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

August 19, 2022 updated by: CLOTILDE FUENTES OROZCO, Instituto Mexicano del Seguro Social

Safety and Efficacy of Enhanced Recovery After Surgery Therapeutic Protocol for Complicated Appendicitis in Children

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. 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.

  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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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).
Other: Enhanced Recovery After Surgery therapeutic protocol
Feeding and early ambulation, double short IV antibiotic regimen.
OTHER: 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).
Other: Conventional management
Delayed feeding and ambulation, triple short IV antibiotic regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalary stay
Time Frame: 120 days
Days elapsed between the admission of the patient for in-hospital management and his discharge by medical decision. Care effectiveness indicator.
120 days
Complications
Time Frame: 120 days
Adverse events presented as a consequence of the evolution of a disease or a medical intervention. Indicator of safety of the intervention carried out.
120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital costs
Time Frame: 120 days
Costs based on unit costs by level of medical care (Official Gazette of the Federation).
120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Study Director: Gabriela Ambriz, MD, UMAE Pediatric Hospital CMNO IMSS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2022

Primary Completion (ANTICIPATED)

January 31, 2023

Study Completion (ANTICIPATED)

January 31, 2023

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (ACTUAL)

August 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-2022-1302-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not required

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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