Pancreas NeoplasmNCT04768660
Effects of Chewing Gum Against Postoperative Ileus
A study testing gum in people with Pancreas Neoplasm, run by Assiut University.
Trial summary
The purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pancreas Neoplasm
- What is being tested?
- gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 14 Feb 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Use of Non-pharmacological Agent to Accelerate Gastrointestinal Recovery in Patients Undergoing Pancreatic Head Resection
The purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy
Read the 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.
- Conditions
- Pancreas Neoplasm
- Being tested
- gum
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gumOther
Other: Chewing gum ChiczaTM organic chewing gum 6 pieces a day Other: Glucose 12ml glucose solution (13,6g) per day
| Study group | Role | What they receive |
|---|---|---|
| normal | Other | people will not use chewing gums after whipple operation Receives: Other: gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
First flatus after surgery
From day of surgery until first postoperative flatus
Measured: (with in the first 21 days)
Length of hospital stay
Time Frame: From day of surgery until discharge from surgical ward
Measured: (with in the first 21 days) ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start14 Feb 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas NeoplasmStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Mokbel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768660
- Sponsor's protocol ID
- chewing gum postoperative
- Status last verified
- Sep 2020
- First submitted
- 21 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Non-pharmacological Agent to Accelerate Gastrointestinal Recovery in Patients Undergoing Pancreatic Head Resection
- ClinicalTrials.gov ID
- NCT04768660
- Acronym / sponsor ID
- chewing gum postoperative
- Conditions
- Pancreas Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Feb 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| normal | Other | Other: gumpeople will not use chewing gums after whipple operation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gumOther: Chewing gum ChiczaTM organic chewing gum 6 pieces a day Other: Glucose 12ml glucose solution (13,6g) per day | Other | normal |
Primary outcome
First flatus after surgery
Time frame: (with in the first 21 days)
From day of surgery until first postoperative flatus
Length of hospital stay
Time frame: (with in the first 21 days) ]
Time Frame: From day of surgery until discharge from surgical ward
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing gum in people with Pancreas Neoplasm, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact andrew mokbel (01090981160, andrew.sawers55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First flatus after surgery (time frame: (with in the first 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.