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Metabolic and inflammatory effects of decreasing preoperative fasting time in preschool children undergoing inguinal hernia repair

Metabolic and inflammatory results of reducing preoperative fasting time in preschool children undergoing inguinal hernia repair

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-59hy2k
Enrollment
Unknown
Registered
2019-08-30
Start date
2016-02-26
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preschool children with inguinal hernia

Interventions

Fifty four children were initially enrolled to participate in the study, and later 14 were excluded. The forty remaining children were randomly assigned into two groups: Control group (fasting): 19 p
Dietary supplement
G07.203.300.456

Sponsors

Santa Casa de Misericórdia de Cuiabá
Lead Sponsor
Santa Casa de Misericórdia de Cuiabá
Collaborator

Eligibility

Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: The enrolled patients were children aged from 2 to 6 years; who were to be treated at the hospital Santa Casa of Misericórdia; presented an anesthetic risk classified as ASA I or II (healthy patient or small morbidity); and were to be operated for inguinal elective herniorrhaphy (small and moderate inguinal hernias).

Exclusion criteria

Exclusion criteria: Where excluded patients with other concomitant surgical diagnoses detected during hospitalization; as well as patients with giant inguinal hernias; those whose surgeries were cancelled due to respiratory symptoms; patients whose parents declined to participate in the study; with failure during collection of blood samples; who did not correctly followed the perioperative protocol delineated by the research where also excluded from the research.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1 A reduction in preoperative fasting time is expected in CHO group patients ;Outcome found 1 There was a reduction in preoperative fasting time in CHO patients (2:29 vs 11:24, p smaller than 0.001) ;Expected outcome 2 A reduction in acute inflammatory function tests related to the organic response to surgical trauma (CRP) is expected in CHO group patients, during the perioperative period ;Outcome found 2 A reduction in CRP values was observed both preoperatively (fasting group: 3.60 ± 7.60 mg/L vs CHO group: 0.53 ± 0.59 mg/L; p equal to 0.05) and postoperatively (fasting group: 3.53 ± 7.75 mg/L vs CHO group: 0.49 ± 0.0 mg/L, p equal to 0.02) ;Expected outcome 3 It is expected that there will be a reduction in acute inflammatory function tests related to the organic response to surgical trauma (CRP/Albumin) in patients in the CHO group during the perioperative period. ;Expected found 3 There was a reduction in the values of the inflammatory test CRP/Albumin in the preoperative period (0.89 ± 1.86 vs 0.13 ± 0.15, p equal to 0.03) in the CHO group patients. In the postoperative period, there was no statistical difference between groups (0.91 ± 1.97 vs 0.13 ± 0.15, p equal to 0.08) ;Expected outcome 4 It is expected that there will be a reduction in acute inflammatory function tests related to the organic response to surgical trauma (Interleukin-6) in CHO patients during the perioperative period ;Expected found 4 There was no statistical difference between the two groups both pre (fasting: 1.5 ± 2.6 pg/ml vs CHO: 2.0 ± 1.3 pg/ml, p equal to 0.98) and postoperatively (fasting: 2.0 ± 2.3 pg/ml vs CHO: 1.5 ± 2.0, pg/ml, p equal to 0.41) ;Expected outcome 5 Better postoperative glucose metabolism is expected in CHO patients ;Expected found 5 There was no statistical difference between groups in preoperative (fasting: 88 ± 16 mg/dl vs CHO: 86 ± 9 mg/dl, p equal to 0.32) or postoperative blood glucose (fasting: 91 ± 34 mg/dl vs CHO: 93 ± 24 mg/dl, p equal

Secondary

MeasureTime frame
Expected outcome 7 Associated with a reduction in the inflammatory response to trauma, a reduction in the occurrence of postoperative vomiting is expected Expected outcome 7 No difference was observed in the incidence of postoperative vomiting between the groups.;Expected outcome 7 In children which preoperative fasting was abbreviated, better degrees of parental satisfaction are expected Expected outcome 7 It was decided not to measure the degree of parental satisfaction due to the lack of an objective and easy measurement

Countries

Brazil

Contacts

Public ContactCarlos Leite de Barros Carvalho

Santa Casa de Misericórdia de Cuiabá

cautocba@hotmail.com+556530511946

Outcome results

None listed

Source: REBEC (via WHO ICTRP)