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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Ileus
• Intervention / Treatment: Behavioral: chewing

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • University Hospital aof Angers
  • Cholet, France
    • CH Cholet
  • Château-Gontier, France
    • CH Château Gontier
  • La Roche-sur-Yon, France
    • CHD Vendee
  • Laval, France
    • CH LAVAL
  • Nantes, France
    • CHU Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chewing gum; POI patients are asked to chew 20 minutes x2/ day	Behavioral: chewing; patients are asked to chew chewing gum X 3/ day
No Intervention: No chewing; POI patients receive no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: Centre Hospitalier de Cholet

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): July 15, 2025

Study Registration Dates

• First Submitted: March 6, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Eating; Mastication
• Other Study ID Numbers: 2021_A03140_41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
• IPD Sharing Access Criteria: The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No