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Editor's Choice
  • Yassi N
  • Zhao H
  • Churilov L
  • Wu TY
  • Ma H
  • et al.
Lancet Neurol. 2024 Jun;23(6):577-587 doi: 10.1016/S1474-4422(24)00128-5.
POPULATION:

Patients with intracerebral haemorrhage treated within 2 hours of symptom onset, enrolled in the STOP-MSU trial conducted at 24 hospitals and one mobile stroke unit in Australia, Finland, New Zealand, Taiwan, and Viet Nam (n= 201).

INTERVENTION:

Tranexamic acid (n= 103).

COMPARISON:

Placebo (n= 98).

OUTCOME:

Haematoma growth occurred in 37 (38%) of 97 assessable participants in the placebo group and 43 (43%) of 101 assessable participants in the tranexamic acid group (adjusted odds ratio (aOR) 1.31; 95% CI [0.72, 2.40]). Major thromboembolic events occurred in one (1%) of 98 participants in the placebo group and three (3%) of 103 in the tranexamic acid group (risk difference 0.02 95% CI [-0.02, 0.06]). By 7 days, eight (8%) participants in the placebo group and eight (8%) in the tranexamic acid group had died (aOR 1.08 95% CI [0.35, 3.35]) and by 90 days, 15 (15%) participants in the placebo group and 19 (18%) in the tranexamic acid group had died (aOR 1.61; 95% CI [0.65, 3.98]).

BACKGROUND:

Tranexamic acid, an antifibrinolytic agent, might attenuate haematoma growth after an intracerebral haemorrhage. We aimed to determine whether treatment with intravenous tranexamic acid within 2 h of an intracerebral haemorrhage would reduce haematoma growth compared with placebo.

METHODS:

STOP-MSU was an investigator-led, double-blind, randomised, phase 2 trial conducted at 24 hospitals and one mobile stroke unit in Australia, Finland, New Zealand, Taiwan, and Viet Nam. Eligible participants had acute spontaneous intracerebral haemorrhage confirmed on non-contrast CT, were aged 18 years or older, and could be treated with the investigational product within 2 h of stroke onset. Using randomly permuted blocks (block size of 4) and a concealed pre-randomised assignment procedure, participants were randomly assigned (1:1) to receive intravenous tranexamic acid (1 g over 10 min followed by 1 g over 8 h) or placebo (saline; matched dosing regimen) commencing within 2 h of symptom onset. Participants, investigators, and treating teams were masked to group assignment. The primary outcome was haematoma growth, defined as either at least 33% relative growth or at least 6 mL absolute growth on CT at 24 h (target range 18-30 h) from the baseline CT. The analysis was conducted within the estimand framework with primary analyses adhering to the intention-to-treat principle. The primary endpoint and secondary safety endpoints (mortality at days 7 and 90 and major thromboembolic events at day 90) were assessed in all participants randomly assigned to treatment groups who did not withdraw consent to use any data. This study was registered with ClinicalTrials.gov, NCT03385928, and the trial is now complete.

FINDINGS:

Between March 19, 2018, and Feb 27, 2023, 202 participants were recruited, of whom one withdrew consent for any data use. The remaining 201 participants were randomly assigned to either placebo (n=98) or tranexamic acid (n=103; intention-to-treat population). Median age was 66 years (IQR 55-77), and 82 (41%) were female and 119 (59%) were male; no data on race or ethnicity were collected. CT scans at baseline or follow-up were missing or of inadequate quality in three participants (one in the placebo group and two in the tranexamic acid group), and were considered missing at random. Haematoma growth occurred in 37 (38%) of 97 assessable participants in the placebo group and 43 (43%) of 101 assessable participants in the tranexamic acid group (adjusted odds ratio [aOR] 1·31 [95% CI 0·72 to 2·40], p=0·37). Major thromboembolic events occurred in one (1%) of 98 participants in the placebo group and three (3%) of 103 in the tranexamic acid group (risk difference 0·02 [95% CI -0·02 to 0·06]). By 7 days, eight (8%) participants in the placebo group and eight (8%) in the tranexamic acid group had died (aOR 1·08 [95% CI 0·35 to 3·35]) and by 90 days, 15 (15%) participants in the placebo group and 19 (18%) in the tranexamic acid group had died (aOR 1·61 [95% CI 0·65 to 3·98]).

