Study of the Efficience of Chewing-gum to Reduce the Duration of Postoperative Ileus

Postoperative Ileus Clinical Trial

— CHEWIP  

Official title:

Efficiency of Chewing-gum to Reduce the Duration Postoperative Ileus: a Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05296967
• Other study ID #: 2021_A03140_41
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Angers
• Contact: Aurélien Venara, MD,PhD
• Phone: 0033241353618
• Email: auvenara[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Behavioral:
• chewing
patients are asked to chew chewing gum X 3/ day

Locations

Country	Name	City	State
France	University Hospital aof Angers	Angers

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Angers	Centre Hospitalier de Cholet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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