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1.
Ann Gastroenterol Surg ; 7(5): 819-831, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37663968

ABSTRACT

Aim: Surgical site infection (SSI) is one of the most common postoperative complications in gastrointestinal surgery. To clarify the superiority of 1.5% olanexidine, we conducted a randomized prospective clinical trial that enrolled patients undergoing gastrointestinal surgery with operative wound classes II-IV. Methods: To evaluate the efficacy of 1.5% olanexidine in preventing SSIs relative to 10% povidone-iodine, we enrolled 298 patients in each group. The primary outcome was a 30-day SSI, and the secondary outcomes were incidences of superficial and deep incisional SSI and organ/space SSI. In addition, subgroup analyses were performed. Results: The primary outcome of the overall 30-day SSI occurred in 38 cases (12.8%) in the 1.5% olanexidine group and in 53 cases (18.0%) in the 10% povidone-iodine group (adjusted risk ratio: 0.716, 95% confidence interval: 0.495-1.057, p = 0.083). Organ/space SSI occurred in 18 cases (6.1%) in the 1.5% olanexidine group and in 31 cases (10.5%) in the 10% povidone-iodine group, with a significant difference (adjusted risk ratio: 0.587, 95% confidence interval: 0.336-0.992, p = 0.049). Subgroup analyses revealed that SSI incidences were comparable in scheduled surgery (relative risk: 0.809, 95% confidence interval: 0.522-1.254) and operative wound class II (relative risk: 0.756, 95% confidence interval: 0.494-1.449) in 1.5% olanexidine group. Conclusion: Our study revealed that 1.5% olanexidine reduced the 30-day overall SSI; however, the result was not significant. Organ/space SSI significantly decreased in the 1.5% olanexidine group. Our results indicate that 1.5% olanexidine has the potential to prevent SSI on behalf of povidone-iodine.

3.
Ther Innov Regul Sci ; 55(4): 841-849, 2021 07.
Article in English | MEDLINE | ID: mdl-33876398

ABSTRACT

BACKGROUND: Risk-based monitoring (RBM) is a slow uptake in some trial sponsors. There are three main reasons for this. First, there is the fear of making large investments into advanced RBM technology solutions. Second, it is considered that RBM is most suitable for large, complex trials. Third, there is the fear of errors in both critical and non-critical data, appearing as reduced on-site monitoring is being conducted. METHODS: Our RBM team identified, evaluated, and mitigated trial risks, as well as devised a monitoring strategy. The clinical research associate (CRA) assessed the site risks, and the RBM team conducted central monitoring. We compared all data errors and on-site monitoring time between the partial switching sites [sites that had switched to partial source data verification (SDV) and source data review (SDR)] and the 100% SDV and SDR sites (sites that had implemented 100% SDV and SDR). RESULTS: Partial switching sites did not require any critical data correction and had a smaller number of data corrections through on-site monitoring than the 100% SDV and SDR sites. The RBM strategy reduced the on-site monitoring time by 30%. CONCLUSIONS: The results suggest that RBM can be successfully implemented through the use of site risk assessment and central monitoring with practically no additional investment in technology and still produced similar results in terms of subject safety and data quality, as well as the cost savings that have been reported in global complex studies.


Subject(s)
Data Accuracy , Research Personnel , Cost Savings , Humans , Japan , Risk Assessment
4.
JSLS ; 25(1)2021.
Article in English | MEDLINE | ID: mdl-33879993

ABSTRACT

OBJECTIVES: The Tokyo Guidelines 2018 have been widely adopted since their publication. However, the few reports on clinical outcomes following laparoscopic cholecystectomy have not taken into account the severity of the acute cholecystitis and the patient's general condition, as estimated by the Charlson comorbidity index. This study aimed to assess the relationships between severity, Charlson comorbidity index, and clinical outcomes subsequent to laparoscopic cholecystectomy. METHODS: We extracted the retrospective data for 370 Japanese patients who underwent emergency or scheduled early laparoscopic cholecystectomy within 72 hours from onset between February 2015 and August 2018. We compared postoperative factors in relationship to severity (grade I versus grade II/III). Then, we made a similar comparison between those with low (< 4) and high Charlson comorbidity index (≥ 4). RESULTS: According to the Tokyo guideline 2018 levels of severity, there were 282 (76.2%), 61 (16.5%), and 27 (7.3%) patients in grades I, II, and III, respectively. With regards to surgical outcomes, the mean operating time was 62.3 minutes and the mean blood loss was 24.4 mL. The mean hospital stay was 3.6 days, with no mortalities. Blood loss was the only factor affected by severity (20.9 mL versus 60.1 mL, P = 0.0164), and operating time was the only factor affected by high Charlson comorbidity index (53.4 versus 67.8 minutes, P = 0.0153). CONCLUSION: Our aggressive strategy is acceptable, and severity and Charlson comorbidity index are not critical factors suggesting the disqualification of early laparoscopic cholecystectomy in patients with any grade acute cholecystitis.


