1.Prevention of symptomatic pulmonary embolism for gynecologic malignancies with preoperative asymptomatic venous thromboembolism: GOTIC-VTE trial
Yoshifumi TAKAHASHI ; Hiroyuki FUJIWARA ; Kouji YAMAMOTO ; Masashi TAKANO ; Morikazu MIYAMOTO ; Kosei HASEGAWA ; Maiko MIWA ; Toyomi SATOH ; Hiroya ITAGAKI ; Takashi HIRAKAWA ; Mayuyo MORI-UCHINO ; Tomonori NAGAI ; Yoshinobu HAMADA ; Soichi YAMASHITA ; Hiroko YANO ; Tomoyasu KATO ; Keiichi FUJIWARA ; Mitsuaki SUZUKI ; On behalf of the GOTIC-VTE Trial Investigators
Journal of Gynecologic Oncology 2024;35(4):e37-
Objective:
In Japan, perioperative prophylaxis of pulmonary embolism (PE) in gynecologic cancer patients with preoperative asymptomatic venous thromboembolism (VTE) has not been well established yet. The GOTIC-VTE trial was a prospective, multi-center, single-arm clinical trial to investigate the prevention of postoperative symptomatic PE onset by seamless anticoagulant therapy from the preoperative period to 4 weeks after surgery instead of using intermittent pneumatic compression.
Methods:
Anticoagulant therapy was started immediately after asymptomatic VTE diagnosis and stopped preoperatively according to the rules of each institution. Unfractionated heparin administration was resumed within 12 hours postoperatively, and this was followed by the switch to low-molecular-weight heparin and subsequently, edoxaban; this cycle was continued for 28 days. Primary outcome was the occurrence of symptomatic PE in 28 days postoperatively. Secondary outcomes were the incidence of VTE-related events in 28 days and 6 months postoperatively and protocol-related adverse events.
Results:
Between February 2018 and September 2020, 99 patients were enrolled; of these, 82patients were assessed as the full analysis set, including 58 for ovarian cancer, fallopian tube, or peritoneal cancer; 21 for endometrial cancer; and 3 for cervical cancer. No symptomatic PE was observed within 28 days postoperatively; two patients had bleeding events (major bleeding and clinically relevant nonmajor bleeding) and three had grade 3 adverse events (increased alanine transaminase, aspartate aminotransferase, or gamma-glutamyl transferase).
Conclusion
The multifaceted perioperative management for gynecologic malignancies with asymptomatic VTE effectively prevented postoperative symptomatic PE.Trial Registration: JRCT Identifier: jRCTs031180124
2.Prevention of symptomatic pulmonary embolism for gynecologic malignancies with preoperative asymptomatic venous thromboembolism: GOTIC-VTE trial
Yoshifumi TAKAHASHI ; Hiroyuki FUJIWARA ; Kouji YAMAMOTO ; Masashi TAKANO ; Morikazu MIYAMOTO ; Kosei HASEGAWA ; Maiko MIWA ; Toyomi SATOH ; Hiroya ITAGAKI ; Takashi HIRAKAWA ; Mayuyo MORI-UCHINO ; Tomonori NAGAI ; Yoshinobu HAMADA ; Soichi YAMASHITA ; Hiroko YANO ; Tomoyasu KATO ; Keiichi FUJIWARA ; Mitsuaki SUZUKI ; On behalf of the GOTIC-VTE Trial Investigators
Journal of Gynecologic Oncology 2024;35(4):e37-
Objective:
In Japan, perioperative prophylaxis of pulmonary embolism (PE) in gynecologic cancer patients with preoperative asymptomatic venous thromboembolism (VTE) has not been well established yet. The GOTIC-VTE trial was a prospective, multi-center, single-arm clinical trial to investigate the prevention of postoperative symptomatic PE onset by seamless anticoagulant therapy from the preoperative period to 4 weeks after surgery instead of using intermittent pneumatic compression.
Methods:
Anticoagulant therapy was started immediately after asymptomatic VTE diagnosis and stopped preoperatively according to the rules of each institution. Unfractionated heparin administration was resumed within 12 hours postoperatively, and this was followed by the switch to low-molecular-weight heparin and subsequently, edoxaban; this cycle was continued for 28 days. Primary outcome was the occurrence of symptomatic PE in 28 days postoperatively. Secondary outcomes were the incidence of VTE-related events in 28 days and 6 months postoperatively and protocol-related adverse events.
Results:
Between February 2018 and September 2020, 99 patients were enrolled; of these, 82patients were assessed as the full analysis set, including 58 for ovarian cancer, fallopian tube, or peritoneal cancer; 21 for endometrial cancer; and 3 for cervical cancer. No symptomatic PE was observed within 28 days postoperatively; two patients had bleeding events (major bleeding and clinically relevant nonmajor bleeding) and three had grade 3 adverse events (increased alanine transaminase, aspartate aminotransferase, or gamma-glutamyl transferase).
