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Effect of Lollipop on Postoperative Gastrointestinal Recovery in Children

NCT ID: NCT06108011

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-06-30

Brief Summary

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Postoperative ileus is common in children. There are various method to prevent postoperative ileus. In this study, the investigators will explore the role of sucking lollipop after operation on the recovery of gastrointestinal function in children.

Detailed Description

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Postoperative ileus is a common occurrence among children undergoing major operations, including gastrointestinal and spinal surgeries. It can result in physical discomfort, extended hospital stays, delayed resumption of activity and poor satisfaction with surgical care. The pathophysiology and course of postoperative ileus occurs in three phases: increased sympathetic activity, release of inflammatory mediators and vagal activation as ileus resolves. Multiple risk factors of postoperative ileus have been identified in various studies, including general risk factors such as significant blood loss, male gender and medical comorbidities like chronic obstructive pulmonary disease (COPD), as well as risk factors specific to the surgery, such as the laparotomy approach, emergency surgery and stoma formation.

Chewing gum, as a form of sham feeding, has been employed in adults and children as a modality to decrease risk of postoperative ileus. There has been concrete evidence that it could result in expedited recovery of gastrointestinal function after surgery in adult populations. However, it may not be a feasible option for infants and young children. Lollipop, on the other hand, is easier to apply in children which only require the action of sucking. It can stimulate the cephalic phase of digestion via vagal cholinergic stimulation and release of gastrointestinal hormone (gastrin and motilin) through its taste and absorption of sugar. The current evidence of lollipop in the recovery of postoperative gastrointestinal function in children is limited with only two randomised controlled trial published so far with satisfactory outcomes, yet both were not indexed and were not carried out in accordance with Consolidated Standards of Reporting Trials (CONSORT). Based on these reasons, the investigators plan to carry out a prospective, multiple-centred, non-blinded, randomized controlled trial using a parallel arm design on the effect of lollipop on recovery of gastrointestinal function after operation in children. Children recruited will be randomly assigned into either lollipop group or non-treatment group; lollipop will be given to children in treatment group after operation. Their outcomes will be compared.

Conditions

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Ileus Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lollipop

Given lollipop 6 hours after operation, sucking of lollipop at least 20mins every 4 hours after operation until feeding is resumed.

Group Type EXPERIMENTAL

Lollipop

Intervention Type OTHER

sucking of lollipop after operation

No Lollipop

No placebo would be given

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lollipop

sucking of lollipop after operation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients receiving major abdominal surgery (e.g.appendicectomy, choledochal cyst surgery, bowel resection etc)

Exclusion Criteria

* Patients with neurological conditions that preclude sucking/swallowing.
* Patients under sedation and/or mechanical ventilation and/or ionotropic support in the post operative period.
* Patients with known food allergy or allergy to food coloring agents
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Surgery, University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Facility Contacts

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Adrian Fung, MBBS

Role: primary

Other Identifiers

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LollipopTrial

Identifier Type: -

Identifier Source: org_study_id