Subject(s)
Cholecystectomy, Laparoscopic , Cholecystitis, Acute/surgery , Adult , Aged , Aged, 80 and over , Cholecystitis, Acute/pathology , Feasibility Studies , Female , Humans , Japan , Length of Stay , Male , Middle Aged , Operative Time , Patient Selection , Practice Guidelines as Topic , Retrospective Studies , Severity of Illness Index
5.
J Minim Access Surg ; 17(1): 131-134, 2021.
Article in English | MEDLINE | ID: mdl-33353900

ABSTRACT

Laparoscopic deroofing of liver cysts is widely accepted as the treatment of symptomatic huge liver cysts. As bile leakage is a common complication of this procedure, indocyanine green (ICG) imaging has played an active role in detecting intrahepatic biliary tract. However, infusion ICG imaging needs time rag after injection due to moving from bloodstream to bile, and also, additional injection is needed when the fluorescent imaging is not clear. To cover this weakness of ICG imaging, we first applied ICG imaging via 5-Fr endoscopic nasal biliary drainage (ENBD) during laparoscopic deroofing of liver cysts. This technique promptly gives us ICG imaging after ICG injection from ENBD; in addition, direct ICG imaging sometimes reveals minor leakage from sealing line and staple lines; therefore, we believe that direct ICG imaging via ENBD helps us to prevent post-operative bile leakage.

6.
Asian J Endosc Surg ; 14(3): 578-581, 2021 Jul.
Article in English | MEDLINE | ID: mdl-33145953

ABSTRACT

We present a rare case of De Garengeot hernia treated with simultaneous laparoscopic appendectomy and transabdominal preperitoneal hernia repair. Our patient was an 85-year-old man with a bulging mass in the right groin. De Garengeot hernia was observed on contrast-enhanced CT. Urgent laparoscopy showed the distal part of the appendix passing through a right-sided femoral hernia. Laparoscopic appendectomy was performed, followed by transabdominal preperitoneal repair of the femoral hernia. Pathological examination revealed ischemic necrosis of the appendix. The patient's postoperative recovery was uneventful.


Subject(s)
Appendectomy , Appendix , Hernia, Femoral , Herniorrhaphy , Laparoscopy , Aged, 80 and over , Appendix/diagnostic imaging , Appendix/surgery , Hernia, Femoral/diagnostic imaging , Hernia, Femoral/surgery , Herniorrhaphy/methods , Humans , Male , Surgical Mesh
7.
Surg Case Rep ; 6(1): 245, 2020 Oct 01.
Article in English | MEDLINE | ID: mdl-33000336

ABSTRACT

BACKGROUND: Littre's hernia containing Meckel's diverticulum is an extremely rare disease. We report an adult case of two-stage laparoscopic surgery for incarceration of Meckel's diverticulum in an umbilical hernia. CASE PRESENTATION: The case involved a 23-year-old, severely obese man with BMI 36.5 kg/m2. After experiencing effusion from the umbilicus for 2 months, and was referred from a local dermatologist. We diagnosed an infected urachal remnant, and antibiotic therapy was performed first. Surgery was planned for after the infection disappeared. During follow-up, effusion from the umbilicus took on an intestinal fluid-like character, so we diagnosed small intestinal cutaneous fistula and performed surgery. Under laparoscopy, we found a Meckel's diverticulum incarcerated in an umbilical hernia. The diverticulum was resected first, and the incarceration was released. The umbilicus was infected, so we planned repair of the umbilical hernia in a second surgery. The postoperative course was uneventful and the patient was discharged on postoperative day 5. One month after the initial operation, we confirmed that there were no signs of infection, and performed umbilical hernia repair using the laparoscopic intraperitoneal onlay mesh (IPOM) repair. Postoperative progress was uneventful and he was discharged on postoperative day 4. No recurrence or infection was observed until 8 months postoperatively. CONCLUSIONS: We performed dissection of the diverticulum and umbilical hernia repair for the incarcerated umbilical Littre's hernia under laparoscopy in a severely obese patient. The risk of mesh infection seems to be avoidable using a two-stage surgery, and the risk of recurrence can be reduced using the IPOM repair compared with simple suture closure.