Conclusion
The multifaceted perioperative management for gynecologic malignancies with asymptomatic VTE effectively prevented postoperative symptomatic PE.Trial Registration: JRCT Identifier: jRCTs031180124
3.Prevention of symptomatic pulmonary embolism for gynecologic malignancies with preoperative asymptomatic venous thromboembolism: GOTIC-VTE trial
Yoshifumi TAKAHASHI ; Hiroyuki FUJIWARA ; Kouji YAMAMOTO ; Masashi TAKANO ; Morikazu MIYAMOTO ; Kosei HASEGAWA ; Maiko MIWA ; Toyomi SATOH ; Hiroya ITAGAKI ; Takashi HIRAKAWA ; Mayuyo MORI-UCHINO ; Tomonori NAGAI ; Yoshinobu HAMADA ; Soichi YAMASHITA ; Hiroko YANO ; Tomoyasu KATO ; Keiichi FUJIWARA ; Mitsuaki SUZUKI ; On behalf of the GOTIC-VTE Trial Investigators
Journal of Gynecologic Oncology 2024;35(4):e37-
Objective:
In Japan, perioperative prophylaxis of pulmonary embolism (PE) in gynecologic cancer patients with preoperative asymptomatic venous thromboembolism (VTE) has not been well established yet. The GOTIC-VTE trial was a prospective, multi-center, single-arm clinical trial to investigate the prevention of postoperative symptomatic PE onset by seamless anticoagulant therapy from the preoperative period to 4 weeks after surgery instead of using intermittent pneumatic compression.
Methods:
Anticoagulant therapy was started immediately after asymptomatic VTE diagnosis and stopped preoperatively according to the rules of each institution. Unfractionated heparin administration was resumed within 12 hours postoperatively, and this was followed by the switch to low-molecular-weight heparin and subsequently, edoxaban; this cycle was continued for 28 days. Primary outcome was the occurrence of symptomatic PE in 28 days postoperatively. Secondary outcomes were the incidence of VTE-related events in 28 days and 6 months postoperatively and protocol-related adverse events.
Results:
Between February 2018 and September 2020, 99 patients were enrolled; of these, 82patients were assessed as the full analysis set, including 58 for ovarian cancer, fallopian tube, or peritoneal cancer; 21 for endometrial cancer; and 3 for cervical cancer. No symptomatic PE was observed within 28 days postoperatively; two patients had bleeding events (major bleeding and clinically relevant nonmajor bleeding) and three had grade 3 adverse events (increased alanine transaminase, aspartate aminotransferase, or gamma-glutamyl transferase).
Conclusion
The multifaceted perioperative management for gynecologic malignancies with asymptomatic VTE effectively prevented postoperative symptomatic PE.Trial Registration: JRCT Identifier: jRCTs031180124
4.Prevalence and risk factors of pre-sick building syndrome: characteristics of indoor environmental and individual factors.
Yoshitake NAKAYAMA ; Hiroko NAKAOKA ; Norimichi SUZUKI ; Kayo TSUMURA ; Masamichi HANAZATO ; Emiko TODAKA ; Chisato MORI
Environmental Health and Preventive Medicine 2019;24(1):77-77
BACKGROUND:
With the aim to prevent sick building syndrome and worsening of allergic symptoms, primarily resulting from the indoor environment, the relationships among people's residential environment in recent years, their lifestyle habits, their awareness, and their symptoms were investigated using an online survey.
METHODS:
In the survey, respondents experiencing symptoms specific to sick building syndrome, although they were not diagnosed with sick building syndrome, were categorized in the pre-sick building syndrome group. The relationships among individual characteristics, residential environment, and individual awareness were analyzed.
RESULTS:
Results showed that the prevalence of pre-sick building syndrome was high among young (aged 20-29 years) population of both sexes. In addition, "condensation," "moisture," "musty odors" in the house, and the "use of deodorant and fragrance" were all significantly associated with pre-sick building syndrome. Conversely, there was no significant association with recently built "wooden" houses that are highly airtight and have thermal insulation.
CONCLUSIONS
Efficient "ventilation" plans and "ventilation" improvement and air conditioning systems to prevent mold and condensation in rooms are necessary to maintain a good, indoor environment that is beneficial for health. Efforts should also be made to encourage individuals to regularly clean and effectively ventilate their homes.
5.Long-term effects of low-intensity training with slow movement on motor function of elderly patients: a prospective observational study.
