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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05962320
Other study ID # KaradenizTU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date May 1, 2024

Study information

Verified date March 2024
Source Karadeniz Technical University
Contact Buket MERAL, Msc
Phone +90 4622300476
Email buketguvenir@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date May 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Education and counselling
Education and counselling of patients and their parents
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
Stimulation of intestinal motility in the postoperative period
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative period
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusion
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative period
Initiation of early mobilization of the patient in the postoperative period
Reducing opioid use and ensuring pain management
Reducing opioid use and ensuring pain management
Implement nausea and vomiting prophylaxis
Implement nausea and vomiting prophylaxis
Management of thirsty
Management of thirsty
Management of fear and stress
Use of recommended non-pharmacological interventions in the management of fear and stress

Locations

Country Name City State
Turkey Karadeniz Technical University Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital length of stay The length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome. up to 2 weeks
Secondary Complications Postoperative minor and major complications will be recorded. up to 30 days after discharge
Secondary Readmission Readmission to the hospital will be recorded in hours. up to 30 days after discharge
Secondary Postoperative pain Postoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome up to 2 weeks
Secondary Postoperative fear Postoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe pain, worse outcome. up to 2 weeks
Secondary Postoperative anxiety Postoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe pain, worse outcome. up to 2 weeks
Secondary Postoperative nausea-vomiting Postoperative nausea-vomiting will be evaluated with Baxter Retching Faces Scale. Higher scores mean more severe pain, worse outcome up to 2 weeks
Secondary Postoperative thirst Postoperative thirst will be evaluated with Numeric Thirst Scale. Higher scores mean more severe pain, worse outcome. up to the first oral intake, an average 2 days
Secondary 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. up to the first mobilization, an average 12 hours
Secondary 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. up to the first defecation, an average 3 days
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