ERASNCT05962320
Effect of Modified ERAS Protocol on Clinical Outcomes in Pediatric Patients With Appendectomy
A study testing Education and counselling, Avoiding the use of nasogastric catheters, drains and urinary catheters and Stimulation of intestinal motility in the postoperative period in people with ERAS and Surgery, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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%. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ERAS, Surgery, Appendicitis
- What is being tested?
- Education and counselling, Avoiding the use of nasogastric catheters, drains and urinary catheters and Stimulation of intestinal motility in the postoperative period
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥6 years and ≤17 years, girls or boys
- Underwent appendectomy
- Written informed consent or requirements of local/national ethical committee
Who cannot join
- ASA (American Society of Anesthesiologists, ASA) score of ≥ 3
- Any comorbidity/contraindication that may prevent mobilization and oral feeding
- The withdrawal criteria:
- During the surgery, the surgeon classified appendicitis as grade 0 (no appendicitis) or grade IIIB and above,
- during the postoperative period need for intensive care hospitalization patients in the control or the mERAS protocol group were staying in the same room,
- contraindications to the application of any intervention in the intervention group and/or the primary physician not approving the application of the intervention,
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- the compliance rate of the interventions determined in the modified ERAS protocol being below 80%,
- the development of any other comorbidity (urinary calculi, intussusception, etc.),
- the change in the type of surgery during the operation, conversion from laparoscopic to open appendectomy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University
Trabzon, Trabzon, 61080
About this study
Official title: Effect of Enhanced Recovery After Surgery Protocol Based Care on Patient Outcomes in Children With Appendicitis: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- ERAS, Surgery, Appendicitis
- Being tested
- 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
- Keywords
- Appendectomy, Nurse, Child, Pain, Length of Stay, Anxiety, Fear, Vomiting
- Medical subject headings
- Appendicitis, Pain, Anxiety Disorders, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and counsellingOther
Education and counselling of patients and their parents
Avoiding the use of nasogastric catheters, drains and urinary cathetersOther
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 periodOther
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative periodOther
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusionOther
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative periodOther
Initiation of early mobilization of the patient in the postoperative period
Reducing opioid use and ensuring pain managementOther
Reducing opioid use and ensuring pain management
Implement nausea and vomiting prophylaxisOther
Implement nausea and vomiting prophylaxis
Management of thirstyOther
Management of thirsty
Management of fear and stressOther
Use of recommended non-pharmacological interventions in the management of fear and stress
| Study group | Role | What they receive |
|---|---|---|
| mERAS Group | Experimental | * 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
* Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions
* Non-pharmacological interventions in management nausea and vomiting
* Management of thirsty through non-pharmacological interventions
* Management of fear and anxiety through non-pharmacological interventions Receives: 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 |
| Standart Care Group | No intervention | Patients in this group will receive standard care according to the practices of the clinic where the study will be conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative length of hospital stay
The postoperative length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome.
Measured: From the end of surgery until hospital discharge, up to 10 days
Secondary outcomes (9)
Complications
Postoperative minor and major complications will be recorded.
Measured: up to 30 days after discharge
Readmission
Readmission to the hospital will be recorded in hours.
Measured: up to 30 days after discharge
Postoperative pain
Postoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome
Measured: Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours
Postoperative fear
Postoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe fear, worse outcome.
Measured: Assessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hours
Postoperative anxiety
Postoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe anxiety, worse outcome.
Measured: Assessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hours
Postoperative nausea-vomiting
Postoperative nausea-vomiting will be evaluated with Baxter Retching Faces Scale. Higher scores mean more severe nause, worse outcome
Measured: Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours
Postoperative thirst
Postoperative thirst will be evaluated with Numeric Thirst Scale. Higher scores mean more severe pain, worse outcome.
Measured: up to the first oral intake, an average 2 days
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.
Measured: up to the first mobilization, an average 12 hours
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.