Kanae KANDA ; Yutaka MORI ; Kunihisa YAMASAKI ; Hiroko KITANO ; Aya KANDA ; Tomohiro HIRAO
Environmental Health and Preventive Medicine 2019;24(1):44-44
BACKGROUND:
Slow-motion training, which comprises exercising using extremely slow-movements, yields a training effect like that of high-intensity training, even when the applied load is small. We developed a slow-training exercise program that allows elderly people to safely use their own body weight without a machine. Previously, it was confirmed that functional gait and lower limb muscle strength were improved by low-intensity training using bodyweight training for 3 months. This study evaluated the long-term effects of low-intensity training using body weight with slow-movements on the motor function of frail, elderly patients.
METHODS:
Ninety-six elderly men and women aged 65 years or older whose level of nursing care was classified as either support required (1 and 2) or long-term care required (care levels 1 and 2) volunteered to participate. Two facilities were used. Participants at the first facility used low-intensity training using body weight with slow-movements (low-stress training [LST] group, n = 65), and participants at another facility used machine training (MT group, n = 31). Exercise interventions were conducted for 12 months, once or twice per week, depending on the required level of nursing care. Changes in motor function were examined.
RESULTS:
Post-intervention measurements based on the results of the chair-stand test after 12 months showed significant improvements from pre-intervention levels (P < 0.0001) in the LST group and MT group. Although the ability of performing the Timed Up & Go test and the ability to stand on one leg with eyes open improved in both groups, no significant change was observed. When changes after 12 months were compared between the two groups, no significant difference was observed for any variables.
CONCLUSIONS:
Slow body weight training for 12 months without a machine improved the lower limb muscle strength. Therefore, it could have the same effects as training using a machine.
TRIAL REGISTRATION
UMIN000030853 . Registered 17 January 2018 (retrospectively registered).
Aged
;
Aged, 80 and over
;
Body Weight
;
Exercise Therapy
;
statistics & numerical data
;
Female
;
Frail Elderly
;
statistics & numerical data
;
Humans
;
Japan
;
Male
;
Movement
;
Prospective Studies
6.Effects of low-intensity bodyweight training with slow movement on motor function in frail elderly patients: a prospective observational study.
Kanae KANDA ; Takeshi YODA ; Hiromi SUZUKI ; Yugo OKABE ; Yutaka MORI ; Kunihisa YAMASAKI ; Hiroko KITANO ; Aya KANDA ; Tomohiro HIRAO
Environmental Health and Preventive Medicine 2018;23(1):4-4
BACKGROUND:
Slow-motion training, an exercise marked by extremely slow movements, yields a training effect like that of a highly intense training, even when the applied load is small. This study evaluated the effects of low-intensity bodyweight training with slow movement on motor function in frail, elderly patients.
METHODS:
Ninety-seven elderly men and women aged 65 years or older, whose level of nursing care was classified as either support required (1 and 2) or long-term care required (care level 1 and 2), volunteered to participate. Two facilities were used. Participants in the first facility used low-intensity bodyweight training with slow movement (the LST group, n = 65), and participants in another facility used machine training (the control group, n = 31). Exercises were conducted for 3 months, once or twice a week, depending on the required level of nursing care. Changes in motor function were examined.
RESULTS:
Post-exercise measurements showed significant improvements from the pre-exercise levels after 3 months, based on the results of the Timed Up and Go test (p = 0.0263) and chair-stand test (p = 0.0016) in the low-intensity exercise with slow movement and tonic force generation (LST) group. Although the ability to stand on one leg with eyes open tended to improve, no significant change was found (p = 0.0964).
CONCLUSIONS:
We confirmed that carrying out LST bodyweight training for 3 months led to improvements in ambulatory function and lower-limb muscle strength. In this way, it is possible that LST training performed by holding a bar or by staying seated on a chair contributes to improved motor function in elderly patients within a short time.
TRIAL REGISTRATION
UMIN000030853 . Registered 17 January 2018. (retrospectively registered).
Aged
;
Aged, 80 and over
;
Female
;
Frail Elderly
;
Humans
;
Long-Term Care
;
Male
;
Motor Activity
;
Movement
;
Prospective Studies
;
Resistance Training
;
methods
7.Difficulties in daily life of post thoracic esophagectomy cancer patients after hospital discharge
Shigeaki Watanuki ; Keiko Iino ; Yurie Koyama ; Miho Kurihara ; Chisato Ichikawa ; Kyoko Okada ; Hideo Uesugi ; Chie Asanuma ; Hiroyuki Daiko ; Takeo Fujita ; Kyoko Suzuki ; Chihoko Wada ; Michiko Mori ; Yoko Hisabe ; Kaori Yagasaki ; Hiroko Komatsu
Palliative Care Research 2014;9(2):128-135
Purpose: This study aimed at identifying difficulties among post thoracic esophagectomy cancer patients during outpatient follow-up. Methods: Patients who had radical esophagectomy at a cancer center hospital in Japan were prospectively observed and were interviewed by a certified nurse assigned at esophageal surgical outpatient division. Their responses were documented in medical records and were analyzed by content analysis method. This study was approved by the study hospital's research ethics committee. Results: The data from 66 patients were obtained. Content analysis yielded 221 extracts, 25 categories, and 65 codes of difficulties, including: concerns or signs/symptoms associated with dietary intake, physical activity, and anxiety. Implications: The majority of post-thoracoabdominal esophagectomy patients experienced multiple dysfunctions and symptoms after discharge. The results underscore the significance of nurses' role in assessing and instructing patients to address these issues.
