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Peroral Endoscopic Myotomy (POEM) is a novel, promising endoscopic technique for achalasia because it is safer and more effective than traditional Heller's myotomy. However, the issue of antibiotic prophylaxis in POEM has evoked considerable controversy recently. Therefore, we conduct this study to elucidate the status of POEM-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed.
Objective: To elucidate the status of POEM-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed.
Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM are randomized to either use antibiotic prophylactically or not.
Main outcome measurements: Blood culture positive incidence; secondary outcomes are procalcitonin levels, C-reactive protein levels, white blood cell counts and so on.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no antibiotic prophylaxis | Active Comparator | These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically. |
|
| second-generation cephalosporin | Active Comparator | These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no antibiotic prophylaxis | Drug | These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood culture positive incidence | To compare the positive incidence of blood cultures between antibiotic prophylaxis and no antibiotic prophylaxis. | after 12 hours of POEM |
| Measure | Description | Time Frame |
|---|---|---|
| procalcitonin level | To observe the changes of procalcitonin levels after POEM in which no antibiotic is administered. To compare the procalcitonin levels between antibiotic prophylaxis and no antibiotic prophylaxis. | after 12 hours of POEM |
| Measure | Description | Time Frame |
|---|---|---|
| clinical manifestation | To observe the changes of temperature, heart rate, respiratory rate, white blood cell counts, neutrophile granulocyte counts in perioperative period. | during hospital stay and up to 1 week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping-Hong Zhou, M.D,PhD | Fudan University | Study Director |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000097909 | Second Generation Cephalosporins |
| ID | Term |
|---|---|
| D000097902 | beta Lactam Antibiotics |
| D000900 | Anti-Bacterial Agents |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
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| second-generation cephalosporin | Drug | These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically. |
|
| D004066 | Digestive System Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |