Postoperative IleusPhase 3NCT02319512
Effects of Chewing Gum Against Postoperative Ileus
A Phase 3 study testing Chewing gum and Glucose in people with Postoperative Ileus, run by Thomas Andersson.
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?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Chewing gum and Glucose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.
- Understand and speak swedish
- No diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function
- No ongoing treatment for mental disease
- No ongoing abuse of alcohol or other drugs
- No previously known allergies to the content of chewing gum
Who cannot join
- Additional surgery after primary surgery.
- No radical curative surgery
- Previous abdominal surgery.
About this study
Official title: Effects of Chewing Gum Against Postoperative Ileus After Pancreaticoduodenectomy - a Randomized Controlled Trial
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.
Participants were included on the day of admission, which was the day prior to surgery. Randomization to the two groups (1:1) was done when patients returned from the intensive care unit (ICU) to the ward. This procedure was chosen in order to avoid perioperative drop-outs due to inoperable tumors. With a power of 80% and a level of significance of 0.05, 18 patients were needed in each group.Comparisons between the groups were analyzed with non-parametric tests; the Mann Whitney U test and Chi 2 test.
Controls received standard care and sips of glucose, in total 3.6g/day in a 12-ml mixture per day, the same amount of glucose per day as the treatment group received via the chewing gum. The chewing gum used was ChiczaTM, a natural organic gum whose main ingredients are latex, glucose and natural flavors (lime or spearmint). Patients started to chew after they returned from the ICU the day after surgery. Chewing gum was administered every fourth hour (08.00-12.00, 12.00-16.00 and 16.00-20.00). During each four-hour period, patients chewed two pieces of gum for 30 minutes each. Chewing gum was used during the whole hospital stay. The time to the first postoperative flatulence and defecation was recorded, in addition to standard clinical data.
- Conditions
- Postoperative Ileus
- Being tested
- Chewing gum, Glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gumOther
ChiczaTM organic chewing gum 6 pieces a day
GlucoseOther
12ml glucose solution (13,6g) per day
| Study group | Role | What they receive |
|---|---|---|
| Chewing gum | Experimental | Chewing gum was administered every fourth hour (08.00-12.00, 12.00-16.00 and 16.00-20.00). During each four-hour period, patients chewed two pieces of gum for 30 minutes each. Chewing gum was used during the whole hospital stay. Receives: Other: Chewing gum |
| Control | Sham comparator | Controls received standard care and sips of glucose, in total 3.6g/day in a 12-ml mixture per day, the same amount of glucose per day as the treatment group received via the chewing gum Receives: Other: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
First flatus after surgery
Measured: From day of surgery until first postoperative flatus (with in the first 21 days)
First stool after surgery
Measured: From day of surgery until first stool (with in the first 21 days)
Secondary outcomes (3)
Start of clear fluids
Measured: From day of surgery until start of clear liquids after surgery (with in the first 21 days)
Start of liquid diet
Measured: From day of surgery until start of liquid diet after surgery (with in the first 21 days)
Length of hospital stay
Measured: From day of surgery until discharge from surgical ward (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 posted18 Dec 2014 (estimated)
- Study startJan 2012
- Primary completionNov 2013
- Study completionDec 2013
Why it stopped: Due to a radical change in postoperative care as well as surgical technique.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Andersson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Andersson, Sahlgrenska University Hospital
- Investigators
- Kristin Falk, PhD, Study director, Institute of Health and Care Sciences, Sahlgrenska Academy at Gothenburg University, Gothenburg, SwedenMonika Fagevik Olsén, PhD, Study director, Department of Gastrosurgical Research and Education, Sahlgrenska Academy at Gothenburg University, Gothenburg, SwedenKristofer Bjerså, PhD, Principal investigator, Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, SwedenThomas Andersson, MSc, Principal investigator, Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319512
- Sponsor's protocol ID
- 1818111
- Other IDs
- VGFOUGSB-1818111
- Status last verified
- Dec 2014
- First submitted
- 7 Dec 2014
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andersson T, Bjersa K, Falk K, Olsen MF. Effects of chewing gum against postoperative ileus after pancreaticoduodenectomy--a randomized controlled trial. BMC Res Notes. 2015 Feb 10;8:37. doi: 10.1186/s13104-015-0996-0.
PubMed 25886536
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chewing Gum Against Postoperative Ileus After Pancreaticoduodenectomy - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02319512
- Acronym / sponsor ID
- 1818111
- Conditions
- Postoperative Ileus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a radical change in postoperative care as well as surgical technique.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Thomas AnderssonUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Dec 2014 (estimated)
- 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.
Participants were included on the day of admission, which was the day prior to surgery. Randomization to the two groups (1:1) was done when patients returned from the intensive care unit (ICU) to the ward. This procedure was chosen in order to avoid perioperative drop-outs due to inoperable tumors. With a power of 80% and a level of significance of 0.05, 18 patients were needed in each group.Comparisons between the groups were analyzed with non-parametric tests; the Mann Whitney U test and Chi 2 test.
Controls received standard care and sips of glucose, in total 3.6g/day in a 12-ml mixture per day, the same amount of glucose per day as the treatment group received via the chewing gum. The chewing gum used was ChiczaTM, a natural organic gum whose main ingredients are latex, glucose and natural flavors (lime or spearmint). Patients started to chew after they returned from the ICU the day after surgery. Chewing gum was administered every fourth hour (08.00-12.00, 12.00-16.00 and 16.00-20.00). During each four-hour period, patients chewed two pieces of gum for 30 minutes each. Chewing gum was used during the whole hospital stay. The time to the first postoperative flatulence and defecation was recorded, in addition to standard clinical data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewing gum | Experimental | Other: Chewing gumChewing gum was administered every fourth hour (08.00-12.00, 12.00-16.00 and 16.00-20.00). During each four-hour period, patients chewed two pieces of gum for 30 minutes each. Chewing gum was used during the whole hospital stay. |
| Control | Sham comparator | Other: GlucoseControls received standard care and sips of glucose, in total 3.6g/day in a 12-ml mixture per day, the same amount of glucose per day as the treatment group received via the chewing gum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.
- Understand and speak swedish
- No diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function
- No ongoing treatment for mental disease
- No ongoing abuse of alcohol or other drugs
Key exclusion criteria (3 listed)
- Additional surgery after primary surgery.
- No radical curative surgery
- Previous abdominal 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 |
|---|---|---|
| Chewing gumChiczaTM organic chewing gum 6 pieces a day | Other | Chewing gum |
| Glucose12ml glucose solution (13,6g) per day | Other | Control |
Primary outcome
First flatus after surgery
Time frame: From day of surgery until first postoperative flatus (with in the first 21 days)
First stool after surgery
Time frame: From day of surgery until first stool (with in the first 21 days)
3 secondary outcomes
Start of clear fluids
Time frame: From day of surgery until start of clear liquids after surgery (with in the first 21 days)
Start of liquid diet
Time frame: From day of surgery until start of liquid diet after surgery (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)
Results and safety
The study was stopped early (reason given: Due to a radical change in postoperative care as well as surgical technique.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Derived from this study: PubMed 25886536Andersson T, Bjersa K, Falk K, Olsen MF. Effects of chewing gum against postoperative ileus after pancreaticoduodenectomy--a randomized controlled trial. BMC Res Notes. 2015 Feb 10;8:37. doi: 10.1186/s13104-015-0996-0.
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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.
Kristin Falk, PhD study director
Institute of Health and Care Sciences, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden
Monika Fagevik Olsén, PhD study director
Department of Gastrosurgical Research and Education, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden
Kristofer Bjerså, PhD principal investigator
Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chewing gum and Glucose in people with Postoperative Ileus, run by Thomas Andersson.
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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 18 Dec 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to a radical change in postoperative care as well as surgical technique.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First flatus after surgery (time frame: From day of surgery until first postoperative flatus (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?
On the ClinicalTrials.gov record for NCT02319512, which also lists 1 linked publication.
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 18 Dec 2014.