8.Content analysis of nurses' interventions for post thoracic esophagectomy cancer patients at the outpatient clinic
Keiko Iino ; Shigeaki Watanuki ; Yurie Koyama ; Miho Kurihara ; Chisato Ichikawa ; Kyoko Okada ; Hideo Uesugi ; Chie Asanuma ; Hiroyuki Daiko ; Takeo Fujita ; Kyoko Suzuki ; Chihoko Wada ; Michiko Mori ; Yoko Hisabe ; Kaori Yagasaki ; Hiroko Komatsu
Palliative Care Research 2014;9(3):110-117
Background: Patients having thoracic esophagectomy, a standardized treatment for esophageal cancer patients in Japan, are known to have various postsurgical signs and symptoms for a period of time. The current status of nursing interventions at outpatients need to be clarified. Purpose: This study aimed at identifying the nurses' interventions for cancer patients at the outpatient setting who previously had thoracic radical esophagectomy. Methods: Patients who had esophagectomy at a cancer center hospital in Japan were prospectively observed and interviewed by outpatient nurses between January 2009 and December 2010. Their documented responses in medical record were prospectively investigated and were qualitatively analyzed via content analysis method. This study was approved by the study hospital's research ethics committee. Results and discussion: The data analysis of nursing interventions for 66 patients yielded 372 extracts, 12 categories, and 74 codes. Nurses were assessing patients' signs and symptoms affected by postsurgical changes, and were utilizing patients' active self-monitoring skills. The results also showed the significance of facilitating postsurgical recovery in relation to nutritional intake and physical activity in patients' daily life. Implications: Based upon the study results, the development of a systematic program is underway, which facilitates esophageal cancer patients' postsurgical recovery.
9.Signs and symptoms associated with postsurgical dysfunctions among upper gastroesophageal cancer patients: an analysis of the published reports
Keiko Iino ; Shigeaki Watanuki ; Yurie Koyama ; Kyoko Suzuki ; Chihoko Wada ; Michiko Mori ; Miho Kurihara ; Kyoko Okada ; Chisato Ichikawa ; Hideo Uesugi ; Tomiko Ichihashi ; Yoko Hisabe ; Kaori Yagasaki ; Hiroko Komatsu
Palliative Care Research 2013;8(2):701-720
Purpose: The review of the published reports was performed with the aim of systematic collection and integration of information related to "signs and symptoms" along with their changes among patients after upper gastroesophageal surgeries. Methods: The PubMed and the Japanese healthcare literature database were searched by the following keywords:"gastric cancer" "esopha∗ cancer" "surgery" and "symptom" As a result, 37 articles related to gastric or esophagus cancer were identified. The data were extracted according to each sign and symptom, and were evaluated and discussed. Results and Conclution: Standardized instruments for gastrointestinal symptoms included evaluations about dysphagia, difficulty in swallowing, reflux etc. The incidence of signs and symptoms, or postsurgical recovery processes are different among individual patients. Healthcare professionals should support patients continuously and systematically so that patients can take appropriate health maintenance behavior according to their signs and symptoms.
10.Effects of Essential Oil Fragrances and Preferences thereof on Blood Pressure and Heart Rate in Healthy Human Subjects
Hiroko MORI ; Akiko KOBAYASHI ; Sanae KIKKAWA ; Hitoshi YAMASHITA
Japanese Journal of Complementary and Alternative Medicine 2009;6(3):137-142
Objective: It has been reported that essential oils used in aromatherapy effect the nervous, immune and endocrine systems. The purpose of this study was to assess the effects of essential oils on the cardiovascular system in healthy human subjects.
Methods: Rosemary essential oil, which reportedly has a vasopressor-like effect, and lavender essential oil which reportedly has a depressor-like effect, were administered to sixty subjects divided into rosemary, lavender, or control groups. Blood pressure and heart rate were measured after two-minutes of smelling. Data were compared among the three groups.
Result: Heart rate increased in the rosemary group. In addition to blood pressure and heart rate increased in subjects who expressed a negative impression from smelling a specific essential oils.
Conclusion: The results suggest that fragrance preference affects the therapeutic effects of aromatherapy.


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