NCT06108011

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

October 23, 2023

Last Update Submit

December 5, 2024

Conditions

Ileus Postoperative

Outcome Measures

Primary Outcomes (2)

  • Time for participants to return of flatus

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

    1 week

  • Time for participants to first stool passage

    The time needed for stool passage, in terms of hours

    1 week

Secondary Outcomes (3)

  • Time for participants to resumption of feeding

    1 month

  • Time for participants to discharge from hospital after operation

    1 month

  • Presence of any complications in participants

    1 month

Study Arms (2)

Lollipop

EXPERIMENTAL

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

Other: Lollipop

No Lollipop

NO INTERVENTION

No placebo would be given

Interventions

LollipopOTHER

sucking of lollipop after operation

Lollipop

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, University of Hong Kong

Hong Kong, 0000, Hong Kong

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 30, 2023

Study Start

December 1, 2023

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

December 11, 2024

Record last verified: 2024-12

Locations

HK(1)