UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of preoperative elemental diet for patients with severe stenotic colorectal cancer undergoing laparoscopic surgery
Title of the study (Brief title)	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	Akinobu Taketomi
Organization	Hokkaido University Graduate School of Medicine
Division name	Gastroenterological Surgery I
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	Shigenori Homma
Organization	Hokkaido University Hospital
Division name	Gastroenterological Surgery I
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029695