Safety and Efficacy of ERAS Therapeutic Protocol for Complicated Appendicitis in Children
NCT ID: NCT05511194
Last Updated: 2022-08-22
Study Results
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Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-10-01
2023-01-31
Brief Summary
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Detailed Description
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2. Post-surgical indications for each group:
For both groups: assisted ambulation when recovering from the anesthetic effect, surgical wound care (daily bathing and cleaning the wound with soap and water, dressing change every 24 hours or as needed), preferably non-opioid analgesics.
Experimental Group: scheduled nausea and vomiting prophylaxis the first postoperative 24 hours, start liquid diet 8 hours postoperative, if tolerated, advance to a soft diet in the next shift, double IV antibiotic scheme (ceftriaxone, metronidazole) for at least 3 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 3 days with IV antibiotic scheme, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever).
Control Group: use of antiemetic only in case of nausea or vomiting, start of liquid diet when presenting intestinal transit data (channeling of gases or presence of evacuation), if they tolerate advancing to a soft diet in the next shift, triple IV antibiotic regimen (ampicillin, amikacin, metronidazole) for at least 5 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 5 days with IV antibiotic regimen, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever).
3. The information on each case will be recorded on a data collection sheet, that will include an identification sheet (number of patient, telephone number, age and sex), date of admission, conditions at the time of admission, weight and height to calculate nutritional status, time of evolution in hours of the clinical picture until admission to the operating room, if he received antibiotic treatment prior to admission, post-surgical diagnosis (appendicitis phase), anesthetic method used, type of analgesic used, antibiotic scheme used, date of discharge and complications at discharge.
4. Outpatient follow-up will be carried out with control at 7, 15 and 30 postoperative days, in person to identify the presence of complications through questioning and physical examination, as well as histopathological diagnosis review. These data will also be recorded on the collection sheet.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental Group
Experimental Group: scheduled nausea and vomiting prophylaxis the first postoperative 24 hours, start liquid diet 8 hours postoperative, if tolerated, advance to a soft diet in the next shift, double IV antibiotic scheme (ceftriaxone, metronidazole) for at least 3 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 3 days with IV antibiotic scheme, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever).
Enhanced Recovery After Surgery therapeutic protocol
Feeding and early ambulation, double short IV antibiotic regimen.
Control Group
Control Group: use of antiemetic only in case of nausea or vomiting, start of liquid diet when presenting intestinal transit data (channeling of gases or presence of evacuation), if they tolerate advancing to a soft diet in the next shift, triple IV antibiotic regimen (ampicillin, amikacin, metronidazole) for at least 5 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 5 days with IV antibiotic regimen, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever).
Conventional management
Delayed feeding and ambulation, triple short IV antibiotic regimen.
Interventions
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Enhanced Recovery After Surgery therapeutic protocol
Feeding and early ambulation, double short IV antibiotic regimen.
Conventional management
Delayed feeding and ambulation, triple short IV antibiotic regimen.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who require placement of a nasogastric tube or abdominal drainage during the intervention.
* Patients who were operated in another unit and enter the service for follow-up.
* Patients whose legal guardians do not agree to sign consent to participate in the protocol.
1 Year
17 Years
ALL
No
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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CLOTILDE FUENTES OROZCO
Principal Investigator
Principal Investigators
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Gabriela Ambriz, MD
Role: STUDY_DIRECTOR
UMAE Pediatric Hospital CMNO IMSS
Central Contacts
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References
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Related Links
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17\. Malaekah H, Makhdoom F, Almedbal H and Aggarwal R. Acute Appendicitis Pathways: A Systemic Review. Surgical Science, 2021; 12: 143-159.
Other Identifiers
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F-2022-1302-028
Identifier Type: -
Identifier Source: org_study_id
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