8.
Surg Case Rep ; 6(1): 246, 2020 Oct 01.
Article in English | MEDLINE | ID: mdl-33000428

ABSTRACT

BACKGROUND: The European and American guidelines recommend that symptomatic umbilical hernias (UHs) are repaired using an open approach with a preperitoneal flat mesh. However, the standard treatment procedure for large UH in patients with extreme obesity is yet to be established. Here, we present the first case of a patient with morbid obesity undergoing laparoscopic UH repair using needlescopic instruments and an intraperitoneal onlay mesh plus repair (IPOM plus). CASE PRESENTATION: A 29-year-old man, who was classified as morbidly obese (body mass index, 36.7 kg/m2) noticed a reducible nontender mass in the umbilical region and was subsequently diagnosed with an UH, with a diameter of 4 cm. Laparoscopic IPOM plus repair was planned using a needlescopic method for a large UH in the patient with morbid obesity. A 3-mm rigid laparoscope was mainly used in the procedure. After a 12-mm trocar and two 3-mm trocars were inserted, fascial defect closure was performed using intracorporeal suturing with 0 monofilament polypropylene threads. Then, IPOM was performed laparoscopically using an 11.4-cm round mesh coated with collagen to prevent adhesions. The operative time and blood loss were 57 min and 1 g, respectively. The postoperative course was uneventful. CONCLUSIONS: Reduced-port laparoscopic surgery using needlescopic instruments and an IPOM plus technique is a minimally invasive and convenient combination option for large UH in a patient with morbid obesity.

9.
Surg Case Rep ; 6(1): 83, 2020 Apr 26.
Article in English | MEDLINE | ID: mdl-32337655

ABSTRACT

BACKGROUND: A standard procedure for the treatment of incarcerated umbilical hernia among severely obese patients has yet to be established. We used the hybrid intraperitoneal onlay mesh repair (IPOM) plus method, which combines open and laparoscopic surgery to treat incarcerated umbilical hernia in a severely obese patient. CASE PRESENTATION: A 46-year-old man presented in our department with a chief complaint of a painful mass in the umbilical region. Incarcerated umbilical hernia was diagnosed on the basis of abdominal computed tomography, and the decision was made to perform emergency surgery. The patient was severely obese (body mass index, 53.8 kg/m2), and the incarcerated portion of the hernia was therefore first addressed by open surgery. As bowel resection was unnecessary, the risk of infection was considered low, and after direct closure of the hernia orifice, IPOM was performed laparoscopically using the hybrid IPOM plus method. CONCLUSION: Among severely obese patients, first trocar insertion is difficult and the wound site tends to come under strain, meaning that simple closure of the hernia orifice results in a high recurrence rate. The hybrid IPOM plus method used in this case combines open surgery and laparoscopy and appears useful for treating uninfected incarcerated umbilical hernia in severely obese patients safely and with an anticipated low rate of postoperative recurrence.

10.
Am J Case Rep ; 20: 1530-1535, 2019 Oct 18.
Article in English | MEDLINE | ID: mdl-31624225

ABSTRACT

BACKGROUND Upside-down stomach (UDS) is the rarest type of hiatal hernia (HH), with organoaxial gastric volvulus. A large HH sometimes causes cardiopulmonary impairments owing to multiple factors. CASE REPORT We herein report a case of a large HH with UDS that had induced weight loss and severe cardiopulmonary dysfunction in a 74-year-old female patient who presented with shortness of breath, chest pain, severe anorexia, and weight loss of 5 kg over the 3 previous months. Chest X-ray and CT examination revealed that her heart was retracted on the right side, and the hernia contents had induced physical compression of the left lung on the cranial side. Spirometry revealed that the patient's vital capacity (VC), percentage VC, and percentage forced expiratory volume (% FEV) at 1 s were 1.32 L, 60.2%, and 67.5%, respectively. A barium swallow test confirmed a diagnosis of HH with UDS. On the basis of these findings, we performed a laparoscopic Nissen procedure, which resulted in the patient's dramatic recovery. Postoperative examinations showed that the stomach and heart were once again normally located, and the left lung had re-inflated. Postoperative spirometry dramatically improved. CONCLUSIONS A large HH causes cardiac and pulmonary compression due to mass effects and leads to cardiopulmonary dysfunction. For cases that have both a complicated HH and cardiopulmonary dysfunction owing to the mass effects of hernia contents, laparoscopic HH repair can be a good alternative procedure.


