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NCT Number: NCT06108011

Effect of Lollipop on Postoperative Gastrointestinal Recovery in Children

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.

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Key information

Conditions

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, University of Hong Kong

Hong Kong, 0000

Location status: Recruiting

Location contact

Adrian Fung, MBBS

CONTACT

[email protected]

+85222554850

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lollipop

Other

sucking of lollipop after operation

Primary outcomes

  1. Time for participants to return of flatus

    Time frame: 1 week

    the time needed for flatus to happen after operation, in term as hours

  2. Time for participants to first stool passage

    Time frame: 1 week

    The time needed for stool passage, in terms of hours

Secondary outcomes

  1. Time for participants to resumption of feeding

    Time frame: 1 month

    time needed to resume feeding in terms of days

  2. Time for participants to discharge from hospital after operation

    Time frame: 1 month

    in term of days

  3. Presence of any complications in participants

    Time frame: 1 month

    any complication happened because of the treatment

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • KK Women's and Children's Hospital

Registry information

Official study title

Effect of Lollipop on Postoperative Gastrointestinal Recovery in Children: A Randomised Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2023
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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