INTERPRETATION:

Intravenous tranexamic acid did not reduce haematoma growth when administered within 2 h of intracerebral haemorrhage symptom onset. There were no observed effects on other imaging endpoints, functional outcome, or safety. Based on our results, tranexamic acid should not be used routinely in primary intracerebral haemorrhage, although results of ongoing phase 3 trials will add further context to these findings.

FUNDING:

Australian Government Medical Research Future Fund.

Editor's Choice
  • Balasubramanian H
  • Bhanushali M
  • Tripathi V
  • Srinivasan L
  • Sakharkar S
  • et al.
J Pediatr. 2024 Jun;269:114002 doi: 10.1016/j.jpeds.2024.114002.
POPULATION:

Infants born extremely preterm (n= 102).

INTERVENTION:

Restricted blood sampling approach (n= 52).

COMPARISON:

Conventional blood sampling approach (n= 50).

OUTCOME:

The primary outcome was the rate of early red blood cell (RBC) transfusions in the first six postnatal weeks. Fidelity to the sampling protocol was achieved in 95% of the infants. Sampling losses in the first six weeks were significantly lower in the restricted sampling group (16.8 ml/kg versus 23.6 ml/kg). The restricted sampling group had a significantly lower rate of early postnatal RBC transfusion (41% versus 73%, RR 0.56; 95% CI [0.39, 0.81]). The hazard of needing a transfusion during neonatal intensive care unit stay was reduced by 55% by restricted sampling. Mortality and neonatal morbidities were similar between the two groups.

OBJECTIVE:

To evaluate the effect of blood sampling stewardship on transfusion requirements among infants born extremely preterm.

STUDY DESIGN:

In this single-center, randomized controlled trial (RCT), infants born at <28 weeks of gestation and birth weight of <1000 g were randomized at 24 hours of age to two different blood sampling approaches: restricted sampling (RS) vs conventional sampling (CS). The stewardship intervention in the RS group included targeted reduction in blood sampling volume and frequency and point of care testing methods in the first 6 weeks after birth. Both groups received early recombinant erythropoietin from day three of age. Primary outcome was the rate of early red blood cell (RBC) transfusions in the first six postnatal weeks.

RESULTS:

A total of 102 infants (mean gestational age: 26 weeks; birth weight: 756 g) were enrolled. Fidelity to the sampling protocol was achieved in 95% of the infants. Sampling losses in the first 6 weeks were significantly lower in the RS group (16.8 ml/kg vs 23.6 ml/kg, P < .001). The RS group had a significantly lower rate of early postnatal RBC transfusions (41% vs 73%, RR: 0.56 [0.39-0.81], P = .001). The hazard of needing a transfusion during neonatal intensive care unit (NICU) stay was reduced by 55% by RS. Mortality and neonatal morbidities were similar between the two groups.

CONCLUSION:

Minimization of blood sampling losses by approximately one-third in the first 6 weeks after birth leads to substantial reduction in the early red blood cell transfusion rate in infants born extremely preterm and weighing <1000 g at birth.

TRIAL REGISTRATION:

http://www.ctri.nic.in (CTRI/2020/01/022  964).

  • Dizdar SK
  • Doğan U
  • Ece M
  • Kaya KS
  • Seyhun N
  • et al.
Auris Nasus Larynx. 2024 Jun;51(3):437-442 doi: 10.1016/j.anl.2023.12.003.
OBJECTIVE(S):

Our aim is to investigate the effects of the submucoperichondrial application of Platelet Rich Plasma (PRP) on nasal mucosal healing after septoplasty surgery.

METHOD(S):

This prospective randomized observational study was conducted between July 2019 and February 2021, with 40 patients aged 18-60 years who underwent closed the only septoplasty operation for similar septal deviations. Patient divided into two group; 21 patients were placed in PRP group to which PRP was applied on all mucosal surface and submucoperichondrial area of septum and 19 patients were placed in control group to which saline solution was applied on same regions. Nasal obstruction score, mucociliary clearance time, presence of nasal crusting, and bleeding time were evaluated on 5th, 10th, 15th day after surgery and compared between groups.

