Unique ID issued by UMIN | UMIN000038361 |
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Receipt number | R000043718 |
Scientific Title | Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients |
Date of disclosure of the study information | 2020/04/01 |
Last modified on | 2023/11/01 17:37:56 |
Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients
Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients
Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients
Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients
Japan |
Esophageal cancer
Gastrointestinal surgery | Dental medicine |
Malignancy
NO
To clarify the relationship between gum chewing training during perioperative period and tongue pressure after surgery in the patients with esophageal cancer surgery
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
The ratio of the patients whose tongue pressure was decreased the day after 2 weeks of surgery
The following data will be evaluated on 1) The starting day of gum chewing, 2) The day before surgery, 3) The day after 2 weeks of surgery.
-Swallowing function: tongue pressure, RSST, presence/absence of recurrent laryngeal nerve palsy, oral diadocokinesis
-Masticatory function: Masticatory ability, occlusal force
-Oral hygiene: degree of tongue coating, total number of bacteria on back of tongue, bacterial flora
-Mouth dryness: Oral moisture meter measurement value
-Equilibrium function: Opening one leg up time
The following data will be evaluated on the period between the starting day of gum chewing and the day of end of observational period
-Adverse events, safety: Postoperative complications such as suture failure, accidents due to gum mastication (detachment of prostheses and restorations, temporomandibular joint pain, etc.), and other adverse events
-Postoperative lung complications (JCOG postoperative complication criteria (Clavien-Dindo classification)) v2.0
-Nutrition related items: Oral intake start time, discharge time, ratio of oral intake to total nutrition intake, ratio of home discharge and hospital transfer, etc.
-Postoperative delirium: Contents of medical records
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
1
Educational,Counseling,Training
Food |
Gum chewing training during perioperative period in the patients with esophageal cancer
20 | years-old | <= |
80 | years-old | > |
Male and Female
The patients who undergo thoracic esophageal cancer surgery at our hospital
1) The patients who will undergo primary radical operation
2) The Patients who have received sufficient explanation for participation in this study, and who have received sufficient written consent from the patient himself / herself with sufficient understanding
1)The patients who cannot gum chewing because of denture or something
2) The Patients who are determined to be inappropriate as research subjects by the principal investigator or other investigators
40
1st name | Reiko |
Middle name | Yamanaka |
Last name | Kohno |
Okayama University Hospital
Hospital Dentistry
7008558
2-5-1, Shikata-cho, Kita-ku, Okayama
81862356588
reiko_y@md.okayama-u.ac.jp
1st name | Reiko |
Middle name | |
Last name | Yamanaka |
Okayama University hospital
Hospital Dentistry
7008558
2-5-1, Shikata-cho, Kita-ku, Okayama
81862356588
reiko_y@md.okayama-u.ac.jp
Okayama University
Reiko Yamanaka
the Japan Society for the Promotion of Science (JSPS)
Japanese Governmental office
Japan
8020 Promotion Foundation
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
2-5-1, Shikata-cho, kita-ku, Okayama, 7008558
086-235-6503, 6938
mae6605@adm.okayama-u.ac.jp
NO
岡山大学病院
2020 | Year | 04 | Month | 01 | Day |
Unpublished
40
Thirty-two patients of all of 40 patients completed perioperative gum chewing training. After the propensity score matching, a matched cohort of 25 pairs of cases was created in Gum Chewing, and Historical Control Group). Eleven patients (44.0%) in Gum Chewing Group was decreased on tongue pressure 2 weeks postoperatively, and significantly fewer than 19 patients (76.0%) in Historical Control Group (95% CI, 0.07 - 0.83, p = 0.02).
2023 | Year | 11 | Month | 01 | Day |
Delay expected |
Because the paper has not been completed yet.
nothing special
No longer recruiting
2019 | Year | 10 | Month | 23 | Day |
2020 | Year | 09 | Month | 29 | Day |
2021 | Year | 03 | Month | 29 | Day |
2022 | Year | 07 | Month | 31 | Day |
2019 | Year | 10 | Month | 22 | Day |
2023 | Year | 11 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043718
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