Subject(s)
Heart/physiopathology , Hernia, Hiatal/diagnostic imaging , Hernia, Hiatal/surgery , Lung/physiopathology , Stomach Volvulus/diagnostic imaging , Stomach Volvulus/surgery , Aged , Anorexia/etiology , Chest Pain/etiology , Dyspnea/etiology , Female , Fundoplication , Humans , Laparoscopy , Spirometry , Vital Capacity
11.
J Diabetes Investig ; 10(6): 1518-1526, 2019 Nov.
Article in English | MEDLINE | ID: mdl-31033218

ABSTRACT

AIMS/INTRODUCTION: Tofogliflozin is a potent and highly selective sodium-glucose cotransporter 2 inhibitor that is currently used to treat patients with type 2 diabetes mellitus. The aim of the present study was to evaluate the safety and efficacy of tofogliflozin add-on to glucagon-like peptide-1 (GLP-1) receptor agonist monotherapy. MATERIALS AND METHODS: In this 52-week, prospective, multicenter, single arm, post-marketing clinical study, Japanese patients who had already been receiving GLP-1 receptor agonist monotherapy for ≥8 weeks, glycated hemoglobin ≥7.0 and <10.5%, and body mass index ≥18.5 and <35.0 kg/m2 were enrolled. Tofogliflozin 20 mg was orally administered once daily for 52 weeks with GLP-1 receptor agonist. Primary end-points were safety and change in glycated hemoglobin from baseline to week 52. Safety was assessed on the basis of the adverse events. Changes from baseline in fasting plasma glucose, bodyweight, blood pressure, uric acid and lipid parameters were assessed as secondary efficacy end-points. RESULTS: Of the 67 patients enrolled, 63 patients completed the study. Overall, 26 adverse drug reactions occurred in 17 patients (25.4%). Adverse drug reactions with a frequency of two or more patients (3.0%) were constipation, thirst, dehydration and pollakiuria. Hypoglycemia (n = 1) was limited. With the addition of tofogliflozin to GLP-1 receptor agonist, the subsequent mean (standard deviation) reduction in glycated hemoglobin was -0.6% (1.0%; P < 0.0001). Fasting plasma glucose, bodyweight and blood pressure were significantly improved. CONCLUSIONS: Tofogliflozin add-on to GLP-1 receptor agonist monotherapy is an effective treatment option with an acceptable safety profile.


Subject(s)
Benzhydryl Compounds/therapeutic use , Biomarkers/analysis , Diabetes Mellitus, Type 2/drug therapy , Glucagon-Like Peptide-1 Receptor/agonists , Glucosides/therapeutic use , Hypoglycemic Agents/therapeutic use , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , Adult , Aged , Blood Glucose/analysis , Diabetes Mellitus, Type 2/pathology , Drug Combinations , Female , Follow-Up Studies , Glycated Hemoglobin/analysis , Humans , Male , Marketing , Middle Aged , Patient Safety , Prognosis , Prospective Studies , Young Adult
12.
J Diabetes Investig ; 10(5): 1272-1283, 2019 Sep.
Article in English | MEDLINE | ID: mdl-30702214

