Status:
UNKNOWN
Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI)
Lead Sponsor:
Beijing Bozhiyin T&S Co., Ltd.
Conditions:
Postoperative Ileus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study is being conducted to determine whether Dexamethasone-Allantoin-Metronidazole (DAM) Solution can accelerate recovery of gastrointestinal function following abdominal operation when compared...
Detailed Description
Postoperative ileus (POI) is temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. This functional impairment persists for a variable durat...
Eligibility Criteria
Inclusion
- are either Male or Female at least 18 years of age;
- Had an American Society of Anesthesiologists (ASA) Physical Status Score of I-III;
- Were scheduled to undergo partial small or large BR with primary anastomosis (performed completely by laparotomy); biliary-enteric Roux-en-Y anastomosis surgery;
- BMI (kg/m\^2) index≥15 and ≤30;
- Understood the procedures, agreed to participate in the study program, and voluntarily signed the informed consent form.
Exclusion
- Had complete bowel obstruction;
- Were scheduled for a total colectomy;
- Were scheduled for a ileal pouch-anal anastomosis;
- Were scheduled for a colostomy, ileostomy;
- Had a history of gastrectomy, total colectomy, gastric bypass, short bowel syndrome, or multiple previous abdominal surgeries;
- Had clinically significant laboratory abnormalities on screening(such as: ALT, AST were more than 2 times the upper limit of normal value; Cr is greater than 1.2 times the upper normal limit, according to the center for the study of the normal value range);
- Applied the intravenous or epidural postoperative analgesia pump;
- Bowel preparation does not meet the requirements;
- Were allergy to components of the investigational drug (allantoin, metronidazole, dexamethasone);
- Had used illicit drugs or had abused alcohol;
- Had a history of illness, or behavior (e.g., depression, psychosis) that in the opinion of the investigator might confound the results of the study or pose an additional risk in participating in the study;
- Women who were pregnant, and women who were of childbearing potential and not using method of birth control;
- Had participated in another clinical drug trial within the last 3 months;
- Were not agreed to participate the clinical trial by investigators.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2014
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT01863407
Start Date
April 1 2013
End Date
November 1 2014
Last Update
May 29 2013
Active Locations (1)
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1
Center for Drug Clinical Research, Shanghai University of Chinese Medicine
Shanghai, Shanghai Municipality, China, 201203