| Registry | NCT03009604 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 90 (Estimated) |
| Sponsor | Assiut University (Other) |
| Conditions | Benign Gynecologic Neoplasm |
| Interventions | Simethicone, Enema (Drug) |
| Dates | start 2017-01-01, primary completion 2017-04-01 (estimated), completion 2017-05-01 (estimated), first posted 2017-01-04, last updated 2017-01-04 |
| Locations | 1 site in Egypt |
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All trials for Benign Gynecologic Neoplasm All trials of Simethicone All trials of Enema
Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which thereby decreases the total colony count of bacteria, thus, decreasing peritoneal contamination in case of bowel injury, improving the access to the surgical field and facilitating intraoperative bowel manipulation
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Simethicone | Experimental | Drug: Simethicone | women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation |
| Enema | Active comparator | Drug: Enema | women take 3 rectal Enema (8:00 pm, 12:00 am \& 8:00 am) and to fast over night before the operation. |
Sex: Female, ages: 20 Years to 60 Years
Inclusion Criteria: Gynecological operations for benign conditions as hysterectomy, ovarian cystectomy and myomectomy. Exclusion Criteria: 1. History of allergic reaction to study drugs. 2. More than one scar of previous operation. 3. Suspicious of malignancy. 4. Psychiatric disorders.
| Facility | City | Country | Status |
|---|---|---|---|
| Assiut University | Asyut | Egypt | Recruiting |