ABSTRACT

AIMS/INTRODUCTION: The present study analysis was carried out to evaluate the safety and efficacy of tofogliflozin, a sodium-glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus in real-world clinical practice. MATERIALS AND METHODS: This was a 3-year non-interventional observational study of patients with type 2 diabetes mellitus newly administered tofogliflozin who were uncontrolled on current therapy. We carried out a 12-week interim analysis of tofogliflozin as part of 3-year post-marketing surveillance study. The incidence of adverse drug reactions was evaluated as a safety end-point. As efficacy end-points, glycated hemoglobin and bodyweight were evaluated. RESULTS: A total of 6,897 patients were enrolled. Tofogliflozin significantly reduced mean changes from baseline glycated hemoglobin (-0.63%, P < 0.0001) and bodyweight (-2.02 kg, P < 0.0001). The change in glycated hemoglobin and bodyweight reductions in response to tofogliflozin was consistently observed in all body mass index subgroups. Adverse drug reactions occurred in 345 of 6,712 patients (5.14%). There was a low incidence of adverse drug reactions known to be associated with sodium-glucose cotransporter 2 inhibitors, and they were reported as non-serious. The incidences of polyuria/pollakiuria were higher in patients aged ≥65 years than <65 years, and were significantly different among estimated glomerular filtration rate subgroups. Urinary tract and genital infections occurred more frequently in women than in men. CONCLUSIONS: Tofogliflozin was well tolerated, and no emerging new safety concerns were observed. Tofogliflozin significantly improved glycemic control with no impact on bodyweight gain. The short-term administration of tofogliflozin is considered to have a favorable benefit-risk profile in Japanese patients with type 2 diabetes mellitus.


Subject(s)
Body Weight/drug effects , Diabetes Mellitus, Type 2/drug therapy , Glucosides/therapeutic use , Practice Patterns, Physicians'/statistics & numerical data , Product Surveillance, Postmarketing , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , Thiophenes/therapeutic use , Adolescent , Adult , Aged , Biomarkers/analysis , Blood Glucose/metabolism , Body Mass Index , Diabetes Mellitus, Type 2/metabolism , Female , Follow-Up Studies , Glycated Hemoglobin/analysis , Humans , Japan , Male , Middle Aged , Prognosis , Prospective Studies , Safety , Young Adult
14.
Dig Surg ; 36(1): 53-58, 2019.
Article in English | MEDLINE | ID: mdl-29393173

ABSTRACT

BACKGROUND: Both single-incision laparoscopic cholecystectomy (SILC) and needlescopic cholecystectomy (NSC) are superior to conventional laparoscopic cholecystectomy in terms of cosmetic outcome and incisional pain. We conducted a prospective, randomized clinical trial to evaluate the surgical outcome, postoperative pain, and cosmetic outcome for SILC and NSC procedures. METHODS: In this trial, 105 patients were enrolled (52 in the SILC group; 53 in the NSC group). A visual analogue scale (VAS) was used to evaluate the cosmetic outcome and incisional pain for patients. Logistic regression analyses were used to evaluate the operative difficulty that was present for both procedures. RESULTS: There were no significant differences in patient characteristics or surgical outcomes, including operative time and blood loss. The mean VAS scores for cosmetic satisfaction were similar in both groups. There were significant differences in the mean VAS scores for incisional pain on postoperative day 1 (p = 0.009), and analgesics were required within 12 h of surgery (p = 0.007). Obesity (body mass index ≥25 kg/m2) was the only significant influential factor for operating time over 100 min (p = 0.031). CONCLUSION: NSC is superior to SILC in terms of short-term incisional pain. Experienced laparoscopic surgeons can perform both SILC and NSC without an increase in operative time.


Subject(s)
Cholecystectomy/methods , Gallstones/surgery , Pain, Postoperative/etiology , Patient Satisfaction , Aged , Analgesics/therapeutic use , Cholecystectomy/adverse effects , Cholecystectomy, Laparoscopic/adverse effects , Cholecystectomy, Laparoscopic/methods , Female , Gallstones/complications , Humans , Male , Middle Aged , Obesity/complications , Operative Time , Pain, Postoperative/drug therapy , Prospective Studies , Treatment Outcome , Visual Analog Scale
15.
J Minim Access Surg ; 15(4): 316-319, 2019.
Article in English | MEDLINE | ID: mdl-30178763

ABSTRACT

INTRODUCTION: Reduced port laparoscopic Well's procedure (RPLWP) is a novel technique used to overcome the limitations of single-incision laparoscopic surgery. The aim of this study was to compare outcomes between RPLWP and conventional laparoscopic Well's procedure (CLWP) and to investigate the learning curve of RPLWP. PATIENTS AND METHODS: From January 2006 to March 2017, a retrospective review of a prospectively maintained laparoscopic surgery database was performed to identify patients had undergone CLWP and RPLWP. From these patients, each of 10 cases were manually matched for age, sex, body mass index. From January 2006 to March 2015, CLWP was used for all procedures whereas, from April 2015, RPLWP was routinely performed as a standard procedure for rectal prolapse. RESULTS: No significant differences were observed between the two groups in terms of operating time, blood loss, intraoperative complications, and conversion to CLWP or open rectopexy. Based on the postoperative outcomes, the hospital stay was significantly shorter in the RPLWP group. The estimated learning curve for RPLWP was fitted and defined as y = 278.47e-0.064x with R2 = 0.838; therefore, a significant decrease in operative time was observed by using the more advanced surgical procedure. CONCLUSIONS: RPLWP is an effective, safe, minimally invasive procedural alternative to CLWP with no disadvantage for patients when a skilled surgeon performs it.

