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

Sponsor
Karadeniz Technical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05962320
Collaborator
(none)
68
1
2
5
13.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Education and counselling
  • Other: Avoiding the use of nasogastric catheters, drains and urinary catheters
  • Other: Stimulation of intestinal motility in the postoperative period
  • Other: Initiation of oral intake in the early postoperative period
  • Other: Early removal of the patient by reducing postoperative IV fluid infusion
  • Other: Initiation of early mobilization of the patient in the postoperative period
  • Other: Reducing opioid use and ensuring pain management
  • Other: Implement nausea and vomiting prophylaxis
  • Other: Management of thirsty
  • Other: Management of fear and stress
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effect of Enhanced Recovery After Surgery Protocol Based Care on Patient Outcomes in Children With Appendicitis: a Randomized Controlled Trial
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: mERAS Group

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

Other: Education and counselling
Education and counselling of patients and their parents

Other: Avoiding the use of nasogastric catheters, drains and urinary catheters
Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible

Other: Stimulation of intestinal motility in the postoperative period
Stimulation of intestinal motility in the postoperative period

Other: Initiation of oral intake in the early postoperative period
Initiation of oral intake in the early postoperative period

Other: Early removal of the patient by reducing postoperative IV fluid infusion
Early removal of the patient by reducing postoperative IV fluid infusion

Other: Initiation of early mobilization of the patient in the postoperative period
Initiation of early mobilization of the patient in the postoperative period

Other: Reducing opioid use and ensuring pain management
Reducing opioid use and ensuring pain management

Other: Implement nausea and vomiting prophylaxis
Implement nausea and vomiting prophylaxis

Other: Management of thirsty
Management of thirsty

Other: Management of fear and stress
Use of recommended non-pharmacological interventions in the management of fear and stress

No Intervention: Standart Care Group

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

Outcome Measures

Primary Outcome Measures

  1. Hospital length of stay [up to 2 weeks]

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

Secondary Outcome Measures

  1. Complications [up to 30 days after discharge]

    Postoperative minor and major complications will be recorded.

  2. Readmission [up to 30 days after discharge]

    Readmission to the hospital will be recorded in hours.

  3. Postoperative pain [up to 2 weeks]

    Postoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome

  4. Postoperative fear [up to 2 weeks]

    Postoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe pain, worse outcome.

  5. Postoperative anxiety [up to 2 weeks]

    Postoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe pain, worse outcome.

  6. Postoperative nausea-vomiting [up to 2 weeks]

    Postoperative nausea-vomiting will be evaluated with Baxter Retching Faces Scale. Higher scores mean more severe pain, worse outcome

  7. Postoperative thirst [up to the first oral intake, an average 2 days]

    Postoperative thirst will be evaluated with Numeric Thirst Scale. Higher scores mean more severe pain, worse outcome.

  8. Time of first mobilization [up to the first mobilization, an average 12 hours]

    The first time of postoperative mobilization will be recorded in hours. Higher scores indicate delayed mobilization. This means a worse outcome.

  9. Time of first defecation [up to the first defecation, an average 3 days]

    The first time of postoperative defecation will be recorded in hours. Higher scores indicate delayed defecation. This means a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karadeniz Technical University Trabzon Turkey 61080

Sponsors and Collaborators

  • Karadeniz Technical University

Investigators

  • Principal Investigator: Buket MERAL, Msc, Karadeniz Technical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Buket MERAL, Research asistant - MSc, Karadeniz Technical University
ClinicalTrials.gov Identifier:
NCT05962320
Other Study ID Numbers:
  • KaradenizTU
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Buket MERAL, Research asistant - MSc, Karadeniz Technical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2023