UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025822 |
|---|---|
| Receipt number | R000029695 |
| Scientific Title | Efficacy of preoperative elemental diet for patients with severe stenotic colorectal cancer undergoing laparoscopic surgery |
| Date of disclosure of the study information | 2017/01/24 |
| Last modified on | 2018/07/27 11:00:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of preoperative elemental diet for patients with severe stenotic colorectal cancer undergoing laparoscopic surgery
Acronym
Efficacy of preoperative elemental diet for patients with severe stenotic colorectal cancer undergoing laparoscopic surgery
Scientific Title
Efficacy of preoperative elemental diet for patients with severe stenotic colorectal cancer undergoing laparoscopic surgery
Scientific Title:Acronym
Efficacy of preoperative elemental diet for patients with severe stenotic colorectal cancer undergoing laparoscopic surgery
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of Elental administration for patients with severe stenotic colorectal cancer undergoing laparoscopic surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. perioperative elements (operation time, blood loss, postoperative complications, postoperative hospital stay)
2. nutritional condition and adverse event after Elental administration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent elective laparoscopic colorectal resection for primary colorectal cancers between December 2012 and November 2015 at Hokkaido University Hospital.
Key exclusion criteria
Excluded were patients who already had ileus on admission and those who refused Elental intake. Ileus is identified as the need for emergent bowel drainage by stoma, stent, or ileus tube because of bowel obstruction.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinobu Taketomi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterological Surgery I
Zip code
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigenori Homma |
Organization
Hokkaido University Hospital
Division name
Gastroenterological Surgery I
Zip code
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5927
Homepage URL
homma.s@nifty.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
No
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
Address
Tel
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 24 | Day |
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The group E patients (who had severe stenotic colorectal cancers) started fasting upon admission. They were given an elemental diet (Elental) from admission until the day before surgery with no rehydration therapy. One pack of Elental, which contained 300 kilocalories (kcal), was dissolved in 300 mL of water for oral use. Generally, patients drank Elental after adding some flavored powder to avoid growing tired of the taste. The oral dose of Elental was escalated gradually: two packs/day (600 kcal) on day 1 and three packs/day (900 kcal) thereafter. Patients were evaluated twice a week via abdominal radiography and blood tests. When patients developed ileus, peritonitis, dehydration, or an electrolyte abnormality, they were given rehydration therapy and, if necessary, stopped the elemental diet.
Group C patients started fasting after lunch the day before surgery and underwent MBP using polyethylene glycol lavage thereafter. They were not given nutritional support before surgery.
Management information
Registered date
| 2017 | Year | 01 | Month | 24 | Day |
Last modified on
| 2018 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029695