16.
Gastric Cancer ; 20(5): 872-877, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28120128

ABSTRACT

BACKGROUND: Pulmonary thromboembolism (PE) is one of the life-threatening complications of gastric cancer surgery. D-dimer assay is a safe and rapid tool to exclude the presence of deep venous thrombosis (DVT). In July 2012, we started preoperative DVT screening of patients scheduled for gastric cancer surgery using a combination of D-dimer measurements and lower extremity venous ultrasonography to prevent PE. METHODS: Between July 2012 and August 2015, 976 consecutive patients underwent gastric cancer surgery with preoperative D-dimer screening. Lower extremity venous ultrasonography was performed in patients with a positive D-dimer assay result (greater than 1.0 µg/ml). The incidence of and risk factors for preoperative DVT and the incidence of PE were examined in patients undergoing gastric cancer surgery. RESULTS: Of the 976 patients, 176 (18.0%) showed positive D-dimer assay results, and in 13 (1.3%) DVT was diagnosed by lower extremity ultrasonography. Our analysis identified neoadjuvant chemotherapy as a risk factor for preoperative detection of DVT in patients undergoing gastric cancer surgery (P = 0.021). The incidence of PE was 0.1% (1/976). CONCLUSION: Preoperative gastric cancer patients receiving neoadjuvant chemotherapy seem to be at higher risk for the development of DVT.


Subject(s)
Fibrin Fibrinogen Degradation Products/analysis , Pulmonary Embolism/diagnosis , Stomach Neoplasms/surgery , Venous Thrombosis/diagnosis , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Female , Humans , Incidence , Lower Extremity/blood supply , Male , Middle Aged , Neoadjuvant Therapy/adverse effects , Neoadjuvant Therapy/methods , Preoperative Care/methods , Pulmonary Embolism/epidemiology , Pulmonary Embolism/prevention & control , Risk Factors , Ultrasonography/methods , Venous Thrombosis/epidemiology , Venous Thrombosis/prevention & control
17.
J Diabetes Investig ; 8(6): 766-775, 2017 Nov.
Article in English | MEDLINE | ID: mdl-28107773

ABSTRACT

AIMS/INTRODUCTION: Although sodium-glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus. MATERIALS AND METHODS: This was a prospective, observational and multicenter post-marketing study carried out in the context of routine clinical practice. The study included all type 2 diabetes patients aged ≥65 years who started treatment with tofogliflozin during the first 3 months after its launch on 23 May 2014. RESULTS: Of 1,535 patients registered, 1,507 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis. A total of 270 of 1,507 patients (17.92%) had at least one adverse drug reaction to tofogliflozin. The incidences of adverse drug reactions of special interest, namely, polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, hypoglycemia and skin disorders were 2.92, 3.85, 2.06, 1.33, 1.06 and 2.39%, respectively. Among those patients evaluable for clinical effectiveness, the mean change in glycated hemoglobin and bodyweight from baseline to last visit was -0.46% (P < 0.0001) and -2.71 kg (P < 0.0001), respectively. CONCLUSIONS: The present study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ≥65 years differed little from the incidence in the preapproval clinical trials. It was shown that tofogliflozin significantly decreased glycated hemoglobin levels.


