Back to resultsEffects of Chewing Gum Against Postoperative Ileus
Primary Purpose
Pancreas Neoplasm
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gum
Sponsored by
About this trial
This is an interventional other trial for Pancreas Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.
Exclusion Criteria:
- 2. 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
normal
Arm Description
people will not use chewing gums after whipple operation
Outcomes
Primary Outcome Measures
First flatus after surgery
From day of surgery until first postoperative flatus
Length of hospital stay
Time Frame: From day of surgery until discharge from surgical ward
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04768660
Brief Title
Effects of Chewing Gum Against Postoperative Ileus
Official Title
The Use of Non-pharmacological Agent to Accelerate Gastrointestinal Recovery in Patients Undergoing Pancreatic Head Resection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 14, 2021 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Neoplasm
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
normal
Arm Type
Other
Arm Description
people will not use chewing gums after whipple operation
Intervention Type
Other
Intervention Name(s)
gum
Intervention Description
Other: Chewing gum ChiczaTM organic chewing gum 6 pieces a day Other: Glucose 12ml glucose solution (13,6g) per day
Primary Outcome Measure Information:
Title
First flatus after surgery
Description
From day of surgery until first postoperative flatus
Time Frame
(with in the first 21 days)
Title
Length of hospital stay
Description
Time Frame: From day of surgery until discharge from surgical ward
Time Frame
(with in the first 21 days) ]
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.
Exclusion Criteria:
2. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
andrew mokbel
Phone
01090981160
Email
andrew.sawers55@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Chewing Gum Against Postoperative Ileus
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