Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative … (NCT01863407) | Clinical Trial Compass
UnknownPhase 3
Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI)
China480 participantsStarted 2013-04
Plain-language 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 with a placebo.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 additio…
What they're measuring
1
Time to achieve recovery of both upper and lower GI function as measured by a composite endpoint of time to the first bowel movement and time to tolerate first solid food. This endpoint is referred to as GI2.