Subject(s)
Benzhydryl Compounds/therapeutic use , Diabetes Mellitus, Type 2/drug therapy , Glucosides/therapeutic use , Hypoglycemic Agents/therapeutic use , Product Surveillance, Postmarketing , Aged , Benzhydryl Compounds/adverse effects , Female , Glucosides/adverse effects , Humans , Hypoglycemic Agents/adverse effects , Japan , Male , Sodium-Glucose Transport Proteins/antagonists & inhibitors
18.
World J Gastrointest Oncol ; 8(9): 707-14, 2016 Sep 15.
Article in English | MEDLINE | ID: mdl-27672429

ABSTRACT

AIM: To verify the current status of super-extended lymph node dissection for advanced gastric cancer according to a questionnaire survey. METHODS: One-hundred and five institutions responded to the questionnaire. The survey included the following items: Number of experiences, whether performed prophylactically and/or therapeutically, whether preoperative chemotherapy was provided, number of preoperative chemotherapy rounds, and therapeutic options after chemotherapy. RESULTS: Eighty-seven of the 105 institutions (83%) had performed D3 gastrectomy in the past or continued to perform D3 gastrectomy at present. However, D3 gastrectomy was rarely performed prophylactically in clinical practice. Seventy-eight institutions (74%) indicated that preoperative chemotherapy with curative intent was required for patients suspected of having para-aortic node (PAN) metastases. After chemotherapy, a D3 gastrectomy was scheduled for patients with a complete or partial response, stable disease, and progressive disease at 36 (46%), 28 (36%), and 13 (17%) of the institutions, respectively. CONCLUSION: For patients with apparent PAN metastasis, a D3 gastrectomy is typically planned if a few courses of preoperative chemotherapy yield at least a stable disease condition.

19.
Indian J Surg ; 78(3): 249-53, 2016 Jun.
Article in English | MEDLINE | ID: mdl-27358526

ABSTRACT

The totally laparoscopic total gastrectomy (TLTG) for gastric cancer has not gained widespread acceptance due to its technical difficulties, especially with the intracorporeal esophagojejunostomy (IEJS). Various modified procedures for the IEJS have been devised, but an optimal method has not yet been standardized. A total of 32 consecutive patients (23 men and 9 women) underwent TLTGs for gastric cancer, between December of 2009 and December of 2014 at the Iwate Medical University Hospital, and were enrolled in this study. Here, we report our institution's experience with TLTGs, with changes in the IEJS. The study participants had a mean age of 66.8 years and a body mass index of 22.8 kg/m2. The mean operation time and blood loss were 356.1 min and 61.2 mL, respectively. According to the IEJS, there were 6 circular stapler (CS) (single and double stapling techniques) and 26 linear stapler (LS) (overlap technique and functional end-to-end anastomosis) procedures performed. Two patients, who had undergone IEJS by double stapling technique, developed anastomotic stenosis and required endoscopic balloon dilatations of the anastomotic sites. Therefore, we changed to LS to secure the abundant anastomotic diameter. In our institute, some problematic complications in the IEJS procedure occurred at the introduction of the TLTG. We have overcome these complications by changing and standardizing the IEJS techniques, and by cultivating the laparoscopic techniques.

20.
Asian J Surg ; 38(2): 102-12, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25458736

ABSTRACT

There has been a recent increase in the use of totally laparoscopic total gastrectomy (TLTG) for gastric cancer. However, there is no scientific evidence to determine which esophagojejunostomy (EJS) technique is the best. In addition, both short- and long-term oncological results of TLTG are inconsistent. We reviewed 25 articles about TLTG for gastric cancer in which at least 10 cases were included. We analyzed the short-term results, relationships between EJS techniques and complications, long-term oncological results, and comparative study results of TLTG. TLTG was performed in a total of 1170 patients. The mortality rate was 0.7%, and the short-term results were satisfactory. Regarding EJS techniques and complications, circular staplers (CSs) methods were significantly associated with leakage (4.7% vs. 1.1%, p < 0.001) and stenosis (8.3% vs. 1.8%, p < 0.001) of the EJS as compared with the linear stapler method. The long-term oncological prognosis was acceptable in patients with early gastric cancers and without metastases to lymph nodes. Although TLTG tended to increase surgical time compared with open total gastrectomy and laparoscopy-assisted total gastrectomy, it reduced intraoperative blood loss and was expected to shorten postoperative hospital stay. TLTG is found to be safer and more feasible than open total gastrectomy and laparoscopy-assisted total gastrectomy. At present, there is no evidence to encourage performing TLTG for patients with advanced gastric cancer from the viewpoint of long-term oncological prognosis. Although the current major EJS techniques are CS and linear stapler methods, in this review, CS methods are significantly associated with leakage and stenosis of the EJS.


Subject(s)
Esophagus/surgery , Gastrectomy/methods , Jejunum/surgery , Laparoscopy/methods , Stomach Neoplasms/surgery , Anastomosis, Surgical/methods , Humans , Treatment Outcome
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