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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
Thomas Andersson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 7, 2014
    Last Updated
    December 13, 2014
    Sponsor
    Thomas Andersson
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    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

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    Effects of Chewing Gum Against Postoperative Ileus

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