Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Purpose: The optimal reconstruction method following distal gastrectomy has not been elucidated. Since Billroth-II (B-II) reconstruction is commonly associated with increased bile reflux, Braun jejunojejunostomy has been proposed to reduce this complication. Materials and Methods: We retrospectively analyzed 325 patients with gastric cancer who underwent distal gastrectomy with B-II reconstruction between January 2015 and December 2017, comprising 159 patients without Braun anastomosis and 166 with Braun anastomosis.Outcomes were assessed over three years using annual gastroscopy based on the residual food, gastritis, and bile reflux criteria and the Los Angeles classification for reflux esophagitis. Results: In the first postoperative year, the group with Braun anastomosis showed a significant reduction in bile reflux compared to the group without Braun anastomosis (75.9% vs. 86.2%; P=0.019). Moreover, multivariate analysis identified Braun anastomosis as the sole factor associated with this outcome. Additionally, the group with Braun anastomosis had a lower incidence of heartburn (12.0% vs. 20.1%; P=0.047) and reduced use of prokinetics (P<0.001) and acid reducers (P=0.002) compared to the group without Braun anastomosis.However, these benefits diminished in subsequent years, with no significant differences in residual food, gastritis, or reflux esophagitis between the groups. Both groups showed similar body mass index scores and nutritional outcomes over the 3-year follow-up period. Conclusions Although Braun anastomosis offers short-term benefits in reducing bile reflux after B-II reconstruction, these effects are not sustainable. The routine use of Braun anastomosis should be reconsidered, though either approach remains a viable option depending on the patient’s circumstances.

Purpose: The optimal reconstruction method following distal gastrectomy has not been elucidated. Since Billroth-II (B-II) reconstruction is commonly associated with increased bile reflux, Braun jejunojejunostomy has been proposed to reduce this complication. Materials and Methods: We retrospectively analyzed 325 patients with gastric cancer who underwent distal gastrectomy with B-II reconstruction between January 2015 and December 2017, comprising 159 patients without Braun anastomosis and 166 with Braun anastomosis.Outcomes were assessed over three years using annual gastroscopy based on the residual food, gastritis, and bile reflux criteria and the Los Angeles classification for reflux esophagitis. Results: In the first postoperative year, the group with Braun anastomosis showed a significant reduction in bile reflux compared to the group without Braun anastomosis (75.9% vs. 86.2%; P=0.019). Moreover, multivariate analysis identified Braun anastomosis as the sole factor associated with this outcome. Additionally, the group with Braun anastomosis had a lower incidence of heartburn (12.0% vs. 20.1%; P=0.047) and reduced use of prokinetics (P<0.001) and acid reducers (P=0.002) compared to the group without Braun anastomosis.However, these benefits diminished in subsequent years, with no significant differences in residual food, gastritis, or reflux esophagitis between the groups. Both groups showed similar body mass index scores and nutritional outcomes over the 3-year follow-up period. Conclusions Although Braun anastomosis offers short-term benefits in reducing bile reflux after B-II reconstruction, these effects are not sustainable. The routine use of Braun anastomosis should be reconsidered, though either approach remains a viable option depending on the patient’s circumstances.

Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Purpose: The optimal reconstruction method following distal gastrectomy has not been elucidated. Since Billroth-II (B-II) reconstruction is commonly associated with increased bile reflux, Braun jejunojejunostomy has been proposed to reduce this complication. Materials and Methods: We retrospectively analyzed 325 patients with gastric cancer who underwent distal gastrectomy with B-II reconstruction between January 2015 and December 2017, comprising 159 patients without Braun anastomosis and 166 with Braun anastomosis.Outcomes were assessed over three years using annual gastroscopy based on the residual food, gastritis, and bile reflux criteria and the Los Angeles classification for reflux esophagitis. Results: In the first postoperative year, the group with Braun anastomosis showed a significant reduction in bile reflux compared to the group without Braun anastomosis (75.9% vs. 86.2%; P=0.019). Moreover, multivariate analysis identified Braun anastomosis as the sole factor associated with this outcome. Additionally, the group with Braun anastomosis had a lower incidence of heartburn (12.0% vs. 20.1%; P=0.047) and reduced use of prokinetics (P<0.001) and acid reducers (P=0.002) compared to the group without Braun anastomosis.However, these benefits diminished in subsequent years, with no significant differences in residual food, gastritis, or reflux esophagitis between the groups. Both groups showed similar body mass index scores and nutritional outcomes over the 3-year follow-up period. Conclusions Although Braun anastomosis offers short-term benefits in reducing bile reflux after B-II reconstruction, these effects are not sustainable. The routine use of Braun anastomosis should be reconsidered, though either approach remains a viable option depending on the patient’s circumstances.

Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Background: The increasing rate of cesarean delivery (CD) is a significant concern in many societies worldwide. Vaginal delivery (VD) is preferred over CD for subsequent pregnancies after successful VD, for women with no specific obstetrical indications, primarily because of concerns about potential complications arising from the surgical procedure. However, the factors that influence the decision of requesting a CD have not yet been thoroughly investigated. This study aimed to examine the underlying reasons that lead mothers to choose CDs in subsequent pregnancies following a VD. Methods: This retrospective study included women who underwent VD in their first pregnancy between 2011 and 2020 and had a second pregnancy and childbirth within the study period. The analysis focused on women eligible for a trial of labor (TOL) in their second pregnancy, excluding those with conditions necessitating a CD. The study defined two groups: the TOL in second pregnancy (TOLS) group, consisting of women with one previous VD who attempted a VD in their subsequent pregnancy; and the CD on maternal request in second pregnancy (CDRS) group, comprising women with one past VD who opted for a CD in their second pregnancy without medical indication. The TOLS and CDRS groups were compared regarding obstetric and neonatal outcomes. Results: During the study period, 372,749 women met the inclusion criteria: 368,311 women in TOLS group and 4,438 women in CDRS group. In the regression analysis for the CDRS, several factors were identified as increasing the risk of choosing CD, including age (adjusted odds ratio [aOR], 1.06; 95% confidence interval [CI], 1.05–1.07), interval between the first and second pregnancies (aOR, 1.32; 95% CI 1.29–1.35), a history of pre-existing hypertension (aOR, 1.76; 95% CI, 1.17–2.65), gestational diabetes mellitus (GDM) during the first pregnancy (aOR, 1.19; 95% CI, 1.05–1.36), hypertensive disease during pregnancy (HDP) (aOR, 1.33; 95% CI, 1.06–1.67), preterm labor during the first pregnancy (aOR, 1.57;95% CI, 1.32–1.86), postpartum hemorrhage (aOR, 1.33; 95% CI, 1.21–1.47), traumatic event during delivery (aOR, 1.19; 95% CI, 1.12–1.28), surgical VD (aOR, 1.29; 95% CI, 1.19–1.40), and pregnancies with abortive outcomes between the first and second pregnancies (aOR, 1.18; 95% CI, 1.08–1.29). Additionally, women with pre-existing diabetes (aOR, 1.53; 95% CI, 1.24–1.89), pre-existing hypertension (aOR, 1.69; 95% CI, 1.26–2.26), GDM (aOR, 1.23; 95% CI, 1.11–1.37), or HDP (aOR, 2.57; 95% CI, 2.24–2.94) during the second pregnancy continued to exhibit an increased risk of opting for CD even after adjustment. Conclusion CD after VD was more prevalent among women with certain demographic characteristics and obstetric histories. Investigating the factors influencing women to request CD can be helpful in making informed decisions about safe delivery methods and may also affect the CD rate.

Background: The increasing rate of cesarean delivery (CD) is a significant concern in many societies worldwide. Vaginal delivery (VD) is preferred over CD for subsequent pregnancies after successful VD, for women with no specific obstetrical indications, primarily because of concerns about potential complications arising from the surgical procedure. However, the factors that influence the decision of requesting a CD have not yet been thoroughly investigated. This study aimed to examine the underlying reasons that lead mothers to choose CDs in subsequent pregnancies following a VD. Methods: This retrospective study included women who underwent VD in their first pregnancy between 2011 and 2020 and had a second pregnancy and childbirth within the study period. The analysis focused on women eligible for a trial of labor (TOL) in their second pregnancy, excluding those with conditions necessitating a CD. The study defined two groups: the TOL in second pregnancy (TOLS) group, consisting of women with one previous VD who attempted a VD in their subsequent pregnancy; and the CD on maternal request in second pregnancy (CDRS) group, comprising women with one past VD who opted for a CD in their second pregnancy without medical indication. The TOLS and CDRS groups were compared regarding obstetric and neonatal outcomes. Results: During the study period, 372,749 women met the inclusion criteria: 368,311 women in TOLS group and 4,438 women in CDRS group. In the regression analysis for the CDRS, several factors were identified as increasing the risk of choosing CD, including age (adjusted odds ratio [aOR], 1.06; 95% confidence interval [CI], 1.05–1.07), interval between the first and second pregnancies (aOR, 1.32; 95% CI 1.29–1.35), a history of pre-existing hypertension (aOR, 1.76; 95% CI, 1.17–2.65), gestational diabetes mellitus (GDM) during the first pregnancy (aOR, 1.19; 95% CI, 1.05–1.36), hypertensive disease during pregnancy (HDP) (aOR, 1.33; 95% CI, 1.06–1.67), preterm labor during the first pregnancy (aOR, 1.57;95% CI, 1.32–1.86), postpartum hemorrhage (aOR, 1.33; 95% CI, 1.21–1.47), traumatic event during delivery (aOR, 1.19; 95% CI, 1.12–1.28), surgical VD (aOR, 1.29; 95% CI, 1.19–1.40), and pregnancies with abortive outcomes between the first and second pregnancies (aOR, 1.18; 95% CI, 1.08–1.29). Additionally, women with pre-existing diabetes (aOR, 1.53; 95% CI, 1.24–1.89), pre-existing hypertension (aOR, 1.69; 95% CI, 1.26–2.26), GDM (aOR, 1.23; 95% CI, 1.11–1.37), or HDP (aOR, 2.57; 95% CI, 2.24–2.94) during the second pregnancy continued to exhibit an increased risk of opting for CD even after adjustment. Conclusion CD after VD was more prevalent among women with certain demographic characteristics and obstetric histories. Investigating the factors influencing women to request CD can be helpful in making informed decisions about safe delivery methods and may also affect the CD rate.