RESULTS:

Intranasal crusting on day 10 was found to be lower in the PRP group (n:13 68.4 %) than control group (n:7 33.3 %) with a statistically significant difference (p = 0.028). The nasal obstruction score on day 10 and 15 were found to be lower in the PRP group (3,33 ± 2,75, 2,07 ± 2,20) (than the control group (5,44 ± 2,26, 3,37 ± 1,92) with a statistically significant difference (p = 0,003,p = 0,009). The mucociliary clearance rate was found to be higher and the bleeding time was found to be lower in the PRP group, but a statistically significant difference was not observed.

CONCLUSIONS:

Application of submucoperichondrial PRP could have beneficial effects on nasal mucosal repair, nasal crusting, and congestion after septoplasty surgery.

  • Khawaja T
  • Kajova M
  • Levonen I
  • Pietilä JP
  • Välimaa H
  • et al.
Infect Dis (Lond). 2024 Jun;56(6):423-433 doi: 10.1080/23744235.2024.2329957.
INTRODUCTION:

Convalescent plasma (CP) emerged as potential treatment for COVID-19 early in the pandemic. While efficacy in hospitalised patients has been lacklustre, CP may be beneficial at the first stages of disease. Despite multiple new variants emerging, no trials have involved analyses on variant-specific antibody titres of CP.

METHODS:

We recruited hospitalised COVID-19 patients within 10 days of symptom onset and, employing a double-blinded approach, randomised them to receive 200 ml convalescent plasma with high (HCP) or low (LCP) neutralising antibody (NAb) titre against the ancestral strain (Wuhan-like variant) or placebo in 1:1:1 ratio. Primary endpoints comprised intubation, corticosteroids for symptom aggravation, and safety assessed as serious adverse events. For a preplanned ad hoc analysis, the patients were regrouped by infused CP's NAb titers to variants infecting the recipients i.e. by titres of homologous HCP (hHCP) or LCP (hLCP).

RESULTS:

Of the 57 patients, 18 received HCP, 19 LCP and 20 placebo, all groups smaller than planned. No significant differences were found for primary endpoints. In ad hoc analysis, hHCPrecipients needed significantly less respiratory support, and appeared to be given corticosteroids less frequently (1/14; 7.1%) than those receiving hLCP (9/23; 39.1%) or placebo (8/20; 40%), (p = 0.077).

DISCUSSION:

Our double-blinded, placebo-controlled CP therapy trial remained underpowered and does not allow any firm conclusions for early-stage hospitalised COVID-19 patients. Interestingly, however, regrouping by homologous - recipients' variant-specific - CP titres suggested benefits for hHCP. We encourage similar re-analysis of ongoing/previous larger CP studies.

TRIAL REGISTRATION:

ClinTrials.gov identifier: NCT0473040.

  • Short V
  • Allen R
  • Earley CJ
  • Bahrain H
  • Rineer S
  • et al.
Am J Hematol. 2024 Jun;99(6):1077-1083 doi: 10.1002/ajh.27290.

Restless legs syndrome (RLS) is a neurological disorder that can have a profound effect on sleep and quality of life. Idiopathic RLS is associated with brain iron insufficiency despite normal peripheral iron stores. There is, however, a five- to six-fold increase in prevalence of RLS in patients with iron deficiency anemia (IDA). Several open-label trials have demonstrated symptomatic improvement in RLS following treatment of IDA using oral or intravenous iron supplementation. To date, there have been no randomized double-blind controlled trials of intravenous iron compared with oral iron for the treatment of RLS patients with IDA. In the current study, oral ferrous sulfate and ferumoxytol were compared for efficacy and speed of response for treatment of RLS occurring in patients with IDA. The planned recruitment for this study was 70 patients with RLS and IDA, to be randomly assigned 1:1 to oral or intravenous iron, using double-blind, double-dummy procedures. At Week 6, the primary outcomes of Clinical Global Impression-Improvement score and change from baseline in the International Restless Legs Syndrome Study Group rating scale score were assessed. Due to challenges, performing the clinical trial during the COVID-19 pandemic, final-week data were found missing for 30 patients. As a result, in order to maintain the prespecified statistical analysis, an additional 30 patients were recruited. Both IV and oral iron were associated with a marked improvement in RLS symptoms, with no statistically significant difference between treatment groups. No serious adverse events were observed in either treatment group.

