one surgeon (AC). In addition to the patient characteristics and surgical approach to hysterectomy, operative time, estimated blood loss, uterine weight, length of hospital stay, intra-operative and immediate post-operative complications were also recorded in obese and non-obese patient groups and comparatively analysed. ResultsA total of 227 women were included in the study. 151 patients underwent VH and 76 LAVH, upon randomisation on a 2:1 basis, reflecting the habitual proportion of hysterectomy cases in the Urogynaecology and Endoscopy Unit at CMJAH.No significant differences were found in mean shift of pre-operative to post-operative serum haemoglobin, uterine weight, intra- and immediate post-operative complications, and convalescence period when comparing obese and non-obese patients in both the VH and LAVH groups. There was a statistically significant difference in operating time between the two procedures. The LAVHs took longer compared to the VHs to be performed (62.8 ± 9.3 vs. 29.9 ± 6.6 min in non-obese patients, and 62.7 ± 9.8 vs 30.0 ± 6,9 min for obese patients). All VHs and LAVHs were successfully accomplished without major complications. ConclusionVH and LAVH for the non-prolapsed uterus is a feasible and safe alternative for obese patients demonstrating similar perioperative outcome measures as non-obese women undergoing VH and LAVH. Where possible, VH should be preferred to LAVH as it is a safe route of hysterectomy, with operation time being significantly shorter.