UMIN-CTR Clinical Trial

Public title

Predisposing factors and clinical impact of high-output syndrome after sphincter-preserving surgery with covering ileostomy for rectal cancer: A retrospective single-center cohort study

Acronym

Predisposing factors and clinical impact of high-output syndrome after sphincter-preserving surgery with covering ileostomy for rectal cancer: A retrospective single-center cohort study

Scientific Title

Predisposing factors and clinical impact of high-output syndrome after sphincter-preserving surgery with covering ileostomy for rectal cancer: A retrospective single-center cohort study

Scientific Title:Acronym

Predisposing factors and clinical impact of high-output syndrome after sphincter-preserving surgery with covering ileostomy for rectal cancer: A retrospective single-center cohort study

Region

Japan

Condition

Rectal cancer

Classification by specialty

Surgery in general

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To clarify the predisposing factors and clinical impact of Ileostomy-related high-output syndrome

Basic objectives2

Bio-availability

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Predisposing factors of Ileostomy-related high-output syndrome

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

20

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

patients with rectal cancer who underwent sphincter-preserving total mesorectal excision with covering ileostomy in our department from June 2016 to December 2017.

Key exclusion criteria

lack of ostomy closure, emergent surgery, lack of laboratory data before ostomy closure

Target sample size

500

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Konishi

Organization

Cancer Institute Hospital of the Japanese Foundation for Cancer Research

Division name

Department of Gastroenterological Surgery

Zip code

135-8550

Address

31-8-3 Ariake, Koto-ku, Tokyo

TEL

03-3520-0111

Email

tkonishi-tky@umin.ac.jp

Name of contact person

1st name	Tsuyoshi
Middle name
Last name	Konishi

Organization

Cancer Institute Hospital of the Japanese Foundation for Cancer Research

Division name

Department of Gastroenterological Surgery

Zip code

135-8550

Address

31-8-3 Ariake, Koto-ku, Tokyo

TEL

03-3520-0111

Homepage URL

Email

tkonishi-tky@umin.ac.jp

Institute

Cancer Institute Hospital of the Japanese Foundation for Cancer Research

Institute

Department

Personal name

Organization

Cancer Institute Hospital of the Japanese Foundation for Cancer Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Cancer Institute Hospital of the Japanese Foundation for Cancer Research

Address

31-8-3 Ariake, Koto-ku, Tokyo

Tel

03-3520-0111

Email

tkonishi-tky@umin.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

05

Month

29

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/32902781/

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/32902781/

Number of participants that the trial has enrolled

195

Results

High-output syndrome developed in 44/195 eligible patients (22.6%).Multivariable analysis revealed that neoadjuvant(chemo)radiotherapy, postoperative complications, postoperative maximal white blood cell, and postoperative maximal C-reactive protein 10 mgdl were independently associated with high-output syndrome. High-output syndrome was associated with increased renal dysfunction at the time of ostomy closure, but not with nutritional imbalance or electrolyte abnormalities.

Results date posted

2022

Year

05

Month

30

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

consecutive patients with rectal cancer undergoing resection with covering ileostomy during 2016-2017

Participant flow

electrolyte abnormality and renal dysfunction were retrospectively investigated in consecutive patients

Adverse events

None

Outcome measures

Incidence of high output syndrome.
Factors associated with renal dysfunction during ileostomy creation

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

01

Month

01

Day

Date of IRB

2019

Year

12

Month

13

Day

Anticipated trial start date

2019

Year

12

Month

14

Day

Last follow-up date

2020

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study aimed to clarify the predisposing factors and clinical impact of ileostomy-related high-output syndrome.

Registered date

2020

Year

05

Month

28

Day

Last modified on

2022

Year

05

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046292