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Effect of Modified ERAS Protocol on Clinical Outcomes in Pediatric Patients With Appendectomy

Primary Purpose

ERAS, Surgery, Appendicitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education and counselling
Avoiding the use of nasogastric catheters, drains and urinary catheters
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative period
Reducing opioid use and ensuring pain management
Implement nausea and vomiting prophylaxis
Management of thirsty
Management of fear and stress
Sponsored by
Karadeniz Technical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ERAS focused on measuring Appendectomy, Nurse, Child, Pain, Length of Stay, Anxiety, Fear, Vomiting

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥6 years and ≤18 years, girls or boys Underwent appendectomy Written informed consent or requirements of local/national ethical committee Exclusion Criteria: ASA (American Society of Anesthesiologists, ASA) score of ≥ 3 Any comorbidity/contraindication that may prevent mobilization and oral feeding

Sites / Locations

  • Karadeniz Technical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mERAS Group

Standart Care Group

Arm Description

Education and counselling of patients and their parents Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible Stimulation of intestinal motility in the postoperative period Initiation of oral intake in the early postoperative period Early removal of the patient by reducing postoperative IV fluid infusion Initiation of early mobilization of the patient in the postoperative period Reducing opioid use and ensuring pain management Implement nausea and vomiting prophylaxis Management of thirsty Management of fear and stress

Patients in this group will receive standard care according to the practices of the clinic where the study will be conducted.

Outcomes

Primary Outcome Measures

Hospital length of stay
The length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome.

Secondary Outcome Measures

Complications
Postoperative minor and major complications will be recorded.
Readmission
Readmission to the hospital will be recorded in hours.
Postoperative pain
Postoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome
Postoperative fear
Postoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe pain, worse outcome.
Postoperative anxiety
Postoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe pain, worse outcome.
Postoperative nausea-vomiting
Postoperative nausea-vomiting will be evaluated with Baxter Retching Faces Scale. Higher scores mean more severe pain, worse outcome
Postoperative thirst
Postoperative thirst will be evaluated with Numeric Thirst Scale. Higher scores mean more severe pain, worse outcome.
Time of first mobilization
The first time of postoperative mobilization will be recorded in hours. Higher scores indicate delayed mobilization. This means a worse outcome.
Time of first defecation
The first time of postoperative defecation will be recorded in hours. Higher scores indicate delayed defecation. This means a worse outcome.

Full Information

First Posted
June 18, 2023
Last Updated
July 24, 2023
Sponsor
Karadeniz Technical University
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1. Study Identification

Unique Protocol Identification Number
NCT05962320
Brief Title
Effect of Modified ERAS Protocol on Clinical Outcomes in Pediatric Patients With Appendectomy
Official Title
Effect of Enhanced Recovery After Surgery Protocol Based Care on Patient Outcomes in Children With Appendicitis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karadeniz Technical University

