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

K

Karadeniz Technical University

Status

Completed

Conditions

ERAS
Appendicitis
Surgery

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05962320
KaradenizTU

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥6 years and ≤17 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

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,
  • 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 design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

82 participants in 2 patient groups

mERAS Group
Experimental group
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 * 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
Treatment:
Other: Stimulation of intestinal motility in the postoperative period
Other: Avoiding the use of nasogastric catheters, drains and urinary catheters
Other: Education and counselling
Other: Management of fear and stress
Other: Implement nausea and vomiting prophylaxis
Other: Early removal of the patient by reducing postoperative IV fluid infusion
Other: Initiation of oral intake in the early postoperative period
Other: Reducing opioid use and ensuring pain management
Other: Initiation of early mobilization of the patient in the postoperative period
Other: Management of thirsty
Standart Care Group
No Intervention group
Description:
Patients in this group will receive standard care according to the practices of the clinic where the study will be conducted.

Trial contacts and locations

1

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Central trial contact

Buket MERAL, Msc

Data sourced from clinicaltrials.gov

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