Measured: up to the first defecation, an average 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Oct 2023
- Primary completion1 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket MERAL, Karadeniz Technical University
- Investigators
- Buket MERAL, Msc, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962320
- Sponsor's protocol ID
- KaradenizTU
- Status last verified
- Sep 2025
- First submitted
- 18 Jun 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data, with identifying information concealed, forming the basis of the results reported in this article, will be made available upon reasonable request to the corresponding author 6-12 months after publication of the article. Researchers should contact the corresponding author to request access to the data.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enhanced Recovery After Surgery Protocol Based Care on Patient Outcomes in Children With Appendicitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05962320
- Acronym / sponsor ID
- KaradenizTU
- Conditions
- ERAS, Surgery, Appendicitis
- Keywords
- Appendectomy, Nurse, Child, Pain, Length of Stay, Anxiety, Fear, Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mERAS Group | Experimental | 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* 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 * Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions * Non-pharmacological interventions in management nausea and vomiting * Management of thirsty through non-pharmacological interventions * Management of fear and anxiety through non-pharmacological interventions |
| Standart Care Group | No intervention | –Patients in this group will receive standard care according to the practices of the clinic where the study will be conducted. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age ≥6 years and ≤17 years, girls or boys
- Underwent appendectomy
- Written informed consent or requirements of local/national ethical committee
Key exclusion criteria (9 listed)
- ASA (American Society of Anesthesiologists, ASA) score of ≥ 3
- Any comorbidity/contraindication that may prevent mobilization and oral feeding
- During the surgery, the surgeon classified appendicitis as grade 0 (no appendicitis) or grade IIIB and above,
- during the postoperative period need for intensive care hospitalization patients in the control or the mERAS protocol group were staying in the same room,
- contraindications to the application of any intervention in the intervention group and/or the primary physician not approving the application of the intervention,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and counsellingEducation and counselling of patients and their parents | Other | mERAS Group |
| Avoiding the use of nasogastric catheters, drains and urinary cathetersAvoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible | Other | mERAS Group |
| Stimulation of intestinal motility in the postoperative periodStimulation of intestinal motility in the postoperative period | Other | mERAS Group |
| Initiation of oral intake in the early postoperative periodInitiation of oral intake in the early postoperative period | Other | mERAS Group |
| Early removal of the patient by reducing postoperative IV fluid infusionEarly removal of the patient by reducing postoperative IV fluid infusion | Other | mERAS Group |
| Initiation of early mobilization of the patient in the postoperative periodInitiation of early mobilization of the patient in the postoperative period | Other | mERAS Group |
| Reducing opioid use and ensuring pain managementReducing opioid use and ensuring pain management | Other | mERAS Group |
| Implement nausea and vomiting prophylaxisImplement nausea and vomiting prophylaxis | Other | mERAS Group |
| Management of thirstyManagement of thirsty | Other | mERAS Group |
| Management of fear and stressUse of recommended non-pharmacological interventions in the management of fear and stress | Other | mERAS Group |
Primary outcome
Postoperative length of hospital stay
Time frame: From the end of surgery until hospital discharge, up to 10 days
The postoperative length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome.
9 secondary outcomes
Complications
Time frame: up to 30 days after discharge
Readmission
Time frame: up to 30 days after discharge
Postoperative pain
Time frame: Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours
Postoperative fear
Time frame: Assessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hours
Postoperative anxiety
Time frame: Assessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hours
Postoperative nausea-vomiting
Time frame: Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours
Postoperative thirst
Time frame: up to the first oral intake, an average 2 days
Time of first mobilization
Time frame: up to the first mobilization, an average 12 hours
Time of first defecation
Time frame: up to the first defecation, an average 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Undecided. The individual participant data, with identifying information concealed, forming the basis of the results reported in this article, will be made available upon reasonable request to the corresponding author 6-12 months after publication of the article. Researchers should contact the corresponding author to request access to the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buket MERAL, Msc principal investigator
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and counselling, Avoiding the use of nasogastric catheters, drains and urinary catheters and Stimulation of intestinal motility in the postoperative period in people with ERAS and Surgery, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative length of hospital stay (time frame: From the end of surgery until hospital discharge, up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.