Unique ID issued by UMIN | UMIN000006657 |
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Receipt number | R000007870 |
Scientific Title | Necessity of rod in loop ileostomy |
Date of disclosure of the study information | 2011/11/03 |
Last modified on | 2016/09/01 11:56:37 |
Necessity of rod in loop ileostomy
Rod in loop ileostomy
Necessity of rod in loop ileostomy
Rod in loop ileostomy
Japan |
ulcerative colitis
Gastrointestinal surgery |
Others
NO
The diverting loop ileostomy has a role for decreasing the re-operation due to septic complications with anastomotic leakage in restorative proctocolectomy for ulcerative colitis. However, there are appreciable complications with ostomy creation which includes necrosis, prolapsed, retraction, peristomal hernia, dermatitis, ulceration, fistula, and outlet obstruction. Traditionally, ileostomy rod is placed to prevent the stoma retraction in many institutions. However, preventive efficacy for retraction was not proved clearly and not seen proper evaluations but it is known to be associated with pressure ulcer and dermatitis by rod. Then, the primary objective of this study is to determine whether ostomy rod was useful to prevent stoma retraction and outlet obstruction when applied diverting loop ileostomy in UC surgery. The secondary objective is to clarify the incidence of pressure ulcer and dermatitis due to ostomy rod.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
stoma retraction
parastomal dermatitis
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Treatment
Maneuver |
insertion of ostomy rod
Without ostomy rod
20 | years-old | <= |
70 | years-old | > |
Male and Female
Patients with UC who underwent elective 2 staged procedures will be randomly divided into two groups with or without ostomy rod.
dirty/infected wound, emergency surgery, laparoscopic surgery, separated double barrel ileostomy and stoma creation without bowel resection
160
1st name | |
Middle name | |
Last name | Motoi Uchino |
Hyogo College of Medicine
Dept of Surgery
1-1,Mukogawacho, Nishinomiya city, Hyogo pref, Japan
0798-45-6371
uchino2s@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Motoi Uchino |
Hyogo College of Medicine
Department of Surgery
1-1,Mukogawacho, Nishinomiya city, Hyogo pref, Japan
0798-45-6371
motoi.uchino@nifty.ne.jp
Hyogo College of Medicine
Hyogo college of Medicine
Self funding
Japan
NO
2011 | Year | 11 | Month | 03 | Day |
Unpublished
Completed
2011 | Year | 11 | Month | 01 | Day |
2011 | Year | 11 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 05 | Month | 01 | Day |
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2015 | Year | 05 | Month | 01 | Day |
2011 | Year | 11 | Month | 02 | Day |
2016 | Year | 09 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007870
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