Unique ID issued by UMIN | UMIN000022206 |
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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 |
Observational analysis of relationship between postoperative diarrhea, including high ostomy output and Clostridium difficile infection, and postoperative complication in colectomy patients with colorectal cancer
Surveillance of Clostridium difficile infection after surgery for the colorectal cancer (SHISA1602)
Observational analysis of relationship between postoperative diarrhea, including high ostomy output and Clostridium difficile infection, and postoperative complication in colectomy patients with colorectal cancer
Surveillance of Clostridium difficile infection after surgery for the colorectal cancer (SHISA1602)
Japan |
Colorectal cancer
Gastrointestinal surgery |
Malignancy
NO
Observasional analysis of relationship between postoperative diarrhea, including high ostomy output and Clostridium difficile infection, and postoperative complication in colectomy patients with colorectal cancer
Others
Identification of the risk factor of postoperative diarrhea, high ostomy output and Clostridium difficile infection
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
Identification of the risk factor of postoperative diarrhea, high ostomy output and Clostridium difficile infection
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Clinically proven colorectal cancer
2. Resectable primary tumor
3. Age equal more 20 years old
4. Ascertained informed consent
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
790
1st name | Hiroyuki |
Middle name | |
Last name | Ohta |
Shiga University of Medical Science
Gastrointestinal surgery
5202192
Seta-tsukinowa cho, Otsu, Shiga, Japan
077-548-2238
hohta@belle.shiga-med.ac.jp
1st name | Hiroyuki |
Middle name | |
Last name | Ohta |
Shiga University of Medical Science
Gastrointestinal surgery
5202192
Seta-tsukinowa cho, Otsu, Shiga, Japan
077-548-2238
hohta@belle.shiga-med.ac.jp
Department of gastrointestinal surgery, Shiga University of Medical Science
Department of gastrointestinal surgery, Shiga University of Medical Science
Self funding
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
Shiga University of Medical Science
Seta-tsukinowa cho, Otsu, Shiga, Japan
077-548-3619
hqrec@belle.shiga-med.ac.jp
NO
2016 | Year | 05 | Month | 16 | Day |
https://doi.org/10.1007/s00384-022-04097-8
Published
https://doi.org/10.1007/s00384-022-04097-8
178
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.
2022 | Year | 01 | Month | 29 | Day |
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.
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.
None
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).
Completed
2016 | Year | 04 | Month | 23 | Day |
2016 | Year | 03 | Month | 22 | Day |
2016 | Year | 06 | Month | 01 | Day |
2017 | Year | 12 | Month | 31 | Day |
2019 | Year | 12 | Month | 31 | Day |
2019 | Year | 12 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
-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
2016 | Year | 05 | Month | 05 | Day |
2022 | Year | 01 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025579
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