NCT04768660

Brief Summary

The purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Status
unknown

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

Study Start

First participant enrolled

February 14, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

February 24, 2021

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

February 21, 2021

Last Update Submit

February 21, 2021

Conditions

Pancreas Neoplasm

Outcome Measures

Primary Outcomes (2)

  • First flatus after surgery

    From day of surgery until first postoperative flatus

    (with in the first 21 days)

  • Length of hospital stay

    Time Frame: From day of surgery until discharge from surgical ward

    (with in the first 21 days) ]

Study Arms (1)

normal

OTHER

people will not use chewing gums after whipple operation

Other: gum

Interventions

gumOTHER

Other: Chewing gum ChiczaTM organic chewing gum 6 pieces a day Other: Glucose 12ml glucose solution (13,6g) per day

normal

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.

You may not qualify if:

  • \. Ongoing treatment for mental disease 3. Diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function 4. Ongoing abuse of alcohol or other drugs 5. Previously known allergies to the content of chewing gum 6. Additional surgery after primary surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

andrew mokbel

CONTACT

01090981160andrew.sawers55@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
andrew mokbel mahani sawers

Study Record Dates

First Submitted

February 21, 2021

First Posted

February 24, 2021

Study Start

February 14, 2021

Primary Completion

March 1, 2023

Study Completion

May 1, 2023

Last Updated

February 24, 2021

Record last verified: 2020-09