UMIN-CTR Clinical Trial

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

Colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hokkaido University

Institute

Department

Personal name

Organization

No

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学病院（北海道）

Date of disclosure of the study information

2017

Year

01

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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