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Safety and Efficacy of ERAS Therapeutic Protocol for Complicated Appendicitis in Children (ERAS)

Primary Purpose

Enhanced Recovery After Surgery, Appendicitis, Children, Only

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced Recovery After Surgery therapeutic protocol
Conventional management
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Enhanced Recovery After Surgery focused on measuring Enhanced Recovery After Surgery, Appendicitis complicated, Appendectomy, Children, Perioperative period

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients between the ages of 1 and 17, who underwent surgery at the UMAE Hospital de Pediatría CMNO and who at the time of surgery are determined to be in a gangrenous or perforated phase.

Exclusion Criteria:

  • Patients who, prior to surgery, present symptoms of intestinal obstruction, abdominal sepsis, or suffer from any underlying disease.
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Experimental Group

    Control Group

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

    Hospitalary stay
    Days elapsed between the admission of the patient for in-hospital management and his discharge by medical decision. Care effectiveness indicator.
    Complications
    Adverse events presented as a consequence of the evolution of a disease or a medical intervention. Indicator of safety of the intervention carried out.

    Secondary Outcome Measures

    Hospital costs
    Costs based on unit costs by level of medical care (Official Gazette of the Federation).

    Full Information

    First Posted
    August 16, 2022
    Last Updated
    August 19, 2022
    Sponsor
    Instituto Mexicano del Seguro Social
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05511194
    Brief Title
    Safety and Efficacy of ERAS Therapeutic Protocol for Complicated Appendicitis in Children
    Acronym
    ERAS
    Official Title
    Safety and Efficacy of Enhanced Recovery After Surgery Therapeutic Protocol for Complicated Appendicitis in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    January 31, 2023 (Anticipated)
    Study Completion Date
    January 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto Mexicano del Seguro Social

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Complicated appendicitis in pediatrics is frequent, potentially serious and complex to manage. The implementation of a ERAS model would allow optimizing perioperative care, offering a shorter hospital stay, reducing complications associated with medical care and costs, although adequate multidisciplinary management is necessary. The objective of the study is to evaluate the safety and efficacy of the application of a ERAS therapeutic protocol and compare them with the safety and efficacy of conventional management in children with complicated appendicitis.
    Detailed Description
    All patients who meet the indicated criteria will be included, including signing an informed consent in the immediate postoperative period, and will be assigned to a control group or an experimental group based on simple random probabilistic sampling, using software (OxMaR: Oxford Minimization and Randomization, 2019) for minimization and randomization of clinical studies, single blind. A different postoperative treatment scheme will be applied for each of the groups. 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). 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Enhanced Recovery After Surgery, Appendicitis, Children, Only
    Keywords
    Enhanced Recovery After Surgery, Appendicitis complicated, Appendectomy, Children, Perioperative period

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled clinical trial, single blind.
    Masking
    Participant
    Masking Description
    The patient will be assigned to a control group or an experimental group based on simple random probabilistic sampling, using software (OxMaR: Oxford Minimization and Randomization, 2019) for minimization and randomization of clinical studies, single blind. A different postoperative treatment scheme will be applied for each of the groups.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Control Group
    Arm Type
    Other
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Enhanced Recovery After Surgery therapeutic protocol
    Intervention Description
    Feeding and early ambulation, double short IV antibiotic regimen.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional management
    Intervention Description
    Delayed feeding and ambulation, triple short IV antibiotic regimen.
    Primary Outcome Measure Information:
    Title
    Hospitalary stay
    Description
    Days elapsed between the admission of the patient for in-hospital management and his discharge by medical decision. Care effectiveness indicator.
    Time Frame
    120 days
    Title
    Complications
    Description
    Adverse events presented as a consequence of the evolution of a disease or a medical intervention. Indicator of safety of the intervention carried out.
    Time Frame
    120 days
    Secondary Outcome Measure Information:
    Title
    Hospital costs
    Description
    Costs based on unit costs by level of medical care (Official Gazette of the Federation).
    Time Frame
    120 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients between the ages of 1 and 17, who underwent surgery at the UMAE Hospital de Pediatría CMNO and who at the time of surgery are determined to be in a gangrenous or perforated phase. Exclusion Criteria: Patients who, prior to surgery, present symptoms of intestinal obstruction, abdominal sepsis, or suffer from any underlying disease. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ana Calderón, MD
    Phone
    6673152519
    Email
    anabe_calderon@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gabriela Ambriz, MD
    Phone
    3339053703
    Email
    ggaby03@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gabriela Ambriz, MD
    Organizational Affiliation
    UMAE Pediatric Hospital CMNO IMSS
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Not required
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    Description
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    Safety and Efficacy of ERAS Therapeutic Protocol for Complicated Appendicitis in Children

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