  • Patidar GK
  • Rath GP
  • Hazarika A
  • Dhiman Y
  • Jena BR
  • et al.
Transfus Apher Sci. 2024 Jun;63(3):103900 doi: 10.1016/j.transci.2024.103900.
BACKGROUND:

Blood transfusion necessity in neurosurgery varies based on surgical type, blood loss, and patient anemia. Leukocytes in red blood cells (RBCs) component release pro-inflammatory cytokines during storage, contributing to transfusion-related immunomodulation (TRIM). Our aim was to examine the impact of the leukocyte content in transfused PRBCs on patients undergoing neurosurgery for meningioma tumours.

STUDY DESIGN AND METHODS:

This prospective randomized controlled trial conducted from 2018 to 2020 by dividing patients randomly into non-leukoreduced (NLR) (n = 65) and leuko-reduced (LR) (n = 65) groups based on PRBCs received during surgery and hospital stay. Hospital and ICU stays, mechanical ventilation duration, and postoperative bacterial infections were observed. Hematological parameters and cytokine levels (IL-10, INF-gamma, and FAS-L) were assessed at pre-transfusion, 24 h, and 7 days post-transfusion. Data analysis included Mann-Whitney U test, Friedman test, Fisher's chi-square test, with statistical significance at p < 0.05.

RESULTS:

In our study, ICU and hospital stay duration showed no significant difference (p = 0.06) between groups. However, NLR group had longer mean mechanical ventilation (18 ± 40.1 h) than the LR group (12.8 ± 8.6 h). Both groups showed statistically significant increase in Fas-L level on days 1 and 7 (p < 0.05). The IL-10 levels rose 43% in the NLR group, while and decreased by 7% the LR group on day 1. On day 7, IL-10 increased by 75% in NLR and decreased by 40% in LR, with no significance (p > 0.05).

CONCLUSION:

In conclusion, leukoreduction appeared to offer some immune response protection in term of reducing mechanical ventilation timings and cytokine level changes.

  • Elshazly WG
  • Abo Elros MA
  • Ali AS
  • Radwan AM
Dis Colon Rectum. 2024 Jun 1;67(6):812-819 doi: 10.1097/DCR.0000000000003273.
BACKGROUND:

Despite the benefits of the stapled hemorrhoidopexy in the short term, management of prolapsing hemorrhoids, the long-term results are still insufficient regarding recurrent prolapse and patient satisfaction. The current study investigates the addition of ligation anopexy to stapled hemorrhoidopexy.

OBJECTIVE:

Valuation of adding ligation anopexy to stapled hemorrhoidopexy in improving short-term and long-term results in the treatment of grade III and IV hemorrhoids.

DATA SOURCES:

Between January 2018 and January 2020, we recruited 124 patients with grade III and IV hemorrhoids at Alexandria Main University Hospital.

STUDY SELECTION:

Randomized controlled trial.

INTERVENTIONS:

One hundred twenty-four patients were blindly randomly assigned to 2 equal groups: stapled hemorrhoidopexy (group I) and stapled hemorrhoidopexy plus ligation anopexy (group II).

MAIN OUTCOME MEASURES:

Recurrence of hemorrhoids and patient satisfaction after a follow-up period of at least 2 years.

RESULTS:

The average operating time was noticeably less in the stapled hemorrhoidopexy group. Postoperative pain, analgesia requirement, hemorrhoid symptoms score, return to work, complications rate, and quality of life 1 month after surgery were similar between groups. Following a mean follow-up of 36 months (interval, 24-47), in group I, 10 patients (16%) reported recurrent external swelling and/or prolapse compared to 3 patients (5%) in group II ( p  = 0.0368). Five patients in group I required redo surgery, whereas no patients required redo surgery in group II. Long-term patient satisfaction was significantly better in group II.

LIMITATIONS:

It was a single-center experience, so longer follow-up was needed.

CONCLUSIONS:

Stapled hemorrhoidopexy and stapled hemorrhoidopexy plus ligation anopexy were similar in short-term results with regard to complications rate, hemorrhoids symptoms score, return to work, and quality of life. Long-term results were significantly better with regard to recurrence of external swelling and/or prolapse and patient satisfaction after stapled hemorrhoidopexy plus ligation anopexy. See Video Abstract .

TRIAL REGISTRATION NUMBER:

Pan African Clinical Trials Registry identifier PACTR20180100293130.

