Effect of Lollipop on Postoperative Gastrointestinal Recovery in Children

Sponsor
The University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06108011
Collaborator
KK Women's and Children's Hospital (Other)
50
2
18

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Lollipop
N/A

Detailed Description

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 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 expeditated 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 CONSORT. Based on these reasons, we 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of Lollipop on Postoperative Gastrointestinal Recovery in Children: A Randomised Controlled Trial
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lollipop

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

Other: Lollipop
sucking of lollipop after operation

No Intervention: No Lollipop

No placebo would be given

Outcome Measures

Primary Outcome Measures

  1. Time to return of flatus [1 week]

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

  2. Time to first stool passage [1 week]

    The time needed for stool passage, in terms of hours

Secondary Outcome Measures

  1. time to resumption of feeding [1 month]

    time needed to resume feeding in terms of days

  2. Time to discharge from hospital after operation [1 month]

    in term of days

  3. complications [1 month]

    any complication happened because of the treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The University of Hong Kong
  • KK Women's and Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT06108011
Other Study ID Numbers:
  • LollipopTrial
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 30, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 30, 2023