Effects of Chewing Gum Against Postoperative Ileus

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04768660

Collaborator

(none)

Enrollment

Arm

26.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreas Neoplasm	Other: gum	N/A

Detailed Description

Postoperative ileus is common after surgery. One non-pharmacological intervention that has shown promising results in reducing the duration of postoperative ileus is chewing gum after surgery. However, this has not been investigated in upper gastrointestinal surgery such as pancreatic surgery. Hence the aim of this study was to investigate the effects of chewing gum treatment on patients undergoing pancreaticoduodenectomy due to pancreatic or periampullary cancer.

This study was conducted as a phase-III trial. Patients diagnosed with pancreatic tumours scheduled for pancreaticoduodenectomy were included. The treatment group received chewing gum postoperatively and standard care. Controls received glucose solution and standard care.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

The Use of Non-pharmacological Agent to Accelerate Gastrointestinal Recovery in Patients Undergoing Pancreatic Head Resection

Anticipated Study Start Date :

Feb 14, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: normal people will not use chewing gums after whipple operation	Other: gum Other: Chewing gum ChiczaTM organic chewing gum 6 pieces a day Other: Glucose 12ml glucose solution (13,6g) per day

Arm

Intervention/Treatment

Other: normal

people will not use chewing gums after whipple operation

Other: gum

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

Outcome Measures

Primary Outcome Measures

First flatus after surgery [(with in the first 21 days)]
From day of surgery until first postoperative flatus
Length of hospital stay [(with in the first 21 days) ]]
Time Frame: From day of surgery until discharge from surgical ward

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.

Exclusion Criteria:

1. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrew Mokbel, andrew mokbel mahani sawers, Assiut University

ClinicalTrials.gov Identifier:

NCT04768660

Other Study ID Numbers:

chewing gum postoperative

First Posted:

Feb 24, 2021

Last Update Posted:

Feb 24, 2021

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Feb 24, 2021