ECA PARA COMPARAR LA HEMORROIDOPEXIA CON GRAPAS MS ANOPEXIA POR LIGADURA CON LA HEMORROIDOPEXIA CON GRAPAS PARA EL TRATAMIENTO DE LA ENFERMEDAD HEMORROIDAL DE GRADO III Y IV:

ANTECEDENTES:A pesar de los beneficios de la hemorroidopexia con grapas a corto plazo, el manejo de las hemorroides prolapsadas, los resultados a largo plazo aún son insuficientes en cuanto al prolapso recurrente y la satisfacción del paciente, por lo que en nuestro estudio actual agregamos anopexia por ligadura a la hemorroidopexia con grapas.OBJETIVO:Valoración de añadir anopexia por ligadura a la hemorroidopexia con grapas para mejorar los resultados a corto y largo plazo en el tratamiento de las hemorroides grado III-IV.FUENTES DE DATOS:Entre enero de 2018 y enero de 2020 reclutamos a 124 pacientes con hemorroides de grado III-IV en el hospital universitario principal de Alexandria.SELECCIÓN DEL ESTUDIO:Ensayo controlado aleatorio PACTR201801002931307.INTERVENCIÓN(S):124 pacientes fueron asignados al azar de forma ciega a dos grupos iguales, hemorroidopexia con grapas (grupo I) y hemorroidopexia con grapas más anopexia por ligadura (grupo II).PRINCIPALES MEDIDAS DE RESULTADO:Recurrencia de hemorroides y satisfacción del paciente después de un período de seguimiento de al menos dos años.RESULTADOS:El tiempo operatorio promedio fue notablemente menor en el grupo de hemorroidopexia con grapas. Mientras tanto, el dolor posoperatorio, la necesidad de analgesia, la puntuación de los síntomas de hemorroides, el regreso al trabajo, la tasa de complicaciones y la calidad de vida un mes después de la cirugía fueron similares. Después de un seguimiento medio de 36 meses (intervalo: 24-47), el Grupo I, 10 pacientes (16%) se quejaron de inflamación externa recurrente y/o prolapso en comparación con 3 pacientes (5%) en el Grupo II ( p = 0,0368) que requiere rehacer la cirugía. No fue necesaria una nueva cirugía en el grupo II; además, la satisfacción del paciente a largo plazo fue significativamente mejor en el grupo II.LIMITACIONES:Se necesita un seguimiento más prolongado y experiencia en un solo centro.CONCLUSIONES:La hemorroidopexia con grapas comparada con la hemorroidopexia con grapas más anopexia por ligadura fue similar en resultados a corto plazo en cuanto a tasa de complicaciones, puntuación de síntomas de hemorroides, regreso al trabajo y calidad de vida. Los resultados a largo plazo fueron significativamente mejores en cuanto a la recurrencia de la inflamación externa y/o el prolapso y la satisfacción del paciente después de la hemorroidopexia con grapas más anopexia por ligadura. (Traducción-Dr. Mauricio Santamaria ).

  • Elheeny AAH
  • Tony GE
J Endod. 2024 Jun;50(6):792-806 doi: 10.1016/j.joen.2024.01.017.
INTRODUCTION:

The primary aim of this study was to compare the radiographic changes of immature incisors with periapical radiolucency after treatment with platelet-rich fibrin (PRF) and concentrated growth factor (CGF) platelet concentrate scaffolds as well as assessment of the clinical success rate over 12 months. The secondary aim was to monitor the radiographic changes in terms of reduction of periapical lesion diameter (PALD), root dentine thickness (RDT), root length (RL), and apical foramen width (AFW). The tertiary aim was to assess and pulp responses, after 12 months.

METHODS:

Fifty six children with seventy necrotic, single-rooted maxillary incisors with periapical radiolucency were treated with either CGF or PRF scaffolds (35 teeth per group). Two patients with 4 teeth (2 teeth in each group) failed to attain the follow-up recalls. Radiographic changes in terms of reduction of PALD, RDT, RL, and AFW were monitored using a 2-dimensional (2D) radiograph and cone-beam computed tomography (CBCT) scan. The clinical performance of teeth receiving both scaffolds was assessed after 6 and 12 months. Categorical and continuous data were analyzed using the chi-square test and the t test, respectively. The time and group effects on the means of different radiographic dimensions were tested using the general linear model. Bland-Altman plots were used to assess the level of agreement between the 2D radiographs and CBCT. The level of significance was defined at 0.05 and a 95% confidence interval.

