Effects of Chewing Gum Against Postoperative Ileus
Primary Purpose
Postoperative Ileus
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Chewing gum
Glucose
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Ileus
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Additional surgery after primary surgery.
- No radical curative surgery
- Previous abdominal surgery.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Chewing gum
Control
Arm Description
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.
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
Outcomes
Primary Outcome Measures
First flatus after surgery
First stool after surgery
Secondary Outcome Measures
Start of clear fluids
Start of liquid diet
Length of hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02319512
Brief Title
Effects of Chewing Gum Against Postoperative Ileus
Official Title
Effects of Chewing Gum Against Postoperative Ileus After Pancreaticoduodenectomy - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Due to a radical change in postoperative care as well as surgical technique.
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Andersson
4. Oversight
Data Monitoring Committee
Yes
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chewing gum
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Chewing gum
Intervention Description
ChiczaTM organic chewing gum 6 pieces a day
Intervention Type
Other
Intervention Name(s)
Glucose
Intervention Description
12ml glucose solution (13,6g) per day
Primary Outcome Measure Information:
Title
First flatus after surgery
Time Frame
From day of surgery until first postoperative flatus (with in the first 21 days)
Title
First stool after surgery
Time Frame
From day of surgery until first stool (with in the first 21 days)
Secondary Outcome Measure Information:
Title
Start of clear fluids
Time Frame
From day of surgery until start of clear liquids after surgery (with in the first 21 days)
Title
Start of liquid diet
Time Frame
From day of surgery until start of liquid diet after surgery (with in the first 21 days)
Title
Length of hospital stay
Time Frame
From day of surgery until discharge from surgical ward (with in the first 21 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Additional surgery after primary surgery.
No radical curative surgery
Previous abdominal surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Falk, PhD
Organizational Affiliation
Institute of Health and Care Sciences, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Monika Fagevik Olsén, PhD
Organizational Affiliation
Department of Gastrosurgical Research and Education, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kristofer Bjerså, PhD
Organizational Affiliation
Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Andersson, MSc
Organizational Affiliation
Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
25886536
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Chewing Gum Against Postoperative Ileus
We'll reach out to this number within 24 hrs