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Not yet recruitingNCT07375511Accelerated ReUpdated Jun 23, 2026

The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases

An interventional study of mERAS Protocol in mERAS Intervention, The ASA (American Society of Anesthesiologists) Score and The Patient Must be Between 4 and 12 Years Old, sponsored by Emel Yürük. Not yet recruiting. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by Emel Yürük · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

Pediatric laparoscopic surgery is a gold standard across all ages, offering benefits like smaller incisions, faster recovery, and better cosmetic outcomes. However, because children require more precise hemodynamic and respiratory management than adults, specialized perioperative care is essential. This study aims to evaluate the impact of a multidisciplinary Enhanced Recovery After Surgery (ERAS) approach on children aged 4-12, specifically measuring its effect on postoperative pain, nausea, thirst, fear levels, and the overall recovery process.

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Conditions studied

  • mERAS Intervention
  • The ASA (American Society of Anesthesiologists) Score
  • The Patient Must be Between 4 and 12 Years Old

Keywords

  • Pediatric laparoscopic surgery
  • ERAS
  • Postoperative Recovery
03

In context

Lead sponsor

This is the only study on the registry with Emel Yürük as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria

  • The patient must be between 4 and 12 years old,
  • The ASA (American Society of Anesthesiologists) score must be 1 or 2,
  • The parent(s) must be cognitively competent to give consent. Exclusion Criteria
  • The child/parents must refuse to participate in the study,
  • The presence of comorbidities that interfere with mobilization or oral feeding (which impairs the pain score),
  • Chronic pain syndrome or regular opioid use,
  • Previous major surgery in the same area (which may affect healing and pain experience).
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    mERAS Protocol Patient Group

    mERAS Protocol Patient Group

    Other: mERAS Protocol

  • No intervention
    Patient Group Receiving Standard Care

    Preoperative Period: Within the scope of standard care, comprehensive education is not provided to patients and their families; only informed relatives are consulted to obtain surgical consent. During this period, patients' comorbidities are evaluated, and necessary medical treatments are applied. However, nutritional risk screening, which is emphasized in the literature, especially in pediatric surgery, is not routinely performed. While prophylactic antibiotic administration is aimed at, there is no standardized protocol for nausea-vomiting and pain management; treatment is carried out at the physician's discretion. Routine bowel preparation in accordance with current guidelines is not performed.

Interventions

  • OthermERAS Protocol

    mERAS Protocol Patient Group 1. Preoperative Period: Preparation and Education Within the scope of the mERAS protocol, both the child and their family are evaluated with a holistic approach in the preoperative period and prepared for the surgical process; this process is structured in accordance with the current ERAS guidelines for pediatric applications. Education and Counseling The child and their family will receive detailed information covering the preoperative, intraoperative, and postoperative processes. The child will be educated on preparing for the surgical experience using age-appropriate audiovisual materials; the family will be informed about the basic components of the recovery process, expected outcomes, and the contributions of the ERAS protocol. In addition, regular internal training for the surgeon, nurses, and anesthesia team will be provided to increase the applicability of the protocol and team cohesion. Preoperative Interventions • Patient and Family Information: P

06

What researchers measure

Primary outcomes

  1. Wong-Baker Faces Pain Rating Scale

    Wong-Baker Faces Pain Rating Scale (Appendix 2): This is a visual self-assessment tool developed to evaluate the physical pain levels of individuals aged three years and older based on their own reports. The scale, consisting of six facial expressions, is scored from 0 = "no pain" to 10 = "very severe pain," and the child is asked to choose the face that best expresses the pain they are experiencing. It is a frequently used, valid, and understandable method for evaluating acute pain, especially in children who have difficulty verbally describing pain (Wong \& Baker, 1988; Cohen et al., 2008). In this study, the postoperative pain levels of all children in the 4-12 age group will be evaluated using the Wong-Baker Faces Pain Rating Scale. In each measurement, the facial expressions will be explained to the children according to the standard instructions of the scale, and they will be asked to choose the face that best reflects the pain they are experiencing. The visual form of the scale

    Time frame: 7 DAY

  2. Baxter Animated Retching Faces Scale (BARF)

    The Baxter Animated Retching Faces (BARF) Scale, developed by Baxter et al., is a self-report tool that assesses the severity of nausea using six-stage visual facial expressions ranging from "no nausea" to "severe nausea/vomiting." The faces on the scale are ordered to represent increasing levels of nausea (Baxter et al., 2011; Şişman et al., 2016).

    Time frame: 7 days

  3. Visual Thirst Scale

    Visual Thirst Scale: The Visual Analog Scale (VAS) will be used to assess the severity of thirst in the postoperative period. On this scale, a value of 0 represents "no thirst" and a value of 10 represents "the most severe thirst the patient has ever felt." This approach is consistent with the method used by Conchon and Fonseca in their perioperative thirst studies to quantitatively assess the subjective severity of thirst (Conchon \& Fonseca, 2015).

    Time frame: 7 days

  4. Children's Fear Scale

    Children's Fear Scale: by McMurtry et al. (2011), the Children's Fear Scale is a visual self-assessment scale consisting of five facial expressions, scored between "no fear" (0) and "very frightened facial expression" (4), used to assess the level of fear experienced by children during medical procedures. The adaptation and validity-reliability study of the scale into Turkish was carried out by Gerçeker et al. (2018). No permission is required for clinical and research use of this scale (Children's Fear Scale - https://www.uoguelph.ca/pphc/childrens-fear-scale).

    Time frame: 7 days

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07375511
Lead sponsor
Emel Yürük
Responsible party
Emel Yürük (ASSISTANT PROFESSOR, Cukurova University) — Sponsor-investigator
First posted
Jan 29, 2026
Start date
Jul 15, 2026 (estimated)
Primary completion
Oct 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Jun 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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