Indocyanine green fluorescence imaging via endoscopic nasal biliary drainage during laparoscopic deroofing of liver cysts.

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.

Comparison of Single-Incision Laparoscopic Cholecystectomy versus Needlescopic Cholecystectomy: A Single Institutional Randomized Clinical Trial.

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.

Retrospective case-matched study between reduced port laparoscopic rectopexy and conventional laparoscopic rectopexy for rectal prolapse.

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.

Incidence of and risk factors for preoperative deep venous thrombosis in patients undergoing gastric cancer surgery.

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.

Single-port versus multiport laparoscopic resection for gastric gastrointestinal stromal tumors: a case-matched comparison.

PURPOSE: The aim of this study was to compare the outcomes of single-port laparoscopic gastric resection (SPLGR) with multiport laparoscopic gastric resection (MPLGR) for gastric gastrointestinal stromal tumors (GISTs). METHODS: Between April 2009 and December 2012, 16 consecutive patients with gastric GISTs underwent SPLGR. The patients undergoing the SPLGR were case-matched for age, sex, body mass index and tumor location with those undergoing MPLGR. The demographic and surgical outcomes were analyzed and compared from the review of a prospectively collected database of 16 patients who underwent MPLGR. RESULTS: All 16 patients underwent complete SPLGR without any intraoperative complications. No significant differences were observed in the mean length of the operation (91.4 vs. 94.1 min), blood loss (6.3 vs. 10.1 ml) and length of postoperative hospital stay (4.7 vs. 5.4 days) between the SPLGR and MPLGR groups. The tumor size was similar (37.8 vs. 32.1 mm) and negative surgical margins were achieved in all patients. At a mean follow-up of 27 months, all 16 SPLGR patients were disease-free. CONCLUSIONS: Our initial comparison demonstrated that SPLGR, when performed by experienced surgeons, is a safe and feasible procedure for patients with gastric GISTs, resulting in good surgical and oncological outcomes.

Comparison of olanexidine versus povidone-iodine as a preoperative antiseptic for reducing surgical site infection in both scheduled and emergency gastrointestinal surgeries: A single-center randomized clinical trial.

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.

[A case of advanced gastric cancer with multiple bone metastases and distant lymph node metastases successfully treated by S-1/CDDP combination chemotherapy].

We describe a 46-year-old man who presented with the chief complaint of lower back pain. The patient was diagnosed with advanced gastric cancer accompanied by multiple bone metastases, with compression fractures in the thoracolumbar vertebrae as well as distant lymph node metastases. He was administered eight courses of S-1/CDDP combination chemotherapy. Treatment results were as follows: primary lesion, non-CR/non-PD; lymph node metastases, CR; and bone metastases, non-CR/non-PD. As only the primary lesion showed a tendency toward progression after completion of eight courses, distal gastrectomy with D1 dissection was performed. Histopathological test results were ypT1b(SM1)and ypN1(2/22). The histological grade following treatment was grade 2 for both the primary lesion and the lymph nodes Following subsequent treatment with S-1 monotherapy and zoledronic acid, the disease did not progress, and at one year and four months since diagnosis and six months since surgery, CR and non-CR/non-PD have been maintained for the lymph node metastases and bone metastases, respectively.

[Usefulness of esophageal stenting for esophagorespiratory fistula with esophageal cancer].

We evaluated the outcome of esophageal stenting for esophagorespiratory fistula in patients with advanced esophageal cancer. Six patients with such fistula underwent esophageal stenting at our department from January 2000 to May 2012. Intraoral ingestion improved in all patients. Cough decreased immediately after stenting in 3 patients, and pneumonia detected by chest radiography improved within 1 week in 2 patients. Ventilation was weaned 2 days after stenting in 1 patient. The median survival duration after stenting was 31 days, and the cause of death was cancer in all patients. The following background factors were identified at the time of death: bleeding(n=3), mediastinitis(n=1), and pneumonia(n=1). Esophageal stenting, which should always be performed with the informed consent of the patient, improves respiratory symptoms, intraoral ingestion, and quality of life. Therefore, it is one of the best palliative therapies for patients with esophagorespiratory fistula associated with advanced esophageal cancer.

[A case of advanced adenocarcinoma of esophagogastric junction with severe esophageal invasion effectively treated by chemoradiotherapy using paclitaxel and cisplatin, and S-1 after chemoradiotherapy].

