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PHASE II-III CLINICAL TRIAL TO EVALUATE THE SAFETY, EFFECTIVENESS AND EFFICIENCY OF DISCHARGE TO OUTPATIENT SURGERY IN PATIENTS WITH ACUTE GANGRENOUS APPENDICITIS UNDERGOING EMERGENCY SURGERY.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Experimental | Out management patient |
|
| Control | Experimental | hospitalised patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| outpatient surgery | Other | outpatient surgery |
| |
| Hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy. | Numer of hospital readmission | 1 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants achieving discharge criteria based on the Modified Aldrete Score (range 0-10, higher scores indicate better recovery) after appendectomy | The Modified Aldrete Score assesses recovery after anesthesia (range 0-10). Participants meeting predefined discharge criteria (e.g., score ≥9) will be considered eligible for outpatient management. Results will be reported as number and percentage of participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del RocÃo | Recruiting | Seville | Sevilla | 41013 | Spain |
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| Other |
Hospitalization after surgery |
|
| Immediately postoperatively (before discharge) |
| Determine the causes of failure of the outpatient regimen in our patients. | Record of the causes of failure of the outpatient system | 30 days since the intervention |
| Association between baseline characteristics and failure of outpatient management within 30 days | The relationship between baseline demographic and clinical variables and outpatient management failure will be assessed using appropriate statistical methods (e.g., logistic regression). Results will be reported as odds ratios with 95% confidence intervals. | 30 days since the intervention |
| Time off work | Time until patients fully return to work | 30 days since surgery |
| Degree of satisfaction | To measure the degree of satisfaction expressed by our patients with outpatient management after laparoscopic appendectomy, using a 14-item patient satisfaction questionnaire based on a 4-point Likert scale (minimum score 1, maximum score 4 per item), where higher scores indicate greater satisfaction (better outcome). | 30 days since surgery |
| Efficiency of outpatient management | Compare the costs of outpatient care versus hospitalization for patients with acute gangrenous appendicitis undergoing laparoscopic surgery (cost-minimization analysis). | 30 days since surgery |
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000556 | Ambulatory Surgical Procedures |
| D006760 | Hospitalization |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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