UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022206
Receipt number R000025579
Scientific Title Observational analysis of relationship between postoperative diarrhea, including high ostomy output and Clostridium difficile infection, and postoperative complication in colectomy patients with colorectal cancer
Date of disclosure of the study information 2016/05/16
Last modified on 2022/01/29 11:51:25

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Basic information

Public title

Observational analysis of relationship between postoperative diarrhea, including high ostomy output and Clostridium difficile infection, and postoperative complication in colectomy patients with colorectal cancer

Acronym

Surveillance of Clostridium difficile infection after surgery for the colorectal cancer (SHISA1602)

Scientific Title

Observational analysis of relationship between postoperative diarrhea, including high ostomy output and Clostridium difficile infection, and postoperative complication in colectomy patients with colorectal cancer

Scientific Title:Acronym

Surveillance of Clostridium difficile infection after surgery for the colorectal cancer (SHISA1602)

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Observasional analysis of relationship between postoperative diarrhea, including high ostomy output and Clostridium difficile infection, and postoperative complication in colectomy patients with colorectal cancer

Basic objectives2

Others

Basic objectives -Others

Identification of the risk factor of postoperative diarrhea, high ostomy output and Clostridium difficile infection

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The incidence of postoperative diarrhea, high ostomy output and Clostridium difficile infection, and relationship of diarrhea and postoperative complication in colectomy patients with colorectal cancer

Key secondary outcomes

Identification of the risk factor of postoperative diarrhea, high ostomy output and Clostridium difficile infection


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Clinically proven colorectal cancer
2. Resectable primary tumor
3. Age equal more 20 years old
4. Ascertained informed consent

Key exclusion criteria

1. Uncontrolled diarrhea or Clostridium difficile infection
2. Patients judged by the principal investigator or subinvestigator to be unsuitable for participation for any other reason

Target sample size

790


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Ohta

Organization

Shiga University of Medical Science

Division name

Gastrointestinal surgery

Zip code

5202192

Address

Seta-tsukinowa cho, Otsu, Shiga, Japan

TEL

077-548-2238

Email

hohta@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Ohta

Organization

Shiga University of Medical Science

Division name

Gastrointestinal surgery

Zip code

5202192

Address

Seta-tsukinowa cho, Otsu, Shiga, Japan

TEL

077-548-2238

Homepage URL


Email

hohta@belle.shiga-med.ac.jp


Sponsor or person

Institute

Department of gastrointestinal surgery, Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Department of gastrointestinal surgery, Shiga University of Medical Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kusatsu general hospital
Bellland general hospital
Nagahama red cross hospital
Nara municipal hospital
Komatsu municipal hospital
Shin-Koga hospital
Ako city hospital
Koga 21 hospital
Higashi-ohmi general medical center
JCHO Shiga hospital
Tesseikai Neurosurgical Hospital
Hino memorial hospital
Toyosato hospital
Konan hospital
Yasu hospital
Koto memorial hospital
Biwako ohashi hospital
Kima hospital
Nishi Kyoto hospital
Makino hospital
Shigaraki hospital
Nagahama City Kohoku Hospital
Ikuta hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shiga University of Medical Science

Address

Seta-tsukinowa cho, Otsu, Shiga, Japan

Tel

077-548-3619

Email

hqrec@belle.shiga-med.ac.jp


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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 16 Day


Related information

URL releasing protocol

https://doi.org/10.1007/s00384-022-04097-8

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1007/s00384-022-04097-8

Number of participants that the trial has enrolled

178

Results

Smoking and hypertension are the independent predictors of postoperative diarrhea after an elective CRC surgery. Rectal cancer surgery seems to be associated with postoperative diarrhea more than colon cancer surgery does. Mild postoperative diarrhea may lead to more severe complications.

Results date posted

2022 Year 01 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

A total of 178 patients were enrolled in this study; of these, 147 were categorized into the non-stoma group. Based on the stoma-creation surgery, 17 and 14 patients were categorized into the colostoma and ileostoma groups, respectively. Table 1 demonstrates the characteristics of the patients in the three groups. All patients in the colostoma and ileostoma groups had permanent colostomy and diverting loop ileostomy, respectively. The entire study sample comprised 96 men and 82 women. The median age was 71 years, and the median BMI was 22 kg/m2; 72 patients (40.4%) were smokers, 69 patients (38.8%) had a high blood pressure, and 28 (15.7%) had diabetes mellitus.

Participant flow

This (Shiga Surgical Association1602) is a multicenter, prospective, observational study involving patients with postoperative diarrhea who underwent CRC surgery at six hospitals in Japan. A total of 178 consecutive patients with CRC, who were scheduled for an elective radical surgery between June 2016 and December 2017, were enrolled in this study.

Adverse events

None

Outcome measures

A total of 178 patients participated in the study. In the nonstoma group, the incidence of postoperative diarrhea was 18.4% (27/147). The incidence of HOS was 28.6% (4/14) in the ileostoma group, and 0% in the colostoma group. Multivariable analyses of the incidence of diarrhea in the nonstoma group indicated that habitual smoking and hypertension were significantly associated with postoperative diarrhea (P=0.012 and P=0.0274, respectively). Postoperative diarrhea was more likely to occur in patients with rectal cancer than in those with colon cancer (P=0.0501). In the nonstoma and ileostoma groups, the probability of the occurrence of other complications with Clavien Dindo (C D) grades II or higher was significantly higher in patients with C-D grade I diarrhea, including HOS, than in patients without diarrhea (39.3% vs. 14.6%, P=0.0061).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 04 Month 23 Day

Date of IRB

2016 Year 03 Month 22 Day

Anticipated trial start date

2016 Year 06 Month 01 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 12 Month 31 Day

Date trial data considered complete

2019 Year 12 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information

-Design and Setting: Prospective observational study
-Primary outcomes:
The incidence of postoperative diarrhea, high ostomy output and Clostridium difficile infection, and relationship of diarrhea and postoperative complication in colectomy patients with colorectal cancer
-Secondary outcomes:
Identification of the risk factor of postoperative diarrhea, high ostomy output and Clostridium difficile infection


Management information

Registered date

2016 Year 05 Month 05 Day

Last modified on

2022 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025579


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name