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: Not yet recruiting
• Conditions: Postoperative Ileus
• Intervention / Treatment: Behavioral: chewing

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

Contacts and Locations

• Study Contact: Name: Aurélien Venara, MD,PhD; Phone Number: 0033241353618; Email: auvenara@chu-angers.fr

Study Locations

• France
  • Angers, France
    • University Hospital aof Angers

Participation Criteria

Eligibility Criteria

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

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 (Anticipated): April 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): May 1, 2023

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 (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• 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
• Other Study ID Numbers: 2021_A03140_41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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