![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000041824 |
Receipt No. | R000047740 |
Scientific Title | Safety and efficacy of preoperative short-term weight loss with formula diet in patients with BMI> 30 in endoscopic surgery |
Date of disclosure of the study information | 2020/10/01 |
Last modified on | 2020/09/17 |
Basic information | ||
Public title | Safety and efficacy of preoperative short-term weight loss with formula diet in patients with BMI> 30 in endoscopic surgery | |
Acronym | Safety and efficacy of preoperative short-term weight loss with formula diet in patients with BMI> 30 in endoscopic surgery | |
Scientific Title | Safety and efficacy of preoperative short-term weight loss with formula diet in patients with BMI> 30 in endoscopic surgery | |
Scientific Title:Acronym | Safety and efficacy of preoperative short-term weight loss with formula diet in patients with BMI> 30 in endoscopic surgery | |
Region |
|
Condition | ||
Condition | Esophageal cancer, Gastric cancer | |
Classification by specialty |
|
|
Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Incidence of postoperative pulmonary complications |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Incidence of postoperative pulmonary complications |
Key secondary outcomes | Visceral fat loss rate, surgical time, intraoperative blood loss, incidence of anastomotic insufficiency, number of lymph node dissections |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | For one month before surgery, one of the three meals should be a formula meal (170 kcal or 340 kcal), and the other two meals should be a normal meal (600 kcal each) | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | BMI>30kg/m2 | |||
Key exclusion criteria | Total protein<6.5, Albumin<4.1,Active cardiac complications, Active pulmonary complications, PS>1 | |||
Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Suwa Red Cross Hospital | ||||||
Division name | Department o surgery | ||||||
Zip code | 392-0022 | ||||||
Address | 5-11-50, Kogandoori, Suwa, Nagano | ||||||
TEL | 0266526111 | ||||||
kiyomaru@suwa.jrc.or.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Suwa Red Cross Hospital | ||||||
Division name | Department of surgery | ||||||
Zip code | 392-0027 | ||||||
Address | 5-11-50, Kogandoori, Suwa, Nagano | ||||||
TEL | 0266526111 | ||||||
Homepage URL | |||||||
kiyomaru@suwa.jrc.or.jp |
Sponsor | |
Institute | Suwa Red Cross Hospital
Department of surgery |
Institute | |
Department |
Funding Source | |
Organization | Suwa Red Cross Hospital |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Suwa Red Cross Hospital |
Address | 5-11-50, Kogandoori, Suwa, Nagano |
Tel | 0266526111 |
kiyomaru@suwa.jrc.or.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
|
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047740 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |