Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
65 participants
INTERVENTIONAL
2012-01-31
2013-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Chewing gum
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.
Chewing gum
ChiczaTM organic chewing gum 6 pieces a day
Control
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
Glucose
12ml glucose solution (13,6g) per day
Interventions
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Chewing gum
ChiczaTM organic chewing gum 6 pieces a day
Glucose
12ml glucose solution (13,6g) per day
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* No radical curative surgery
* Previous abdominal surgery.
18 Years
ALL
No
Sponsors
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Thomas Andersson
OTHER
Responsible Party
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Thomas Andersson
RN, CNS, MSc
Principal Investigators
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Kristin Falk, PhD
Role: STUDY_DIRECTOR
Institute of Health and Care Sciences, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden
Monika Fagevik Olsén, PhD
Role: STUDY_DIRECTOR
Department of Gastrosurgical Research and Education, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden
Kristofer Bjerså, PhD
Role: PRINCIPAL_INVESTIGATOR
Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden
Thomas Andersson, MSc
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
References
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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.
Other Identifiers
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VGFOUGSB-1818111
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1818111
Identifier Type: -
Identifier Source: org_study_id