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

Sponsor

Instituto Mexicano del Seguro Social (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05511194

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Enhanced Recovery After Surgery Appendicitis Children, Only	Other: Enhanced Recovery After Surgery therapeutic protocol Other: Conventional management	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled clinical trial, single blind.Randomized controlled clinical trial, single blind.

Masking:

Single (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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

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.

Arm

Intervention/Treatment

Experimental: Experimental Group

Other: Enhanced Recovery After Surgery therapeutic protocol

Feeding and early ambulation, double short IV antibiotic regimen.

Other: Control Group

Other: Conventional management

Delayed feeding and ambulation, triple short IV antibiotic regimen.

Outcome Measures

Primary Outcome Measures

Hospitalary stay [120 days]
Days elapsed between the admission of the patient for in-hospital management and his discharge by medical decision. Care effectiveness indicator.
Complications [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.

Secondary Outcome Measures

Hospital costs [120 days]
Costs based on unit costs by level of medical care (Official Gazette of the Federation).

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 17 Years

Sexes Eligible for Study:

All

Accepts 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.