Study of the Efficience of Chewing-gum to Reduce the Duration of Postoperative Ileus
CHEWIP
Efficiency of Chewing-gum to Reduce the Duration Postoperative Ileus: a Randomized Controlled Study
1 other identifier
interventional
128
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2022
CompletedFirst Posted
Study publicly available on registry
March 25, 2022
CompletedStudy Start
First participant enrolled
September 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2025
CompletedOctober 1, 2025
March 1, 2022
2.7 years
March 6, 2022
September 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
collected each day until the end of the POI, assessed up to day 21
Study Arms (2)
Chewing gum
EXPERIMENTALPOI patients are asked to chew 20 minutes x2/ day
No chewing
NO INTERVENTIONPOI patients receive no intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- contra-indication of chewing
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Angerslead
- Centre Hospitalier de Choletcollaborator
Study Sites (6)
University Hospital aof Angers
Angers, France
CH Château Gontier
Château-Gontier, France
CH Cholet
Cholet, France
CHD Vendée
La Roche-sur-Yon, France
CH Laval
Laval, France
CHU Nantes
Nantes, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2022
First Posted
March 25, 2022
Study Start
September 14, 2022
Primary Completion
June 5, 2025
Study Completion
July 15, 2025
Last Updated
October 1, 2025
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
- Access Criteria
- The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.