RESULTS:

The means of PALD and RL showed significant enhancement in the CGF group compared to the PRF group (P < .05). While the difference between the 2 scaffolds in terms of RDT and AFW was not significant (P > .05). The findings of the 2D radiograph and CBCT were consistent. Clinically, both scaffold success rates were similar (93.9%) over the follow-up intervals. The influence of study independent variables had no significant effect on the success of the regenerative endodontic procedures outcome (P > .05). There was no significant difference in the positive pulp responses to the thermal and electric pulp tests after one year of treatment (P > .05).

CONCLUSIONS:

According to the short-term follow-up, PRF and CGF were successful in treating immature teeth with periapical radiolucency by regenerative endodontics. Both scaffold systems induced periapical healing and root lengthening with significant superiority of CGF.

  • Nasirmohtaram S
  • Jalali MM
  • Faghih Habibi A
  • Akbarpour M
J Laryngol Otol. 2024 Jun;138(6):638-641 doi: 10.1017/S0022215123002311.
OBJECTIVE:

Rhinosinusitis is one of the most common reasons for a visit to otolaryngology clinics. Some patients are candidates for sinus surgery. Infiltration of 1:100 000 adrenaline in the pterygopalatine fossa was studied, with the aim of evaluating the effect on bleeding in the surgical field.

METHODS:

This double-blind clinical trial was conducted in 2021-2022 on 40 candidates for endoscopic sinus surgery. For each patient, one side of the pterygopalatine fossa was randomly selected to be infiltrated with a vasoconstrictor. Surgical field bleeding on each side was evaluated.

RESULTS:

Blood loss was 35.8 ± 20.9 ml in the study group and 38.4 ± 23.7 ml for the control group, with no statistically significant difference between groups (p = 0.49). In addition, there was no difference between the two groups in terms of the surgical field based on Boezaart scores.

CONCLUSION:

Although there are some recommendations on the usage of vasoconstrictors via the pterygopalatine foramen, debate remains.

  • Yl MK
  • Patil NS
  • Mohapatra N
  • Sindwani G
  • Dhingra U
  • et al.
Ann Surg. 2024 Jun 1;279(6):932-944 doi: 10.1097/SLA.0000000000006200.
OBJECTIVE:

To compare intraoperative hemodynamic parameters, blood loss, renal function, and duration of surgery with and without temporary portocaval shunt (TPCS) in live donor liver transplantation (LT) recipients. Secondary objectives were postoperative early graft dysfunction, morbidity, mortality, total intensive care unit, and hospital stay.

BACKGROUND:

Blood loss during recipient hepatectomy for LT remains a major concern. Routine use of TPCS during LT is not yet elucidated.

METHODS:

This study is a single-center, open-label, randomized control trial. The sample size was calculated based on intraoperative blood loss. After exclusion, a total of 60 patients, 30 in each arm (TPCS vs no TPCS) were recruited in the trial.

RESULTS:

The baseline recipient and donor characteristics were comparable between the groups. The median intraoperative blood loss ( P = 0.004) and blood product transfusions ( P < 0.05) were significantly less in the TPCS group. The TPCS group had significantly improved intraoperative hemodynamics in the anhepatic phase as compared with the no TPCS group ( P < 0.0001), requiring significantly less vasopressor support. This led to significantly better renal function as evidenced by higher intraoperative urine output in the TPCS group ( P = 0.002). Because of technical simplicity, the TPCS group had significantly fewer inferior vena cava injuries (3.3 vs 26.7%, P = 0.026) and substantially shorter hepatectomy time and total duration of surgery (529.4 ± 35.54 vs 606.83 ± 48.13 min, P < 0.0001). The time taken for normalization of lactate in the immediate postoperative period was significantly shorter in the TPCS group (median, 6 vs 13 h; P = 0.04). Although postoperative endotoxemia, major morbidity, 90-day mortality, total intensive care unit, and hospital stay were comparable between both groups, tolerance to enteral feed was earlier in the TPCS group.

CONCLUSIONS:

In live donor LT, TPCS is a simple and effective technique that provides superior intraoperative hemodynamics and reduces blood loss and duration of surgery.