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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025822
Receipt No. 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

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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
Email 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
Email homma.s@nifty.com

Sponsor
Institute Hokkaido University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029695

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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