4. Oversight

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

5. Study Description

Brief Summary
Acute appendicitis is the most common abdominal emergency with more than 15 million cases reported worldwide. Although appendectomy is considered a safe surgical procedure, the incidence of complications is up to 10%. The Enhanced Recovery After Surgery (ERAS) has developed guidelines to improve postoperative patient outcomes. The protocol, which consists of more than 20 interventions in the preoperative, intraoperative and postoperative periods, shows that early discharge can be possible with multidisciplinary care given to surgical patients without risking patient safety.
Detailed Description
Appendicitis is a common clinical condition and often requires emergency treatment. Although appendectomy is a safe surgical procedure, there is a risk of complications. Pain is common, especially in the postoperative period, and the lack of care management leads to delayed mobilization and oral intake, delayed recovery and prolonged length of hospital stay. However, pain, nausea-vomiting, thirst, fear and stress could be managed with perioperative care. In addition, it is reported that the care provided based on the ERAS protocol shortens the length of hospital stay. In this respect, the aim of this study was to investigate the effect of ERAS protocol-based care on the length of hospital stay of children who were planned to undergo appendectomy. Postoperative pain level, stress and fear level, time to first mobilization, flatulence, defecation and oral intake, nausea, thirst were the secondary outcomes of this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ERAS, Surgery, Appendicitis
Keywords
Appendectomy, Nurse, Child, Pain, Length of Stay, Anxiety, Fear, Vomiting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mERAS Group
Arm Type
Experimental
Arm Description
Education and counselling of patients and their parents Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible Stimulation of intestinal motility in the postoperative period Initiation of oral intake in the early postoperative period Early removal of the patient by reducing postoperative IV fluid infusion Initiation of early mobilization of the patient in the postoperative period Reducing opioid use and ensuring pain management Implement nausea and vomiting prophylaxis Management of thirsty Management of fear and stress
Arm Title
Standart Care Group
Arm Type
No Intervention
Arm Description
Patients in this group will receive standard care according to the practices of the clinic where the study will be conducted.
Intervention Type
Other
Intervention Name(s)
Education and counselling
Intervention Description
Education and counselling of patients and their parents
Intervention Type
Other
Intervention Name(s)
Avoiding the use of nasogastric catheters, drains and urinary catheters
Intervention Description
Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
Intervention Type
Other
Intervention Name(s)
Stimulation of intestinal motility in the postoperative period
Intervention Description
Stimulation of intestinal motility in the postoperative period
Intervention Type
Other
Intervention Name(s)
Initiation of oral intake in the early postoperative period
Intervention Description
Initiation of oral intake in the early postoperative period
Intervention Type
Other
Intervention Name(s)
Early removal of the patient by reducing postoperative IV fluid infusion
Intervention Description
Early removal of the patient by reducing postoperative IV fluid infusion
Intervention Type
Other
Intervention Name(s)
Initiation of early mobilization of the patient in the postoperative period
Intervention Description
Initiation of early mobilization of the patient in the postoperative period
Intervention Type
Other
Intervention Name(s)
Reducing opioid use and ensuring pain management
Intervention Description
Reducing opioid use and ensuring pain management
Intervention Type
Other
Intervention Name(s)
Implement nausea and vomiting prophylaxis
Intervention Description
Implement nausea and vomiting prophylaxis
Intervention Type
Other
Intervention Name(s)
Management of thirsty
Intervention Description
Management of thirsty
Intervention Type
Other
Intervention Name(s)
Management of fear and stress
Intervention Description
Use of recommended non-pharmacological interventions in the management of fear and stress
Primary Outcome Measure Information:
Title
Hospital length of stay
Description
The length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome.
Time Frame
up to 2 weeks
Secondary Outcome Measure Information:
Title
Complications
Description
Postoperative minor and major complications will be recorded.
Time Frame
up to 30 days after discharge
Title
Readmission
Description
Readmission to the hospital will be recorded in hours.
Time Frame
up to 30 days after discharge
Title
Postoperative pain
Description
Postoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome
Time Frame
up to 2 weeks
Title
Postoperative fear
Description
Postoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe pain, worse outcome.
Time Frame
up to 2 weeks
Title
Postoperative anxiety
Description
Postoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe pain, worse outcome.
Time Frame
up to 2 weeks
Title
Postoperative nausea-vomiting
Description
Postoperative nausea-vomiting will be evaluated with Baxter Retching Faces Scale. Higher scores mean more severe pain, worse outcome
Time Frame
up to 2 weeks
Title
Postoperative thirst
Description
Postoperative thirst will be evaluated with Numeric Thirst Scale. Higher scores mean more severe pain, worse outcome.
Time Frame
up to the first oral intake, an average 2 days
Title
Time of first mobilization
Description
The first time of postoperative mobilization will be recorded in hours. Higher scores indicate delayed mobilization. This means a worse outcome.
Time Frame
up to the first mobilization, an average 12 hours
Title
Time of first defecation
Description
The first time of postoperative defecation will be recorded in hours. Higher scores indicate delayed defecation. This means a worse outcome.
Time Frame
up to the first defecation, an average 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥6 years and ≤18 years, girls or boys Underwent appendectomy Written informed consent or requirements of local/national ethical committee Exclusion Criteria: ASA (American Society of Anesthesiologists, ASA) score of ≥ 3 Any comorbidity/contraindication that may prevent mobilization and oral feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Buket MERAL, Msc
Phone
+90 4622300476
Email
buketguvenir@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buket MERAL, Msc
Organizational Affiliation
Karadeniz Technical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karadeniz Technical University
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Buket MERAL
Phone
+90 4622300476
Email
buketguvenir@hotmail.com
First Name & Middle Initial & Last Name & Degree
Birsen Mutlu, PhD
First Name & Middle Initial & Last Name & Degree
Hatice Sonay Yalcın Cömert, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Modified ERAS Protocol on Clinical Outcomes in Pediatric Patients With Appendectomy

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