Study of the Efficience of Chewing-gum to Reduce the Duration of Postoperative Ileus (CHEWIP)
Primary Purpose
Postoperative Ileus
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
chewing
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Ileus
Eligibility Criteria
Inclusion Criteria:
- patients undergoing colorectal surgery or small bowel surgery
- elective or in emergency
- open surgery or laparoscopy
- diagnosis of POI
- indication of fasting or nasogastric tube placement
Exclusion Criteria:
- contra-indication of chewing
- pregnancy
Sites / Locations
- University Hospital aof Angers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Chewing gum
No chewing
Arm Description
POI patients are asked to chew 20 minutes x2/ day
POI patients receive no intervention
Outcomes
Primary Outcome Measures
To assess the efficiency of chewing gum in reducing the duration of POI. POI is defined by the criteria of Vather from the postoperative day 1 up to day 30
The duration of POI is the time between the first day of meeting the criteria of Vather to the day of recovery of tolerance of solid food and of exoneration of stool and/or flatus (GI-3 recovery).
Patients will be asked to report in their diary the day of tolerance of solid food and of exoneration of stool and/or flatus (GI-3 recovery) after the diagnosis of POI
Secondary Outcome Measures
Full Information
NCT ID
NCT05296967
First Posted
March 6, 2022
Last Updated
March 16, 2022
Sponsor
University Hospital, Angers
Collaborators
Centre Hospitalier de Cholet
1. Study Identification
Unique Protocol Identification Number
NCT05296967
Brief Title
Study of the Efficience of Chewing-gum to Reduce the Duration of Postoperative Ileus
Acronym
CHEWIP
Official Title
Efficiency of Chewing-gum to Reduce the Duration Postoperative Ileus: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
Collaborators
Centre Hospitalier de Cholet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Postoperative ileus (POI) is a serious complication after surgery. While it complicates all type of surgery, it is more frequent after abdominal surgery (especially bowel or colorectal surgery).
Many studies aim to reduce the occurence of POI without efficiency. The aim of this study is to assess the efficiency of the vagal stimulation, by the mean of chewing, to reduce the duration of POI.
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
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chewing gum
Arm Type
Experimental
Arm Description
POI patients are asked to chew 20 minutes x2/ day
Arm Title
No chewing
Arm Type
No Intervention
Arm Description
POI patients receive no intervention
Intervention Type
Behavioral
Intervention Name(s)
chewing
Intervention Description
patients are asked to chew chewing gum X 3/ day
Primary Outcome Measure Information:
Title
To assess the efficiency of chewing gum in reducing the duration of POI. POI is defined by the criteria of Vather from the postoperative day 1 up to day 30
Description
The duration of POI is the time between the first day of meeting the criteria of Vather to the day of recovery of tolerance of solid food and of exoneration of stool and/or flatus (GI-3 recovery).
Patients will be asked to report in their diary the day of tolerance of solid food and of exoneration of stool and/or flatus (GI-3 recovery) after the diagnosis of POI
Time Frame
collected each day until the end of the POI, assessed up to day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing colorectal surgery or small bowel surgery
elective or in emergency
open surgery or laparoscopy
diagnosis of POI
indication of fasting or nasogastric tube placement
Exclusion Criteria:
contra-indication of chewing
pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélien Venara, MD,PhD
Phone
0033241353618
Email
auvenara@chu-angers.fr
Facility Information:
Facility Name
University Hospital aof Angers
City
Angers
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of the Efficience of Chewing-gum to Reduce the Duration of Postoperative Ileus
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