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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.
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 duration following surgery, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. When POI persists for more than 5 days, it is generally considered severe, sometimes referred to as complicated or prolonged POI, and increases the risk for related morbidity. This is a randomized, controlled, double-blind study designed to evaluate the tolerability and efficacy of DAM solution for the treatment of POI in patients following abdominal operation. It will be conducted at multiple centers in China. A total of 480 patients will be enrolled in the study. Patient participation in the study will last for up to postoperative day 7 [POD 7] , with follow-up safety assessments to occur 7 days after the operation.The treatment outcome measures include: 1) GI2(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). 2) Time to ready for discharge. 3) Time to the first flatus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAM Solution | Experimental | Preheated to a temperature level, mixed the DAM Solution 2ml and Normal Saline 250ml, poured into abdominal cavity and infiltrate the operative field before the abdominal closure |
|
| Normal Saline | Placebo Comparator | Preheated the Normal Saline 250ml to a temperature level, poured into abdominal cavity and infiltrate the operative field before the abdominal closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAM | Drug | composed of dexamethasone, allantoin and metronidazole |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7d |
| Measure | Description | Time Frame |
|---|---|---|
| Time to ready for discharge | 7 days | |
| Time to the first flatus | 7 days | |
| Comparison between the 2 groups of analgesics (morphine) dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing-shan Zheng, professor | Contact | 13817078595 | qingshan.zheng@drugchina.net |
| Name | Affiliation | Role |
|---|---|---|
| Ying-jiang Ye, professor | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Drug Clinical Research, Shanghai University of Chinese Medicine | Recruiting | Shanghai | Shanghai Municipality | 201203 | China |
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| ID | Term |
|---|---|
| D045823 | Ileus |
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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| Normal Saline | Drug | Normal Saline 250ml |
|
|
| 7 days |
| peritoneal exudate volume of 72 hours after operation | 3 days |
| C reactive protein changes from baseline | 7 days |