The patient was a 66-year-old male with adenocarcinoma of the esophagogastric junction and severe esophageal invasion, which was diagnosed as cType 3, cT4a (SE) cN3cM1 (LYM), cStage IV(histopathology: por 1). We tried concurrent chemoradiotherapy consisting of PTX 60 mg/m(2) and CDDP 25 mg/m(2), respectively (once a week), and a total of 45 Gy of radiotherapy treatment. Then, for effective continuation, chemotherapy using S-1 was performed as second-line therapy. A complete response was achieved and continued for more than 2 years after initial chemoradiotherapy; his complaints abated and his quality of life improved. Although gastro-intestinal symptoms and bone marrow suppression were observed as adverse effects, they were within a tolerable range and did not interfere with the concurrent chemoradiotherapy. This regimen appears to be feasible and effective for advanced gastric carcinoma refractory to other regimens.

Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment.

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.

Aggressive Laparoscopic Cholecystectomy in Accordance with the Tokyo Guideline 2018.

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.

Rare presentation of De Garengeot hernia treated by transabdominal preperitoneal hernia repair: A case report.

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.

[Five cases of advanced gastroesophageal junction adenocarcinoma successfully treated with chemoradiotherapy followed by curative resection].

We reviewed five patients with advanced gastroesophageal cancer who were successfully treated with chemoradiotherapy followed by a curative resection. Patients with histologically-documented adenocarcinoma of the gastroesophageal junction were eligible. Direct tumor extension into the stomach (cT3 or cT4), and involvement of lymph nodes were observed. The patients stopped receiving orally administered carcinostatic drugs due to digestive stenosis or tumor bleeding. They received 25 mg/m2 of cisplatin and 60 mg/m2 of paclitaxel once a week on days 1, 8, 15 and 22. Radiation was administered concurrently at a total dose of 45 Gy in 1.8 Gy fractions for over 25 treatments. Effectiveness of the therapy was evaluated 4 weeks after the chemoradiotherapy. All patients with clinical partial responses underwent gastrectomy (n=4) or esophagogastrectomy (n=1). Curative resection was performed in 5 patients (resection A/B 4/1), and no patient suffered from major postoperative complications. Four patients were downstaged according to the pathological findings. The histologically effective responses of all patients were Grade 2. The obvious chemotherapeutic efficacy of the present regimen suggested that it may be a good treatment option for advanced gastroesophageal cancers. Further studies including randomized controlled trials are needed to evaluate the significance of preoperative chemoradiotherapy.

Intraperitoneal onlay mesh repair (IPOM) plus technique using a hybrid procedure of open laparotomy and laparoscopic approach (hybrid IPOM plus) for incarceration of umbilical hernia in a severely obese patient: a case report.

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.

Two-stage laparoscopic surgery for incarcerated umbilical Littre's hernia in severely obese patient: a case report.

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.

Needlescopic surgery for large umbilical hernia in a patient with morbid obesity using intraperitoneal onlay mesh with fascial defect closure: a case report.

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.

Ghrelin and leptin levels in cachectic patients with cancer of the digestive organs.

BACKGROUND: Cancer cachexia, a catabolic state characterized by weight loss, occurs frequently in patients with terminal-stage neoplastic diseases. Gastrointestinal hormones and cytokines may be associated with anorexia and wasting in cancer cachexia. METHODS: This study aimed to examine the mechanism of anorexia in cachectic patients through a prospective investigation of plasma cytokines, ghrelin, and leptin in 16 cachectic patients with cancer of the digestive organs and 10 healthy volunteers. RESULTS: Tumor necrosis factor (TNF)-alpha, interleukin (IL)-6, IL-1 receptor antagonist (IL-1Ra), and ghrelin levels were significantly higher in cachectic cancer patients than in the healthy volunteers, whereas leptin was significantly lower in the cachectic cancer patients. Plasma leptin levels and cytokine levels (TNF-alpha and IL-6) correlated significantly with body mass index (BMI), but plasma ghrelin levels did not correlate with BMI or with the grade of symptoms. CONCLUSION: Neither weight loss nor the grade of symptoms seemed to be directly associated with the increase in ghrelin levels. Hence, it is considered that the increase in ghrelin levels cannot simply be explained by an increase in ghrelin secretion, suggesting that other mechanisms, such as the decreased inactivation of ghrelin, may also play a role. Further studies are needed to clarify the mechanisms of the increase in ghrelin levels. Additionally, the changes in plasma cytokines (TNF-alpha and IL-6) and leptin in cachectic cancer patients suggest that these molecules may be useful markers for the evaluation of cancer cachexia.

Long-term safety and efficacy of the sodium-glucose cotransporter 2 inhibitor, tofogliflozin, added on glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week open-label, multicenter, post-marketing clinical study.

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.

Safety and efficacy of tofogliflozin in Japanese patients with type 2 diabetes mellitus in real-world clinical practice: Results of 3-month interim analysis of a long-term post-marketing surveillance study (J-STEP/LT).

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.